ONGLYZA
These highlights do not include all the information needed to use ONGLYZA safely and effectively. See full prescribing information for ONGLYZA. ONGLYZA (saxagliptin) tablets Initial U.S. Approval: 2009
Approved
Approval ID
d45fc842-2563-4421-86af-a55b3191e19b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SAXAGLIPTIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6309
Application NumberNDA022350
Product Classification
M
Marketing Category
C73594
G
Generic Name
SAXAGLIPTIN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2012
FDA Product Classification
INGREDIENTS (5)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
saxagliptin hydrochlorideActive
Quantity: 5 mg in 1 1
Code: Z8J84YIX6L
Classification: ACTIM