Tradjenta
These highlights do not include all the information needed to use TRADJENTA safely and effectively. See full prescribing information for TRADJENTA. TRADJENTA (linagliptin tablets), for oral useInitial U.S. Approval: 2011
Approved
Approval ID
b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2024
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
linagliptin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-4383
Application NumberNDA201280
Product Classification
M
Marketing Category
C73594
G
Generic Name
linagliptin
Product Specifications
Route of AdministrationORAL
Effective DateJune 26, 2023
FDA Product Classification
INGREDIENTS (1)
LINAGLIPTINActive
Quantity: 5 mg in 1 1
Code: 3X29ZEJ4R2
Classification: ACTIB