MedPath

CISPLATIN

Cisplatin Injection Rx only

Approved
Approval ID

0372598e-4837-43c6-b56f-63527ac94559

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 18, 2023

Manufacturers
FDA

BluePoint Laboratories

DUNS: 985523874

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 Code68001-609
Application NumberANDA207323
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 18, 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 Code68001-608
Application NumberANDA207323
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cisplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 18, 2023
FDA Product Classification

INGREDIENTS (4)

SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
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