Aciphex
These highlights do not include all the information needed to use ACIPHEX safely and effectively. See full prescribing information for ACIPHEX. ACIPHEX (rabeprazole sodium) tablet, delayed release for oral use Initial U.S. Approval: 1999
Approved
Approval ID
dbfa7ae4-35af-4ed3-bca4-7900cd92047c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4185
Application NumberNDA020973
Product Classification
M
Marketing Category
C73594
G
Generic Name
rabeprazole sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2011
FDA Product Classification
INGREDIENTS (12)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
RABEPRAZOLE SODIUMActive
Quantity: 20 mg in 1 1
Code: 3L36P16U4R
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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