Decitabine (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Decitabine

GENERIC: Decitabine

DOSAGE: Injection, powder, lyophilized, for solution

ADMINSTRATION: Intravenous

NDC: 64679-067-01

STRENGTH: 50 mg per vial

QTY: 20 mL Single Use Vial Label

vial label
(click image for full-size original)

DRUG: Decitabine

GENERIC: Decitabine

DOSAGE: Injection, powder, lyophilized, for solution

ADMINSTRATION: Intravenous

NDC: 64679-067-02

STRENGTH: 50 mg per vial

QTY: 20 mL Single Use Vial Carton

vial carton
(click image for full-size original)
DECITABINE decitabine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-067
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DECITABINE (DECITABINE) DECITABINE 50 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM PHOSPHATE, MONOBASIC
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-067-02 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (64679-067-01)
1 NDC:64679-067-01 20 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (64679-067-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209056 12/14/2020
Labeler — Wockhardt USA LLC. (170508365)
Registrant — Wockhardt Limited (650069115)
Establishment
Name Address ID/FEI Operations
Shilpa Medicare Limited 650644136 ANALYSIS (64679-067), LABEL (64679-067), MANUFACTURE (64679-067), PACK (64679-067)

Revised: 11/2020 Wockhardt USA LLC.

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