Cisplatin
These highlights do not include all the information needed to use CISPLATIN INJECTION safely and effectively. See full prescribing information for CISPLATIN INJECTION. CISPLATIN injection, for intravenous use Initial U.S. Approval: 1978
Approved
Approval ID
b2b029f5-0d7e-4e7f-accc-b722aec34c68
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2021
Manufacturers
FDA
Accord Healthcare
DUNS: 604222237
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 Code16729-288
Application NumberANDA206774
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 8, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CISPLATINActive
Quantity: 1 mg in 1 mL
Code: Q20Q21Q62J
Classification: ACTIB