🇺🇸
United States · US · US:66887-004_0a13cf12-e51e-4d3d-a7c4-ea74712e6db2
Testopel
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 · 2
- ndc11668870041010 AMPULE in 1 BOX (66887-004-10) / 1 PELLET in 1 AMPULE (66887-004-01)
- ndc116688700420100 AMPULE in 1 BOX (66887-004-20) / 1 PELLET in 1 AMPULE (66887-004-01)
Annotations
UNII (FDA Substance ID)
3XMK78S47O
TESTOSTERONE
RxCUI 10379
Orange Book
A080911
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": "SUBCUTANEOUS",
"spl_meta": {
"03b9c0b1-5884-11e4-8ed6-0800200c9a66": {
"match": "brand_token",
"title": "TESTOPEL (TESTOSTERONE) PELLET [ENDO USA, INC.]",
"spl_version": "28",
"published_date": "2025-07-24"
}
},
"productid": "66887-004_0a13cf12-e51e-4d3d-a7c4-ea74712e6db2",
"productndc": "66887-004",
"dosage_form": "PELLET",
"orange_book": {
"appl_no": "080911",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "75MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"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": "Testopel",
"active_ingred_unit": "mg/1",
"application_number": "ANDA080911",
"marketing_category": "ANDA",
"nonproprietary_name": "testosterone",
"start_marketing_date": "20141031",
"active_numerator_strength": "75"
}Related drugs
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- 🇺🇸AndroGelASCEND Therapeutics U.S., LLC
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- CZANDROGELBesins Healthcare S.A., Ixelles
- CZANDROGELBesins Healthcare S.A., Ixelles
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