Cisplatin (Page 5 of 5)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Cisplatin for Injection, USP 50 mg label image
(click image for full-size original)

CISplatin doses greater than 100 mg/m2 once every 3 to
4 weeks are rarely used. See Prescribing information.

NDC 44567-530-01 Single-dose vial

Discard unused portion

CISplatin for Injection, USP

For Intravenous Infusion

50 mg per vial Rx only

Caution: Cytotoxic Agent WG Critical Care

CISPLATIN
cisplatin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44567-530
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
cisplatin (cisplatin) cisplatin 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride
Mannitol
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44567-530-01 1 VIAL in 1 CARTON contains a VIAL
1 50 mL in 1 VIAL This package is contained within the CARTON (44567-530-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018057 04/05/2019
Labeler — WG Critical Care, LLC (829274633)
Establishment
Name Address ID/FEI Operations
Corden Pharma Latina S.p.A. 339062883 MANUFACTURE (44567-530)

Revised: 09/2021 WG Critical Care, LLC

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