FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
55154-7634
11-digit product format
551547634
Labeler code
55154
Product ID
55154-7634_d99c629e-c9b9-4ce8-82d1-739225057681
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA090074
Marketing category
ANDA
Marketing start
2015-06-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole Sodium
Listing expiration
2027-12-31

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
55154-7634-0Pantoprazole Sodium10 in 1 BAGTABLET, DELAYED RELEASE1014
55154-7634-0Pantoprazole Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7634PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH 107, LLC]12Current NDC, Legacy NDC, 2 package rows20250305_6b5ed424-2203-482f-bb85-2c97d9c356f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN6b5ed424-2203-482f-bb85-2c97d9c356f214
314200pantoprazole 40 MG Delayed Release Oral TabletSCD6b5ed424-2203-482f-bb85-2c97d9c356f214
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY6b5ed424-2203-482f-bb85-2c97d9c356f214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7634-05515476340010 BLISTER PACK in 1 BAG (55154-7634-0) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2015-06-010000-00-00NoNoCurrent