🇺🇸
United States · US · US:62332-488_5ce13b01-78d1-49fa-80c9-6e54d0774e14
TESTOSTERONE
In shortageOrange BookUNIISPLATC G03BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG03BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1162332488111 BOTTLE, WITH APPLICATOR in 1 CARTON (62332-488-11) / 110 mL in 1 BOTTLE, WITH APPLICATOR
Annotations
UNII (FDA Substance ID)
3XMK78S47O
TESTOSTERONE
RxCUI 10379
Orange Book
A212882
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Testosterone Gel; Gel, Metered
Raw payload (JSON)
{
"unii": {
"unii": "3XMK78S47O",
"rxcui": "10379",
"inchikey": "MUMGGOZAMZWBJJ-DYKIIFRCSA-N",
"display_name": "TESTOSTERONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"28e8d504-5073-1d78-f351-bcb7c5188ee6": {
"match": "brand_token",
"title": "TESTOSTERONE GEL, METERED [XIROMED, LLC]",
"spl_version": "7",
"published_date": "2026-06-01"
}
},
"productid": "62332-488_5ce13b01-78d1-49fa-80c9-6e54d0774e14",
"productndc": "62332-488",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "212882",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "30MG/1.5ML ACTUATION",
"product_no": "001",
"approval_date": "Jun 14, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TESTOSTERONE",
"shortage_reason": "Testosterone Gel; Gel, Metered",
"shortage_status": "current",
"proprietary_name": "TESTOSTERONE",
"active_ingred_unit": "mg/1.5mL",
"application_number": "ANDA212882",
"marketing_category": "ANDA",
"nonproprietary_name": "TESTOSTERONE",
"start_marketing_date": "20211208",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code G03BA03.
- GBAndroderm 5mg/24hours transdermal patchesImported (United States)
- GBAndrofeme 1% creamImported (Australia)
- 🇺🇸AndroGelASCEND Therapeutics U.S., LLC
- 🇺🇸AndroGelASCEND Therapeutics U.S., LLC
- 🇺🇸AndroGelASCEND Therapeutics U.S., LLC
- 🇺🇸AndroGelASCEND Therapeutics U.S., LLC
- CZANDROGELBesins Healthcare S.A., Ixelles
- CZANDROGELBesins Healthcare S.A., Ixelles
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