Pantoprazole Sodium

Product NDC
43353-343
11-digit product format
433530343
Labeler code
43353
Product ID
43353-343_add29ca5-ecb5-4b8c-b35f-83a58dbd91bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077056
Marketing category
ANDA
Marketing start
2016-02-22
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-343-30EA - Each43353-3433157b707-86cb-444a-9032-802b87a15b6e12017-11-06
43353-343-53EA - Each43353-343b53030d9-2554-48a8-b234-4b1590d0df1d12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-343PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC20171021_576be79e-a2a2-4318-a462-8f1496bba220.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-343-304335303433030 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-343-30) 2017-08-080000-00-00NoNoCurrent
43353-343-534335303435360 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-343-53) 2017-06-220000-00-00NoNoCurrent