FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
50090-5793
11-digit product format
500905793
Labeler code
50090
Product ID
50090-5793_0f5a6040-d8d9-4620-aef7-b25f2cd64201
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202882
Marketing category
ANDA
Marketing start
2014-09-10
Substance
PANTOPRAZOLE SODIUM
Active strength
20 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 SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui251872

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
50090-5793-02023-02-07C16284748780-1f386c649-e765-0266-e053-dadaa90a7c1aThese 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
50090-5793-12023-02-07C16284748780-1f386c649-e765-0266-e053-dadaa90a7c1aThese 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
50090-5793-22023-02-07C16284748780-1f386c649-e765-0266-e053-dadaa90a7c1aThese 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
50090-5793-02023-01-30C16284748780-1f386c649-e765-0266-e053-dadaa90a7c1aThese 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
50090-5793-12023-01-30C16284748780-1f386c649-e765-0266-e053-dadaa90a7c1aThese 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
50090-5793-22023-01-30C16284748780-1f386c649-e765-0266-e053-dadaa90a7c1aThese 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
50090-5793-0PANTOPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE607
50090-5793-1PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE907
50090-5793-2PANTOPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5793-0EA - Each50090-57935ef6bb66-7f80-483d-a3a5-d8461985747412023-03-13
50090-5793-1EA - Each50090-5793816c513e-b5d1-43de-9145-2ac12858204612023-03-13
50090-5793-2EA - Each50090-5793122c96b1-49d1-4622-9035-1b0be631680312022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5793PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 3 package rows20240426_39ba58cc-e4ef-4b82-a0f3-9583fa123a38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN39ba58cc-e4ef-4b82-a0f3-9583fa123a387
251872pantoprazole 20 MG Delayed Release Oral TabletSCD39ba58cc-e4ef-4b82-a0f3-9583fa123a387
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY39ba58cc-e4ef-4b82-a0f3-9583fa123a387

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5793-05009057930060 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-5793-0) 2021-10-110000-00-00NoNoCurrent
50090-5793-15009057930190 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-5793-1) 2021-10-110000-00-00NoNoCurrent
50090-5793-25009057930230 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-5793-2) 2021-10-110000-00-00NoNoCurrent