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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

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CISPLATIN - FDA Drug Approval Details