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United States · US · US:69097-363_ce2732a6-d90e-442c-b7d0-dc1d65a7e3cc
Testosterone
In shortageOrange BookUNIISPLATC G03BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeG03BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169097363441 BOTTLE in 1 CARTON (69097-363-44) / 90 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
3XMK78S47O
TESTOSTERONE
RxCUI 10379
Orange Book
A209533
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": "69097-363_ce2732a6-d90e-442c-b7d0-dc1d65a7e3cc",
"productndc": "69097-363",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "209533",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AT",
"strength": "30MG/1.5ML ACTUATION",
"product_no": "001",
"approval_date": "Jan 29, 2018"
}
],
"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": "ANDA209533",
"marketing_category": "ANDA",
"nonproprietary_name": "Testosterone",
"start_marketing_date": "20180330",
"active_numerator_strength": "30"
}Related drugs
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- 🇺🇸AndroGelASCEND Therapeutics U.S., LLC
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- 🇺🇸AndroGelASCEND Therapeutics U.S., LLC
- 🇺🇸AndroGelASCEND Therapeutics U.S., LLC
- CZANDROGELBesins Healthcare S.A., Ixelles
- CZANDROGELBesins Healthcare S.A., Ixelles
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