FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
43353-916
11-digit product format
433530916
Labeler code
43353
Product ID
43353-916_2d3ce59f-9be8-43ca-bbf7-06ee7f55d047
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078281
Marketing category
ANDA
Marketing start
2011-01-20
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
2020-12-31
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
43353-916-09Pantoprazole Sodium9000 in 1 BOTTLETABLET, DELAYED RELEASE90003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-916-09EA - Each43353-9167235a978-1ea0-405e-acfc-4573522c635c12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-916PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 1 package rows20171024_c9bc288b-e84c-4e31-a769-c87a59226086.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNc9bc288b-e84c-4e31-a769-c87a592260863
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNc9bc288b-e84c-4e31-a769-c87a592260863
251872pantoprazole 20 MG Delayed Release Oral TabletSCDc9bc288b-e84c-4e31-a769-c87a592260863
314200pantoprazole 40 MG Delayed Release Oral TabletSCDc9bc288b-e84c-4e31-a769-c87a592260863
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYc9bc288b-e84c-4e31-a769-c87a592260863
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYc9bc288b-e84c-4e31-a769-c87a592260863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-916-09433530916099000 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-916-09) 2014-04-060000-00-00NoNoCurrent