FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
80425-0133
11-digit product format
804250133
Labeler code
80425
Product ID
80425-0133_2a99a7c1-c4bc-2b01-e063-6294a90aa3b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA202882
Marketing category
ANDA
Marketing start
2014-09-10
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
Brand name suffix
DR
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0133-1Pantoprazole SodiumDR30 in 1 BOTTLETABLET, DELAYED RELEASE309
80425-0133-2Pantoprazole SodiumDR60 in 1 BOTTLETABLET, DELAYED RELEASE609
80425-0133-3Pantoprazole SodiumDR90 in 1 BOTTLETABLET, DELAYED RELEASE909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0133PANTOPRAZOLE SODIUM DR (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 3 package rows20250101_bd4759ac-46b5-6903-e053-2a95a90a6319.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNbd4759ac-46b5-6903-e053-2a95a90a63199
314200pantoprazole 40 MG Delayed Release Oral TabletSCDbd4759ac-46b5-6903-e053-2a95a90a63199
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYbd4759ac-46b5-6903-e053-2a95a90a63199

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0133-18042501330130 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0133-1) 2014-09-100000-00-00NoNoCurrent
80425-0133-28042501330260 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0133-2) 2014-09-100000-00-00NoNoCurrent
80425-0133-38042501330390 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0133-3) 2014-09-100000-00-00NoNoCurrent