CISPLATIN
CISplatin Injection Rx only
Approved
Approval ID
0219eae9-82b4-b779-e063-6394a90a311e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 4, 2023
Manufacturers
FDA
FOSUN PHARMA USA INC
DUNS: 080920998
Products 2
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 Code72266-253
Application NumberANDA207323
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 4, 2023
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CISPLATINActive
Quantity: 1 mg in 1 mL
Code: Q20Q21Q62J
Classification: ACTIB
Cisplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72266-252
Application NumberANDA207323
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 4, 2023
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
CISPLATINActive
Quantity: 1 mg in 1 mL
Code: Q20Q21Q62J
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT