Rabeprazole Sodium: Package Insert and Label Information (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NDC 65162-724-03

Rabeprazole Sodium Delayed-release Tablets, 20 mg

Rx only

30 Tablets

Amneal Pharmaceuticals LLC

30 s
(click image for full-size original)
RABEPRAZOLE SODIUM rabeprazole tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-724
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
AMMONIA
CROSPOVIDONE (12 MPA.S AT 5%)
DIETHYL PHTHALATE
ETHYLCELLULOSES
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
MAGNESIUM OXIDE
MANNITOL
MAGNESIUM STEARATE
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
SODIUM STEARYL FUMARATE
SHELLAC
TALC
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7mm
Flavor Imprint Code AR
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-724-03 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:65162-724-09 90 TABLET, DELAYED RELEASE in 1 BOTTLE None
3 NDC:65162-724-50 500 TABLET, DELAYED RELEASE in 1 BOTTLE None
4 NDC:65162-724-11 1000 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204179 10/01/2015
Labeler — Amneal Pharmaceuticals LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals Private Limited 915076126 analysis (65162-724), label (65162-724), manufacture (65162-724), pack (65162-724)

Revised: 05/2022 Amneal Pharmaceuticals LLC

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