FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
50436-0712
11-digit product format
504360712
Labeler code
50436
Product ID
50436-0712_ae162219-9aba-4fb6-a51f-2ff19e24b52a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA202882
Marketing category
ANDA
Marketing start
2014-09-10
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
2022-12-31
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
50436-0712-22023-01-30C16284748780-19d75b9d0-9b47-f424-e053-dadaa90a57ceThese 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
50436-0712-22021-08-24C16284748780-19d75b9d0-9b47-f424-e053-dadaa90a57ceThese 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
50436-0712-22020-01-31C16284748780-19d75b9d0-9b47-f424-e053-dadaa90a57ceThese 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
50436-0712-2PANTOPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE609

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0712PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]9Legacy NDC, 1 package rows20210825_e7cb5fa2-8d3b-4fbb-b70b-72f9f831765f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNe7cb5fa2-8d3b-4fbb-b70b-72f9f831765f9
251872pantoprazole 20 MG Delayed Release Oral TabletSCDe7cb5fa2-8d3b-4fbb-b70b-72f9f831765f9
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYe7cb5fa2-8d3b-4fbb-b70b-72f9f831765f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-0712-25043607120260 TABLET, DELAYED RELEASE in 1 BOTTLE (50436-0712-2) 2016-07-040000-00-00NoNoCurrent