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United States · US · US:63323-103_24604fc6-875c-4f70-973a-9cca93f9a7a7

Cisplatin

Orange BookUNIISPLATC L01XA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01XA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6332310351
    1 VIAL in 1 CARTON (63323-103-51) / 50 mL in 1 VIAL
  • ndc11
    6332310364
    1 VIAL in 1 CARTON (63323-103-64) / 200 mL in 1 VIAL
  • ndc11
    6332310365
    1 VIAL in 1 CARTON (63323-103-65) / 100 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
Q20Q21Q62J
CISPLATIN
RxCUI 2555
Orange Book
A074735
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "Q20Q21Q62J",
    "rxcui": "2555",
    "inchikey": "LXZZYRPGZAFOLE-UHFFFAOYSA-L",
    "display_name": "CISPLATIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "76aea034-6d58-4390-a164-36aa09c1f101": {
      "match": "brand_token",
      "title": "CISPLATIN INJECTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "3",
      "published_date": "2025-11-20"
    }
  },
  "productid": "63323-103_24604fc6-875c-4f70-973a-9cca93f9a7a7",
  "productndc": "63323-103",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "074735",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Jul 16, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CISPLATIN",
  "proprietary_name": "Cisplatin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA074735",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CISPLATIN",
  "start_marketing_date": "20000905",
  "active_numerator_strength": "1"
}

Related drugs

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