NDC 55513-843

AIMOVIG

Erenumab-aooe

AIMOVIG is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Erenumab.

Product ID55513-843_017de7ab-e700-44c1-a15d-8f1ad3fbb56f
NDC55513-843
Product TypeHuman Prescription Drug
Proprietary NameAIMOVIG
Generic NameErenumab-aooe
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-03-15
Marketing CategoryBLA / BLA
Application NumberBLA761077
Labeler NameAmgen Inc
Substance NameERENUMAB
Active Ingredient Strength140 mg/mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 55513-843-00

1 SYRINGE in 1 CARTON (55513-843-00) > 1 mL in 1 SYRINGE
Marketing Start Date2019-03-15
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 55513-843-01 [55513084301]

AIMOVIG INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761077
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-15

Drug Details

Active Ingredients

IngredientStrength
ERENUMAB-AOOE140 mg/mL

OpenFDA Data

SPL SET ID:b998ed05-94b0-47fd-b28f-cddd1e128fd8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2045627
  • 2120195
  • 2045636
  • 2056670
  • 2045638
  • 2120198
  • 2120199
  • 2056680
  • 2056681
  • 2045632
  • 2120193
  • 2056669
  • UPC Code
  • 0355513843010
  • NDC Crossover Matching brand name "AIMOVIG" or generic name "Erenumab-aooe"

    NDCBrand NameGeneric Name
    55513-840AIMOVIGerenumab-aooe
    55513-841AIMOVIGerenumab-aooe
    55513-842AIMOVIGerenumab-aooe
    55513-843AIMOVIGerenumab-aooe

    Trademark Results [AIMOVIG]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AIMOVIG
    AIMOVIG
    87325932 5536605 Live/Registered
    Amgen Inc.
    2017-02-06
    AIMOVIG
    AIMOVIG
    87079789 5530809 Live/Registered
    Amgen Inc.
    2016-06-22

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.