NDC Code(s) : 55111-602-16
Packager : Dr. Reddy's Laboratories Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ranitidine Ranitidine SYRUP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-602
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE(UNII: BK76465IHM)
(Ranitidine - UNII:884KT10YB7) 		Ranitidine15 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
SODIUM PHOSPHATE, DIBASIC(UNII: GR686LBA74)
HYPROMELLOSE(UNII: 3NXW29V3WO)
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
MINT(UNII: FV98Z8GITP)
WATER(UNII: 059QF0KO0R)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SORBITOL(UNII: 506T60A25R)
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55111-602-16480 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090102 05/26/2009