MedPath

CISplatin

Approved
Approval ID

be185d9c-d82f-442b-81db-348e3715e7a4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 21, 2023

Manufacturers
FDA

Apotex Corp.

DUNS: 845263701

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CISplatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60505-6277
Product Classification
G
Generic Name
CISplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 21, 2023
FDA Product Classification

INGREDIENTS (5)

HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CISPLATINActive
Quantity: 50 mg in 50 mL
Code: Q20Q21Q62J
Classification: ACTIB

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CISplatin - FDA Drug Approval Details