PANTOPRAZOLE SODIUM

Product NDC
42291-765
11-digit product format
422910765
Labeler code
42291
Product ID
42291-765_d5c99427-ea8e-47d7-e053-2a95a90a9384
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA211368
Marketing category
ANDA
Marketing start
2019-10-21
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-765-10EA - Each42291-765c37e3769-7281-48ec-aaa3-2b83d21fd08a12019-11-12
42291-765-90EA - Each42291-765b921d190-2591-4d78-ad8c-9aef9139240112019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-765PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AVKARE]3Legacy NDC20230707_9570a071-c732-dd33-e053-2a95a90add26.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-765-10422910765101000 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-765-10) 2019-10-210000-00-00NoNoCurrent
42291-765-904229107659090 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-765-90) 2019-10-210000-00-00NoNoCurrent