BEIZRAY

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
7071020913
1 KIT in 1 KIT (70710-2091-3) * 4 mL in 1 VIAL, GLASS (70710-2090-1) * 50 mL in 1 VIAL, GLASS (64208-2512-4)

Annotations

Orange Book

N218711

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "8fb7d980-d6c7-468b-a9f0-adff16101a4b": {
      "match": "brand_token",
      "title": "BEIZRAY ( DOCETAXEL ) KIT BEIZRAY ( DOCETAXEL ) KIT BEIZRAY (DOCETAXEL) INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]",
      "spl_version": "4",
      "published_date": "2025-12-25"
    }
  },
  "productid": "70710-2091_4efe8f3a-a176-4b69-90c8-5ba5891dccfd",
  "productndc": "70710-2091",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "218711",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "80MG/4ML (20MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 23, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "BEIZRAY",
  "active_ingred_unit": null,
  "application_number": "NDA218711",
  "marketing_category": "NDA",
  "nonproprietary_name": "docetaxel",
  "start_marketing_date": "20250828",
  "active_numerator_strength": null
}

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