Rabeprazole Sodium (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


RABEPRAZOLE SODIUM DELAYED — RELEASE TABLETS 20 MG 30 Tablets

30 Tablets
(click image for full-size original)
RABEPRAZOLE SODIUM rabeprazole sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-123(NDC:67877-443)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABEPRAZOLE SODIUM (RABEPRAZOLE) RABEPRAZOLE SODIUM 20 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
CROSPOVIDONE
MAGNESIUM OXIDE
ISOPROPYL ALCOHOL
SODIUM STEARYL FUMARATE
MAGNESIUM STEARATE
ETHYLCELLULOSES
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST)
CARNAUBA WAX
ALCOHOL
DIACETYLATED MONOGLYCERIDES
POLYVINYL ALCOHOL
TALC
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
LECITHIN, SOYBEAN
FERRIC OXIDE YELLOW
SHELLAC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
BUTYL ALCOHOL
AMMONIA
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Product Characteristics
Color yellow Score no score
Shape ROUND (Biconvex) Size 8mm
Flavor Imprint Code 20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45865-123-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:45865-123-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208644 04/27/2018
Labeler — Medsource Pharmaceuticals (833685915)
Establishment
Name Address ID/FEI Operations
Medsource Pharmaceuticals 833685915 repack (45865-123)

Revised: 10/2020 Medsource Pharmaceuticals

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