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Active ingredient

Amphetamine

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

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FDA NDC Directory

Ingredient names as written by FDA
AMPHETAMINE, AMPHETAMINE ASPARTATE, AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE DL-ASPARTATE, AMPHETAMINE DL-ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE
Dosage forms
Suspension, Extended Release, Tablet, Tablet, Extended Release, Tablet, Orally Disintegrating
Routes
Oral
Manufacturers / labelers
16
Strengths listed
10 mg/1 · 12.5 mg/1 · 15 mg/1 · 15.7 mg/1 · 18.8 mg/1 · 2.5 mg/ml · 20 mg/1 · 3.1 mg/1 · 5 mg/1 · 6.3 mg/1 · 9.4 mg/1
Brand names in FDA listings
Adzenys Xr-Odt, Amphetamine Sulfate, Dyanavel Xr, Evekeo

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 725

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
ANDA 200166AZURITY2012-08-098
NDA 208147TRIS PHARMA INC2015-10-191
NDA 204326NEOS THERAPS2016-01-2712
ANDA 211139AMNEAL PHARMS2018-09-262
ANDA 211639AUROLIFE PHARMA LLC2019-04-172
ANDA 212619GRANULES2019-08-052
ANDA 212582SANALUZ2020-02-042
ANDA 211861PRINSTON INC2020-03-116
ANDA 212901SENORES PHARMS2020-05-229
ANDA 213980EPIC PHARMA LLC2020-10-272
ANDA 213583SPECGX LLC2021-01-222
NDA 210526TRIS PHARMA INC2021-11-044
ANDA 209253ACTAVIS LABS FL INC2023-06-226

Official labeling on DailyMed

Showing the 12 most recent of 25 labels.

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