NDC Code(s) : 55154-2851-5
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BumetanideBumetanide INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-2851(NDC:10019-506)
Route of Administration INTRAVENOUS, INTRAMUSCULAR 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)10 mg in 1 mL
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-2851-55 in 1 BAG 27/01/2009
14 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079196 01/27/2009 02/28/2013

PRINCIPAL DISPLAY PANEL

Bumetanide Injection, USP

1 mg/4 ml (0.25 mg/ml)

5 x 4 ml Single Dose Vials

Bag Label