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
7dc9ffa8-9d10-b5a3-e053-2991aa0a5118
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 24, 2018
Manufacturers
FDA
medsource pharmaceuticals
DUNS: 833685915
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
NDC Product Code45865-802
Application NumberANDA078964
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 24, 2018
Generic NameRABEPRAZOLE SODIUM
INGREDIENTS (19)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
RABEPRAZOLE SODIUMActive
Quantity: 20 mg in 1 1
Code: 3L36P16U4R
Classification: ACTIB