FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
53808-1123
11-digit product format
538081123
Labeler code
53808
Product ID
53808-1123_60f27399-3537-4ba4-9211-4d21bae91978
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
ANDA202038
Marketing category
ANDA
Marketing start
2017-08-21
Marketing end
0000-00-00
Substance
PANTOPRAZOLE 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
ae9ebba7-ac9e-4a6e-90ef-4bd9760ec041Product name820260304
41d62193-73fc-49cf-9907-add9588e2da1Product name920260112
f12d0d0d-c068-46c6-872c-96c9d38533bbProduct name120250116
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-1123-12024-01-30C16284748780-11030e365-002a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1123-1Pantoprazole Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1123PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20190125_f92276a1-b286-489d-a372-f441e49cfd63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNf92276a1-b286-489d-a372-f441e49cfd631
251872pantoprazole 20 MG Delayed Release Oral TabletSCDf92276a1-b286-489d-a372-f441e49cfd631
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYf92276a1-b286-489d-a372-f441e49cfd631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53808-1123-15380811230130 TABLET, DELAYED RELEASE in 1 BLISTER PACK (53808-1123-1) 2017-08-210000-00-00NoNoCurrent