MedPath

CISplatin

CISplatin Injection

Approved
Approval ID

2bf8d2fb-80c8-401d-8e9b-d58463f5e954

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 16, 2021

Manufacturers
FDA

WG Critical Care, LLC

DUNS: 829274633

Products 3

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 Code44567-510
Application NumberNDA018057
Product Classification
M
Marketing Category
C73594
G
Generic Name
CISplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 16, 2021
FDA Product Classification

INGREDIENTS (6)

Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
cisplatinActive
Quantity: 1 mg in 1 mL
Code: Q20Q21Q62J
Classification: ACTIB
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 mL
Code: 2LQ0UUW8IN
Classification: CNTM
WaterInactive
Code: 059QF0KO0R
Classification: IACT

CISplatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code44567-511
Application NumberNDA018057
Product Classification
M
Marketing Category
C73594
G
Generic Name
CISplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 16, 2021
FDA Product Classification

INGREDIENTS (6)

cisplatinActive
Quantity: 1 mg in 1 mL
Code: Q20Q21Q62J
Classification: ACTIB
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 mL
Code: 2LQ0UUW8IN
Classification: CNTM

CISplatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code44567-509
Application NumberNDA018057
Product Classification
M
Marketing Category
C73594
G
Generic Name
CISplatin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 16, 2021
FDA Product Classification

INGREDIENTS (6)

cisplatinActive
Quantity: 1 mg in 1 mL
Code: Q20Q21Q62J
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 mL
Code: 2LQ0UUW8IN
Classification: CNTM

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CISplatin - FDA Drug Approval Details