FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
71335-1558
11-digit product format
713351558
Labeler code
71335
Product ID
71335-1558_cd70a996-b785-4b4b-b0d5-868c7aaf323e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205761
Marketing category
ANDA
Marketing start
2017-02-17
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rabeprazole Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RABEPRAZOLE SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3L36P16U4R
Rxcui854868

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4Product name420180626
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
9a0b93b8-7081-4ac2-867c-2955b2d759fdProduct name220170909

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1558-22024-05-20C16284748780-11030e365-2dd9-111a-e063-dadaa90a10e2These 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
71335-1558-32024-05-20C16284748780-11030e365-2dd9-111a-e063-dadaa90a10e2These 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
71335-1558-42024-05-20C16284748780-11030e365-2dd9-111a-e063-dadaa90a10e2These 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
71335-1558-52024-05-20C16284748780-11030e365-2dd9-111a-e063-dadaa90a10e2These 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
71335-1558-62024-05-20C16284748780-11030e365-2dd9-111a-e063-dadaa90a10e2These 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
71335-1558-22024-01-30C16284748780-11030e365-2dd9-111a-e063-dadaa90a10e2These 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
71335-1558-32024-01-30C16284748780-11030e365-2dd9-111a-e063-dadaa90a10e2These 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
71335-1558-42024-01-30C16284748780-11030e365-2dd9-111a-e063-dadaa90a10e2These 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
71335-1558-52024-01-30C16284748780-11030e365-2dd9-111a-e063-dadaa90a10e2These 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
71335-1558-62024-01-30C16284748780-11030e365-2dd9-111a-e063-dadaa90a10e2These 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1558-2Rabeprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE904
71335-1558-3Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE304
71335-1558-4Rabeprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE604
71335-1558-5Rabeprazole Sodium28 in 1 BOTTLETABLET, DELAYED RELEASE284
71335-1558-6Rabeprazole Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1558-3EA - Each71335-155815958c1e-2982-4078-8e88-ea124706d79012025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1558RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 5 package rows20240522_b35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNb35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf4
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDb35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1558-27133515580290 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1558-2) 2022-05-020000-00-00NoNoCurrent
71335-1558-37133515580330 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1558-3) 2020-04-200000-00-00NoNoCurrent
71335-1558-47133515580460 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1558-4) 2020-06-080000-00-00NoNoCurrent
71335-1558-57133515580528 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1558-5) 2022-05-020000-00-00NoNoCurrent
71335-1558-671335155806120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1558-6) 2022-05-020000-00-00NoNoCurrent