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, for subcutaneous useInitial U.S. Approval: 2005
Approved
Approval ID
53d03c03-ebf7-418d-88a8-533eabd2ee4f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2022
Manufacturers
FDA
AstraZeneca Pharmaceuticals LP
DUNS: 054743190
Products 2
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 Code0310-6512
Application NumberNDA021773
Product Classification
M
Marketing Category
C73594
G
Generic Name
exenatide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 21, 2022
FDA Product Classification
INGREDIENTS (6)
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
metacresolInactive
Quantity: 2.2 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
exenatideActive
Quantity: 250 ug in 1 mL
Code: 9P1872D4OL
Classification: ACTIB
exenatide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-6524
Application NumberNDA021773
Product Classification
M
Marketing Category
C73594
G
Generic Name
exenatide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 21, 2022
FDA Product Classification
INGREDIENTS (6)
exenatideActive
Quantity: 250 ug in 1 mL
Code: 9P1872D4OL
Classification: ACTIB
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT
metacresolInactive
Quantity: 2.2 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT