Quick answers
- What is Clonidine used for?
- The FDA-approved label (Catapres-TTS-1, Technomed Inc., January 6, 2026) says: “Catapres‑TTS ® is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clonidine have a boxed warning?
- The label we quote has no boxed warning, but 2 of 119 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Clonidine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Clonidine been recalled?
- FDA enforcement reports list 11 recalls of products of this medicine; the newest started March 19, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Clonidine?
- 48 companies list prescription products of Clonidine in the FDA NDC Directory, including Bryant Ranch Prepack, TruPharma, LLC and Remedyrepack Inc..
What Clonidine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Catapres‑TTS ® is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.
— FDA label: Catapres-TTS-1, Technomed Inc., effective January 6, 2026. Read the full label on DailyMed →
The FDA has 119 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
2 of 119 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Patch · Tablet, extended release · Injection, solution · Patch, extended release · Solution · Suspension, extended release |
|---|---|
| Route | Oral · Transdermal · Intravenous · Epidural |
| Prescription products | 175 in the FDA NDC Directory |
| Brand names | Clonidine Transdermal System, Catapres-Tts-1, Clonidine Transdermal System Usp, 0.1 Mg/Day, Clonidine Transdermal System Usp, 0.3 Mg/Day, Catapres-Tts-2, Catapres-Tts-3, Clonidine Transdermal System Usp, 0.2 Mg/Day, Javadin, Qlonilik, Duraclon, Onyda XR, Nexiclon XR |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| clonidine 0.1 mg/24 h patch, extended release | Generic | $6.55 per patch |
| clonidine 0.1 mg/d patch | Generic | $6.55 per patch |
| clonidine 0.17 mg tablet, extended release | Generic | $15.21 per tablet |
| clonidine 0.2 mg/24 h patch, extended release | Generic | $8.77 per patch |
| clonidine 0.2 mg/d patch | Generic | $8.77 per patch |
| clonidine 0.3 mg/24 h patch, extended release | Generic | $12.38 per patch |
| clonidine 0.3 mg/d patch | Generic | $12.38 per patch |
| clonidine hydrochloride 0.05 mg tablet | Generic | $1.17 per tablet |
| clonidine hydrochloride 0.1 mg tablet | Generic | $0.0233 per tablet |
| clonidine hydrochloride 0.1 mg tablet, extended release | Generic | $0.2236 per tablet |
| clonidine hydrochloride 0.1 mg/mL suspension, extended release | Brand: Onyda XR | $13.37 per mL |
| clonidine hydrochloride 0.2 mg tablet | Generic | $0.0336 per tablet |
| clonidine hydrochloride 0.3 mg tablet | Generic | $0.0407 per tablet |
| clonidine hydrochloride 20 ug/mL solution | Brand: Javadin | $1.53 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack25 products
- TruPharma, LLC11 products
- Remedyrepack Inc.9 products
- NuCare Pharmaceuticals, Inc.8 products
- A-S Medication Solutions8 products
- Asclemed USA, Inc.7 products
- Actavis Pharma, Inc.7 products
- Northwind Health Company, LLC6 products
- Technomed Inc.6 products
- Proficient Rx LP5 products
- BluePoint Laboratories4 products
- Alembic Pharmaceuticals Inc.4 products
- Preferred Pharmaceuticals Inc.4 products
- Solco Healthcare LLC4 products
- Alembic Pharmaceuticals Limited4 products
- Aurobindo Pharma Limited3 products
- Unichem Pharmaceuticals (USA), Inc.3 products
- Coupler LLC3 products
- PD-Rx Pharmaceuticals, Inc.3 products
- AvPAK3 products
- Method Pharmaceuticals, LLC3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- American Health Packaging3 products
- Cardinal Health 107, LLC3 products
- Dr. Reddy's Labratories Inc.3 products
- Mylan Pharmaceuticals Inc.3 products
- Verityrx, LLC2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Unit Dose Solutions, Inc.2 products
- Aphena Pharma Solutions - Tennessee, LLC2 products
- St. Mary's Medical Park Pharmacy2 products
- Major Pharmaceuticals2 products
- XGen Pharmaceuticals DJB, Inc.2 products
- Redpharm Drug2 products
- Azurity Pharmaceuticals, Inc.1 product
- HF Acquisition Co LLC, DBA HealthFirst1 product
- Ajanta Pharma USA Inc.1 product
- CMP Pharma, Inc.1 product
- Mylan Institutional LLC1 product
- Somerset Therapeutics, LLC1 product
- DirectRx1 product
- Ingenus Pharmaceuticals, LLC1 product
- Lupin Pharmaceuticals, Inc.1 product
- NextWave Pharmaceuticals, Inc1 product
- Xiamen LP Pharmaceutical Co., Ltd.1 product
- Palmetto Pharmaceuticals Inc.1 product
- Mayne Pharma Inc.1 product
- Rosemont Pharmaceuticals LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018891 CATAPRES-TTS-1, CATAPRES-TTS-2, CATAPRES-TTS-3 | Lavipharm | October 10, 1984 | 28, latest December 4, 2025 2025: Manufacturing (CMC) · 2023: Labeling · 2012: Labeling |
| NDA020615 DURACLON | Mylan Institutional | October 2, 1996 | 6, latest August 1, 2016 2016: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
| NDA022500 NEXICLON XR | Rosemont | December 3, 2009 | 1, latest September 23, 2010 2010: Labeling |
| NDA217645 ONYDA XR | Tris Pharma Inc | May 24, 2024 | 2, latest May 7, 2025 2025: Labeling · 2024: Labeling |
| NDA220256 JAVADIN | Azurity | October 23, 2025 | — |
| NDA221094 QLONILIK | Cmp Dev LLC | July 29, 2026 | — |
Generic approvals (22)
- ANDA070974Actavis Elizabeth · December 16, 1986
- ANDA070975Actavis Elizabeth · December 16, 1986
- ANDA070976Actavis Elizabeth · December 16, 1986
- ANDA070923Tp Anda Holdings · September 4, 1987
- ANDA070886Aurobindo Pharma Ltd · August 31, 1988
- ANDA077901Prinston Inc · March 9, 2007
- ANDA078895Unichem · August 26, 2009
- ANDA076166Mylan Technologies · July 16, 2010
- ANDA079090DR Reddys Labs SA · August 20, 2010
- ANDA200300Hikma Farmaceutica · January 26, 2011
- ANDA091368Alembic Pharms Ltd · December 6, 2011
- ANDA202297Yung Shin Pharm · June 13, 2013
- ANDA203167Xgen Pharms · October 29, 2013
- ANDA090873Actavis Labs Ut Inc · May 6, 2014
- ANDA203320Actavis Elizabeth · May 15, 2015
- ANDA209285Chartwell Rx · October 23, 2017
- ANDA209686Ajanta Pharma Ltd · November 20, 2017
- ANDA209757Xiamen LP Pharm Co · November 20, 2017
- ANDA211433Somerset Theraps LLC · October 12, 2018
- ANDA209675Novast Labs · March 5, 2019
- ANDA070924—
- ANDA070925—
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 19, 2026 · Class II · Ongoing · D-0472-2026
CGMP Deviations: use of an unapproved raw material
Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc — Teva Pharmaceuticals USA, Inc
-
March 19, 2026 · Class II · Ongoing · D-0474-2026
CGMP Deviations: use of an unapproved raw material
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc — Teva Pharmaceuticals USA, Inc
-
March 19, 2026 · Class II · Ongoing · D-0473-2026
CGMP Deviations: use of an unapproved raw material
Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc — Teva Pharmaceuticals USA, Inc
-
September 19, 2022 · Class III · Terminated · D-1541-2022
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA) — UNICHEM PHARMACEUTICALS USA INC
-
June 9, 2022 · Class II · Terminated · D-1152-2022
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834 — Mayne Pharma Inc
-
April 13, 2022 · Class II · Terminated · D-1091-2022
cGMP deviations: Temperature abuse
Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL single-dose vial, Rx only, MFG: Mylan Pharma, NDC 67457-218-10 — Mckesson Medical-Surgical Inc. Corporate Office
-
October 28, 2021 · Class III · Terminated · D-0235-2022
Failed Impurities/Degradation Specifications
Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04 — Teva Pharmaceuticals USA
-
May 26, 2020 · Class III · Terminated · D-1291-2020
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem Pharmaceuticals (USA) — UNICHEM PHARMACEUTICALS USA INC
-
January 29, 2020 · Class III · Terminated · D-0829-2020
Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pilerne Bardez, Goa 403 511 India. Manufactured for: Unichem Pharmaceuticals (USA), I — UNICHEM PHARMACEUTICALS USA INC
-
March 29, 2019 · Class III · Terminated · D-1084-2019
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1. — X-Gen Pharmaceuticals Inc.
-
July 17, 2014 · Class III · Terminated · D-1444-2014
Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".
Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1. — X-Gen Pharmaceuticals Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 884173, 884185, 884189, 884221, 884223, 884225, 885880, 998671, 998673, 998675 … (+10) |
|---|---|
| SPL set ID of the quoted label | 39e1d35e-533c-4647-8649-8168a6e92dfa |
| FDA labels (SPL) | 119 |
| FDA applications | NDA018891, NDA020615, NDA022500, NDA217645, NDA220256, NDA221094, 22 ANDA |
| Active ingredients (FDA) | CLONIDINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Catapres-TTS-1, Technomed Inc., effective January 6, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →