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Active ingredient

Norethindrone

26 finished FDA listings contain Norethindrone as their only active ingredient; 42 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
NORETHINDRONE, NORETHINDRONE ACETATE
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
18
Strengths listed
.35 mg/1 · 5 mg/1
Brand names in FDA listings
Affodel, Camila, Emzahh, Errin, Gallifrey, Heather, Incassia, Jencycla, Lyleq, Meleya, Nora Be, Norethindrone Acetate, Orquidea

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 7514

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 017060TEVA BRANDED PHARM1973-01-021
ANDA 075951BARR2001-05-252
ANDA 076225DR REDDYS LABS SA2002-10-212
ANDA 076177DR REDDYS LABS SA2002-10-211
ANDA 090454GLENMARK PHARMS LTD2010-04-231
ANDA 091090GLENMARK PHARMS LTD2010-07-212
ANDA 091209GLENMARK PHARMS LTD2010-07-222
ANDA 091325LUPIN LTD2011-09-193
ANDA 200275AMNEAL PHARMS2012-07-302
ANDA 091323LUPIN LTD2013-03-281
ANDA 200980XIROMED2013-06-121
ANDA 201483XIROMED2013-06-242
ANDA 207304AUROBINDO PHARMA2016-09-232
ANDA 205278XIROMED2016-11-101
ANDA 206807NAARI PTE2016-12-131
ANDA 206490INGENUS PHARMS LLC2018-11-051
ANDA 216796AUROBINDO PHARMA2023-01-061

Official labeling on DailyMed

Showing the 12 most recent of 25 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.