Pantoprazole Sodium

Product NDC
72789-086
11-digit product format
727890086
Labeler code
72789
Product ID
72789-086_4031c357-7001-521b-e063-6294a90a232c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078281
Marketing category
ANDA
Marketing start
2011-01-20
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
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
72789-086-30Pantoprazole Sodium30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3053

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-086-30EA - Each72789-086cb67603e-f2de-48ba-a9b9-b5452f5e482d12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-086PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]52Current NDC, Legacy NDC, 1 package rows20241010_b422c5eb-9a6d-4f8c-863d-ca515ec780c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNb422c5eb-9a6d-4f8c-863d-ca515ec780c253
314200pantoprazole 40 MG Delayed Release Oral TabletSCDb422c5eb-9a6d-4f8c-863d-ca515ec780c253
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYb422c5eb-9a6d-4f8c-863d-ca515ec780c253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-086-307278900863030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-086-30) 2020-06-040000-00-00NoNoCurrent