NDC 55513-078

Imlygic

Talimogene Laherparepvec

Imlygic is a Intralesional Injection, Suspension in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Talimogene Laherparepvec.

Product ID55513-078_0ff7fc11-9247-4b5b-a0bc-ca1d3f29eec2
NDC55513-078
Product TypeHuman Prescription Drug
Proprietary NameImlygic
Generic NameTalimogene Laherparepvec
Dosage FormInjection, Suspension
Route of AdministrationINTRALESIONAL
Marketing Start Date2015-11-02
Marketing CategoryBLA / BLA
Application NumberBLA125518
Labeler NameAmgen Inc
Substance NameTALIMOGENE LAHERPAREPVEC
Active Ingredient Strength1000000 [PFU]/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55513-078-01

1 VIAL in 1 CARTON (55513-078-01) > 1 mL in 1 VIAL
Marketing Start Date2015-11-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55513-078-01 [55513007801]

Imlygic INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125518
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-11-02

Drug Details

Active Ingredients

IngredientStrength
TALIMOGENE LAHERPAREPVEC1000000 [PFU]/mL

OpenFDA Data

SPL SET ID:64ffb680-ea8c-42fc-9649-9e8c0eb77ddb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1721289
  • 1721287
  • 1721278
  • 1721283
  • UPC Code
  • 0355513078016
  • 0355513079013
  • NDC Crossover Matching brand name "Imlygic" or generic name "Talimogene Laherparepvec"

    NDCBrand NameGeneric Name
    55513-078Imlygictalimogene laherparepvec
    55513-079Imlygictalimogene laherparepvec

    Trademark Results [Imlygic]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    IMLYGIC
    IMLYGIC
    85692936 4889808 Live/Registered
    Amgen Inc.
    2012-08-01

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