FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
50090-4905
11-digit product format
500904905
Labeler code
50090
Product ID
50090-4905_c6051e97-9ad5-4aab-9794-02057eb68b5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078281
Marketing category
ANDA
Marketing start
2011-01-20
Marketing end
0000-00-00
Substance
PANTOPRAZOLE SODIUM
Active strength
40 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
50090-4905-02023-01-30C16284748780-1f386c649-d906-0266-e053-dadaa90a7c1aThese 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
50090-4905-12023-01-30C16284748780-1f386c649-d906-0266-e053-dadaa90a7c1aThese 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
50090-4905-0Pantoprazole Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE10001
50090-4905-1Pantoprazole Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4905PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20210303_95640d00-4047-43cd-b1d7-8aa34fc974cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN95640d00-4047-43cd-b1d7-8aa34fc974cd1
314200pantoprazole 40 MG Delayed Release Oral TabletSCD95640d00-4047-43cd-b1d7-8aa34fc974cd1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY95640d00-4047-43cd-b1d7-8aa34fc974cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4905-0500904905001000 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4905-0) 2020-02-170000-00-00NoNoCurrent
50090-4905-1500904905011000 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4905-1) 2020-04-060000-00-00NoNoCurrent