Lupron Depot-PED

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
0074357501
1 KIT in 1 CARTON (0074-3575-01) * 1.5 mL in 1 SYRINGE (0074-3410-01) * 2 SWAB in 1 PACKET (0074-0010-01)

Annotations

Orange Book

N020263

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": "0074-3575_24e33d5f-c64b-4d45-a5ae-e18a1f696cfa",
  "productndc": "0074-3575",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "020263",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "Apr 16, 1993"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Apr 16, 1993"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Apr 16, 1993"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "11.25MG",
        "product_no": "005",
        "approval_date": "Jan 21, 1994"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "15MG",
        "product_no": "006",
        "approval_date": "Jan 21, 1994"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "11.25MG",
        "product_no": "007",
        "approval_date": "Aug 15, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "30MG",
        "product_no": "008",
        "approval_date": "Aug 15, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "45MG",
        "product_no": "009",
        "approval_date": "Apr 14, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Lupron Depot-PED",
  "active_ingred_unit": null,
  "application_number": "NDA020263",
  "marketing_category": "NDA",
  "nonproprietary_name": "leuprolide acetate",
  "start_marketing_date": "20230414",
  "active_numerator_strength": null
}

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