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Active ingredient

Atomoxetine

137 finished FDA listings contain Atomoxetine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ATOMOXETINE HYDROCHLORIDE
Dosage forms
Capsule, Solution
Routes
Oral
Manufacturers / labelers
23
Strengths listed
10 mg/1 · 100 mg/1 · 18 mg/1 · 25 mg/1 · 4 mg/ml · 40 mg/1 · 60 mg/1 · 80 mg/1
Brand names in FDA listings
Atoncy, Strattera

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 38400

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 021411LILLY2002-11-267
ANDA 079017ZYDUS PHARMS USA INC2010-09-161
ANDA 078983APOTEX2017-05-3019
ANDA 079022TEVA PHARMS USA2017-05-3018
ANDA 079016AUROBINDO PHARMA2017-05-3021
ANDA 079019GLENMARK PHARMS LTD2017-05-3019
ANDA 090609DR REDDYS2018-02-2311
ANDA 079021STRIDES PHARMA2021-02-1815
ANDA 202682HETERO LABS LTD V2021-03-1117
NDA 220320MAP772026-03-202
ANDA 218875PHARMAZONE2026-06-167

Official labeling on DailyMed

Showing the 12 most recent of 50 labels.

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