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Active ingredient

Dextroamphetamine

62 finished FDA listings contain Dextroamphetamine as their only active ingredient; 231 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
DEXTROAMPHETAMINE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE
Dosage forms
Capsule, Extended Release, Patch, Extended Release, Solution, Tablet
Routes
Oral, Transdermal
Manufacturers / labelers
17
Strengths listed
10 mg/1 · 13.5 mg/1 · 15 mg/1 · 18 mg/1 · 2.5 mg/1 · 20 mg/1 · 30 mg/1 · 4.5 mg/1 · 5 mg/1 · 5 mg/5ml · 7.5 mg/1 · 9 mg/1
Brand names in FDA listings
Dexedrine Spansule, Dextroamphetamine Sulfate Extended-Release, Procentra, Xelstrym, Zenzedi

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 3288

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 017078IMPAX LABS INC1976-08-026
ANDA 040361BARR2001-01-312
ANDA 040436SPECGX LLC2002-01-292
ANDA 076353SPECGX LLC2003-05-063
ANDA 040776PRASCO2008-01-292
ANDA 090533AZURITY2011-10-2517
ANDA 203901ACTAVIS ELIZABETH2012-11-303
ANDA 203644TRIS PHARMA INC2013-05-292
ANDA 202893AUROLIFE PHARMA LLC2013-07-312
ANDA 203548AVANTHI INC2015-11-232
ANDA 204330NOVEL LABS INC2016-03-162
ANDA 210059NUVO PHARM2017-10-186
ANDA 212160WINDER LABS LLC2021-06-077
NDA 215401NOVEN PHARMS INC2022-03-224
ANDA 206095TRIS PHARMA INC2022-08-182

Official labeling on DailyMed

Showing the 12 most recent of 27 labels.

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