FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
67046-536
11-digit product format
670460536
Labeler code
67046
Product ID
67046-536_7d65b248-5324-8a2f-e053-2a91aa0a1209
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
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
2020-12-31
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
67046-536-142022-01-28C16284748780-1d6a99b39-3542-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 536 Initial U.S. approval: 2000
67046-536-302022-01-28C16284748780-1d6a99b39-3542-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 536 Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-536-14Pantoprazole Sodium14 in 1 BLISTER PACKTABLET, DELAYED RELEASE143
67046-536-30Pantoprazole Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-536PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]3Legacy NDC, 2 package rows20181220_58b379ed-8603-4c2d-e053-2991aa0a8919.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN58b379ed-8603-4c2d-e053-2991aa0a89193
314200pantoprazole 40 MG Delayed Release Oral TabletSCD58b379ed-8603-4c2d-e053-2991aa0a89193
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY58b379ed-8603-4c2d-e053-2991aa0a89193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-536-146704605361414 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-536-14) 2017-09-280000-00-00NoNoCurrent
67046-536-306704605363030 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-536-30) 2017-09-080000-00-00NoNoCurrent