NDC Code(s) : 55154-4728-8
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BumetanideBUMETANIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-4728(NDC:0409-1412)
Route of Administration INTRANODAL, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUMETANIDE(UNII: 0Y2S3XUQ5H)
(BUMETANIDE - UNII:0Y2S3XUQ5H) 		BUMETANIDE0.25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)8.5 mg in 1 mL
AMMONIUM ACETATE(UNII: RRE756S6Q2)4 mg in 1 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.1 mg in 1 mL
BENZYL ALCOHOL(UNII: LKG8494WBH)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-4728-81 in 1 BAG
110 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074332 11/16/2011

PRINCIPAL DISPLAY PANEL

Bumetanide Injection, USP

0.25 mg/mL

1 x 10 mL Multiple-Dose Vial

bag label