FDA.reportPublic FDA data

Testosterone

Product NDC
44117-0002
Requested package NDC
44117-0002-1
11-digit product format
441170002
Labeler code
44117
Product ID
44117-0002_0d0022f3-9676-4fa7-b349-8d0ce26d1f1f
Type
HUMAN OTC DRUG
Nonproprietary name
Testosterone,
Dosage form
TABLET
Route
ORAL
Labeler
Zoe Processing
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-04-29
Marketing end
0000-00-00
Substance
TESTOSTERONE
Active strength
30 [hp_X]/1
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage44117-000244117-0002-1DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TESTOSTERONEACTIVE INGREDIENT3XMK78S47OTESTOSTERONE (TESTOSTERONE,) TABLET [ZOE PROCESSING]1
TESTOSTERONEACTIVE MOIETY3XMK78S47OTESTOSTERONE (TESTOSTERONE,) TABLET [ZOE PROCESSING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTESTOSTERONE (TESTOSTERONE,) TABLET [ZOE PROCESSING]1
CREATINE MONOHYDRATEINACTIVE INGREDIENT9603LN7R2QTESTOSTERONE (TESTOSTERONE,) TABLET [ZOE PROCESSING]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TESTOSTERONE (TESTOSTERONE,) TABLET [ZOE PROCESSING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TESTOSTERONE (TESTOSTERONE,) TABLET [ZOE PROCESSING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TESTOSTERONE (TESTOSTERONE,) TABLET [ZOE PROCESSING]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTESTOSTERONE (TESTOSTERONE,) TABLET [ZOE PROCESSING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44117-0002TESTOSTERONE (TESTOSTERONE,) TABLET [ZOE PROCESSING]3Legacy NDC20250523_584c2080-1360-40ee-ad54-e13ff5d72be0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44117-0002-14411700020150 TABLET in 1 BOTTLE (44117-0002-1) 50 tablet2014-04-290000-00-00NoNoCurrent