Lupron Depot

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAbbVie Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0074366303
1 KIT in 1 CARTON (0074-3663-03) * 1.5 mL in 1 SYRINGE * 1 mL in 1 PACKET

Annotations

Orange Book

N020708

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "e99f47d2-da10-3127-ecb3-e5d942ae6e81": {
      "match": "brand_token",
      "title": "LUPRON DEPOT-PED (LEUPROLIDE ACETATE) KIT [ABBVIE INC.]",
      "spl_version": "97",
      "published_date": "2025-11-26"
    }
  },
  "productid": "0074-3663_fef36994-8fde-4b22-99a9-aa850c147eee",
  "productndc": "0074-3663",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "020708",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "11.25MG",
        "product_no": "001",
        "approval_date": "Mar 7, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Lupron Depot",
  "active_ingred_unit": null,
  "application_number": "NDA020708",
  "marketing_category": "NDA",
  "nonproprietary_name": "leuprolide acetate",
  "start_marketing_date": "20101108",
  "active_numerator_strength": null
}

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