Rabeprazole Sodium (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rabeprazole Sodium Delayed-Release Tablets 20 mg

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RABEPRAZOLE SODIUM rabeprazole sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-107
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
TITANIUM DIOXIDE
DIETHYL PHTHALATE
ETHYLCELLULOSES
FERRIC OXIDE YELLOW
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
MAGNESIUM OXIDE
MAGNESIUM STEARATE
MANNITOL
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 107
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-107-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:13668-107-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE None
3 NDC:13668-107-74 100 TABLET, DELAYED RELEASE in 1 CARTON None
4 NDC:13668-107-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE None
5 NDC:13668-107-40 4000 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202376 11/08/2013
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 manufacture (13668-107)

Revised: 12/2020 Torrent Pharmaceuticals Limited

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