Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE HYDROCHLORIDE 25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL
POTASSIUM PHOSPHATE, MONOBASIC
SODIUM PHOSPHATE, DIBASIC
Product Characteristics
Color YELLOW (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0173-0363-01 6 mL In 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019090 10/01/1989
ZANTAC
ranitidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0173-0441
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE HYDROCHLORIDE 50 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
CITRIC ACID
SODIUM PHOSPHATE, DIBASIC
WATER
Product Characteristics
Color YELLOW (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0173-0441-00 50 mL In 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019593 11/20/1992
Labeler - SmithKline Beecham Corporation (167380711)
Revised: 04/2009SmithKline Beecham Corporation
