FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
80425-0179
11-digit product format
804250179
Labeler code
80425
Product ID
80425-0179_2a99a7c1-c4c4-2b01-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
ANDA090970
Marketing category
ANDA
Marketing start
2011-01-19
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
Brand name suffix
DR
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
80425-0179-2Pantoprazole SodiumDR60 in 1 BOTTLETABLET, DELAYED RELEASE605
80425-0179-3Pantoprazole SodiumDR90 in 1 BOTTLETABLET, DELAYED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0179-2EA - Each80425-0179ec85c5fc-4329-4ce3-8b1f-b2f89920fac512023-04-07
80425-0179-3EA - Each80425-0179ea4e3343-e0e2-4eae-b3c9-2b33fcda718412023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0179PANTOPRAZOLE SODIUM DR (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 2 package rows20250101_d27e1fdd-e23f-0d60-e053-2a95a90a9087.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNd27e1fdd-e23f-0d60-e053-2a95a90a90875
251872pantoprazole 20 MG Delayed Release Oral TabletSCDd27e1fdd-e23f-0d60-e053-2a95a90a90875
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYd27e1fdd-e23f-0d60-e053-2a95a90a90875

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0179-28042501790260 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0179-2) 2011-01-190000-00-00NoNoCurrent
80425-0179-38042501790390 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0179-3) 2011-01-190000-00-00NoNoCurrent