FDA.reportPublic FDA data

Pantoprazole

Product NDC
68071-3524
11-digit product format
680713524
Labeler code
68071
Product ID
68071-3524_2d3f76b4-d1b8-0d4a-e063-6294a90ac5f9
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
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui314200

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3524-32025-02-03C16284748780-12cef2736-9c3f-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
68071-3524-32025-01-30C16284748780-12cef2736-9c3f-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
68071-3524-3Pantoprazole30 in 1 BOTTLETABLET, DELAYED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3524PANTOPRAZOLE TABLET, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250205_07ff83f9-7039-ac26-e063-6394a90a37ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN07ff83f9-7039-ac26-e063-6394a90a37ce2
314200pantoprazole 40 MG Delayed Release Oral TabletSCD07ff83f9-7039-ac26-e063-6394a90a37ce2
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY07ff83f9-7039-ac26-e063-6394a90a37ce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3524-36807135240330 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3524-3) 2023-10-18NoNoCurrent