DECITABINE for injection, for intravenous use

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]

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

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

DECITABINE
decitabine injection, powder, lyophilized, for solution

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70771-1713-1	1 in 1 CARTON	05/11/2023	03/25/2025
1		20 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA214486	05/11/2023	05/31/2025

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Pharmaceuticals USA Inc. (156861945)

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

Revised: 5/2025

Document Id: 57e2b084-81c3-45e5-a28f-607385c0550f

Set id: bcda3a7c-f760-4dfe-a1b6-5602fea86794

Version: 3

Effective Time: 20250531