FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
71335-1429
11-digit product format
713351429
Labeler code
71335
Product ID
71335-1429_5f80809c-74f4-49e3-863e-d9c1244ba956
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090970
Marketing category
ANDA
Marketing start
2011-01-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui314200

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
71335-1429-12024-05-21C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-22024-05-21C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-32024-05-21C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-42024-05-21C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-52024-05-21C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-62024-05-21C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-72024-05-21C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-82024-05-21C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-92024-05-21C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-12024-01-30C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-22024-01-30C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-32024-01-30C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-42024-01-30C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-52024-01-30C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-62024-01-30C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-72024-01-30C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-82024-01-30C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-92024-01-30C16284748780-11030e365-34b2-111a-e063-dadaa90a10e2These 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
71335-1429-1Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE906
71335-1429-2Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE306
71335-1429-3Pantoprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE606
71335-1429-4Pantoprazole Sodium58 in 1 BOTTLETABLET, DELAYED RELEASE586
71335-1429-5Pantoprazole Sodium14 in 1 BOTTLETABLET, DELAYED RELEASE146
71335-1429-6Pantoprazole Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE1006
71335-1429-7Pantoprazole Sodium10 in 1 BOTTLETABLET, DELAYED RELEASE106
71335-1429-8Pantoprazole Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE1206
71335-1429-9Pantoprazole Sodium180 in 1 BOTTLETABLET, DELAYED RELEASE1806

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1429-1EA - Each71335-1429bf6ea35c-aaec-453d-b112-2aabac06bed112021-07-15
71335-1429-2EA - Each71335-14298d086cbd-5538-4651-8871-4c35e275ff7f12021-07-15
71335-1429-3EA - Each71335-1429c4384349-b0b8-49ed-a70c-4607fd8985a012021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1429PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 9 package rows20240522_7d51104d-b135-421f-8425-03b5772e7103.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN7d51104d-b135-421f-8425-03b5772e71036
314200pantoprazole 40 MG Delayed Release Oral TabletSCD7d51104d-b135-421f-8425-03b5772e71036
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY7d51104d-b135-421f-8425-03b5772e71036

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1429-17133514290190 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1429-1) 2019-12-090000-00-00NoNoCurrent
71335-1429-27133514290230 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1429-2) 2019-12-190000-00-00NoNoCurrent
71335-1429-37133514290360 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1429-3) 2020-01-200000-00-00NoNoCurrent
71335-1429-47133514290458 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1429-4) 2024-05-200000-00-00NoNoCurrent
71335-1429-57133514290514 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1429-5) 2024-05-200000-00-00NoNoCurrent
71335-1429-671335142906100 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1429-6) 2024-05-200000-00-00NoNoCurrent
71335-1429-77133514290710 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1429-7) 2024-05-200000-00-00NoNoCurrent
71335-1429-871335142908120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1429-8) 2024-05-200000-00-00NoNoCurrent
71335-1429-971335142909180 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1429-9) 2024-05-200000-00-00NoNoCurrent