FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
68071-4917
11-digit product format
680714917
Labeler code
68071
Product ID
68071-4917_2d05a3f9-8e2a-3c79-e063-6294a90afc04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202038
Marketing category
ANDA
Marketing start
2012-09-28
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 Sodium
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
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4917-42021-02-18C16284748780-1ba0f9c33-2767-a910-e053-dadaa90a0b85These 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
68071-4917-42021-01-29C16284748780-1ba0f9c33-2767-a910-e053-dadaa90a0b85These 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
68071-4917-3Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4917PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20250202_8aac1642-6cb0-6ad2-e053-2a95a90a4cbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN8aac1642-6cb0-6ad2-e053-2a95a90a4cbd5
314200pantoprazole 40 MG Delayed Release Oral TabletSCD8aac1642-6cb0-6ad2-e053-2a95a90a4cbd5
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY8aac1642-6cb0-6ad2-e053-2a95a90a4cbd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4917-36807149170330 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4917-3) 2025-01-31NoNoHistorical
68071-4917-46807149170414 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4917-4) 2019-06-060000-00-00NoNoCurrent