Quick answers
- What is Norethindrone used for?
- The FDA-approved label (Errin, Dr. Reddy's Labratories Inc., March 1, 2024) says: “1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Table 1 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Norethindrone have a boxed warning?
- The label we quote has no boxed warning, but 5 of 17 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Norethindrone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Norethindrone been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Norethindrone?
- 11 companies list prescription products of Norethindrone in the FDA NDC Directory, including Proficient Rx LP, Dr. Reddy's Labratories Inc. and Aurobindo Pharma Limited.
What Norethindrone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Table 1 …
— FDA label: Errin, Dr. Reddy's Labratories Inc., effective March 1, 2024. Read the full label on DailyMed →
The FDA has 17 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.
5 of 17 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 0.35 mg tablet | Generic | $0.0982 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.
- Proficient Rx LP3 products
- Dr. Reddy's Labratories Inc.2 products
- Aurobindo Pharma Limited2 products
- Lupin Pharmaceuticals, Inc.2 products
- Xiromed, LLC2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Teva Pharmaceuticals, Inc.1 product
- Afaxys Pharma, LLC1 product
- Naari Pte. Limited1 product
- Mylan Pharmaceuticals Inc.1 product
- A-S Medication Solutions1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017060 NOR-QD | Teva Branded Pharm | January 2, 1973 | 38, latest December 3, 2015 2015: Manufacturing (CMC) · 2015: Manufacturing (CMC) · 2012: Manufacturing (CMC) |
Generic approvals (11)
- ANDA076177DR Reddys Labs SA · October 21, 2002
- ANDA076225DR Reddys Labs SA · October 21, 2002
- ANDA090454Glenmark Pharms Ltd · April 23, 2010
- ANDA091209Glenmark Pharms Ltd · July 22, 2010
- ANDA091325Lupin Ltd · September 19, 2011
- ANDA091323Lupin Ltd · March 28, 2013
- ANDA200980Xiromed · June 12, 2013
- ANDA201483Xiromed · June 24, 2013
- ANDA207304Aurobindo Pharma · September 23, 2016
- ANDA206807Naari Pte · December 13, 2016
- ANDA216796Aurobindo Pharma · January 6, 2023
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Errin, Dr. Reddy's Labratories Inc., effective March 1, 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 →