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United States · US · US:45802-754_a7c10e20-f92f-4b14-a281-8118abfd4809
testosterone
In shortageOrange BookUNIISPLATC G03BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeG03BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1145802754011 BOTTLE, PUMP in 1 CARTON (45802-754-01) / 88 g in 1 BOTTLE, PUMP
Annotations
UNII (FDA Substance ID)
3XMK78S47O
TESTOSTERONE
RxCUI 10379
Orange Book
A204268
AB
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": "45802-754_a7c10e20-f92f-4b14-a281-8118abfd4809",
"productndc": "45802-754",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "204268",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1.62% (20.25MG/1.25GM ACTUATION)",
"product_no": "001",
"approval_date": "Aug 4, 2015"
}
],
"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/g",
"application_number": "ANDA204268",
"marketing_category": "ANDA",
"nonproprietary_name": "testosterone",
"start_marketing_date": "20181012",
"active_numerator_strength": "16.2"
}Related drugs
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- CZANDROGELBesins Healthcare S.A., Ixelles
- CZANDROGELBesins Healthcare S.A., Ixelles
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