LEUPROLIDE ACETATE

Orange BookSPL

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7071017693
1 KIT in 1 CARTON (70710-1769-3) * 1 VIAL, MULTI-DOSE in 1 CARTON (70710-1768-1) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (70710-1897-8)

Annotations

Orange Book

A215826

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": "70710-1769_fc662130-c2dd-4ff3-829b-9af6c52c5faf",
  "productndc": "70710-1769",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "215826",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "14MG/2.8ML (1MG/0.2ML)",
        "product_no": "001",
        "approval_date": "Nov 13, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "LEUPROLIDE ACETATE",
  "active_ingred_unit": null,
  "application_number": "ANDA215826",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LEUPROLIDE ACETATE",
  "start_marketing_date": "20260108",
  "active_numerator_strength": null
}

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