Rabeprazole Sodium
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
c1910485-1954-4fbe-9717-4cb9e6fe84a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 18, 2020
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-3430
Application NumberANDA204237
Product Classification
M
Marketing Category
C73584
G
Generic Name
RABEPRAZOLE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2017
FDA Product Classification
INGREDIENTS (16)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
RABEPRAZOLE SODIUMActive
Quantity: 20 mg in 1 1
Code: 3L36P16U4R
Classification: ACTIB
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT