cisplatin

Generic: cisplatin

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cisplatin
Generic Name cisplatin
Labeler apotex corp.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cisplatin 1 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-6279
Product ID 60505-6279_0e147fbc-5660-4d80-b834-f069e8487f59
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218868
Listing Expiration 2026-12-31
Marketing Start 2024-09-13

Pharmacologic Class

Established (EPC)
platinum-based drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605056279
Hyphenated Format 60505-6279

Supplemental Identifiers

RxCUI
309311
UPC
0360505627905
UNII
Q20Q21Q62J
NUI
N0000175413 N0000175073

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cisplatin (source: ndc)
Generic Name cisplatin (source: ndc)
Application Number ANDA218868 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6279-0) / 50 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

60505-6279-0 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6279-0) / 50 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

cisplatin (1 mg/mL)

Linked Drug Pages (1)

CISplatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0e147fbc-5660-4d80-b834-f069e8487f59", "openfda": {"nui": ["N0000175413", "N0000175073"], "upc": ["0360505627905"], "unii": ["Q20Q21Q62J"], "rxcui": ["309311"], "spl_set_id": ["8d170f6f-37d7-41ce-aae2-33307a6ef3ae"], "pharm_class_epc": ["Platinum-based Drug [EPC]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (60505-6279-0)  / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "60505-6279-0", "marketing_start_date": "20240913"}], "brand_name": "CISplatin", "product_id": "60505-6279_0e147fbc-5660-4d80-b834-f069e8487f59", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Platinum-based Drug [EPC]", "Platinum-containing Compounds [EXT]"], "product_ndc": "60505-6279", "generic_name": "CISplatin", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CISplatin", "active_ingredients": [{"name": "CISPLATIN", "strength": "1 mg/mL"}], "application_number": "ANDA218868", "marketing_category": "ANDA", "marketing_start_date": "20240913", "listing_expiration_date": "20261231"}