FDA.reportPublic FDA data

Pantoprazole

Product NDC
72603-178
11-digit product format
726030178
Labeler code
72603
Product ID
72603-178_57338853-6995-de1e-62ca-be5505c8d656
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA077619
Marketing category
ANDA
Marketing start
2023-12-15
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui251872, 314200

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-178-01Pantoprazole90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-178PANTOPRAZOLE TABLET, DELAYED RELEASE [NORTHSTAR RXLLC]1Current NDC, 1 package rows20240104_82f0103a-2b97-d210-6d7d-c627d60ad694.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN82f0103a-2b97-d210-6d7d-c627d60ad6941
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN51033ddc-a11a-80fa-e063-6394a90ac54c1
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN82f0103a-2b97-d210-6d7d-c627d60ad6941
251872pantoprazole 20 MG Delayed Release Oral TabletSCD82f0103a-2b97-d210-6d7d-c627d60ad6941
314200pantoprazole 40 MG Delayed Release Oral TabletSCD51033ddc-a11a-80fa-e063-6394a90ac54c1
314200pantoprazole 40 MG Delayed Release Oral TabletSCD82f0103a-2b97-d210-6d7d-c627d60ad6941
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY82f0103a-2b97-d210-6d7d-c627d60ad6941
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY51033ddc-a11a-80fa-e063-6394a90ac54c1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY82f0103a-2b97-d210-6d7d-c627d60ad6941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-178-017260301780190 TABLET, DELAYED RELEASE in 1 BOTTLE (72603-178-01) 2023-12-15NoNoCurrent