Leuprolide Acetate

Orange BookSPL

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7128856990
1 KIT in 1 CARTON (71288-569-90) * 1 VIAL, MULTI-DOSE in 1 CARTON (71288-565-03) / 2.8 mL in 1 VIAL, MULTI-DOSE * .5 mL in 1 PACKET (71288-350-91)

Annotations

Orange Book

A075471

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "35634415-000f-47db-9bd7-9e16eef3f02e": {
      "match": "brand_token",
      "title": "LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) KIT [ZYDUS PHARMACEUTICALS USA INC.]",
      "spl_version": "6",
      "published_date": "2026-05-28"
    }
  },
  "productid": "71288-569_fed2b538-4e01-4e4b-9e92-1750554aba61",
  "productndc": "71288-569",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "075471",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "14MG/2.8ML (1MG/0.2ML)",
        "product_no": "001",
        "approval_date": "Oct 25, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Leuprolide Acetate",
  "active_ingred_unit": null,
  "application_number": "ANDA075471",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Leuprolide Acetate",
  "start_marketing_date": "20240515",
  "active_numerator_strength": null
}

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