NDC Code(s) : 45865-802-30, 45865-802-60
Packager : medsource pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

RABEPRAZOLE SODIUMRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-802(NDC:68180-220)
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, UNSPECIFIED(UNII: 2S7830E561)
DIACETYLATED MONOGLYCERIDES(UNII: 5Z17386USF)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(UNII: 87Y6436BKR)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
MAGNESIUM OXIDE(UNII: 3A3U0GI71G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
SHELLAC(UNII: 46N107B71O)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color yellow (yellow) Score no score
Shape ROUND (biconvex) Size 7 mm
Flavor Imprint Code L020
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45865-802-3030 in 1 BOTTLE Type 0: Not a Combination Product06/01/2018
2NDC:45865-802-6060 in 1 BOTTLE Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078964 11/08/2013

LABELER - medsource pharmaceuticals(833685915)

Establishment
Name Address ID/FEI Business Operations
medsource pharmaceuticals 833685915 repack(45865-802)

PRINCIPAL DISPLAY PANEL

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