Active ingredient
Clonidine
174 finished FDA listings contain Clonidine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CLONIDINE, CLONIDINE HYDROCHLORIDE
- Dosage forms
- Injection, Solution, Patch, Patch, Extended Release, Solution, Suspension, Extended Release, Tablet, Tablet, Extended Release
- Routes
- Epidural, Intravenous, Oral, Transdermal
- Manufacturers / labelers
- 50
- Strengths listed
- .05 mg/1 · .05 mg/ml · .1 mg/1 · .1 mg/24h · .1 mg/d · .1 mg/ml · .17 mg/1 · .2 mg/1 · .2 mg/24h · .2 mg/d · .3 mg/1 · .3 mg/24h · .3 mg/d · 100 ug/ml · 20 ug/ml · 500 ug/ml
- Brand names in FDA listings
- Catapres-Tts-1, Catapres-Tts-2, Catapres-Tts-3, Clonidine Transdermal System, Clonidine Transdermal System Usp, 0.1 Mg/Day, Clonidine Transdermal System Usp, 0.2 Mg/Day, Clonidine Transdermal System Usp, 0.3 Mg/Day, Duraclon, Javadin, Nexiclon Xr, Onyda Xr, Qlonilik
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2599
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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 018891 | LAVIPHARM | 1984-10-10 | 12 |
| ANDA 070976 | ACTAVIS ELIZABETH | 1986-12-16 | 4 |
| ANDA 070974 | ACTAVIS ELIZABETH | 1986-12-16 | 10 |
| ANDA 070975 | ACTAVIS ELIZABETH | 1986-12-16 | 9 |
| ANDA 070923 | TP ANDA HOLDINGS | 1987-09-04 | 9 |
| ANDA 070886 | AUROBINDO PHARMA LTD | 1988-08-31 | 7 |
| NDA 020615 | MYLAN INSTITUTIONAL | 1996-10-02 | 1 |
| ANDA 077901 | PRINSTON INC | 2007-03-09 | 6 |
| ANDA 078895 | UNICHEM | 2009-08-26 | 28 |
| NDA 022500 | ROSEMOUNT | 2009-12-03 | 3 |
| ANDA 076166 | MYLAN TECHNOLOGIES | 2010-07-16 | 3 |
| ANDA 079090 | DR REDDYS LABS SA | 2010-08-20 | 4 |
| ANDA 200300 | HIKMA FARMACEUTICA | 2011-01-26 | 3 |
| ANDA 091368 | ALEMBIC PHARMS LTD | 2011-12-06 | 26 |
| ANDA 202297 | YUNG SHIN PHARM | 2013-06-13 | 20 |
| ANDA 203167 | XGEN PHARMS | 2013-10-29 | 2 |
| ANDA 090873 | ACTAVIS LABS UT INC | 2014-05-06 | 3 |
| ANDA 203320 | ACTAVIS ELIZABETH | 2015-05-15 | 1 |
| ANDA 209285 | CHARTWELL RX | 2017-10-23 | 1 |
| ANDA 209757 | XIAMEN LP PHARM CO | 2017-11-20 | 3 |
| ANDA 209686 | AJANTA PHARMA LTD | 2017-11-20 | 3 |
| ANDA 211433 | SOMERSET THERAPS LLC | 2018-10-12 | 1 |
| ANDA 209675 | NOVAST LABS | 2019-03-05 | 1 |
| NDA 217645 | TRIS PHARMA INC | 2024-05-24 | 1 |
| NDA 220256 | AZURITY | 2025-10-23 | 1 |
| NDA 221094 | CMP DEV LLC | 2026-07-29 | 1 |
Official labeling on DailyMed
- CLONIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-10
- CLONIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 2 · 2026-09-10
- CLONIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-10
- QLONILIK (CLONIDINE HYDROCHLORIDE) SOLUTION [CMP PHARMA, INC.] · version 1 · 2026-08-31
- CLONIDINE HYDROCHLORIDE TABLET [COUPLER LLC] · version 1 · 2026-08-10
- CLONIDINE PATCH [MYLAN PHARMACEUTICALS INC.] · version 13 · 2026-08-10
- CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS] · version 4 · 2026-08-07
- CLONIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 16 · 2026-08-06
- CLONIDINE HYDROCHLORIDE TABLET [REDPHARM DRUG] · version 2 · 2026-08-03
- CLONIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 11 · 2026-07-23
- CLONIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 15 · 2026-07-06
- CLONIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 6 · 2026-07-06
Showing the 12 most recent of 128 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.