NDC 49938-110

Ruzurgi

Amifampridine

Ruzurgi is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Jacobus Pharmaceutical Company,inc. The primary component is Amifampridine.

Product ID49938-110_0fca1a28-6f92-48ce-9c22-98e40a6b9a6b
NDC49938-110
Product TypeHuman Prescription Drug
Proprietary NameRuzurgi
Generic NameAmifampridine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-02
Marketing CategoryNDA / NDA
Application NumberNDA209321
Labeler NameJacobus Pharmaceutical Company,Inc
Substance NameAMIFAMPRIDINE
Active Ingredient Strength10 mg/1
Pharm ClassesPotassium Channel Blocker [EPC],Potassium Channel Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49938-110-01

1 BOTTLE, PLASTIC in 1 CARTON (49938-110-01) > 100 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date2019-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49938-110-01 [49938011001]

Ruzurgi TABLET
Marketing CategoryNDA
Application NumberNDA209321
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-02

Drug Details

Active Ingredients

IngredientStrength
AMIFAMPRIDINE10 mg/1

OpenFDA Data

SPL SET ID:2731310a-c060-4d3e-ba41-763d791f63a9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2106343
  • 2174818
  • UPC Code
  • 0349938110017
  • Pharmacological Class

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

    Trademark Results [Ruzurgi]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RUZURGI
    RUZURGI
    87638007 5950658 Live/Registered
    Jacobus Pharmaceutical Co., Inc.
    2017-10-09

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