FDA.reportPublic FDA data

Pantoprazole Sodium DR

Product NDC
72189-514
11-digit product format
721890514
Labeler code
72189
Product ID
72189-514_4c4adb93-e6cf-6f33-e063-6294a90a063b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium DR
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA202882
Marketing category
ANDA
Marketing start
2023-09-11
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole Sodium DR
Listing expiration
2027-12-31

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
72189-514-30Pantoprazole Sodium DR30 in 1 BOTTLETABLET, DELAYED RELEASE303
72189-514-90Pantoprazole Sodium DR90 in 1 BOTTLETABLET, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-514-90EA - Each72189-514c27b7bb6-1f89-485e-8653-28f816cd658312023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-514PANTOPRAZOLE SODIUM DR TABLET, DELAYED RELEASE [DIRECT_RX]2Current NDC, 2 package rows20250123_0515ceaa-7d17-c92f-e063-6294a90a044e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN0515ceaa-7d17-c92f-e063-6294a90a044e3
314200pantoprazole 40 MG Delayed Release Oral TabletSCD0515ceaa-7d17-c92f-e063-6294a90a044e3
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY0515ceaa-7d17-c92f-e063-6294a90a044e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-514-307218905143030 TABLET, DELAYED RELEASE in 1 BOTTLE (72189-514-30) 2023-09-11NoNoCurrent
72189-514-907218905149090 TABLET, DELAYED RELEASE in 1 BOTTLE (72189-514-90) 2023-09-11NoNoCurrent