FDA.reportPublic FDA data

RABEPRAZOLE SODIUM

Product NDC
45865-802
11-digit product format
458650802
Labeler code
45865
Product ID
45865-802_7dc9ffa8-9d11-b5a3-e053-2991aa0a5118
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RABEPRAZOLE SODIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA078964
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
45865-802-302025-01-30C16284748780-12cef2736-a8cb-d83d-e063-dadaa90ab31fThese 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
45865-802-602025-01-30C16284748780-12cef2736-a8cb-d83d-e063-dadaa90ab31fThese 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
45865-802-30RABEPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE302
45865-802-60RABEPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-802RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20181225_7dc9ffa8-9d10-b5a3-e053-2991aa0a5118.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN7dc9ffa8-9d10-b5a3-e053-2991aa0a51182
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD7dc9ffa8-9d10-b5a3-e053-2991aa0a51182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-802-304586508023030 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-802-30) 2018-06-010000-00-00NoNoCurrent
45865-802-604586508026060 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-802-60) 2018-06-010000-00-00NoNoCurrent