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 ID0310-6530_160ba882-6c8c-4495-8c99-37cf8d20ac77
NDC0310-6530
Product TypeHuman Prescription Drug
Proprietary NameBYDUREON
Generic NameExenatide
Dosage FormInjection, Suspension, Extended Release
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2014-09-08
Marketing CategoryNDA / NDA
Application NumberNDA022200
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameEXENATIDE
Active Ingredient Strength2 mg/.65mL
Pharm ClassesGLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [CS],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0310-6530-01

1 CARTRIDGE in 1 TRAY (0310-6530-01) > .65 mL in 1 CARTRIDGE
Marketing Start Date2014-09-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-6530-01 [00310653001]

BYDUREON INJECTION, SUSPENSION, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022200
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-08

NDC 0310-6530-85 [00310653085]

BYDUREON INJECTION, SUSPENSION, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022200
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-08

NDC 0310-6530-04 [00310653004]

BYDUREON INJECTION, SUSPENSION, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022200
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-08

Drug Details

Active Ingredients

IngredientStrength
EXENATIDE2 mg/.65mL

OpenFDA Data

SPL SET ID:71fe88be-b4e6-4c2d-9cc3-8b1864467776
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0310-6520BYDUREONexenatide
    0310-6530BYDUREONexenatide
    0310-6540BYDUREON BCiseexenatide
    0310-6512Byettaexenatide
    0310-6524Byettaexenatide

    Trademark Results [BYDUREON]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BYDUREON
    BYDUREON
    85329947 4169150 Live/Registered
    AMYLIN PHARMACEUTICALS, LLC
    2011-05-25
    BYDUREON
    BYDUREON
    77331009 not registered Dead/Abandoned
    Amylin Pharmaceuticals, Inc
    2007-11-15

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