Aciphex
These highlights do not include all the information needed to use ACIPHEX DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for ACIPHEX DELAYED-RELEASE TABLETS. ACIPHEX (rabeprazole sodium) delayed-release tablets, for oral use Initial U.S. Approval: 1999
Approved
Approval ID
1eb38279-0237-4967-be7a-c53a826c1138
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2023
Manufacturers
FDA
Waylis Therapeutics LLC
DUNS: 117678921
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 Code80725-243
Application NumberNDA020973
Product Classification
M
Marketing Category
C73594
G
Generic Name
rabeprazole sodium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2023
FDA Product Classification
INGREDIENTS (16)
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
rabeprazole sodiumActive
Quantity: 20 mg in 1 1
Code: 3L36P16U4R
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USF
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT