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Active ingredient

Progesterone

95 finished FDA listings contain Progesterone as their only active ingredient; 29 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
PROGESTERONE
Dosage forms
Capsule, Cream, Gel, Injection, Injection, Solution, Insert, Liquid, Oil, Paste, Spray
Routes
Intramuscular, Oral, Topical, Transdermal, Vaginal
Manufacturers / labelers
42
Strengths listed
1 mg/mg · 100 mg/1 · 12.8 g/60g · 15 [hp_x]/ml · 16.9 mg/ml · 20 mg/58g · 200 mg/1 · 25 mg/85g · 45 mg/1.125g · 5 [hp_x]/ml · 50 mg/1 · 50 mg/ml · 6 [hp_x]/ml · 6.4 g/30g · 8 [hp_x]/ml · 9 [hp_x]/29.5ml · 90 mg/1.125g
Brand names in FDA listings
Bunuss Phyto-Pro Skin Cream, Crinone, Endometrin, Natural Progesterone, P25 Progesterone Cream, P50 Progesterone Cream, P75 Lav Progesterone Cream, P75 Maxx With Retinol All Natural Progesterone 75 Cream, Progesterone 1538, Progesterone Combo, Progesterone Phenolic, Progesterone Vaginal Insert, Progesterone Vaginal Inserts, Prometrium

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 8727

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 020701ABBVIE1997-07-312
NDA 019781ACERTIS PHARMS1998-05-142
ANDA 075906FRESENIUS KABI USA2001-04-251
NDA 022057FERRING2007-06-212
ANDA 091033HIKMA FARMACEUTICA2010-10-281
ANDA 200456SOFGEN PHARMS2012-09-282
ANDA 200900BIONPHARMA2013-08-1617
ANDA 208801DR REDDYS2017-02-282
ANDA 207724AMNEAL PHARMS NY2017-09-078
ANDA 205229XIROMED2017-10-2021
ANDA 211285EUGIA PHARMA2018-10-2617
ANDA 210965EUGIA PHARMA2018-12-061
ANDA 215634XIROMED2022-01-051
ANDA 218391XIROMED2025-09-191
ANDA 216363GLENMARK PHARMS2026-04-081

Official labeling on DailyMed

Showing the 12 most recent of 72 labels.

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