NDC 69616-211

Firdapse

Amifampridine Phosphate

Firdapse is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Catalyst Pharmaceuticals, Inc.. The primary component is Amifampridine Phosphate.

Product ID69616-211_0cecc1e6-ebdf-480a-be77-f2ef0fcbc897
NDC69616-211
Product TypeHuman Prescription Drug
Proprietary NameFirdapse
Generic NameAmifampridine Phosphate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-01-07
Marketing CategoryNDA / NDA
Application NumberNDA208078
Labeler NameCatalyst Pharmaceuticals, Inc.
Substance NameAMIFAMPRIDINE PHOSPHATE
Active Ingredient Strength10 mg/1
Pharm ClassesPotassium Channel Blocker [EPC],Potassium Channel Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 69616-211-03

240 TABLET in 1 BOTTLE, PLASTIC (69616-211-03)
Marketing Start Date2019-01-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69616-211-06 [69616021106]

Firdapse TABLET
Marketing CategoryNDA
Application NumberNDA208078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-07

NDC 69616-211-08 [69616021108]

Firdapse TABLET
Marketing CategoryNDA
Application NumberNDA208078
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-07

NDC 69616-211-03 [69616021103]

Firdapse TABLET
Marketing CategoryNDA
Application NumberNDA208078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-07

NDC 69616-211-04 [69616021104]

Firdapse TABLET
Marketing CategoryNDA
Application NumberNDA208078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-07

Drug Details

Active Ingredients

IngredientStrength
AMIFAMPRIDINE PHOSPHATE10 mg/1

OpenFDA Data

SPL SET ID:f015fe60-3128-4a43-8c31-19fc6b5def3f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2106343
  • 2107518

    • Pharmacological Class

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

    Trademark Results [Firdapse]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FIRDAPSE
    FIRDAPSE
    86082826 4700764 Live/Registered
    BioMarin Huxley Ltd.
    2013-10-04
    FIRDAPSE
    FIRDAPSE
    77904586 not registered Dead/Abandoned
    Huxley Pharmaceuticals, Inc.
    2010-01-04
    FIRDAPSE
    FIRDAPSE
    77830438 not registered Dead/Abandoned
    Huxley Pharmaceuticals, Inc.
    2009-09-19
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