Rabeprazole Sodium
Rabeprazole Sodium Delayed-Release Tablets These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999
Approved
Approval ID
c5c43222-d167-4152-b5c7-84b55920a7ce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 2, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rabeprazole Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-503
Application NumberANDA090678
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rabeprazole Sodium
Product Specifications
Route of AdministrationORAL
Effective DateMay 2, 2023
FDA Product Classification
INGREDIENTS (1)
RABEPRAZOLE SODIUMActive
Quantity: 20 mg in 1 1
Code: 3L36P16U4R
Classification: ACTIB