FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
50090-5361
11-digit product format
500905361
Labeler code
50090
Product ID
50090-5361_7becc541-9068-4c11-9211-e000b9e57ee6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202038
Marketing category
ANDA
Marketing start
2012-09-28
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
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5361-0Pantoprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE609
50090-5361-1Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE909
50090-5361-2Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5361PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 3 package rows20231217_517d6b02-0e68-4d6b-98b3-eac0be457e6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN517d6b02-0e68-4d6b-98b3-eac0be457e6b9
251872pantoprazole 20 MG Delayed Release Oral TabletSCD517d6b02-0e68-4d6b-98b3-eac0be457e6b9
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY517d6b02-0e68-4d6b-98b3-eac0be457e6b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5361-05009053610060 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-5361-0) 2020-11-130000-00-00NoNoCurrent
50090-5361-15009053610190 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-5361-1) 2020-11-130000-00-00NoNoCurrent
50090-5361-25009053610230 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-5361-2) 2020-11-130000-00-00NoNoCurrent