FDA.reportPublic FDA data

Rabeprazole Sodium

Product NDC
50436-0302
11-digit product format
504360302
Labeler code
50436
Product ID
50436-0302_2c7b54cd-e68b-408e-ad8c-cb946979a4d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rabeprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Unit Dose Services
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
2020-12-31
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
50436-0302-12021-01-29C16284748780-1ba0f9c33-2c9a-a910-e053-dadaa90a0b85These 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
50436-0302-1Rabeprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0302-1EA - Each50436-0302c21b64dc-adba-4190-a686-164ffc2d37df12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RABEPRAZOLE SODIUMACTIVE INGREDIENT3L36P16U4RRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]2
RABEPRAZOLEACTIVE MOIETY32828355LLRABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0302RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]4Legacy NDC, 1 package rows20170702_8699d125-0928-458f-a232-9864497c73cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854868RABEprazole sodium 20 MG Delayed Release Oral TabletPSN8699d125-0928-458f-a232-9864497c73cb4
854868rabeprazole sodium 20 MG Delayed Release Oral TabletSCD8699d125-0928-458f-a232-9864497c73cb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0302-15043603020130 in 1 BOTTLEHistorical