Leuprolide Acetate

Orange BookSPL

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

Identification

ManufacturerNorthStar RxLLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7260334401
1 KIT in 1 CARTON (72603-344-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (72603-201-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 28 PACKET in 1 CARTON / 1 mL in 1 PACKET

Annotations

Orange Book

A213829

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": "72603-344_384e8664-07e6-3817-e063-6294a90a8385",
  "productndc": "72603-344",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "213829",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "14MG/2.8ML (1MG/0.2ML)",
        "product_no": "001",
        "approval_date": "Aug 13, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Leuprolide Acetate",
  "active_ingred_unit": null,
  "application_number": "ANDA213829",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Leuprolide Acetate",
  "start_marketing_date": "20240301",
  "active_numerator_strength": null
}

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