FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
53002-1419
11-digit product format
530021419
Labeler code
53002
Product ID
53002-1419_d3c9b311-6f15-496a-b075-e08d2440722a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA078281
Marketing category
ANDA
Marketing start
2011-01-20
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
2021-12-31
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
53002-1419-32025-01-30C16284748780-19d75b9d0-4327-f424-e053-dadaa90a57ceThese 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
53002-1419-92025-01-30C16284748780-19d75b9d0-4327-f424-e053-dadaa90a57ceThese 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
53002-1419-32023-06-07C16284748780-19d75b9d0-4327-f424-e053-dadaa90a57ceThese 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
53002-1419-92023-06-07C16284748780-19d75b9d0-4327-f424-e053-dadaa90a57ceThese 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
53002-1419-32023-01-30C16284748780-19d75b9d0-4327-f424-e053-dadaa90a57ceThese 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
53002-1419-92023-01-30C16284748780-19d75b9d0-4327-f424-e053-dadaa90a57ceThese 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
53002-1419-32020-12-16C16284748780-19d75b9d0-4327-f424-e053-dadaa90a57ceThese 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
53002-1419-92020-12-16C16284748780-19d75b9d0-4327-f424-e053-dadaa90a57ceThese 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
53002-1419-32020-01-31C16284748780-19d75b9d0-4327-f424-e053-dadaa90a57ceThese 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
53002-1419-92020-01-31C16284748780-19d75b9d0-4327-f424-e053-dadaa90a57ceThese 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
53002-1419-3Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE305
53002-1419-9Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1419PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_ee7f6011-09dc-405d-8fd7-cd48e8bfa71a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNee7f6011-09dc-405d-8fd7-cd48e8bfa71a5
314200pantoprazole 40 MG Delayed Release Oral TabletSCDee7f6011-09dc-405d-8fd7-cd48e8bfa71a5
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYee7f6011-09dc-405d-8fd7-cd48e8bfa71a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1419-35300214190330 TABLET, DELAYED RELEASE in 1 BOTTLE (53002-1419-3) 2017-09-010000-00-00NoNoCurrent
53002-1419-95300214190990 TABLET, DELAYED RELEASE in 1 BOTTLE (53002-1419-9) 2017-09-010000-00-00NoNoCurrent