Lansoprazole

Product NDC
55154-4848
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA208784
Marketing category
ANDA
Substance
LANSOPRAZOLE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
55154-4848-010 BLISTER PACK in 1 BAG (55154-4848-0) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK20180308NoHistorical

Related DailyMed Labels

Set IDTitleManufacturerEffective dateTypeVersion
c9a43df0-efab-4486-860f-92afdb258c8bThese highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets Initial U.S. Approval: 1995Cardinal Health 107, LLC2025-10-17HUMAN PRESCRIPTION DRUG LABEL4
c9a43df0-efab-4486-860f-92afdb258c8bThese highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE delayed-release orally disintegrating tablets Initial U.S. Approval: 1995Cardinal Health 107, LLC2024-09-23HUMAN PRESCRIPTION DRUG LABEL3