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Active ingredient

Testosterone

123 finished FDA listings contain Testosterone as their only active ingredient; 34 combination products also contain it.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
TESTOSTERONE, TESTOSTERONE CYPIONATE, TESTOSTERONE DECANOATE, TESTOSTERONE ENANTHATE, TESTOSTERONE ISOCAPROATE, TESTOSTERONE PROPIONATE, TESTOSTERONE UNDECANOATE
Dosage forms
Capsule, Liquid Filled, Gel, Gel, Metered, Injection, Injection, Solution, Liquid, Pellet, Solution, Tablet
Routes
Intramuscular, Nasal, Oral, Subcutaneous, Topical, Transdermal
Manufacturers / labelers
43
Strengths listed
1.62 mg/g · 10 mg/g · 100 mg/.5ml · 100 mg/ml · 1000 mg/10ml · 112.5 mg/1 · 12.5 mg/1 · 12.5 mg/1.25g · 150 mg/1 · 158 mg/1 · 16.2 mg/g · 198 mg/1 · 20.25 mg/1.25g · 200 mg/1 · 200 mg/ml · 2000 mg/10ml · 237 mg/1 · 25 mg/2.5g · 250 mg/ml · 30 [hp_x]/1 · 30 mg/1.5ml · 40.5 mg/2.5g · 5.5 mg/.122g · 50 mg/.5ml · 50 mg/1 · 50 mg/5g · 75 mg/.5ml · 75 mg/1 · 8 [hp_x]/ml
Brand names in FDA listings
Aveed, Azmiro, Depo-Testosterone, Jatenzo, Kyzatrex, Natesto Nasal Gel, Testim, Testopel, Tlando, Vogelxo, Xyosted

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 10379

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
ANDA 080911ENDO OPERATIONS1972-07-131
ANDA 085635PFIZER1979-07-257
NDA 021015BESINS HLTHCARE2000-02-283
NDA 021454ENDO OPERATIONS2002-10-311
ANDA 040530PADAGIS US2005-01-316
ANDA 076737ACTAVIS LABS UT INC2006-01-273
ANDA 076744STRIDES PHARMA INTL2007-05-232
NDA 022309BESINS HLTHCARE2011-04-292
ANDA 091244HIKMA FARMACEUTICA2012-05-0115
ANDA 091120HIKMA FARMACEUTICA2012-09-181
ANDA 201720SUN PHARM INDS LTD2013-06-033
NDA 022219ENDO OPERATIONS2014-03-051
NDA 205488ACERUS2014-05-281
NDA 204399UPSHER SMITH LABS2014-06-044
ANDA 204268PADAGIS ISRAEL2015-08-044
ANDA 204255PADAGIS ISRAEL2017-02-283
ANDA 207742AM REGENT2017-06-166
ANDA 205781PADAGIS ISRAEL2017-07-124
ANDA 205328ACTAVIS LABS UT INC2017-08-071
ANDA 091073ACTAVIS LABS UT INC2017-09-181
ANDA 209533CIPLA2018-01-291
ANDA 210362CIPLA2018-06-193
NDA 209863ANTARES PHARMA INC2018-09-283
NDA 206089TOLMAR2019-03-273
ANDA 207373AMNEAL2019-04-101
ANDA 204570ACTAVIS LABS UT INC2019-04-102
ANDA 208620ENCUBE2019-04-102
ANDA 206368WILSHIRE PHARMS INC2019-04-245
ANDA 209390TWI PHARMS2019-09-231
ANDA 210835XIROMED2020-04-164
ANDA 212301ENCUBE2021-01-111
ANDA 213922ALEMBIC2021-03-031
ANDA 212882ALEMBIC2021-06-141
ANDA 212984ENCUBE2021-11-092
NDA 216318AZURITY2022-06-022
NDA 213953MARIUS2022-07-273
ANDA 215351XIROMED2023-04-136
ANDA 211817EUGIA PHARMA2023-10-203
ANDA 212659EUGIA PHARMA2024-02-281
ANDA 219478BPI LABS2026-09-034

Showing 40 of 43 applications.

Official labeling on DailyMed

Showing the 12 most recent of 86 labels.

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