Norethindrone
Norethindrone is a progestin hormone used in progestin-only birth control pills to prevent pregnancy, and (as norethindrone acetate) to treat secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 31 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Norethindrone is a progestin (a man-made form of progesterone) best known as the estrogen-free “mini-pill,” a common birth control choice that thickens cervical mucus and partly blocks ovulation, on the market since about 1980 and available generically; a related form, norethindrone acetate (such as Gallifrey), treats missed periods, endometriosis and abnormal uterine bleeding. It is usually well tolerated, though irregular, unpredictable bleeding is common, with headache or breast tenderness for some. Do not smoke while taking it, since its boxed warning says smoking greatly raises the risk of heart attack and stroke. For birth control, take it at the same time every day, with no break between packs.
Clinical pearls
- The mini-pill is less forgiving of late doses than combination pills, so set a daily phone alarm.
- Carbamazepine, rifampicin and St. John’s wort can weaken it; use a non-hormonal back-up until 28 days after stopping them.
- After ulipristal emergency contraception, wait at least 5 days to start norethindrone, and use a barrier method until your next period.
- Lower abdominal pain on this medicine deserves a prompt call, since ectopic pregnancy (outside the uterus) is a known risk.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Cigarette smoking greatly increases the chance of heart attacks and strokes in women who use oral contraceptives. Women who use these pills are strongly advised not to smoke. If you smoke, talk with your doctor or pharmacist about quitting and about your birth control options.
Patient information guide A plain-language walkthrough of Norethindrone, written from its FDA label.
What Norethindrone is used for
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Norethindrone is used in two main ways, depending on the product.
- Progestin-only birth control pills (such as Emzahh, Errin, Camila, Affodel and others) prevent pregnancy.
- Norethindrone acetate tablets, including Gallifrey, treat secondary amenorrhea (missed periods).
- Norethindrone acetate tablets, including Gallifrey, treat endometriosis.
- Norethindrone acetate tablets, including Gallifrey, treat abnormal uterine bleeding due to hormonal imbalance when no structural cause is found.
How Norethindrone works
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In its birth control form, norethindrone is a progestin, a hormone similar to progesterone. It suppresses ovulation in about half of users. It also thickens cervical mucus to block sperm and lowers the midcycle LH and FSH hormone peaks.
It also slows the egg's movement through the fallopian tubes and alters the uterine lining.
Norethindrone dosage
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Birth control brands such as Errin, Emzahh, Camila, Heather, Jencycla, Incassia, Lyleq, Meleya and Orquidea are taken by mouth, one tablet daily at the same time. There is no break between packs.
Norethindrone acetate (including Gallifrey) is taken by mouth, with a plan matched to the condition. For these, your prescriber decides how long and how often. Follow your label and your prescriber's directions.
Dosing details from the FDA-approved label
From the Norethindrone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology
- 2.5 to 10 mg norethindrone acetate tablets 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
- Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy
- Endometriosis
- Initial daily dosage of 5 mg norethindrone acetate tablets for two weeks
- Increase by 2.5 mg per day every two weeks until 15 mg per day is reached
- Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination
- Maximum: 15 mg per day
- Contraception (norethindrone tablets)
- One tablet is taken every day, at the same time
- Administration is continuous, with no interruption between pill packs
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION To achieve maximum contraceptive effectiveness, norethindrone tablets must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See Detailed Patient Labeling for detailed instruction.
Read the full Dosage and Administration section on DailyMed →
Norethindrone side effects
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The most common effect is a change in your bleeding pattern.
Common side effects
- Irregular periods (the most common side effect)
- Frequent or unpredictable bleeding
- Headache
- Breast tenderness
- Nausea
- Dizziness
- Less often: acne, extra hair growth or weight gain
When to get medical help
- Call your doctor if you become pregnant or have lower abdominal pain while on the pill, since this could be an ectopic pregnancy (a pregnancy outside the uterus).
- Get help for severe or ongoing abdominal pain, which can happen with ovarian cysts that twist or rupture.
- Tell your doctor if you have bleeding that seems unusual or may point to infection or another problem.
- Check for pregnancy and call your doctor if your period stops for a long time.
- Seek care right away for signs of a serious allergic reaction, such as trouble breathing, swelling or a widespread rash.
- Call your doctor for yellowing of the skin or eyes (jaundice) or signs of hepatitis.
Norethindrone warnings and precautions
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- Smoking: it greatly raises the risk of heart attack and stroke with oral contraceptives.
- Ectopic pregnancy: watch for lower abdominal pain or pregnancy while on the pill.
- Ovarian cysts: enlarged follicles are usually harmless but can rarely twist or rupture.
- Irregular bleeding: common, but unusual bleeding should be checked, and prolonged missed periods call for a pregnancy check.
- Breast and liver tumors: data are insufficient to say whether these pills raise the risk.
Norethindrone interactions
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Some medicines and herbal products change hormone levels.
- Seizure medicines such as phenytoin, carbamazepine, barbiturates and oxcarbazepine can lower hormone levels and cause contraceptive failure.
- Rifampicin, rifabutin, griseofulvin, bosentan, felbamate, rufinamide, aprepitant and efavirenz can do the same.
- St. John's wort can lower effectiveness.
- Itraconazole, voriconazole, fluconazole, ketoconazole and grapefruit juice may raise norethindrone levels.
- Some HIV and hepatitis C medicines raise or lower hormone levels.
- Ulipristal can reduce effectiveness if the pill is started within 5 days after it.
Interactions listed in the FDA-approved label
From the Norethindrone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Enzyme inducers (CYP3A4 inducers): efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, rifabutin, rufinamide, aprepitant, St. John's wort: May decrease systemic concentrations of HCs and potentially diminish their effectiveness or increase breakthrough bleeding, and may lead to contraceptive failure. Counsel women to use an alternative non-hormonal method of contraception or a back-up method, and continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer.
- Strong or moderate CYP3A4 inhibitors (itraconazole, voriconazole, fluconazole, grapefruit juice, ketoconazole): May increase the systemic concentrations of progestins, including norethindrone.
- HIV protease inhibitors (nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, tipranavir/ritonavir), HCV protease inhibitors (boceprevir, telaprevir), NNRTIs (nevirapine, efavirenz): Significant decreases in systemic concentrations of progestin have been noted with some of these drugs. Consult the prescribing information of anti-viral and anti-retroviral concomitant medications to identify potential interactions.
- Other HIV protease inhibitors (indinavir, atazanavir/ritonavir) and etravirine: Significant increases in systemic exposure of the progestin have been noted; these changes may be clinically relevant in some cases. Consult the prescribing information of anti-viral and anti-retroviral concomitant medications to identify potential interactions.
- Other drugs affected by hormonal contraceptives (e.g., cyclosporine): Hormonal contraceptives may affect the metabolism of other drugs, so systemic concentrations may either increase (for example, cyclosporine) or decrease. Consult the labeling of all concurrently-used drugs for information about interactions or potential for enzyme alterations.
- Ulipristal acetate: Effectiveness of progestin-containing hormonal contraceptives and ulipristal acetate may be decreased if the contraceptives are used within five days after ulipristal acetate dosing. Use norethindrone tablets no sooner than 5 days after ulipristal acetate and use a reliable barrier method for subsequent acts of intercourse until the next menstrual period.
Read the label’s full interactions text
4. Drug Interactions Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. • Effects of Other Drugs on Hormonal Contraceptives Substances decreasing the systemic concentrations of hormonal contraceptives (HCs) and potentially diminishing the efficacy of HCs: Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the systemic concentrations of HCs and potentially diminish the effectiveness of HCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with HCs, and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. Substances increasing the systemic concentrations of HCs: Co-administration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the systemic concentrations of progestins, including norethindrone.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Norethindrone
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- Do not use if pregnant or possibly pregnant.
- Do not use with known or suspected breast cancer.
- Do not use with undiagnosed abnormal genital bleeding.
- Do not use with liver tumors or acute liver disease.
- Do not use if allergic to any component.
- Tell your doctor if you smoke.
Norethindrone overdose
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No serious ill effects have been reported from overdose, including when children have swallowed the pills. If someone takes too much, contact your doctor or poison control for advice.
What Norethindrone does in the body
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As a contraceptive, norethindrone suppresses ovulation in about half of users. It lowers the midcycle LH and FSH peaks, thickens cervical mucus, slows egg movement through the fallopian tubes and alters the uterine lining.
How your body processes Norethindrone
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Norethindrone is absorbed quickly, with peak levels about 1 to 2 hours after a dose. About 65% reaches the bloodstream because the liver breaks down part of it first. It travels in the blood bound to proteins and is broken down extensively. It is cleared through urine and stool, mostly as metabolites, with a half-life of about 8 hours.
How to store Norethindrone
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Keep out of reach of children.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Norethindrone
152 supplements and herbal products have documented interactions with Norethindrone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 108
- Minor · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Norethindrone: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Norethindrone — the kind of thing our pharmacy team would talk through with you at the counter.
What is norethindrone used for?
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How do I take the birth control pill?
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What side effects should I expect?
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Can I smoke while taking it?
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Do other medicines affect it?
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When should I call my doctor?
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Is Norethindrone available over the counter?
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When was Norethindrone first available?
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Who makes Norethindrone?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Norethindrone on HelloPharmacist
Norethindrone forms and strengths (how it comes)
Norethindrone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Emzahh, Errin and Camila are progestin-only birth control pills used to prevent pregnancy.
- Affodel is a progestin-only oral contraceptive used to prevent pregnancy.
- Gallifrey (norethindrone acetate) treats secondary amenorrhea, endometriosis and abnormal uterine bleeding due to hormonal imbalance.
- Emzahh and Errin: take one tablet every day at the same time, with no break between packs.
- Gallifrey: therapy is adapted to the condition and your response, so follow your prescriber's plan.
- Gallifrey is not intended or approved for use with estrogen in postmenopausal women for endometrial protection.
Norethindrone on the U.S. market: products, makers and brands
How Norethindrone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
18 companies list 28 Norethindrone product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1962. Brand names on the directory include Aygestin, Norlutate, Norlutin and 13 more; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (15) · Kit (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Norethindrone is used (Medicaid data)
A general measure of how commonly Norethindrone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Norethindrone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Norethindrone prescribed? Of the 1,601 medications we measure, Norethindrone ranks #157 by Medicaid prescriptions — more than 90% of them.
Utilization by Norethindrone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
norethindrone acetate 5 MG Oral Tablet
Summed across the 6 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000405
Other Norethindrone products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 21 of 93 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Norethindrone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 27 of 111 listed Norethindrone NDCs with Medicaid activity.
Compare Norethindrone products
A representative set of FDA-listed product records for Norethindrone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 0.35 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 0.35 mg | Oral | Afaxys Pharma, LLC | ANDA | View NDC → |
| 5 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 5 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 0.35 mg | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | AvKARE | ANDA | View NDC → |
| 0.35 mg | Oral | Dr. Reddy's Labratories Inc. × 2 listings | ANDA | View NDC → |
| 0.35 mg | Oral | Glenmark Pharmaceuticals Inc., USA × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 5 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Ingenus Pharmaceuticals, LLC | ANDA | View NDC → |
| 0.35 mg | Oral | Lupin Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 0.35 mg | Oral | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 0.35 mg | Oral | Naari Pte. Limited | ANDA | View NDC → |
| 0.35 mg | Oral | Proficient Rx LP × 3 listings | ANDA | View NDC → |
| 0.35 mg | Oral | Teva Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 5 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 0.35 mg | Oral | Xiromed, LLC | ANDA | View NDC → |
| 0.35 mg | Oral | Xiromed LLC | ANDA | View NDC → |
| 5 mg | Oral | Xiromed LLC | ANDA | View NDC → |
| 💊Kits | ||||
| — | — | Northstar Rx LLC × 2 listings | ANDA | View NDC → |
Showing 28 of 28 products — FDA National Drug Code Directory. See every product, package size and price: browse all 28 Norethindrone NDCs →
Norethindrone side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Norethindrone — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Norethindrone are nausea, headache, fatigue; about 40% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Norethindrone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Norethindrone FDA approval history
How Norethindrone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Norethindrone was first approved by the FDA in 1962 (Brand: ORTHO-NOVUM 1/50 21 · Ortho Mcneil Pharm); the first generic version was approved in 1987. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Norethindrone recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Norethindrone recalls since July 2021.
✅No Norethindrone recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 7514 2 dose forms · 3 strengths
-
Dose form (SCDF) Injectable Solution RxCUI 373116No current FDA listingClinical drug / strength (SCD) enanthate 200 MG/MLRxCUI 1359235 -
Dose form (SCDF) Oral Tablet RxCUI 373114In current FDA listings
Look up RxCUI 7514 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Norethindrone supply and shortage status
Whether Norethindrone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Norethindrone costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 0.35 mg | $0.091 per tablet | NDC details & price history |
| Tablet · Oral | 5 mg | $0.290 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Norethindrone brand names
Norethindrone is sold under 16 brand names in the FDA directory — Aygestin, Norlutate, Norlutin, Gallifrey and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Norethindrone: manufacturers and labelers
18 companies list Norethindrone products with the FDA. By number of product records, the largest are Glenmark Pharmaceuticals Inc., USA, Proficient Rx LP, Xiromed LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Norethindrone drug class (RxNorm)
Norethindrone belongs to the Progestin class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Norethindrone page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Teva Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →