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Active ingredient

Doxepin

206 finished FDA listings contain Doxepin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DOXEPIN HYDROCHLORIDE
Dosage forms
Capsule, Cream, Solution, Tablet, Tablet, Film Coated
Routes
Oral, Topical
Manufacturers / labelers
52
Strengths listed
10 mg/1 · 10 mg/ml · 100 mg/1 · 150 mg/1 · 25 mg/1 · 3 mg/1 · 50 mg/1 · 50 mg/g · 6 mg/1 · 75 mg/1
Brand names in FDA listings
Doxepin, Doxepin Hydrochloride, Prudoxin, Silenor, Zonalon

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 3638

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 070791MYLAN PHARMS INC1986-05-1318
NDA 020126MYLAN1994-04-013
ANDA 074721LANNETT CO INC1998-12-291
NDA 022036CURRAX2010-03-174
ANDA 201951ACTAVIS ELIZABETH2013-07-262
ANDA 202337RK PHARMA2016-01-206
ANDA 207482AMNEAL PHARMS CO2017-06-2812
ANDA 211603AUROBINDO PHARMA LTD2019-03-2710
ANDA 212624AJANTA PHARMA LTD2019-09-1315
ANDA 213063TARO2020-07-014
ANDA 202510STRIDES PHARMA INTL2020-07-246
ANDA 213474AIPING PHARM INC2020-07-2815
ANDA 210268CHARTWELL RX2020-09-045
ANDA 210675EPIC PHARMA LLC2020-10-1610
ANDA 211618VELZEN PHARMA PVT2021-03-012
ANDA 211619LEADING2021-03-095
ANDA 214908APPCO2021-04-0110
ANDA 215076ALEMBIC2021-04-2118
ANDA 215710MANKIND PHARMA2022-02-0918
ANDA 215113MSN2022-06-2416
ANDA 215408TEVA PHARMS2023-02-171
ANDA 214823MSN2023-04-035
ANDA 202761ZYDUS LIFESCIENCES2023-08-164
ANDA 212357AMNEAL2023-08-161
ANDA 217975UNIQUE2023-08-215
ANDA 218564AJANTA PHARMA LTD2024-07-012
ANDA 216041AUROBINDO PHARMA LTD2024-07-254
ANDA 219058TARO2025-08-064

Official labeling on DailyMed

Showing the 12 most recent of 101 labels.

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