LEUPROLIDE ACETATE DEPOT

Orange BookSPL

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

Identification

ManufacturerCIPLA USA INC.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6909790950
1 KIT in 1 CARTON (69097-909-50) * 2 mL in 1 VIAL, SINGLE-DOSE (69097-950-32) * 2 mL in 1 SYRINGE (69097-960-31)

Annotations

Orange Book

N205054

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": "69097-909_15d87847-b4c3-48bc-8c40-d8fc63fcb1b0",
  "productndc": "69097-909",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "205054",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "22.5MG/VIAL",
        "product_no": "001",
        "approval_date": "Aug 28, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "LEUPROLIDE ACETATE DEPOT",
  "active_ingred_unit": null,
  "application_number": "NDA205054",
  "marketing_category": "NDA",
  "nonproprietary_name": "leuprolide acetate",
  "start_marketing_date": "20220715",
  "active_numerator_strength": null
}

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