FDA.reportPublic FDA data

Pantoprazole

Product NDC
68071-2891
11-digit product format
680712891
Labeler code
68071
Product ID
68071-2891_f18ca2ba-b401-0d88-e053-2a95a90a76f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077619
Marketing category
ANDA
Marketing start
2011-01-19
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
2024-12-31
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
68071-2891-32025-01-30C16284748780-12cef2736-b333-d83d-e063-dadaa90ab31fThese 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
68071-2891-62025-01-30C16284748780-12cef2736-b333-d83d-e063-dadaa90ab31fThese 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
68071-2891-3Pantoprazole30 in 1 BOTTLETABLET, DELAYED RELEASE303
68071-2891-6Pantoprazole60 in 1 BOTTLETABLET, DELAYED RELEASE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2891PANTOPRAZOLE TABLET, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 2 package rows20231019_eeb5f3b4-5e6e-8bec-e053-2995a90a6457.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNeeb5f3b4-5e6e-8bec-e053-2995a90a64573
251872pantoprazole 20 MG Delayed Release Oral TabletSCDeeb5f3b4-5e6e-8bec-e053-2995a90a64573
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYeeb5f3b4-5e6e-8bec-e053-2995a90a64573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2891-36807128910330 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-2891-3) 2023-01-050000-00-00NoNoCurrent
68071-2891-66807128910660 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-2891-6) 2022-11-300000-00-00NoNoCurrent