NDC 0310-6530

BYDUREON

Exenatide

BYDUREON is a Subcutaneous Injection, Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Exenatide.

• Product ID: 0310-6530_160ba882-6c8c-4495-8c99-37cf8d20ac77
• NDC: 0310-6530
• Product Type: Human Prescription Drug
• Proprietary Name: BYDUREON
• Generic Name: Exenatide
• Dosage Form: Injection, Suspension, Extended Release
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2014-09-08
• Marketing Category: NDA / NDA
• Application Number: NDA022200
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: EXENATIDE
• Active Ingredient Strength: 2 mg/.65mL
• 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: 2021-12-31

Packaging

NDC 0310-6530-01

1 CARTRIDGE in 1 TRAY (0310-6530-01) > .65 mL in 1 CARTRIDGE

• Marketing Start Date: 2014-09-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-6530-01 [00310653001]

BYDUREON INJECTION, SUSPENSION, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022200
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-08

NDC 0310-6530-85 [00310653085]

BYDUREON INJECTION, SUSPENSION, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022200
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-09-08

NDC 0310-6530-04 [00310653004]

BYDUREON INJECTION, SUSPENSION, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022200
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-08

Drug Details

Active Ingredients

Ingredient	Strength
EXENATIDE	2 mg/.65mL

OpenFDA Data

• SPL SET ID: 71fe88be-b4e6-4c2d-9cc3-8b1864467776
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 9P1872D4OL
• RxNorm Concept Unique ID - RxCUI:
  • 1242968
  • 1242963
  • 1544918
  • 1544916

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 "BYDUREON" or generic name "Exenatide"

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