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United States · US · US:67979-002_917e915f-4793-48bf-84c3-50272421616f
SUPPRELIN
Orange BookUNIISPLATC L02AE05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeL02AE05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167979002011 VIAL, GLASS in 1 CARTON (67979-002-01) / 1 IMPLANT in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
QMG7HLD1ZE
HISTRELIN ACETATE
RxCUI 1294622
Orange Book
N022058
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "QMG7HLD1ZE",
"rxcui": "1294622",
"inchikey": "BKEMVGVBBDMHKL-VYFXDUNUSA-N",
"display_name": "HISTRELIN ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"d8fb000e-3cc9-4803-b71d-2cc597661977": {
"match": "brand_token",
"title": "SUPPRELIN LA (HISTRELIN ACETATE) IMPLANT [ENDO USA, INC.]",
"spl_version": "38",
"published_date": "2025-09-29"
}
},
"productid": "67979-002_917e915f-4793-48bf-84c3-50272421616f",
"productndc": "67979-002",
"dosage_form": "IMPLANT",
"orange_book": {
"appl_no": "022058",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "50MG",
"product_no": "001",
"approval_date": "May 3, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HISTRELIN ACETATE",
"proprietary_name": "SUPPRELIN",
"active_ingred_unit": "mg/1",
"application_number": "NDA022058",
"marketing_category": "NDA",
"nonproprietary_name": "histrelin acetate",
"start_marketing_date": "20070531",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L02AE05.
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