FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
63187-837
11-digit product format
631870837
Labeler code
63187
Product ID
63187-837_06cc0229-6d8c-4b43-9936-391dd39975d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA205119
Marketing category
ANDA
Marketing start
2016-06-20
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
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
63187-837-10Pantoprazole Sodium10 in 1 BOTTLETABLET, DELAYED RELEASE107
63187-837-30Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE307
63187-837-60Pantoprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE607
63187-837-90Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-837-30EA - Each63187-8370479865a-222a-4429-b5c7-d4734b9d69f312020-01-03
63187-837-60EA - Each63187-8374ef4f1bb-5854-4c8d-b6ad-5f87f9abe2cd12017-06-15
63187-837-90EA - Each63187-837128f8dc1-ae5b-4b79-842f-e2d7985356a912019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-837PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [PROFICIENT RX LP]7Current NDC, Legacy NDC, 4 package rows20220528_a7dc4321-331d-49af-976c-cfd69d0055d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNa7dc4321-331d-49af-976c-cfd69d0055d97
251872pantoprazole 20 MG Delayed Release Oral TabletSCDa7dc4321-331d-49af-976c-cfd69d0055d97
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYa7dc4321-331d-49af-976c-cfd69d0055d97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-837-106318708371010 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-837-10) 2020-02-010000-00-00NoNoCurrent
63187-837-306318708373030 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-837-30) 2017-05-010000-00-00NoNoCurrent
63187-837-606318708376060 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-837-60) 2017-05-010000-00-00NoNoCurrent
63187-837-906318708379090 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-837-90) 2017-05-010000-00-00NoNoCurrent