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United States · US · US:70700-112_28a07d51-b9bc-b13e-145d-56a5c6d50b4c
Testosterone
In shortageOrange BookUNIISPLATC G03BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXiromed, LLC
CountryUS (United States)
ATC codeG03BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170700112211 BOTTLE, PUMP in 1 CARTON (70700-112-21) / 88 g in 1 BOTTLE, PUMP
Annotations
UNII (FDA Substance ID)
3XMK78S47O
TESTOSTERONE
RxCUI 10379
Orange Book
A210835
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": "TRANSDERMAL",
"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": "70700-112_28a07d51-b9bc-b13e-145d-56a5c6d50b4c",
"productndc": "70700-112",
"dosage_form": "GEL, METERED",
"orange_book": {
"appl_no": "210835",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1.62% (20.25MG/1.25GM ACTUATION)",
"product_no": "001",
"approval_date": "Apr 16, 2020"
}
],
"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/1.25g",
"application_number": "ANDA210835",
"marketing_category": "ANDA",
"nonproprietary_name": "Testosterone",
"start_marketing_date": "20200508",
"active_numerator_strength": "20.25"
}Related drugs
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- CZANDROGELBesins Healthcare S.A., Ixelles
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