FDA label
What is norethindrone acetate used for?
The FDA-approved uses of norethindrone acetate, 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 says: “Norethindrone acetate tablets, USP 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.”
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Norethindrone, tablet
Indications and Usage, quoted from the label by Amneal Pharmaceuticals LLC (ANDA200275). Cross-references to other label sections are left out.
Norethindrone acetate tablets, USP 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.
Source: DailyMed label, set id 64cb920c-36e8-4d62-9d08-3ddf3989d313, version 18, effective October 30, 2024. NDC 65162-475, one of 8 listings for this product.
Questions
What is norethindrone acetate used for?
The FDA label says: “Norethindrone acetate tablets, USP 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.”
What drug class is norethindrone acetate?
FDA lists norethindrone acetate 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.