Bumetanide (Page 4 of 4)

SERIALIZATION IMAGE

Layout 1

BUMETANIDE bumetanide injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6161
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUMETANIDE (BUMETANIDE) BUMETANIDE 0.25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.5 mg in 1 mL
AMMONIUM ACETATE 4 mg in 1 mL
EDETATE DISODIUM 0.1 mg in 1 mL
BENZYL ALCOHOL 10 mg in 1 mL
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0641-6161-10 10 VIAL in 1 CARTON contains a VIAL (0641-6161-01)
1 NDC:0641-6161-01 4 mL in 1 VIAL This package is contained within the CARTON (0641-6161-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079196 04/30/2008
BUMETANIDE bumetanide injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6162
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUMETANIDE (BUMETANIDE) BUMETANIDE 0.25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8.5 mg in 1 mL
AMMONIUM ACETATE 4 mg in 1 mL
EDETATE DISODIUM 0.1 mg in 1 mL
BENZYL ALCOHOL 10 mg in 1 mL
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0641-6162-10 10 VIAL in 1 CARTON contains a VIAL (0641-6162-01)
1 NDC:0641-6162-01 10 mL in 1 VIAL This package is contained within the CARTON (0641-6162-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079196 04/30/2008
Labeler — Hikma Pharmaceuticals USA Inc. (946499746)
Registrant — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 04/2022 Hikma Pharmaceuticals USA Inc.

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.