NDC 0310-6512

Byetta

Exenatide

Byetta is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Exenatide.

• Product ID: 0310-6512_4c7b5a43-c4ed-4970-a6e6-c8aaf34d626b
• NDC: 0310-6512
• Product Type: Human Prescription Drug
• Proprietary Name: Byetta
• Generic Name: Exenatide
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2014-12-10
• Marketing Category: NDA / NDA
• Application Number: NDA021773
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: EXENATIDE
• Active Ingredient Strength: 250 ug/mL
• Pharm Classes: GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2024-12-31

Packaging

NDC 0310-6512-01

1 CARTRIDGE in 1 CARTON (0310-6512-01) > 1.2 mL in 1 CARTRIDGE

• Marketing Start Date: 2014-12-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-6512-85 [00310651285]

Byetta INJECTION

• Marketing Category: NDA
• Application Number: NDA021773
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-06-15
• Marketing End Date: 2019-01-31

NDC 0310-6512-01 [00310651201]

Byetta INJECTION

• Marketing Category: NDA
• Application Number: NDA021773
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-12-10

Drug Details

Active Ingredients

Ingredient	Strength
EXENATIDE	250 ug/mL

OpenFDA Data

• SPL SET ID: 53d03c03-ebf7-418d-88a8-533eabd2ee4f
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 9P1872D4OL
• RxNorm Concept Unique ID - RxCUI:
  • 847915
  • 847917
  • 847910
  • 847913

Pharmacological Class

• GLP-1 Receptor Agonist [EPC]
• Glucagon-Like Peptide 1 [CS]
• Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]

NDC Crossover Matching brand name "Byetta" or generic name "Exenatide"

NDC	Brand Name	Generic Name
0310-6512	Byetta	exenatide
0310-6524	Byetta	exenatide
0310-6520	BYDUREON	exenatide
0310-6530	BYDUREON	exenatide
0310-6540	BYDUREON BCise	exenatide