FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
67296-1812
11-digit product format
672961812
Labeler code
67296
Product ID
67296-1812_d61cf246-1d23-3017-e053-2a95a90ab32e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
RedPharm Drug
Application
ANDA202038
Marketing category
ANDA
Marketing start
2012-09-28
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
2023-12-31
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
67296-1812-72026-01-29C16284748780-11030e365-36f5-111a-e063-dadaa90a10e2Pantoprazole DR 40mg
67296-1812-72024-07-25C16284748780-11030e365-36f5-111a-e063-dadaa90a10e2Pantoprazole DR 40mg
67296-1812-72024-01-30C16284748780-11030e365-36f5-111a-e063-dadaa90a10e2Pantoprazole DR 40mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1812-7Pantoprazole Sodium14 in 1 BOTTLETABLET, DELAYED RELEASE149

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1812PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [REDPHARM DRUG]9Legacy NDC, 1 package rows20240727_b2d26299-a48e-7b23-e053-2a95a90ae9e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNb2d26299-a48e-7b23-e053-2a95a90ae9e69
314200pantoprazole 40 MG Delayed Release Oral TabletSCDb2d26299-a48e-7b23-e053-2a95a90ae9e69
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYb2d26299-a48e-7b23-e053-2a95a90ae9e69

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1812-76729618120714 TABLET, DELAYED RELEASE in 1 BOTTLE (67296-1812-7) 2012-09-280000-00-00NoNoCurrent