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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

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BYETTA - FDA Drug Approval Details