FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
72189-112
11-digit product format
721890112
Labeler code
72189
Product ID
72189-112_2be8f6ba-3289-86ab-e063-6394a90acb89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA202882
Marketing category
ANDA
Marketing start
2020-06-12
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-112-30PANTOPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE304
72189-112-60PANTOPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE604
72189-112-90PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-112PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [DIRECT RX]4Current NDC, Legacy NDC, 3 package rows20250119_a7e7c1ab-3e75-1ff8-e053-2995a90a7539.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNa7e7c1ab-3e75-1ff8-e053-2995a90a75394
251872pantoprazole 20 MG Delayed Release Oral TabletSCDa7e7c1ab-3e75-1ff8-e053-2995a90a75394
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYa7e7c1ab-3e75-1ff8-e053-2995a90a75394

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-112-307218901123030 TABLET, DELAYED RELEASE in 1 BOTTLE (72189-112-30) 2020-06-120000-00-00NoNoCurrent
72189-112-607218901126060 TABLET, DELAYED RELEASE in 1 BOTTLE (72189-112-60) 2020-06-120000-00-00NoNoCurrent
72189-112-907218901129090 TABLET, DELAYED RELEASE in 1 BOTTLE (72189-112-90) 2020-06-120000-00-00NoNoCurrent