PANTOPRAZOLE SODIUM

Product NDC
68071-2215
11-digit product format
680712215
Labeler code
68071
Product ID
68071-2215_23838cc7-f093-d306-e063-6394a90a1647
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202882
Marketing category
ANDA
Marketing start
2014-09-10
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
68071-2215-36807122150330 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-2215-3) 2020-07-08NoNoHistorical
68071-2215-46807122150414 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-2215-4) 2020-07-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.2024-10-02HUMAN PRESCRIPTION DRUG LABEL5