NDC 0002-1436

EMGALITY

Galcanezumab-gnlm

EMGALITY is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Galcanezumab.

Product ID0002-1436_4b767820-97fe-430d-8e77-6047e82ac81e
NDC0002-1436
Product TypeHuman Prescription Drug
Proprietary NameEMGALITY
Generic NameGalcanezumab-gnlm
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2018-09-27
Marketing CategoryBLA / BLA
Application NumberBLA761063
Labeler NameEli Lilly and Company
Substance NameGALCANEZUMAB
Active Ingredient Strength120 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0002-1436-11

1 SYRINGE in 1 CARTON (0002-1436-11) > 1 mL in 1 SYRINGE (0002-1436-01)
Marketing Start Date2018-09-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0002-1436-27 [00002143627]

EMGALITY INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761063
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-27
Marketing End Date2018-09-27

NDC 0002-1436-01 [00002143601]

EMGALITY INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761063
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-27

NDC 0002-1436-61 [00002143661]

EMGALITY INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761063
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-27

NDC 0002-1436-11 [00002143611]

EMGALITY INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA761063
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-27

Drug Details

Active Ingredients

IngredientStrength
GALCANEZUMAB120 mg/mL

OpenFDA Data

SPL SET ID:33a147be-233a-40e8-a55e-e40936e28db0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2058872
  • 2058885
  • 2058877
  • 2058887
  • NDC Crossover Matching brand name "EMGALITY" or generic name "Galcanezumab-gnlm"

    NDCBrand NameGeneric Name
    0002-1436EMGALITYgalcanezumab-gnlm
    0002-2377EMGALITYgalcanezumab-gnlm
    0002-3115EMGALITYgalcanezumab-gnlm

    Trademark Results [EMGALITY]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EMGALITY
    EMGALITY
    88112647 not registered Live/Pending
    Eli Lilly and Company
    2018-09-11
    EMGALITY
    EMGALITY
    87435081 5633683 Live/Registered
    Eli Lilly and Company
    2017-05-03
    EMGALITY
    EMGALITY
    87263356 5628446 Live/Registered
    Eli Lilly and Company
    2016-12-09

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