leuprolide acetate

Orange BookSPL

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

Identification

ManufacturerPAI Holdings, LLC dba PAI Pharma

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0121210602
1 KIT in 1 CARTON (0121-2106-02) * 1 VIAL, MULTI-DOSE in 1 CARTON (0121-1053-02) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (0121-2105-01)

Annotations

Orange Book

A217957

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": "0121-2106_b1a3e37b-0513-40cc-ab82-a6ec15dc533c",
  "productndc": "0121-2106",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "217957",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "14MG/2.8ML (1MG/0.2ML)",
        "product_no": "001",
        "approval_date": "Oct 17, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "leuprolide acetate",
  "active_ingred_unit": null,
  "application_number": "ANDA217957",
  "marketing_category": "ANDA",
  "nonproprietary_name": "leuprolide acetate",
  "start_marketing_date": "20250201",
  "active_numerator_strength": null
}

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