FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
50090-3145
11-digit product format
500903145
Labeler code
50090
Product ID
50090-3145_44dc5e7c-65e9-48a1-bd7d-876c16c6d80a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090678
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4Product name420180626
9a0b93b8-7081-4ac2-867c-2955b2d759fdProduct name220170909

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3145-02023-01-30C16284748780-1f386c649-c018-0266-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
50090-3145-12023-01-30C16284748780-1f386c649-c018-0266-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
50090-3145-22023-01-30C16284748780-1f386c649-c018-0266-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
50090-3145-0Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE309
50090-3145-1Rabeprazole Sodium90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE909
50090-3145-2Rabeprazole Sodium60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3145-0EA - Each50090-314552c2929d-fb1f-4c61-a00f-087361b5b93d12019-05-02
50090-3145-1EA - Each50090-314553f07902-258a-4df2-b6bc-bb523c47067a12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3145RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]9Legacy NDC, 3 package rows20210417_6b34e763-d874-46a4-98ac-261fdec62a87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN6b34e763-d874-46a4-98ac-261fdec62a879
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD6b34e763-d874-46a4-98ac-261fdec62a879

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3145-05009031450030 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-3145-0) 2017-09-280000-00-00NoNoCurrent
50090-3145-15009031450190 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (50090-3145-1) 2014-11-280000-00-00NoNoCurrent
50090-3145-25009031450260 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (50090-3145-2) 2014-11-280000-00-00NoNoCurrent