NDC 0310-6524

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 ID0310-6524_4c7b5a43-c4ed-4970-a6e6-c8aaf34d626b
NDC0310-6524
Product TypeHuman Prescription Drug
Proprietary NameByetta
Generic NameExenatide
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2014-12-12
Marketing CategoryNDA / NDA
Application NumberNDA021773
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameEXENATIDE
Active Ingredient Strength250 ug/mL
Pharm ClassesGLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 0310-6524-01

1 CARTRIDGE in 1 CARTON (0310-6524-01) > 2.4 mL in 1 CARTRIDGE
Marketing Start Date2014-12-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-6524-01 [00310652401]

Byetta INJECTION
Marketing CategoryNDA
Application NumberNDA021773
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-12-12

Drug Details

Active Ingredients

IngredientStrength
EXENATIDE250 ug/mL

OpenFDA Data

SPL SET ID:53d03c03-ebf7-418d-88a8-533eabd2ee4f
Manufacturer
UNII
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"

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

    Trademark Results [Byetta]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BYETTA
    BYETTA
    85263200 4026241 Dead/Cancelled
    AMYLIN PHARMACEUTICALS, LLC
    2011-03-10
    BYETTA
    BYETTA
    78891856 3241856 Live/Registered
    AMYLIN PHARMACEUTICALS, LLC
    2006-05-24
    BYETTA
    BYETTA
    78863870 3229429 Live/Registered
    AMYLIN PHARMACEUTICALS, LLC
    2006-04-18
    BYETTA
    BYETTA
    78594808 3446509 Dead/Cancelled
    AMYLIN PHARMACEUTICALS, LLC
    2005-03-24
    BYETTA
    BYETTA
    78594748 3106331 Live/Registered
    AMYLIN PHARMACEUTICALS, LLC
    2005-03-24
    BYETTA
    BYETTA
    78352074 2990556 Dead/Cancelled
    Amylin Pharmaceuticals, Inc.
    2004-01-14

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