NDC 55513-770

REPATHA

Evolocumab

REPATHA is a Subcutaneous Kit in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is .

Product ID55513-770_02a067d5-ee1b-4d79-aea5-d0e843246a64
NDC55513-770
Product TypeHuman Prescription Drug
Proprietary NameREPATHA
Generic NameEvolocumab
Dosage FormKit
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2016-08-01
Marketing CategoryBLA / BLA
Application NumberBLA125522
Labeler NameAmgen Inc
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 55513-770-01

1 KIT in 1 CARTON (55513-770-01) * 1 CARTRIDGE in 1 TRAY > 3.5 mL in 1 CARTRIDGE
Marketing Start Date2016-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55513-770-01 [55513077001]

REPATHA KIT
Marketing CategoryBLA
Application NumberBLA125522
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-08-01

Drug Details

OpenFDA Data

SPL SET ID:709338ae-ab8f-44a9-b7d5-abaabec3493a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1665895
  • 1801322
  • 1801319
  • 1665904
  • 1665906
  • 1665900
  • Medicade Reported Pricing

    55513077001 REPATHA 420 MG/3.5 ML PUSHTRONX

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "REPATHA" or generic name "Evolocumab"

    NDCBrand NameGeneric Name
    55513-750REPATHAEvolocumab
    55513-760REPATHAEvolocumab
    55513-770REPATHAEvolocumab
    72511-750REPATHAEvolocumab
    72511-760REPATHAEvolocumab
    72511-770REPATHAREPATHA

    Trademark Results [REPATHA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    REPATHA
    REPATHA
    86436098 not registered Dead/Abandoned
    Amgen Inc.
    2014-10-27
    REPATHA
    REPATHA
    86066934 4837298 Live/Registered
    Amgen Inc.
    2013-09-17
    REPATHA
    REPATHA
    76463628 not registered Dead/Abandoned
    Amgen Inc.
    2002-11-01

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