NDC Code(s) : 50436-0724-1
Packager : Unit Dose Services

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rabeprazole SodiumRabeprazole TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50436-0724(NDC:65162-724)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABEPRAZOLE SODIUM(UNII: 3L36P16U4R)
(RABEPRAZOLE - UNII:32828355LL) 		RABEPRAZOLE SODIUM20 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
CROSPOVIDONE (12 MPA.S AT 5%)(UNII: 40UAA97IT9)
DIETHYL PHTHALATE(UNII: UF064M00AF)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 2165RE0K14)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(UNII: 87Y6436BKR)
MAGNESIUM OXIDE(UNII: 3A3U0GI71G)
MANNITOL(UNII: 3OWL53L36A)
MAGNESIUM STEARATE(UNII: 70097M6I30)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
SHELLAC(UNII: 46N107B71O)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code AR
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50436-0724-1 30 in 1 BOTTLE Type 0: Not a Combination Product07/04/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204179 10/01/2015

LABELER - Unit Dose Services(831995316)

Establishment
Name Address ID/FEI Business Operations
Unit Dose Services 831995316 REPACK(50436-0724), RELABEL(50436-0724)

PRINCIPAL DISPLAY PANEL

Label Image