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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

  • ndc11
    6797900201
    1 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

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