FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
55154-2645
11-digit product format
551542645
Labeler code
55154
Product ID
55154-2645_cb2133e3-b30c-4492-b438-efc08caf3fd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA202038
Marketing category
ANDA
Marketing start
2025-02-25
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
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 SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui251872, 314200

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
55154-2645-0Pantoprazole Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE16
55154-2645-0Pantoprazole Sodium10 in 1 BAGTABLET, DELAYED RELEASE106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2645PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH 107, LLC]4Current NDC, 2 package rows20250228_6229247e-ee15-466e-a8ac-adcd646b738d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN6229247e-ee15-466e-a8ac-adcd646b738d6
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN6229247e-ee15-466e-a8ac-adcd646b738d6
251872pantoprazole 20 MG Delayed Release Oral TabletSCD6229247e-ee15-466e-a8ac-adcd646b738d6
314200pantoprazole 40 MG Delayed Release Oral TabletSCD6229247e-ee15-466e-a8ac-adcd646b738d6
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY6229247e-ee15-466e-a8ac-adcd646b738d6
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY6229247e-ee15-466e-a8ac-adcd646b738d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-2645-05515426450010 BLISTER PACK in 1 BAG (55154-2645-0) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2025-02-25NoNoCurrent