NDC 55513-740

PARSABIV

Etelcalcetide

PARSABIV is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Etelcalcetide Hydrochloride.

Product ID55513-740_012ce6ec-5707-49fa-9e39-6932948c2283
NDC55513-740
Product TypeHuman Prescription Drug
Proprietary NamePARSABIV
Generic NameEtelcalcetide
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-04-03
Marketing CategoryNDA / NDA
Application NumberNDA208325
Labeler NameAmgen Inc
Substance NameETELCALCETIDE HYDROCHLORIDE
Active Ingredient Strength3 mg/.5mL
Pharm ClassesCalcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55513-740-10

10 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-10) > .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01)
Marketing Start Date2017-04-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55513-740-10 [55513074010]

PARSABIV INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208325
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-04-03

NDC 55513-740-01 [55513074001]

PARSABIV INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208325
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-04-03

Drug Details

Active Ingredients

IngredientStrength
ETELCALCETIDE HYDROCHLORIDE2.5 mg/.5mL

OpenFDA Data

SPL SET ID:cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1876138
  • 1876132
  • 1876137
  • 1876136
  • 1876135
  • 1876127
  • UPC Code
  • 0355513741101
  • 0355513740104
  • 0355513742108
  • Pharmacological Class

    • Calcium-sensing Receptor Agonist [EPC]
    • Increased Calcium-sensing Receptor Sensitivity [MoA]

    NDC Crossover Matching brand name "PARSABIV" or generic name "Etelcalcetide"

    NDCBrand NameGeneric Name
    55513-740PARSABIVetelcalcetide
    55513-741PARSABIVetelcalcetide
    55513-742PARSABIVetelcalcetide

    Trademark Results [PARSABIV]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PARSABIV
    PARSABIV
    87038725 5438851 Live/Registered
    Amgen Inc.
    2016-05-16
    PARSABIV
    PARSABIV
    86523783 5428730 Live/Registered
    Amgen Inc.
    2015-02-04

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