FDA.reportPublic FDA data

PANTOPRAZOLE SODIUM

Product NDC
63187-654
11-digit product format
631870654
Labeler code
63187
Product ID
63187-654_4c17524f-b4e2-4ca8-8c64-466783ce759b
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
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
63187-654-30PANTOPRAZOLE SODIUM30 in 1 BOTTLETABLET, DELAYED RELEASE305
63187-654-90PANTOPRAZOLE SODIUM90 in 1 BOTTLETABLET, DELAYED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-654-30EA - Each63187-65485b2c20a-1e98-4c31-a8d1-abdf99d22cd312020-01-03
63187-654-90EA - Each63187-6541b00be10-1beb-430b-8fe5-93e1879fba9f12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-654PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20240731_50a278de-bd16-417c-a741-81bfe0d745f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN50a278de-bd16-417c-a741-81bfe0d745f25
314200pantoprazole 40 MG Delayed Release Oral TabletSCD50a278de-bd16-417c-a741-81bfe0d745f25
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY50a278de-bd16-417c-a741-81bfe0d745f25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-654-306318706543030 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-654-30) 2018-12-010000-00-00NoNoCurrent
63187-654-606318706546060 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-654-60) 2018-12-010000-00-00NoNoCurrent
63187-654-906318706549090 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-654-90) 2018-12-010000-00-00NoNoCurrent