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Active ingredient

Estradiol

274 finished FDA listings contain Estradiol as their only active ingredient; 50 combination products also contain it.

FDA NDC Directory

Ingredient names as written by FDA
ESTRADIOL, ESTRADIOL ACETATE, ESTRADIOL BENZOATE, ESTRADIOL CYPIONATE, ESTRADIOL HEMIHYDRATE, ESTRADIOL VALERATE, FLUOROESTRADIOL F-18
Dosage forms
Cream, Film, Extended Release, Gel, Gel, Metered, Injection, Injection, Solution, Insert, Liquid, Patch, Patch, Extended Release, Ring, Spray, System, Tablet, Tablet, Film Coated
Routes
Intramuscular, Intravenous, Oral, Topical, Transdermal, Vaginal
Manufacturers / labelers
56
Strengths listed
.014 mg/d · .025 mg/d · .0375 mg/d · .05 mg/d · .06 mg/d · .075 mg/d · .1 mg/d · .1 mg/g · .25 mg/.25g · .5 mg/.5g · .5 mg/1 · .52 mg/.87g · .75 mg/.75g · .75 mg/1.25g · 1 mg/1 · 1 mg/g · 1.25 mg/1.25g · 1.53 mg/1 · 10 mg/ml · 10 ug/1 · 100 mci/ml · 14 ug/d · 2 mg/1 · 20 mg/ml · 4 [hp_x]/ml · 40 mg/ml · 5 mg/ml · 6 [hp_x]/ml · 9 [hp_x]/29.5ml
Brand names in FDA listings
Cerianna, Climara, Delestrogen, Depo-Estradiol, Divigel, Dotti, Elestrin, Estrace, Estradiol, Estradiol 1557, Estradiol Gel, Estradiol Transdermal System, Estradiol Vaginal, Estradiol Vaginal Cream, Estradiol Vaginal Inserts, Estring, Estrogel, Estrogen 4x, Estrogen Phenolic, Evamist, Femring, Lyllana, Menostar, Minivelle, Vagifem, Vivelle-Dot, Yuvafem

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 4083

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 009402PH HEALTH1954-07-152
ANDA 086069ABBVIE1984-01-314
NDA 020375BAYER HLTHCARE1994-12-2213
NDA 020472PFIZER1996-04-261
NDA 020538SANDOZ1996-07-3110
ANDA 040197BARR LABS INC1997-10-2221
ANDA 040275EPIC PHARMA LLC1998-12-2927
NDA 020908NOVO NORDISK INC1999-03-261
ANDA 075182MYLAN TECHNOLOGIES2000-02-2412
NDA 021367MILLICENT MFG PR2003-03-202
NDA 021166ASCEND THERAPS US2004-02-091
NDA 022038VERTICAL PHARMS2007-06-0410
ANDA 090920AM REGENT2010-01-192
NDA 203752NOVEN2012-10-2911
ANDA 201675MYLAN TECHNOLOGIES2014-12-195
ANDA 205256AMNEAL PHARMS2015-05-293
ANDA 206388TEVA PHARMS USA2017-07-213
ANDA 208788MYLAN2017-12-291
ANDA 210194PADAGIS ISRAEL2018-01-228
ANDA 209767ENCUBE2018-03-055
ANDA 206685MYLAN TECHNOLOGIES2018-08-155
ANDA 210264GLENMARK PHARMS LTD2018-09-141
ANDA 211293AMNEAL2019-02-0515
ANDA 203723HIKMA2020-04-213
ANDA 211396AMNEAL2020-09-2810
ANDA 212313PRASCO2021-07-152
ANDA 211783XIROMED2022-08-105
ANDA 206241ZYDUS PHARMS2022-12-0110
ANDA 202985ZYDUS PHARMS2023-03-2912
ANDA 204379ZYDUS PHARMS2023-04-172
ANDA 216656XIROMED2023-04-283
ANDA 217610NOVITIUM PHARMA2023-08-2410
ANDA 217334NOVITIUM PHARMA2023-09-0623
ANDA 216524PADAGIS ISRAEL2023-11-149
ANDA 216160SOLARIS PHARMA CORP2024-04-221
ANDA 216055AMNEAL2024-07-125
ANDA 216550AUROBINDO PHARMA2024-08-022
ANDA 217882NOVITIUM PHARMA2024-10-231
ANDA 218507ENCUBE2025-03-055
ANDA 218214ENCUBE2026-05-111

Showing 40 of 44 applications.

Official labeling on DailyMed

Showing the 12 most recent of 144 labels.

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