CISplatin

Orange BookUNIISPLATC L01XA01

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

Identification

ManufacturerWG Critical Care, LLC

CountryUS (United States)

ATC codeL01XA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4456751101
1 VIAL, MULTI-DOSE in 1 CARTON (44567-511-01) / 200 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)

Q20Q21Q62J

CISPLATIN

RxCUI 2555

Orange Book

N018057

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": "44567-511_dd45d777-d4c1-40ee-b4f0-c9e001a15a8c",
  "productndc": "44567-511",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "018057",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG/VIAL",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50MG/VIAL",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG/ML",
        "product_no": "003",
        "approval_date": "Jul 18, 1984"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "004",
        "approval_date": "Nov 8, 1988"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CISPLATIN",
  "proprietary_name": "CISplatin",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA018057",
  "marketing_category": "NDA",
  "nonproprietary_name": "CISplatin",
  "start_marketing_date": "20150415",
  "active_numerator_strength": "1"
}

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