Pantoprazole Sodium

Product NDC
71610-103
11-digit product format
716100103
Labeler code
71610
Product ID
71610-103_f6d59cf3-a7cb-4d70-94c3-0465f32a4ffb
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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-103-09EA - Each71610-10379cf819d-c1b0-4532-a3d4-a93476af8b5e12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-103PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20180816_a3793556-ba2f-4fab-a44e-f3e7bfc187c3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-103-09716100103099000 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-103-09) 2018-07-260000-00-00NoNoCurrent