LEUPROLIDE ACETATE

Orange BookSPL

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

Identification

ManufacturerEugia US LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5515047801
1 KIT in 1 CARTON (55150-478-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (55150-338-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (60913-006-01)

Annotations

Orange Book

A212963

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "55150-478_25c69313-82c8-41fb-8bf5-13faf47519c5",
  "productndc": "55150-478",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "212963",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "14MG/2.8ML (1MG/0.2ML)",
        "product_no": "001",
        "approval_date": "Jun 6, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "LEUPROLIDE ACETATE",
  "active_ingred_unit": null,
  "application_number": "ANDA212963",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LEUPROLIDE ACETATE",
  "start_marketing_date": "20220606",
  "active_numerator_strength": null
}

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