🇺🇸
United States · US · US:0591-2114_6fb6ef6d-5ed8-4565-916e-30e7b117d612
Testosterone
In shortageOrange BookUNIISPLATC G03BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeG03BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105912114811 BOTTLE, WITH APPLICATOR in 1 CARTON (0591-2114-81) / 90 mL in 1 BOTTLE, WITH APPLICATOR
Annotations
UNII (FDA Substance ID)
3XMK78S47O
TESTOSTERONE
RxCUI 10379
Orange Book
A205328
AT
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": "0591-2114_6fb6ef6d-5ed8-4565-916e-30e7b117d612",
"productndc": "0591-2114",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "205328",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "30MG/1.5ML ACTUATION",
"product_no": "001",
"approval_date": "Aug 7, 2017"
}
],
"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": "ANDA205328",
"marketing_category": "ANDA",
"nonproprietary_name": "Testosterone",
"start_marketing_date": "20170818",
"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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