NDC 65862-863

DALFAMPRIDINE

Dalfampridine

DALFAMPRIDINE is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Dalfampridine.

Product ID65862-863_22be5ce2-8b4d-4bd7-be16-4f34577803a6
NDC65862-863
Product TypeHuman Prescription Drug
Proprietary NameDALFAMPRIDINE
Generic NameDalfampridine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-06-25
Marketing CategoryANDA / ANDA
Application NumberANDA206811
Labeler NameAurobindo Pharma Limited
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 65862-863-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-01)
Marketing Start Date2018-06-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-863-05 [65862086305]

DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206811
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-25

NDC 65862-863-01 [65862086301]

DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206811
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-25

NDC 65862-863-60 [65862086360]

DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206811
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-25

Drug Details

Active Ingredients

IngredientStrength
DALFAMPRIDINE10 mg/1

OpenFDA Data

SPL SET ID:43996322-7d83-4420-9e61-4ed37f710fee
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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