FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
55154-4346
11-digit product format
551544346
Labeler code
55154
Product ID
55154-4346_0e08a205-45c7-4ce8-8482-ef4b3134a9c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA078281
Marketing category
ANDA
Marketing start
2021-01-28
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4346-0Pantoprazole Sodium10 in 1 BAGTABLET, DELAYED RELEASE105
55154-4346-0Pantoprazole Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4346PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH 107, LLC]3Current NDC, 2 package rows20240627_410d5577-e50a-44f3-aaa8-fbf391a0c261.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN410d5577-e50a-44f3-aaa8-fbf391a0c2615
251872pantoprazole 20 MG Delayed Release Oral TabletSCD410d5577-e50a-44f3-aaa8-fbf391a0c2615
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY410d5577-e50a-44f3-aaa8-fbf391a0c2615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-4346-05515443460010 BLISTER PACK in 1 BAG (55154-4346-0) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2021-01-28NoNoCurrent