Rabeprazole Sodium (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEl
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RABEPRAZOLE SODIUM rabeprazole sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76420-107(NDC:65862-721)
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
CROSPOVIDONE (120 .MU.M)
DIACETYLATED MONOGLYCERIDES
ETHYLCELLULOSE (7 MPA.S)
FERRIC OXIDE YELLOW
HYDROXYPROPYL CELLULOSE (110000 WAMW)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MANNITOL
MAGNESIUM OXIDE
MAGNESIUM HYDROXIDE
SODIUM CARBONATE
TALC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
SHELLAC
Product Characteristics
Color yellow (LIGHT YELLOW TO YELLOW) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code Y70
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76420-107-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:76420-107-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE None
3 NDC:76420-107-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205761 02/17/2017
Labeler — Asclemed USA, Inc. (059888437)
Establishment
Name Address ID/FEI Operations
ASCLEMED USA INC. DBA ENOVACHEM 059888437 relabel (76420-107), repack (76420-107)

Revised: 06/2020 Asclemed USA, Inc.

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