FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
68071-2215
11-digit product format
680712215
Labeler code
68071
Product ID
68071-2215_23838cc7-f093-d306-e063-6394a90a1647
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202882
Marketing category
ANDA
Marketing start
2014-09-10
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
68071-2215-42022-02-18C16284748780-1d6a99b39-41dd-a426-e053-dadaa90af4c2These 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
68071-2215-42022-01-28C16284748780-1d6a99b39-41dd-a426-e053-dadaa90af4c2These 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
68071-2215-3PANTOPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE305
68071-2215-4PANTOPRAZOLE SODIUM14 in 1 BOTTLETABLET, DELAYED RELEASE145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2215PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 2 package rows20241004_a9f32edf-e0b9-4e96-e053-2a95a90afbc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNa9f32edf-e0b9-4e96-e053-2a95a90afbc85
314200pantoprazole 40 MG Delayed Release Oral TabletSCDa9f32edf-e0b9-4e96-e053-2a95a90afbc85
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYa9f32edf-e0b9-4e96-e053-2a95a90afbc85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2215-36807122150330 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-2215-3) 2020-07-080000-00-00NoNoCurrent
68071-2215-46807122150414 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-2215-4) 2020-07-080000-00-00NoNoCurrent