FDA.reportPublic FDA data

Protonix

Product NDC
67296-0029
11-digit product format
672960029
Labeler code
67296
Product ID
67296-0029_d7c5336e-3b00-2763-e053-2a95a90ae78f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
NDA020987
Marketing category
NDA
Marketing start
2000-05-01
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
67296-0029-72024-01-30C16284748780-11030e364-fd19-111a-e063-dadaa90a10e2PROTONIX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0029-7ProtonixDelayed-Release14 in 1 BOTTLETABLET, DELAYED RELEASE146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0029PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [REDPHARM DRUG, INC.]6Legacy NDC, 1 package rows20220212_d7c43ad6-99b8-16fb-e053-2995a90a3ff2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNd7c43ad6-99b8-16fb-e053-2995a90a3ff26
284400Protonix 40 MG Delayed Release Oral TabletPSNd7c43ad6-99b8-16fb-e053-2995a90a3ff26
284400pantoprazole 40 MG Delayed Release Oral Tablet [Protonix]SBDd7c43ad6-99b8-16fb-e053-2995a90a3ff26
314200pantoprazole 40 MG Delayed Release Oral TabletSCDd7c43ad6-99b8-16fb-e053-2995a90a3ff26
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYd7c43ad6-99b8-16fb-e053-2995a90a3ff26
284400Protonix 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYd7c43ad6-99b8-16fb-e053-2995a90a3ff26
284400Protonix 40 MG Delayed Release Oral TabletSYd7c43ad6-99b8-16fb-e053-2995a90a3ff26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-0029-76729600290714 TABLET, DELAYED RELEASE in 1 BOTTLE (67296-0029-7) 2000-05-010000-00-00NoNoCurrent