Norethindronedrug info
norethindrone acetate 5 MG Oral Tablet [Gallifrey]
What it is used for
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.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 31, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Gallifrey (Norethindrone acetate tablets, USP), 5 mg oral tablets. Gallifrey, (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder. Gallifrey tablets contain the following inactive ingredients: lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The USP Dissolution Test is pending. Norethindrone Acetate Structural Formula
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 31, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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