BYETTA
These highlights do not include all the information needed to use BYETTA safely and effectively. See full prescribing information for BYETTA. BYETTA (exenatide) Injection Initial U.S. Approval: 2005
Approved
Approval ID
c621d002-b7bf-4f3a-af68-4f70fd298d05
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 12, 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.
exenatide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5384
Application NumberNDA021773
Product Classification
M
Marketing Category
C73594
G
Generic Name
exenatide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 12, 2012
FDA Product Classification
INGREDIENTS (6)
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
exenatideActive
Quantity: 250 ug in 1 mL
Code: 9P1872D4OL
Classification: ACTIB
metacresolInactive
Quantity: 2.2 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT