CYTARABINE- cytarabine injection 
Gland Pharma Limited

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Cytarabine Injection

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 67457-455-00

Cytarabine Injection

100 mg/5 mL (20 mg/mL)

CYTOTOXIC AGENT

Isotonic

Sterile

For Intravenous, Intrathecal, or Subcutaneous Use Only

Mylan

Rx only

Single-Dose Vial

Carton-1's

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 67457-455-52

Cytarabine Injection

100 mg/5 mL (20 mg/mL)

CYTOTOXIC AGENT

Isotonic

Sterile

For Intravenous, Intrathecal, or Subcutaneous Use Only

Mylan

Rx only

10 x 5 mL Single-Dose Vials

Carton-10's
CYTARABINE 
cytarabine injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68083-344
Route of AdministrationINTRAVENOUS, INTRATHECAL, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CYTARABINE (UNII: 04079A1RDZ) (CYTARABINE - UNII:04079A1RDZ) CYTARABINE100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Product Characteristics
ColorWHITE (Clear colorless aqueous solution) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68083-344-1010 in 1 CARTON02/14/2018
1NDC:68083-344-015 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractANDA20091502/14/2018
Labeler - Gland Pharma Limited (918601238)

Revised: 2/2018
Document Id: 4e2f7000-f717-4f2b-910d-6ad1995f007c
Set id: 4e2f7000-f717-4f2b-910d-6ad1995f007c
Version: 1
Effective Time: 20180212
 
Gland Pharma Limited