NDC 72511-750

REPATHA

Evolocumab

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

Product ID72511-750_5c290345-517d-4a4f-8a6c-7b84f07e7033
NDC72511-750
Product TypeHuman Prescription Drug
Proprietary NameREPATHA
Generic NameEvolocumab
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2018-10-09
Marketing CategoryBLA / BLA
Application NumberBLA125522
Labeler NameAmgen USA Inc.
Substance NameEVOLOCUMAB
Active Ingredient Strength140 mg/mL
Pharm ClassesAntibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 72511-750-01

1 SYRINGE in 1 CARTON (72511-750-01) > 1 mL in 1 SYRINGE
Marketing Start Date2018-10-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72511-750-01 [72511075001]

REPATHA INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125522
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-10-09

Drug Details

Active Ingredients

IngredientStrength
EVOLOCUMAB140 mg/mL

OpenFDA Data

SPL SET ID:cd61e902-166d-4aa6-9f3c-a18c1008d07e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1665895
  • 1801322
  • 1801319
  • 1665904
  • 1665906
  • 1665900
  • Pharmacological Class

    • PCSK9 Inhibitor [EPC]
    • PCSK9 Inhibitors [MoA]
    • Antibodies
    • Monoclonal [CS]

    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

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