FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
63187-831
11-digit product format
631870831
Labeler code
63187
Product ID
63187-831_15e6f1c7-bbe1-4b4c-a32e-260bfca5e9b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202882
Marketing category
ANDA
Marketing start
2014-09-10
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
63187-831-30PANTOPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE303
63187-831-60PANTOPRAZOLE SODIUM60 in 1 BOTTLETABLET, DELAYED RELEASE603
63187-831-90PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-831-60EA - Each63187-831c1003b53-6b82-4071-b3ee-9a0afc98d62512017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-831PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191113_dce2e97a-cd92-46b9-9444-91739bdcd526.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNdce2e97a-cd92-46b9-9444-91739bdcd5263
251872pantoprazole 20 MG Delayed Release Oral TabletSCDdce2e97a-cd92-46b9-9444-91739bdcd5263
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYdce2e97a-cd92-46b9-9444-91739bdcd5263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-831-306318708313030 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-831-30) 2017-04-030000-00-00NoNoCurrent
63187-831-606318708316060 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-831-60) 2017-04-030000-00-00NoNoCurrent
63187-831-906318708319090 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-831-90) 2017-04-030000-00-00NoNoCurrent