FDA label

What is norethindrone used for?

The FDA-approved uses of norethindrone, quoted from the Indications and Usage section of its DailyMed label.

Source: DailyMed SPL label file dated 2026-10-23. Publisher page

The FDA label for norethindrone lists 2 uses: . Indications; . Efficacy.

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Norethindrone, tablet

Indications and Usage, quoted from the label by Glenmark Pharmaceuticals Inc., USA (ANDA090454). Cross-references to other label sections are left out.

. Indications

Progestin-only oral contraceptives are indicated for the prevention of pregnancy.

. Efficacy

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 following table lists the pregnancy rates for users of all major methods of contraception.

Source: DailyMed label, set id 35b5ddb5-1729-4588-b2a2-ead56d78b6f9, version 12, effective January 23, 2026. NDC 68462-303, one of 17 listings for this product.

Questions

What is norethindrone used for?

The FDA label for norethindrone lists 2 uses: . Indications; . Efficacy.

What drug class is norethindrone?

FDA lists norethindrone in the Progestin established pharmacologic class.

Does this page cover off-label uses or dosing?

No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.

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