FDA.reportPublic FDA data

AcipHex

Product NDC
62856-243
11-digit product format
628560243
Labeler code
62856
Product ID
62856-243_e00fa711-01d4-48ba-9c3a-594fb6abff02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Eisai Inc.
Application
NDA020973
Marketing category
NDA
Marketing start
1999-08-19
Marketing end
0000-00-00
Substance
RABEPRAZOLE SODIUM
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4Product name420180626
9a0b93b8-7081-4ac2-867c-2955b2d759fdProduct name220170909
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62856-243-302024-01-30C16284748780-11030e365-1d8f-111a-e063-dadaa90a10e2These 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 . A CIPHEX ® (rabeprazole sodium) d elayed - r elease t ablets , for oral use Initial U.S. Approval: 1999
62856-243-412024-01-30C16284748780-11030e365-1d8f-111a-e063-dadaa90a10e2These 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 . A CIPHEX ® (rabeprazole sodium) d elayed - r elease t ablets , for oral use Initial U.S. Approval: 1999
62856-243-902024-01-30C16284748780-11030e365-1d8f-111a-e063-dadaa90a10e2These 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 . A CIPHEX ® (rabeprazole sodium) d elayed - r elease t ablets , for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62856-243-30AcipHex30 in 1 BOTTLETABLET, DELAYED RELEASE3045
62856-243-41AcipHex100 in 1 CARTONTABLET, DELAYED RELEASE10045
62856-243-41AcipHex1 in 1 BLISTER PACKTABLET, DELAYED RELEASE145
62856-243-90AcipHex90 in 1 BOTTLETABLET, DELAYED RELEASE9045

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62856-243-30EA - Each62856-2433e2e57a7-c262-4ed2-94d0-94ec60491d8812012-07-24
62856-243-90EA - Each62856-2431a83b15c-4f73-4dbc-98fa-8c2364f7dd9b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RABEPRAZOLE SODIUMACTIVE INGREDIENT3L36P16U4RACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
RABEPRAZOLEACTIVE MOIETY32828355LLACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
MANNITOLINACTIVE INGREDIENT3OWL53L36AACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
TALCINACTIVE INGREDIENT7SEV7J4R1UACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]23
RABEPRAZOLE SODIUMACTIVE INGREDIENT3L36P16U4RACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
RABEPRAZOLE SODIUMACTIVE INGREDIENT3L36P16U4RACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
RABEPRAZOLEACTIVE MOIETY32828355LLACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
RABEPRAZOLEACTIVE MOIETY32828355LLACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62856-243ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [EISAI INC.]45Legacy NDC, 4 package rows20220105_5d103551-978f-472a-9c62-51e6e4dea068.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854870AcipHex 20 MG Delayed Release Oral TabletPSN5d103551-978f-472a-9c62-51e6e4dea06845
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN5d103551-978f-472a-9c62-51e6e4dea06845
854870rabeprazole sodium 20 MG Delayed Release Oral Tablet [Aciphex]SBD5d103551-978f-472a-9c62-51e6e4dea06845
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD5d103551-978f-472a-9c62-51e6e4dea06845
854870Aciphex 20 MG Delayed Release Oral TabletSY5d103551-978f-472a-9c62-51e6e4dea06845
854870AcipHex 20 MG Delayed Release Oral TabletPSN001dd372-2692-4d6f-a71c-95e7056349a93
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN001dd372-2692-4d6f-a71c-95e7056349a93
854870rabeprazole sodium 20 MG Delayed Release Oral Tablet [Aciphex]SBD001dd372-2692-4d6f-a71c-95e7056349a93
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD001dd372-2692-4d6f-a71c-95e7056349a93
854870Aciphex 20 MG Delayed Release Oral TabletSY001dd372-2692-4d6f-a71c-95e7056349a93
854870AcipHex 20 MG Delayed Release Oral TabletPSNdbfa7ae4-35af-4ed3-bca4-7900cd92047c2
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNdbfa7ae4-35af-4ed3-bca4-7900cd92047c2
854870rabeprazole sodium 20 MG Delayed Release Oral Tablet [Aciphex]SBDdbfa7ae4-35af-4ed3-bca4-7900cd92047c2
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDdbfa7ae4-35af-4ed3-bca4-7900cd92047c2
854870Aciphex 20 MG Delayed Release Oral TabletSYdbfa7ae4-35af-4ed3-bca4-7900cd92047c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62856-243-306285602433030 TABLET, DELAYED RELEASE in 1 BOTTLE (62856-243-30) 1999-08-190000-00-00NoNoCurrent
62856-243-4162856024341100 in 1 CARTONHistorical
62856-243-906285602439090 in 1 BOTTLEHistorical