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
0074364203
1 KIT in 1 CARTON (0074-3642-03) * 1 mL in 1 SYRINGE * 1 SWAB in 1 PACKET

Annotations

Orange Book

N019732

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": "0074-3642_98a4f293-ee7c-44d0-9a1e-9dc7faf8aaf8",
  "productndc": "0074-3642",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "019732",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "7.5MG",
        "product_no": "001",
        "approval_date": "Jan 26, 1989"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Lupron Depot",
  "active_ingred_unit": null,
  "application_number": "NDA019732",
  "marketing_category": "NDA",
  "nonproprietary_name": "leuprolide acetate",
  "start_marketing_date": "19890126",
  "active_numerator_strength": null
}

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