FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
63187-938
11-digit product format
631870938
Labeler code
63187
Product ID
63187-938_96e2029a-2614-4862-b7de-dbbdbf10006b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
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
63187-938-30Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE305
63187-938-60Pantoprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE605
63187-938-90Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-938-30EA - Each63187-93862e6f8cd-b7f4-47ed-8f8a-3c17614e91a012018-02-20
63187-938-90EA - Each63187-938110f5887-c21b-4883-b93a-996d6ae4e26012023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-938PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20220702_a03aa46f-9eb5-4cf4-addf-745d94af8261.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNa03aa46f-9eb5-4cf4-addf-745d94af82615
314200pantoprazole 40 MG Delayed Release Oral TabletSCDa03aa46f-9eb5-4cf4-addf-745d94af82615
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYa03aa46f-9eb5-4cf4-addf-745d94af82615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-938-306318709383030 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-938-30) 2017-12-010000-00-00NoNoCurrent
63187-938-606318709386060 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-938-60) 2017-12-010000-00-00NoNoCurrent
63187-938-906318709389090 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-938-90) 2017-12-010000-00-00NoNoCurrent