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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 009402 | PH HEALTH | 1954-07-15 | 2 |
| ANDA 086069 | ABBVIE | 1984-01-31 | 4 |
| NDA 020375 | BAYER HLTHCARE | 1994-12-22 | 13 |
| NDA 020472 | PFIZER | 1996-04-26 | 1 |
| NDA 020538 | SANDOZ | 1996-07-31 | 10 |
| ANDA 040197 | BARR LABS INC | 1997-10-22 | 21 |
| ANDA 040275 | EPIC PHARMA LLC | 1998-12-29 | 27 |
| NDA 020908 | NOVO NORDISK INC | 1999-03-26 | 1 |
| ANDA 075182 | MYLAN TECHNOLOGIES | 2000-02-24 | 12 |
| NDA 021367 | MILLICENT MFG PR | 2003-03-20 | 2 |
| NDA 021166 | ASCEND THERAPS US | 2004-02-09 | 1 |
| NDA 022038 | VERTICAL PHARMS | 2007-06-04 | 10 |
| ANDA 090920 | AM REGENT | 2010-01-19 | 2 |
| NDA 203752 | NOVEN | 2012-10-29 | 11 |
| ANDA 201675 | MYLAN TECHNOLOGIES | 2014-12-19 | 5 |
| ANDA 205256 | AMNEAL PHARMS | 2015-05-29 | 3 |
| ANDA 206388 | TEVA PHARMS USA | 2017-07-21 | 3 |
| ANDA 208788 | MYLAN | 2017-12-29 | 1 |
| ANDA 210194 | PADAGIS ISRAEL | 2018-01-22 | 8 |
| ANDA 209767 | ENCUBE | 2018-03-05 | 5 |
| ANDA 206685 | MYLAN TECHNOLOGIES | 2018-08-15 | 5 |
| ANDA 210264 | GLENMARK PHARMS LTD | 2018-09-14 | 1 |
| ANDA 211293 | AMNEAL | 2019-02-05 | 15 |
| ANDA 203723 | HIKMA | 2020-04-21 | 3 |
| ANDA 211396 | AMNEAL | 2020-09-28 | 10 |
| ANDA 212313 | PRASCO | 2021-07-15 | 2 |
| ANDA 211783 | XIROMED | 2022-08-10 | 5 |
| ANDA 206241 | ZYDUS PHARMS | 2022-12-01 | 10 |
| ANDA 202985 | ZYDUS PHARMS | 2023-03-29 | 12 |
| ANDA 204379 | ZYDUS PHARMS | 2023-04-17 | 2 |
| ANDA 216656 | XIROMED | 2023-04-28 | 3 |
| ANDA 217610 | NOVITIUM PHARMA | 2023-08-24 | 10 |
| ANDA 217334 | NOVITIUM PHARMA | 2023-09-06 | 23 |
| ANDA 216524 | PADAGIS ISRAEL | 2023-11-14 | 9 |
| ANDA 216160 | SOLARIS PHARMA CORP | 2024-04-22 | 1 |
| ANDA 216055 | AMNEAL | 2024-07-12 | 5 |
| ANDA 216550 | AUROBINDO PHARMA | 2024-08-02 | 2 |
| ANDA 217882 | NOVITIUM PHARMA | 2024-10-23 | 1 |
| ANDA 218507 | ENCUBE | 2025-03-05 | 5 |
| ANDA 218214 | ENCUBE | 2026-05-11 | 1 |
Showing 40 of 44 applications.
Official labeling on DailyMed
- ESTRADIOL GEL [ANI PHARMACEUTICALS, INC.] · version 6 · 2026-09-10
- ESTRADIOL CREAM [A-S MEDICATION SOLUTIONS] · version 13 · 2026-08-31
- ESTRADIOL GEL [TRIGEN LABORATORIES, LLC] · version 10 · 2026-08-24
- ESTRADIOL VAGINAL (ESTRADIOL) CREAM [REDPHARM DRUG] · version 1 · 2026-08-12
- ESTRADIOL VAGINAL CREAM (ESTRADIOL) CREAM [PRASCO LABORATORIES] · version 12 · 2026-08-11
- MINIVELLE (ESTRADIOL) FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC] · version 20 · 2026-08-03
- ESTRADIOL TABLET [REDPHARM DRUG] · version 1 · 2026-07-22
- ESTRADIOL VALERATE INJECTION [XIROMED, LLC] · version 10 · 2026-07-07
- ESTRADIOL TABLET [A-S MEDICATION SOLUTIONS] · version 3 · 2026-07-02
- ESTRADIOL VAGINAL (ESTRADIOL) CREAM [REDPHARM DRUG] · version 1 · 2026-06-18
- ESTRADIOL GEL [BRYANT RANCH PREPACK] · version 2 · 2026-06-18
- ESTRADIOL TABLET [REMEDYREPACK INC.] · version 6 · 2026-06-12
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.