NDC 0024-5747

ADLYXIN

Lixisenatide

ADLYXIN is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Lixisenatide.

Product ID0024-5747_46bfa5a6-3b18-46da-95d0-0a7ac6983cb1
NDC0024-5747
Product TypeHuman Prescription Drug
Proprietary NameADLYXIN
Generic NameLixisenatide
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2016-07-27
Marketing CategoryBLA / NDA
Application NumberBLA208471
Labeler Namesanofi-aventis U.S. LLC
Substance NameLIXISENATIDE
Active Ingredient Strength100 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 Through2022-12-31

Packaging

NDC 0024-5747-02

2 SYRINGE in 1 CARTON (0024-5747-02) > 3 mL in 1 SYRINGE
Marketing Start Date2016-07-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0024-5747-02 [00024574702]

ADLYXIN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA208471
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-07-27

Drug Details

Active Ingredients

IngredientStrength
LIXISENATIDE100 ug/mL

OpenFDA Data

SPL SET ID:1727cc16-4f86-4f13-b8b5-804d4984fa8c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1803894
  • 1803896
  • 1803902
  • 1803903
  • 1803892
  • 1803893
  • 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 "ADLYXIN" or generic name "Lixisenatide"

    NDCBrand NameGeneric Name
    0024-5745ADLYXINLixisenatide
    0024-5747ADLYXINLixisenatide

    Trademark Results [ADLYXIN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ADLYXIN
    ADLYXIN
    86566455 5209846 Live/Registered
    Sanofi
    2015-03-17

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