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Active ingredient

Dalfampridine

11 finished FDA listings contain Dalfampridine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DALFAMPRIDINE
Dosage forms
Tablet, Extended Release, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
10
Strengths listed
10 mg/1
Brand names in FDA listings
Ampyra

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 897018

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 022250MERZ2010-01-222
ANDA 206836ACTAVIS LABS FL INC2017-01-231
ANDA 206811AUROBINDO PHARMA2017-01-231
ANDA 206863ACCORD HLTHCARE2018-07-111
ANDA 206765ALKEM LABS LTD2018-07-303
ANDA 210158MICRO LABS2019-03-112
ANDA 208292SUN PHARM2019-05-211

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.