NDC 10144-427

AMPYRA

Dalfampridine

AMPYRA is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Acorda Therapeutics, Inc.. The primary component is Dalfampridine.

Product ID10144-427_5a970cb6-fb01-1f85-e053-2a91aa0a4608
NDC10144-427
Product TypeHuman Prescription Drug
Proprietary NameAMPYRA
Generic NameDalfampridine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-03-01
Marketing CategoryNDA / NDA
Application NumberNDA022250
Labeler NameAcorda Therapeutics, Inc.
Substance NameDALFAMPRIDINE
Active Ingredient Strength10 mg/1
Pharm ClassesPotassium Channel Blocker [EPC],Potassium Channel Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10144-427-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10144-427-60)
Marketing Start Date2010-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10144-427-60 [10144042760]

AMPYRA TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022250
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-01

Drug Details

Active Ingredients

IngredientStrength
DALFAMPRIDINE10 mg/1

OpenFDA Data

SPL SET ID:550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 897025
  • 897021
  • UPC Code
  • 0310144427602
  • Pharmacological Class

    • Potassium Channel Blocker [EPC]
    • Potassium Channel Antagonists [MoA]

    NDC Crossover Matching brand name "AMPYRA" or generic name "Dalfampridine"

    NDCBrand NameGeneric Name
    10144-427AMPYRADalfampridine
    0054-0479DalfampridineDalfampridine
    0378-0509dalfampridinedalfampridine
    0378-4504dalfampridinedalfampridine
    0591-2533DalfampridineDalfampridine
    16729-292DalfampridineDalfampridine
    42571-275DALFAMPRIDINEDALFAMPRIDINE
    51407-246DalfampridineDalfampridine
    62756-429DalfampridineDalfampridine
    63629-9450DalfampridineDalfampridine
    65862-863DALFAMPRIDINEDALFAMPRIDINE
    67877-444DalfampridineDalfampridine

    Trademark Results [AMPYRA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AMPYRA
    AMPYRA
    86363294 not registered Dead/Abandoned
    ACORDA THERAPEUTICS, INC.
    2014-08-11
    AMPYRA
    AMPYRA
    86363283 not registered Dead/Abandoned
    ACORDA THERAPEUTICS, INC.
    2014-08-11
    AMPYRA
    AMPYRA
    77948571 4727839 Live/Registered
    Acorda Therapeutics, Inc.
    2010-03-02
    AMPYRA
    AMPYRA
    77948545 4625151 Live/Registered
    Acorda Therapeutics, Inc.
    2010-03-02
    AMPYRA
    AMPYRA
    77448693 3803730 Live/Registered
    Acorda Therapeutics, Inc.
    2008-04-15

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