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United States · US · US:66887-001_366a5e88-4a23-46b0-94e5-e7f7deb7acbe
Testim
In shortageOrange BookUNIISPLATC G03BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeG03BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11668870010530 TUBE in 1 CARTON (66887-001-05) / 5 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
3XMK78S47O
TESTOSTERONE
RxCUI 10379
Orange Book
N021454
AB2
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": {
"9f2aae1f-898d-4955-be31-678e0cf85395": {
"match": "brand_token",
"title": "TESTIM (TESTOSTERONE) GEL [ENDO USA, INC.]",
"spl_version": "29",
"published_date": "2026-03-05"
}
},
"productid": "66887-001_366a5e88-4a23-46b0-94e5-e7f7deb7acbe",
"productndc": "66887-001",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "021454",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB2",
"strength": "50MG/5GM PACKET",
"product_no": "001",
"approval_date": "Oct 31, 2002"
}
],
"appl_type": "N"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TESTOSTERONE",
"shortage_reason": "Testosterone Gel; Gel, Metered",
"shortage_status": "current",
"proprietary_name": "Testim",
"active_ingred_unit": "mg/5g",
"application_number": "NDA021454",
"marketing_category": "NDA",
"nonproprietary_name": "testosterone",
"start_marketing_date": "20021031",
"active_numerator_strength": "50"
}Related drugs
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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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