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Active ingredient

Doxycycline

334 finished FDA listings contain Doxycycline as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
DOXYCYCLINE, DOXYCYCLINE ANHYDROUS, DOXYCYCLINE HYCLATE
Dosage forms
Capsule, For Suspension, Injection, Powder, For Solution, Injection, Powder, Lyophilized, For Solution, Powder, For Solution, Powder, For Suspension, Tablet, Tablet, Coated, Tablet, Delayed Release, Tablet, Film Coated
Routes
Intravenous, Oral
Manufacturers / labelers
93
Strengths listed
100 mg/1 · 100 mg/100mg · 100 mg/10ml · 150 mg/1 · 20 mg/1 · 200 mg/1 · 200 mg/20ml · 25 mg/5ml · 40 mg/1 · 50 mg/1 · 60 mg/1 · 75 mg/1
Brand names in FDA listings
Acticlate Cap, Doryx Mpc, Doxy 100, Doxycyclate Hyclate, Doxycycline, Doxycycline Doxycycline, Doxycycline Hyclate, Doxycycline Hyclate Delayed Release, Oracea, Targadox

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 3640

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 062269EPIC PHARMA LLC1982-11-0812
ANDA 062475FRESENIUS KABI USA1983-12-094
ANDA 062505CHARTWELL1984-09-1111
ANDA 062500CHARTWELL1984-09-1119
ANDA 062396HIKMA INTL PHARMS1984-11-0718
ANDA 062676SUN PHARM INDUSTRIES1986-07-1014
ANDA 062677SUN PHARM INDUSTRIES1986-07-106
NDA 050641CHARTWELL RX1989-12-295
ANDA 065053SUN PHARM INDS LTD2000-11-225
ANDA 065055STRIDES PHARMA INTL2000-12-0116
ANDA 065070STRIDES PHARMA INTL2000-12-154
ANDA 065095HIKMA INTL PHARMS2003-07-0210
ANDA 065182EPIC PHARMA LLC2005-05-133
ANDA 065285LANNETT CO INC2005-12-086
ANDA 065356SUN PHARM INDS LTD2006-05-314
ANDA 065454CHARTWELL2008-07-163
ANDA 091605HERITAGE2011-12-209
ANDA 091406MYLAN LABS LTD2012-08-212
ANDA 200856HERITAGE2013-04-304
ANDA 204234LUPIN2014-03-055
NDA 205931CHARTWELL RX2014-07-252
ANDA 204446COSETTE PHARMS NC2015-05-284
ANDA 205115ZYDUS PHARMS2016-02-1817
NDA 208253CHARTWELL RX2016-04-262
ANDA 207289AMNEAL PHARMS2016-06-275
ANDA 207494PRINSTON INC2016-11-154
ANDA 209165ALEMBIC2017-07-286
ANDA 207558NOVEL LABS INC2017-09-062
ANDA 208818LUPIN2017-09-272
ANDA 207757ZYDUS PHARMS2017-09-284
ANDA 209582ZYDUS PHARMS2017-09-2812
ANDA 207773ZYDUS LIFESCIENCES2017-10-305
ANDA 207774ZYDUS LIFESCIENCES2018-05-3113
ANDA 210527ALEMBIC2018-06-134
ANDA 209402CHANGZHOU PHARM2019-10-0713
ANDA 211343CHANGZHOU PHARM2019-10-0912
ANDA 210536ALEMBIC2020-05-144
ANDA 211744ALEMBIC2020-06-304
ANDA 213075ALEMBIC2022-01-038
ANDA 215583GLAND2023-04-124

Showing 40 of 73 applications.

Official labeling on DailyMed

Showing the 12 most recent of 239 labels.

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