CLOFARABINE - clofarabine injection 
Zydus Lifesciences Limited

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Clofarabine Injection, for Intravenous use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49315-003-06

Rx only

Clofarabine Injection 20 mg/20 mL (1 mg/mL)

Must Be Diluted Prior To Intravenous Use

Contains 1 (20 mL) Single-Dose Vial

Sterile

Carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49315-003-06

Clofarabine Injection 20 mg/20 mL (1 mg/mL)

Must Be Diluted Prior To Intravenous Use

Rx only Single-Dose Vial

vial label
CLOFARABINE 
clofarabine injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49315-003
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOFARABINE (UNII: 762RDY0Y2H) (CLOFARABINE - UNII:762RDY0Y2H) CLOFARABINE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49315-003-061 in 1 CARTON05/10/2017
120 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20402905/10/2017
Labeler - Zydus Lifesciences Limited (650348852)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited650348852ANALYSIS(49315-003) , MANUFACTURE(49315-003)

Revised: 10/2022
Document Id: a6a1f86a-61c0-4769-8f6a-2b7af01c1410
Set id: 4d8d8e81-01ba-4493-b458-7f6375c5bbae
Version: 2
Effective Time: 20221018
 
Zydus Lifesciences Limited