CISPLATIN
Cisplatin Injection Rx only
Approved
Approval ID
a32820f7-9ff6-4c13-a96a-4483a943fe82
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 26, 2023
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
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 Code68083-162
Application NumberANDA207323
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 26, 2023
FDA Product Classification
INGREDIENTS (4)
CISPLATINActive
Quantity: 1 mg in 1 mL
Code: Q20Q21Q62J
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Cisplatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-163
Application NumberANDA207323
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 26, 2023
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CISPLATINActive
Quantity: 1 mg in 1 mL
Code: Q20Q21Q62J
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT