DECITABINE - decitabine injection, powder, lyophilized, for solution 
Zydus Lifesciences Limited

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DECITABINE for injection, for intravenous use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1713-1

Decitabine for Injection

50 mg per vial

FOR INTRAVENOUS INFUSION ONLY

WARNING: Cytotoxic Agent

Single-Dose Sterile Vial – Discard unused portion.

Rx only

container label

NDC 70771-1713-1

Decitabine for Injection

50 mg per vial

FOR INTRAVENOUS INFUSION ONLY

WARNING: Cytotoxic Agent

Single-Dose Sterile Vial – Discard unused portion.

Rx only

carton label
DECITABINE 
decitabine injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1713
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DECITABINE (UNII: 776B62CQ27) (DECITABINE - UNII:776B62CQ27) DECITABINE50 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1713-11 in 1 CARTON05/11/2023
120 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21448605/11/2023
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Pharmaceuticals USA Inc. (156861945)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Hospira Oncology Private Limited676190889ANALYSIS(70771-1713) , LABEL(70771-1713) , MANUFACTURE(70771-1713) , PACK(70771-1713)

Revised: 10/2022
Document Id: ad7749b0-df9a-48bb-aea5-3a603ecb0704
Set id: bcda3a7c-f760-4dfe-a1b6-5602fea86794
Version: 2
Effective Time: 20221017
 
Zydus Lifesciences Limited