Quick answers
- What is Norethindrone acetate used for?
- The FDA-approved label (Gallifrey, Xiromed LLC, August 31, 2024) says: “Gallifrey (Norethindrone Acetate Tablets, USP), 5 mg Gallifrey 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. Gallifrey is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Norethindrone acetate have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Norethindrone acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Norethindrone acetate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Norethindrone acetate?
- 8 companies list prescription products of Norethindrone acetate in the FDA NDC Directory, including Teva Pharmaceuticals USA, Inc., Amneal Pharmaceuticals LLC and AvKARE.
What Norethindrone acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Gallifrey (Norethindrone Acetate Tablets, USP), 5 mg Gallifrey 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. Gallifrey is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
— FDA label: Gallifrey, Xiromed LLC, effective August 31, 2024. Read the full label on DailyMed →
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 8 in the FDA NDC Directory |
| Brand names | Gallifrey |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| norethindrone acetate 5 mg tablet | Generic | $0.2903 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Teva Pharmaceuticals USA, Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- AvKARE1 product
- Ingenus Pharmaceuticals, LLC1 product
- Golden State Medical Supply, Inc.1 product
- Xiromed, LLC1 product
- American Health Packaging1 product
- Glenmark Pharmaceuticals Inc., USA1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA075951Barr · May 25, 2001
- ANDA091090Glenmark Pharms Ltd · July 21, 2010
- ANDA200275Amneal Pharms · July 30, 2012
- ANDA205278Xiromed · November 10, 2016
- ANDA206490Ingenus Pharms LLC · November 5, 2018
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1000405, 2696255 |
|---|---|
| SPL set ID of the quoted label | 26130af6-221b-2349-81b6-0c0132d6e524 |
| FDA labels (SPL) | 8 |
| FDA applications | 5 ANDA |
| Active ingredients (FDA) | NORETHINDRONE ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Gallifrey, Xiromed LLC, effective August 31, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →