FDA.reportPublic FDA data

Rabeprazole sodium

Product NDC
50090-3182
11-digit product format
500903182
Labeler code
50090
Product ID
50090-3182_49beeddd-9818-4713-b1cd-1de19823f380
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202376
Marketing category
ANDA
Marketing start
2013-11-08
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
50090-3182-02023-01-30C16284748780-1f386c64a-43cd-0266-e053-dadaa90a7c1aThese 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
50090-3182-12023-01-30C16284748780-1f386c64a-43cd-0266-e053-dadaa90a7c1aThese 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
50090-3182-22023-01-30C16284748780-1f386c64a-43cd-0266-e053-dadaa90a7c1aThese 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
50090-3182-0Rabeprazole sodium30 in 1 BOTTLETABLET, DELAYED RELEASE307
50090-3182-1Rabeprazole sodium90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE907
50090-3182-2Rabeprazole sodium60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3182-0EA - Each50090-31826bc2b182-5d0d-4a12-bc06-20ac539045d112018-12-13
50090-3182-1EA - Each50090-3182a2dd8de0-2bf0-4cc5-b500-21c20e481ba612019-05-02
50090-3182-2EA - Each50090-31820aae8a2f-85e6-493f-be3b-38ea056fe0b212019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3182RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]7Legacy NDC, 3 package rows20190427_ea013e44-8b21-46c5-bedf-7e956a3b8aa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSNea013e44-8b21-46c5-bedf-7e956a3b8aa57
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCDea013e44-8b21-46c5-bedf-7e956a3b8aa57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3182-05009031820030 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-3182-0) 2018-01-020000-00-00NoNoCurrent
50090-3182-15009031820190 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (50090-3182-1) 2014-11-280000-00-00NoNoCurrent
50090-3182-25009031820260 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (50090-3182-2) 2014-11-280000-00-00NoNoCurrent