Pantoprazole Sodium

Product NDC
43353-569
11-digit product format
433530569
Labeler code
43353
Product ID
43353-569_3b96d2e8-c6df-487e-a159-b094dba435cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA205119
Marketing category
ANDA
Marketing start
2016-06-20
Marketing end
0000-00-00
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
2019-12-31
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-569-30Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE301
43353-569-53Pantoprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE601
43353-569-80Pantoprazole Sodium180 in 1 BOTTLETABLET, DELAYED RELEASE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-569-30EA - Each43353-5697c3e0778-e133-4668-91f4-f229be6e7dff12017-12-14
43353-569-53EA - Each43353-569c26c88a1-ae22-4bd4-9134-cf5c3eba014312017-12-14
43353-569-80EA - Each43353-56993bf8d49-dd88-4c20-a8d2-a88464d02c6912017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-569PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 3 package rows20171003_07d68e39-155f-4816-989c-4df00b5cca4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN07d68e39-155f-4816-989c-4df00b5cca4b1
314200pantoprazole 40 MG Delayed Release Oral TabletSCD07d68e39-155f-4816-989c-4df00b5cca4b1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY07d68e39-155f-4816-989c-4df00b5cca4b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-569-304335305693030 in 1 BOTTLEHistorical
43353-569-534335305695360 in 1 BOTTLEHistorical
43353-569-8043353056980180 in 1 BOTTLEHistorical