NDC 67877-444

Dalfampridine

Dalfampridine

Dalfampridine is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Ascend Laboratories, Llc. The primary component is Dalfampridine.

Product ID67877-444_168ec659-c056-46d0-8469-684dcab57cb2
NDC67877-444
Product TypeHuman Prescription Drug
Proprietary NameDalfampridine
Generic NameDalfampridine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA206765
Labeler NameAscend Laboratories, LLC
Substance NameDALFAMPRIDINE
Active Ingredient Strength10 mg/1
Pharm ClassesPotassium Channel Blocker [EPC],Potassium Channel Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 67877-444-05

500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-05)
Marketing Start Date2018-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67877-444-05 [67877044405]

Dalfampridine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206765
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-31

NDC 67877-444-60 [67877044460]

Dalfampridine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206765
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-31

NDC 67877-444-90 [67877044490]

Dalfampridine TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206765
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-31

Drug Details

Active Ingredients

IngredientStrength
DALFAMPRIDINE10 mg/1

OpenFDA Data

SPL SET ID:e10b2d92-2824-4395-8883-6fd52c784aa4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 897021

    • Pharmacological Class

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

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

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