FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
50090-7512
11-digit product format
500907512
Labeler code
50090
Product ID
50090-7512_a12b8b2c-799f-4090-81be-340ac97c6920
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090074
Marketing category
ANDA
Marketing start
2011-01-20
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
50090-7512-0Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE903
50090-7512-1Pantoprazole Sodium12960 in 1 CASETABLET, DELAYED RELEASE129603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7512-0EA - Each50090-75121f7f73df-c32d-4b96-a8cf-b5d550dfc94b12025-05-14
50090-7512-1EA - Each50090-751236654376-8d98-47e6-b47d-9b812ed522de12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7512PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20250316_81696241-17d5-4d35-9e59-8c28469ffd2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN81696241-17d5-4d35-9e59-8c28469ffd2c3
314200pantoprazole 40 MG Delayed Release Oral TabletSCD81696241-17d5-4d35-9e59-8c28469ffd2c3
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY81696241-17d5-4d35-9e59-8c28469ffd2c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7512-05009075120090 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7512-0) 2025-03-10NoNoCurrent
50090-7512-15009075120112960 TABLET, DELAYED RELEASE in 1 CASE (50090-7512-1) 2025-03-10NoNoCurrent