DECITABINE injection, powder, lyophilized, for solution

Decitabine by

Drug Labeling and Warnings

Decitabine by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc., Zydus Hospira Oncology Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

DECITABINE 
decitabine injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1713
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DECITABINE (UNII: 776B62CQ27) (DECITABINE - UNII:776B62CQ27)	DECITABINE	50 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1713-1	1 in 1 CARTON	05/11/2023
1		20 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214486	05/11/2023

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Pharmaceuticals USA Inc. (156861945)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Hospira Oncology Private Limited		676190889	ANALYSIS(70771-1713) , LABEL(70771-1713) , MANUFACTURE(70771-1713) , PACK(70771-1713)