Pantoprazole

Product NDC
68071-3524
11-digit product format
680713524
Labeler code
68071
Product ID
68071-3524_2d3f76b4-d1b8-0d4a-e063-6294a90ac5f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077619
Marketing category
ANDA
Marketing start
2011-01-19
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6871619Q5XPANTOPRAZOLE SODIUM164579-32-2PANTOPRAZOLE SODIUM
D8TST4O562PANTOPRAZOLE102625-70-7Pantoprazole

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3524-36807135240330 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3524-3) 2023-10-18NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PantoprazoleNuCare Pharmaceuticals,Inc.2025-02-03HUMAN PRESCRIPTION DRUG LABEL2