FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
50090-1415
11-digit product format
500901415
Labeler code
50090
Product ID
50090-1415_239087e9-c35f-44b0-bb96-ab0ae115a85c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077056
Marketing category
ANDA
Marketing start
2007-12-21
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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
50090-1415-0Pantoprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE6010
50090-1415-1Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9010
50090-1415-2Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1415-0EA - Each50090-14155ddff0ad-4e98-4aca-9fa6-95d59e2b6c8b12018-11-06
50090-1415-1EA - Each50090-14154c19a9e7-7862-4b98-a4aa-3996aeb9797d12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1415PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]10Legacy NDC, 3 package rows20200220_763b2df8-6d83-4d98-b12e-594f45d0aae8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN763b2df8-6d83-4d98-b12e-594f45d0aae810
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN763b2df8-6d83-4d98-b12e-594f45d0aae810
251872pantoprazole 20 MG Delayed Release Oral TabletSCD763b2df8-6d83-4d98-b12e-594f45d0aae810
314200pantoprazole 40 MG Delayed Release Oral TabletSCD763b2df8-6d83-4d98-b12e-594f45d0aae810
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY763b2df8-6d83-4d98-b12e-594f45d0aae810
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY763b2df8-6d83-4d98-b12e-594f45d0aae810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1415-05009014150060 in 1 BOTTLEHistorical
50090-1415-15009014150190 in 1 BOTTLEHistorical
50090-1415-25009014150230 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-1415-2) 2019-01-310000-00-00NoNoCurrent