FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
50436-0429
11-digit product format
504360429
Labeler code
50436
Product ID
50436-0429_5ff6264f-9b0d-4eb0-8baa-b5189fb1312d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA090074
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
2019-12-31
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
50436-0429-12020-01-31C16284748780-19d75b9cf-e060-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
50436-0429-1Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0429PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3Legacy NDC, 1 package rows20180929_8fbb2e3d-6354-401d-a403-b2541081e096.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN8fbb2e3d-6354-401d-a403-b2541081e0963
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN8fbb2e3d-6354-401d-a403-b2541081e0963
251872pantoprazole 20 MG Delayed Release Oral TabletSCD8fbb2e3d-6354-401d-a403-b2541081e0963
314200pantoprazole 40 MG Delayed Release Oral TabletSCD8fbb2e3d-6354-401d-a403-b2541081e0963
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY8fbb2e3d-6354-401d-a403-b2541081e0963
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY8fbb2e3d-6354-401d-a403-b2541081e0963

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0429-15043604290130 in 1 BOTTLEHistorical