NDC Code(s) : 49999-447-90
Packager : Lake Erie Medical DBA Quality Care Produtcs LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AcipHexrabeprazole sodium TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49999-447(NDC:62856-243)
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
CARNAUBA WAX(UNII: R12CBM0EIZ)
CROSPOVIDONE(UNII: 2S7830E561)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(UNII: 87Y6436BKR)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color yellow (yellow) Score no score
Shape ROUND (ROUND) Size 8 mm
Flavor Imprint Code ACIPHEX;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49999-447-9090 in 1 BOTTLE Type 0: Not a Combination Product17/02/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020973 02/17/2012 06/01/2012

PRINCIPAL DISPLAY PANEL

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