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Active ingredient

Mirtazapine

144 finished FDA listings contain Mirtazapine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
MIRTAZAPINE, MIRTAZAPINE HEMIHYDRATE
Dosage forms
Tablet, Tablet, Film Coated, Tablet, Orally Disintegrating
Routes
Oral
Manufacturers / labelers
37
Strengths listed
15 mg/1 · 30 mg/1 · 45 mg/1 · 7.5 mg/1
Brand names in FDA listings
Remeron, Remeronsoltab

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 15996

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 020415ORGANON1996-06-142
NDA 021208ORGANON USA ORGANON2001-01-123
ANDA 076122MYLAN2003-06-1917
ANDA 076541SUN PHARM INDS INC2004-04-2215
ANDA 076921AUROBINDO2004-10-2259
ANDA 077376AUROBINDO PHARMA2005-12-088
ANDA 077666APOTEX2007-08-2216
ANDA 205798SQUARE PHARMS PLC2017-06-017
ANDA 216751PRASCO2023-01-186
ANDA 219721ANNORA PHARMA2025-10-029
ANDA 219919NOVITIUM PHARMA2026-02-022

Official labeling on DailyMed

Showing the 12 most recent of 92 labels.

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