Label: DECITABINE injection, powder, lyophilized, for solution
- NDC Code(s): 70771-1713-1
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 17, 2022
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- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Decitabine for Injection
50 mg per vial
FOR INTRAVENOUS INFUSION ONLY
WARNING: Cytotoxic Agent
Single-Dose Sterile Vial – Discard unused portion.
Rx only
Decitabine for Injection
50 mg per vial
FOR INTRAVENOUS INFUSION ONLY
WARNING: Cytotoxic Agent
Single-Dose Sterile Vial – Discard unused portion.
Rx only
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INGREDIENTS AND APPEARANCE
DECITABINE
decitabine injection, powder, lyophilized, for solutionProduct 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)