ONGLYZA

Product NDC
55154-6931
11-digit product format
551546931
Labeler code
55154
Product ID
55154-6931_048ab1ca-6e74-49ad-9a9e-c866a2b9ce01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SAXAGLIPTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
NDA022350
Marketing category
NDA
Marketing start
2014-11-20
Marketing end
0000-00-00
Substance
SAXAGLIPTIN HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
saxagliptin hydrochlorideACTIVE INGREDIENTZ8J84YIX6LONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]1
saxagliptin anhydrousACTIVE MOIETY8I7IO46IVQONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-6931ONGLYZA (SAXAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]12Legacy NDC20241010_e4f2a84f-5117-4738-b769-aba8debbddb0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-6931-2551546931021080 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-6931-2) 2014-11-200000-00-00NoNoCurrent