Drug · Labels read August 26, 2026
Norethindrone, and the two different drugs wearing that one name
Check the strength printed on your bottle before you read anything about this drug, because the internet describes it as one medicine and your pharmacy stocks it as two.
Norethindrone names two prescriptions. At 0.35 mgit is the progestin-only mini-pill, approved, in its label's words, “for the prevention of pregnancy”, sold as generics like Camila and Errin. As norethindrone acetate, 2.5 to 10 mg daily, it is a different product (the Aygestin class) approved for secondary amenorrhea, endometriosis and abnormal uterine bleeding. A third tier hides inside menopause HRT: 0.1 to 0.5 mg of the acetate paired with estradiol in Activella and CombiPatch. None of the 13women's-wing platforms we price-verify lists norethindrone by name; what they publish is micronized progesterone, from $23/mo at the cheapest published line.
By Iacob Pastina. Every clinical claim below is read from a primary source: the prescribing information on DailyMed, checked against the structured SPL XML, and the application records on Drugs@FDA. Prices are read from our own price-verification pass.
This is general information, not medical advice. Norethindrone in every form is a prescription medicine. Whether any form is right for you, at what dose, with what monitoring, is a decision for you and a licensed clinician.
What is norethindrone?
Norethindrone is a synthetic progestin: a lab-made molecule built to act on the same receptors as the progesterone the body produces. Taken daily at contraceptive doses it prevents pregnancy by, in the label's words, suppressing ovulation in approximately half of users and thickening cervical mucus to inhibit sperm penetration, while at higher doses it transforms the uterine lining directly. The name covers two different prescription products, and the dose tells them apart: norethindrone 0.35 mg is the contraceptive mini-pill, while norethindrone acetate 2.5 to 10 mg treats secondary amenorrhea, endometriosis and abnormal uterine bleeding.
Norethindrone is a progestin, and a progestin is a different thing from the progesterone molecule itself. Micronized progesterone, the body-identical capsule, is a separate prescription with its own label and its own evidence. Our progesterone-vs-progestin comparison holds that full distinction.
Which norethindrone were you prescribed?
Four product families carry this progestin, at daily doses spanning a hundredfold range, 0.1 mg to 10 mg. Every row below was read from a current label on August 26, 2026, except the two combination HRT rows, which import from the estradiol product register this site read on 2026-08-16. Find the strength on your prescription and read down.
| Product | Norethindrone dose | Approved for |
|---|---|---|
| The mini-pillGenerics: Camila, Errin, Heather, Sharobel | 0.35 mg norethindrone, one tablet daily, no pill-free days | Prevention of pregnancy |
| Norethindrone acetate tabletsThe Aygestin class, now generic | 2.5 to 10 mg daily for bleeding indications; 5 mg rising to 15 mg for endometriosis | Secondary amenorrhea, endometriosis, abnormal uterine bleeding |
| Activellaestradiol/norethindrone acetate tablets, oral tablet | 1 mg estradiol / 0.5 mg norethindrone acetate; 0.5 mg estradiol / 0.1 mg norethindrone acetate | Moderate to severe vasomotor symptoms due to menopause; Moderate to severe symptoms of vulvar and vaginal atrophy due to menopause; Prevention of postmenopausal osteoporosis |
| CombiPatchestradiol/norethindrone acetate transdermal system, transdermal patch | 0.05 mg estradiol / 0.14 mg norethindrone acetate per day (9 cm2 system); 0.05 mg estradiol / 0.25 mg norethindrone acetate per day (16 cm2 system) | Moderate to severe vasomotor symptoms due to menopause; Moderate to severe symptoms of vulvar and vaginal atrophy due to menopause; Hypoestrogenism due to hypogonadism, castration or primary ovarian failure |
| Combined birth control pillsJunel, Lo Loestrin Fe and many others | Norethindrone or its acetate plus ethinyl estradiol, doses vary by product | Prevention of pregnancy (a combined estrogen product, out of scope for this page) |
One near-miss to rule out: Opill, the pill sold over the counter, is often called “the mini-pill” too, and its Drug Facts label lists Norgestrel 0.075 mg, a different progestin. A norethindrone prescription and an Opill box are different drugs.
The chemistry behind the split is smaller than the split itself. The acetate label states: “Norethindrone acetate is completely and rapidly deacetylated to norethindrone (NET) after oral administration, and the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone.”One molecule in the bloodstream, then. What actually separates the products is dose, a 5 mg acetate tablet against the mini-pill's 0.35 mg, roughly 14 times the milligrams, and the label sharpens it further: “Norethindrone acetate induces secretory changes in an estrogen-primed endometrium. On a weight basis, it is twice as potent as norethindrone.” That is why the two are prescribed for different problems and why their labels read so differently.
Where the brand names went
Both original brands have left the market. Micronor, the first 0.35 mg mini-pill, was approved on January 2, 1973 under NDA 016954 and is now listed Discontinued; Aygestin was approved on April 21, 1982 under NDA 018405 and is listed the same way. Both records carry the note that this was a “Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons”, so the drugs themselves remain on pharmacy shelves as generics while the names people still search for are retired.
How does the 0.35 mg mini-pill work?
The label lists five mechanisms rather than one: “Camila progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the mid-cycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.”Read the first clause twice, because it is the one that surprises people: ovulation is suppressed in approximately half of users. The mini-pill's contraception rests as much on cervical mucus and the endometrium as on stopping the egg.
The two efficacy numbers, from INDICATIONS AND USAGE
“If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills.”
Camila prescribing information, DailyMed, SPL effective August 24, 2026, read August 26, 2026.
A tenfold gap separates perfect use from typical use, and the label names the cause in the same sentence: late or omitted pills. The pharmacology explains the strictness. The label reports that “The mean terminal elimination half-life of norethindrone following single dose administration of Camila is approximately 8 hours.”An 8-hour half-life means yesterday's tablet is mostly gone by tonight, so the counseling section leads with “The necessity of taking pills at the same time every day, including throughout all bleeding episodes.”
The 3-hour rule, in the label's own capitals
“If you are more than 3 hours late or you miss one or more POPs: TAKE a missed pill as soon as you remember that you missed it, THEN go back to taking POPs at your regular time, BUT be sure to use a backup method (such as condom and/or spermicide) every time you have sex for the next 48 hours.” The prescriber-facing version of the same rule: “The need to use a backup method such as condoms and spermicides for the next 48 hours whenever a progestin-only oral contraceptive is taken 3 or more hours late.” Three hours is a shorter window than most people assume, and readers switching from a combined pill, which forgives more, miss it constantly.
Can you use the mini-pill for birth control in perimenopause?
Fertility in perimenopause turns erratic rather than switching off, and an erratic cycle still needs contraception if pregnancy is unwanted. The mini-pill is one of the options clinicians reach for in this window for a reason printed on the label: “Camila does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives.”The estrogen-associated risks that complicate combined pills at midlife are the ones this product leaves out, which is also why the label's bluntest sentence, “Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.”, sits beside it as a general oral-contraceptive warning.
Two peri-specific catches, both from the same label. First, the most common side effect is menstrual irregularity, and irregular bleeding is also the signature symptom of perimenopause itself. On the mini-pill, a bleeding change could be the drug or could be the transition, and that ambiguity is a real cost: the label separately instructs users to report prolonged bleeding episodes or amenorrhea to a clinician. Second, the 3-hour timing rule above applies at any age. How long contraception is still needed as periods wind down is an individual clinical question, and the honest answer is that this page cannot answer it for you.
One roster fact belongs here. Of the 13women's-wing platforms we price-verify, one publishes a birth-control price on its menopause-care menu: Alloy lists “Low-dose birth control ($39.99/mo)” alongside its HRT lines, which is exactly the peri overlap this section describes, one platform serving both sides of the same transition. For the symptom side of that overlap, our perimenopause hub covers what peri is, what it costs to treat, and who treats it.
What is norethindrone acetate used for?
The 5 mg tablet is gynecology's workhorse progestin, and its approved uses are one sentence long: “Norethindrone acetate is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.” Contraception is absent from that sentence. So is menopause. A reader prescribed this tablet for heavy bleeding is on a different treatment, at roughly 14 times the mini-pill's milligrams, with a different schedule and a different stop date.
Bleeding indications, from the label
“2.5 to 10 mg norethindrone acetate may be given daily for 5 to 10 days to produce secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen.” Then the label tells you what to expect when the course ends: “Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing norethindrone acetate therapy.” This is a short, deliberate course, a scheduled reset of the uterine lining rather than a daily maintenance drug.
Endometriosis, from the label
“Initial daily dosage of 5 mg norethindrone acetate for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of norethindrone acetate is reached.” The label allows holding that dose for six to nine months. Same molecule as the mini-pill, at up to 43 times the milligrams, which is the cleanest illustration on this page of why the strength on the bottle matters more than the name.
The sentence that surprises HRT readers, from INDICATIONS AND USAGE
“Norethindrone acetate is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.”
Read it precisely. Low-dose norethindrone acetate inside Activella and CombiPatch is FDA-approved with estrogen, at 0.1 to 0.5 mg. The standalone 5 mg tablet is what this sentence is about: it was never approved as the progestogen half of a menopause regimen, and its own label says so. A prescriber pairing it with estrogen is making an off-label call, which is legal and common, and a thing to ask about by name.
Norethindrone acetate 5 mg prescribing information, DailyMed, SPL effective January 29, 2026, read August 26, 2026.
Where does norethindrone fit in menopause HRT?
In HRT the progestogen has one job: protecting the uterine lining from the estrogen. Two FDA-approved combination products do that job with norethindrone acetate, at doses far below the 5 mg tablet. Both rows are read from this site's estradiol product register, which read the labels and application records on 2026-08-16.
- 1 mg estradiol / 0.5 mg norethindrone acetate
- 0.5 mg estradiol / 0.1 mg norethindrone acetate
- Schedule: Once daily
- Approved for: Moderate to severe vasomotor symptoms due to menopause; Moderate to severe symptoms of vulvar and vaginal atrophy due to menopause; Prevention of postmenopausal osteoporosis
The clearest case on this page of a label and a marketing record disagreeing. The label prints two strengths and directs the lower one for two of the three indications; the application record has that strength as Discontinued. Lopreeza is the authorized generic on the same application, and Mimvey is a separate abbreviated approval of the 1 mg/0.5 mg strength only.
- 0.05 mg estradiol / 0.14 mg norethindrone acetate per day (9 cm2 system)
- 0.05 mg estradiol / 0.25 mg norethindrone acetate per day (16 cm2 system)
- Schedule: Twice weekly, a new system every 3 to 4 days
- Approved for: Moderate to severe vasomotor symptoms due to menopause; Moderate to severe symptoms of vulvar and vaginal atrophy due to menopause; Hypoestrogenism due to hypogonadism, castration or primary ovarian failure
The estradiol dose is identical in both systems at 0.05 mg per day. What changes between them is the progestin, from 0.14 mg to 0.25 mg per day. A few lines after the starting-dose sentence the label adds that the lowest effective dose of CombiPatch has not been determined in clinical trials.
What the platforms we price-verify actually publish
Here is the honest roster state: none of the 13women's-wing platforms we price-verify lists norethindrone by name in its published product list. The progestin reaches our roster once, wearing a brand name: Sesame Care lists “Estrogen-progestin (generic Prempro, Bijuva, Mimvey)”, and Mimvey is an estradiol and norethindrone acetate combination, the generic of Activella's 1 mg/0.5 mg strength. What the telehealth platforms publish instead is micronized progesterone, so if you arrived here pricing the progestogen half of an HRT regimen, these are the published routes:
Published progestogen line: “Progesterone capsules (from $39/mo)”. Compounded formulary, so the products are not FDA-approved, a distinction Winona's own record on this site carries.
Published progestogen line: “Micronized progesterone (from $23/mo)”. The molecule is named as micronized progesterone, which is the naming precision this page exists to reward.
Published line: “Estrogen and progesterone hormone replacement in patch, suppository and topical forms”. Wisp sends the prescription to your own pharmacy, so which progestogen you receive, and at what drug price, is settled at that counter rather than on Wisp's menu.
The molecule-by-molecule pricing table for the whole wing, with the providers that publish no progestogen price named as such, is on the progesterone page. The scored ranking is on the HRT rankings.
Norethindrone or micronized progesterone: which is in your regimen?
If your HRT includes a progestogen, it is one of two kinds: a synthetic progestin like norethindrone acetate, or micronized progesterone, the same molecule the body makes, taken as a capsule. The practical differences start on the labels. The micronized progesterone label warns: “Prometrium capsules contain peanut oil and are contraindicated in patients allergic to peanuts.” And it directs the dose to bedtime because, in its words, “Prometrium capsules may cause transient dizziness and drowsiness and should be used with caution when driving a motor vehicle or operating machinery. Prometrium capsules should be taken as a single daily dose at bedtime.” Norethindrone acetate's label carries neither instruction; its concerns are the progestin class effects, thrombotic events and vision changes among them, listed in the side-effects section below.
The approved-products landscape says which way the market leans: Bijuva is the only FDA-approved product combining estradiol with progesterone itself; every other approved combination on our estradiol register pairs estradiol with a synthetic progestin, and two of those use norethindrone acetate. On our roster the published progestogen is micronized progesterone, from $23/mo at Alloy and from $39/mo at Winona, so a shopper comparing telehealth HRT is in practice comparing micronized progesterone offers, whichever progestin this page just taught them to pronounce.
The evidence question, whether the progestin class and the body-identical molecule differ on breast cancer and cardiovascular risk, deserves more than a paragraph, and it has its own page. The short version: the trial everyone cites tested a different progestin entirely, and the micronized-progesterone data is observational. Progesterone against progestin, with the trial arms printed, holds the full argument.
What are the side effects of norethindrone?
Two products, two labels, two answers. Quoting one list under the bare name “norethindrone” is how most pages on this keyword go wrong, so the lists stay separate here.
The 0.35 mg mini-pill label
“Menstrual irregularity is the most frequently reported side effect. Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely. Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies. Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.”
The warning section adds a number: “The incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine.” A pregnancy on the mini-pill is rare; when one happens, the label wants ectopic considered early.
The 5 mg acetate label
The label lists the adverse reactions observed in women taking progestins as a class, including:
- Breakthrough bleeding
- Spotting
- Change in menstrual flow
- Amenorrhea
- Changes in weight (decreases, increases)
- Clinical depression
- Acne
- Breast enlargement/tenderness
Plus the two serious rows at the bottom of the list: thrombotic and thromboembolic events, and optic neuritis. The warning that follows from the second: “Discontinue medication pending examination if there is a sudden partial or complete loss of vision or if there is sudden onset of proptosis, diplopia, or migraine.”
The acetate label also carries contraindications the intake form should have asked you about: known or suspected pregnancy, undiagnosed vaginal bleeding, known, suspected or history of cancer of the breast, active deep vein thrombosis, pulmonary embolism or history of these conditions, and impaired liver function or liver disease. A prescriber who never asked about clots, breast cancer history or liver disease skipped the label's own list.
Boxed-warning check, run the way this site runs it: counting LOINC 34066-1 sections in each SPL XML on August 26, 2026 found 0 on the mini-pill label and 0 on the acetate label, so neither standalone product carries a boxed warning. The estradiol combinations above both do: each of those labels carries the estrogen-plus-progestin boxed warning, one 34066-1 section apiece in the same check. Context for what that warning now says sits in our black-box guide.
FAQ
Norethindrone, answered
What is norethindrone?
Norethindrone is a synthetic progestin, a lab-made molecule built to act on the same receptors as the progesterone your body produces. The name covers two different prescription products. At 0.35 mg it is the progestin-only contraceptive mini-pill, indicated, in the label's words, "for the prevention of pregnancy," and sold as generics such as Camila, Errin and Heather. As norethindrone acetate, at 2.5 to 10 mg daily, it is a different product indicated for secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance. A third, lower dose tier of the acetate (0.1 to 0.5 mg) is the progestin inside the combination HRT products Activella and CombiPatch. Which product you have determines the dose, the schedule and the side-effect discussion, so check the strength on the bottle first.
Is norethindrone the same as norethindrone acetate?
Chemically they are one ester apart and biologically they converge. The acetate label states: "Norethindrone acetate is completely and rapidly deacetylated to norethindrone (NET) after oral administration, and the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone." So once swallowed, both deliver norethindrone. What separates the products is dose and approved use. The mini-pill carries 0.35 mg of norethindrone and is approved only for contraception. Norethindrone acetate tablets carry 5 mg, roughly 14 times as much, and the label adds: "Norethindrone acetate induces secretory changes in an estrogen-primed endometrium. On a weight basis, it is twice as potent as norethindrone." The acetate is approved for secondary amenorrhea, endometriosis and abnormal uterine bleeding. A prescription for one is never interchangeable with the other.
How effective is the norethindrone mini-pill?
The label answers with two numbers rather than one: "If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills." The gap between 0.5% and 5% is timing. Norethindrone's elimination half-life is approximately 8 hours, so the label's counseling section leads with the necessity of taking the pill at the same time every day, and instructs a backup method for 48 hours whenever a pill is taken 3 or more hours late.
Is norethindrone the same as progesterone?
No. Progesterone is the hormone itself, available as micronized progesterone (Prometrium and generics). Norethindrone is a synthetic progestin: it acts on progesterone receptors through a different structure, which is why the two carry different labels, different approved uses and different evidence. On the platforms we price-verify, micronized progesterone is what is actually published: Alloy lists it from $23/mo and Winona lists progesterone capsules from $39/mo. Our progesterone-vs-progestin page holds the full class comparison.
Is norethindrone used in HRT?
Yes, at a dose most readers have never seen written down. The FDA-approved combination products Activella (oral) and CombiPatch (transdermal) pair estradiol with 0.1 to 0.5 mg of norethindrone acetate to protect the uterine lining while the estrogen treats menopause symptoms. The standalone 5 mg norethindrone acetate tablet is a different matter, and its own label draws the line: "Norethindrone acetate is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection." None of the 13 women's-wing platforms we price-verify lists norethindrone by name in its published product list. One platform, Sesame Care, lists "Estrogen-progestin (generic Prempro, Bijuva, Mimvey)", and Mimvey is an estradiol and norethindrone acetate combination. The platforms we track publish micronized progesterone lines instead.
What are the side effects of norethindrone?
Each product's label answers for itself. The 0.35 mg mini-pill label reports: "Menstrual irregularity is the most frequently reported side effect. Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely. Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies. Androgenic side effects such as acne, hirsutism, and weight gain occur rarely." It also puts a number on ectopic risk: "The incidence of ectopic pregnancies for progestin-only oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine." The 5 mg acetate label lists the progestin class effects, including breakthrough bleeding, spotting, weight change, clinical depression, breast tenderness, headache and thrombotic events, and instructs discontinuing the drug pending examination after any sudden partial or complete loss of vision. Neither standalone label carries a boxed warning; the estradiol combinations, Activella and CombiPatch, each carry the estrogen-plus-progestin boxed warning on their own labels.
Can you use the mini-pill for birth control in perimenopause?
Pregnancy remains possible in perimenopause, and the mini-pill is one of the options clinicians reach for at this age because it contains no estrogen. The label says it plainly: "Camila does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives." Two peri-specific catches are on the same label. First: "Menstrual irregularity is the most frequently reported side effect." Irregular bleeding is also the signature of perimenopause itself, so attributing a bleeding change to the pill or to the transition gets genuinely hard, and that overlap belongs in the conversation with your prescriber. Second, the timing rule is strict: a backup method for 48 hours whenever a pill is 3 or more hours late. How long contraception is still needed as periods wind down is an individual clinical question this page does not answer.
Related
- Progesterone vs progestin the class comparison, with the trial arms printed and the boxed-warning check
- Progesterone why it is in your regimen, and what each platform charges for it
- Perimenopause the transition this page's contraception question lives inside
- Winona review and Wisp review two of the progestogen routes this page prices
- Every estradiol brand the register the combination rows on this page import from
Sources
- Camila (norethindrone tablets USP, 0.35 mg) prescribing information, Mayne Pharma, DailyMed SPL effective August 24, 2026, read August 26, 2026.
- Norethindrone acetate tablets USP, 5 mg prescribing information, Glenmark Pharmaceuticals, DailyMed SPL effective January 29, 2026, read August 26, 2026.
- Activella (estradiol/norethindrone acetate tablets) prescribing information, Amneal Pharmaceuticals, DailyMed Strengths and indications as recorded in this site's estradiol product register, read 2026-08-16.
- CombiPatch (estradiol/norethindrone acetate transdermal system) prescribing information, Noven Therapeutics, DailyMed Strengths and indications as recorded in this site's estradiol product register, read 2026-08-16.
- Micronor, NDA 016954, Drugs@FDA application record Approved January 2, 1973. Marketing status Discontinued, with the Federal Register not-for-safety-reasons determination.
- Aygestin, NDA 018405, Drugs@FDA application record Approved April 21, 1982. Marketing status Discontinued, with the Federal Register not-for-safety-reasons determination.
- Opill (norgestrel 0.075 mg) Drug Facts, L. Perrigo Company, DailyMed Cited only to state that the over-the-counter pill is a different progestin.
- Prometrium (progesterone) prescribing information, DailyMed The micronized progesterone label this site's progesterone pages read on 2026-08-15.
www.fda.gov returns a 404 to automated clients, so the FDA is named in prose throughout and every link above resolves to DailyMed or the Drugs@FDA records at accessdata.fda.gov. Every URL returned HTTP 200 when checked on August 26, 2026. Label quotes were verified against the structured SPL XML rather than the rendered page.
This is general information, not medical advice. The norethindrone mini-pill, norethindrone acetate tablets and every combination product on this page are prescription medicines with contraindications printed on their labels. Choosing between them, or between a progestin and micronized progesterone, requires a licensed clinician who knows your history. HRT Picks is not a medical provider and has no role in your care. Reviewed by Iacob Pastina.
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