PANTOPRAZOLE SODIUM

Product NDC
59651-671
11-digit product format
596510671
Labeler code
59651
Product ID
59651-671_b3cec41e-e98b-470a-8ba2-c31537023989
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
GRANULE, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA217923
Marketing category
ANDA
Marketing start
2025-03-31
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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-671-305965106713030 PACKET in 1 CARTON (59651-671-30) / 1 GRANULE, DELAYED RELEASE in 1 PACKET30 packet2025-03-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PANTOPRAZOLE SODIUMAurobindo Pharma Limited | APL HEALTHCARE LIMITED2025-04-02Human Prescription Drug Label1