FDA.reportPublic FDA data

RABEPRAZOLE SODIUM

Product NDC
61919-467
11-digit product format
619190467
Labeler code
61919
Product ID
61919-467_a5b3a886-074b-a9b4-e053-2a95a90a8334
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RABEPRAZOLE SODIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090678
Marketing category
ANDA
Marketing start
2020-03-02
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
2021-12-31
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
61919-467-302025-01-30C16284748780-12cef2736-a2cb-d83d-e063-dadaa90ab31fRABEPRAZOLE SODIUM
61919-467-602025-01-30C16284748780-12cef2736-a2cb-d83d-e063-dadaa90ab31fRABEPRAZOLE SODIUM
61919-467-902025-01-30C16284748780-12cef2736-a2cb-d83d-e063-dadaa90ab31fRABEPRAZOLE SODIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-467-30RABEPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE303
61919-467-60RABEPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE603
61919-467-90RABEPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-467-30EA - Each61919-467d72d50e5-cc98-4359-95f4-fec53d26378512020-03-10
61919-467-60EA - Each61919-46701fb9395-a998-4f0a-992e-74138f149c2112020-09-14
61919-467-90EA - Each61919-4674cb0aa3c-2ae2-4ffe-b925-47c78817f34412020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-467RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECT RX]3Legacy NDC, 3 package rows20230425_9fe50049-72a7-0284-e053-2a95a90a93b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN9fe50049-72a7-0284-e053-2a95a90a93b23
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD9fe50049-72a7-0284-e053-2a95a90a93b23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-467-306191904673030 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-467-30) 2020-03-020000-00-00NoNoCurrent
61919-467-606191904676060 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-467-60) 2020-03-020000-00-00NoNoCurrent
61919-467-906191904679090 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-467-90) 2020-03-020000-00-00NoNoCurrent