CISplatin

CISplatin

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 845263701

Effective Date

December 21, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Cisplatin(50 mg in 50 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Apotex Corp.

DUNS Number

544532200

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

60505-6277

Route of Administration

INTRAVENOUS

Effective Date

December 21, 2023

Ingredients

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

Code: Q20Q21Q62JClass: ACTIBQuantity: 50 mg in 50 mL