Rabeprazole Sodium (Page 10 of 10)

image description
(click image for full-size original)

RABEPRAZOLE SODIUM rabeprazole sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-767(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:55700-767-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:55700-767-60 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 06/21/2019
Labeler — Quality Care Products, LLC (831276758)
Establishment
Name Address ID/FEI Operations
Quality Care Products, LLC 831276758 repack (55700-767)

Revised: 04/2020 Quality Care Products, LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.