FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
67046-534
11-digit product format
670460534
Labeler code
67046
Product ID
67046-534_59b5bb7c-89cc-4ae6-e053-2991aa0ad7f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA077056
Marketing category
ANDA
Marketing start
2017-09-21
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
67046-534-072022-01-28C16284748780-1d6a99b39-68a1-a426-e053-dadaa90af4c2534 Pantoprazole 40 mg These 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
67046-534-142022-01-28C16284748780-1d6a99b39-68a1-a426-e053-dadaa90af4c2534 Pantoprazole 40 mg These 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
67046-534-152022-01-28C16284748780-1d6a99b39-68a1-a426-e053-dadaa90af4c2534 Pantoprazole 40 mg These 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
67046-534-202022-01-28C16284748780-1d6a99b39-68a1-a426-e053-dadaa90af4c2534 Pantoprazole 40 mg These 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
67046-534-212022-01-28C16284748780-1d6a99b39-68a1-a426-e053-dadaa90af4c2534 Pantoprazole 40 mg These 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
67046-534-282022-01-28C16284748780-1d6a99b39-68a1-a426-e053-dadaa90af4c2534 Pantoprazole 40 mg These 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
67046-534-302022-01-28C16284748780-1d6a99b39-68a1-a426-e053-dadaa90af4c2534 Pantoprazole 40 mg These 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
67046-534-602022-01-28C16284748780-1d6a99b39-68a1-a426-e053-dadaa90af4c2534 Pantoprazole 40 mg These 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
67046-534-07Pantoprazole Sodium7 in 1 BLISTER PACKTABLET, DELAYED RELEASE71
67046-534-14Pantoprazole Sodium14 in 1 BLISTER PACKTABLET, DELAYED RELEASE141
67046-534-15Pantoprazole Sodium15 in 1 BLISTER PACKTABLET, DELAYED RELEASE151
67046-534-20Pantoprazole Sodium20 in 1 BLISTER PACKTABLET, DELAYED RELEASE201
67046-534-21Pantoprazole Sodium21 in 1 BLISTER PACKTABLET, DELAYED RELEASE211
67046-534-28Pantoprazole Sodium28 in 1 BLISTER PACKTABLET, DELAYED RELEASE281
67046-534-30Pantoprazole Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE301
67046-534-60Pantoprazole Sodium60 in 1 BLISTER PACKTABLET, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-534PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170921_59b5bb7c-89cb-4ae6-e053-2991aa0ad7f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN59b5bb7c-89cb-4ae6-e053-2991aa0ad7f11
314200pantoprazole 40 MG Delayed Release Oral TabletSCD59b5bb7c-89cb-4ae6-e053-2991aa0ad7f11
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY59b5bb7c-89cb-4ae6-e053-2991aa0ad7f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-534-07670460534077 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-534-07) 2017-09-210000-00-00NoNoCurrent
67046-534-146704605341414 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-534-14) 2017-09-210000-00-00NoNoCurrent
67046-534-156704605341515 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-534-15) 2017-09-210000-00-00NoNoCurrent
67046-534-206704605342020 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-534-20) 2017-09-210000-00-00NoNoCurrent
67046-534-216704605342121 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-534-21) 2017-09-210000-00-00NoNoCurrent
67046-534-286704605342828 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-534-28) 2017-09-210000-00-00NoNoCurrent
67046-534-306704605343030 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-534-30) 2017-09-210000-00-00NoNoCurrent
67046-534-606704605346060 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-534-60) 2017-09-210000-00-00NoNoCurrent