FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
33261-629
11-digit product format
332610629
Labeler code
33261
Product ID
33261-629_05549cf2-8db6-4a3c-aa48-16beec5691be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078281
Marketing category
ANDA
Marketing start
2017-11-16
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
33261-629-902020-01-31C16284748780-19d75b9cf-def2-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
33261-629-90Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-629-90EA - Each33261-629fbfb4c51-5afe-499a-8f3a-5ba3c0fd706212018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-629PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180814_3d081e89-cc4b-411d-8f2a-5ba345e35a37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN3d081e89-cc4b-411d-8f2a-5ba345e35a371
314200pantoprazole 40 MG Delayed Release Oral TabletSCD3d081e89-cc4b-411d-8f2a-5ba345e35a371
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY3d081e89-cc4b-411d-8f2a-5ba345e35a371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-629-903326106299090 in 1 BOTTLEHistorical