Rabeprazole Sodium (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 30 Tablets Bottle

NDC 65862-721-30
Rx only
Rabeprazole Sodium
Delayed-release Tablets
20 mg
PHARMACIST: Dispense the Medication Guide
provided separately to each patient.
AUROBINDO 30 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL -- 30 Tablets Bottle
(click image for full-size original)

RABEPRAZOLE SODIUM rabeprazole sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:65862-721-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:65862-721-90 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 — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-721), MANUFACTURE (65862-721)

Revised: 02/2024 Aurobindo Pharma Limited

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