Vancomycin Hydrochloride: Package Insert and Label Information (Page 2 of 2)

PRINCIPAL DISPLAY PANEL

NDC 62559-830-80
Vancomycin Hydrochloride for Oral Solution USP
250 mg per 5 mL*
FOR ORAL USE ONLY
Rx only
80 mL (when mixed)

Label
(click image for full-size original)

VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-830
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN) VANCOMYCIN 250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
SODIUM BENZOATE
SUCRALOSE
Product Characteristics
Color WHITE (light pink) Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-830-80 80 mL in 1 BOTTLE, PLASTIC None
2 NDC:62559-830-55 150 mL in 1 BOTTLE, PLASTIC None
3 NDC:62559-830-03 300 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061667 09/09/2019
Labeler — ANI Pharmaceuticals, Inc. (145588013)
Registrant — ANI Pharmaceuticals, Inc. (145588013)

Revised: 09/2019 ANI Pharmaceuticals, Inc.

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