Drug
Who makes clonidine hydrochloride?
37 companies list clonidine hydrochloride as a human prescription drug, including under the names Duraclon, ONYDA XR, QLONILIK. Forms: injection, solution; solution; suspension, extended release; tablet; tablet, extended release. Routes: epidural, intravenous, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing clonidine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | tablet; tablet, extended release | ANDAANDA070886, ANDA070923, ANDA070924 | 25 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA070974, ANDA070975, ANDA078895 | 9 | 1 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA070886, ANDA078895, ANDA091368 | 8 | 3 |
| NuCare Pharmaceuticals,Inc.United States | tablet | ANDAANDA070925, ANDA070974, ANDA078895 | 8 | 1 |
| Alembic Pharmaceuticals LimitedIndia | tablet | ANDAANDA091368 | 7 | 7 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet | ANDAANDA070923, ANDA070924, ANDA070925 | 7 | 1 |
| Northwind Health Company, LLCUnited States | tablet | ANDAANDA070923, ANDA070924, ANDA070925 | 6 | 1 |
| Proficient Rx LPUnited States | tablet | ANDAANDA070924, ANDA070925, ANDA078895 | 5 | 1 |
| Actavis LLCUnited States | tablet; tablet, extended release | ANDAANDA070974, ANDA070975, ANDA070976 | 4 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet | ANDAANDA078895, ANDA091368 | 4 | 1 |
| BluePoint Laboratories Inc. | tablet; tablet, extended release | ANDAANDA070974, ANDA070975, ANDA070976 | 4 | 0 |
| Solco healthcare U.S., LLC | tablet; tablet, extended release | ANDAANDA077901, ANDA209757 | 4 | 0 |
| TruPharma LLC. | tablet | ANDAANDA070923 | 4 | 0 |
| Cardinal Health 418, Inc.United States | tablet | ANDAANDA070974, ANDA070975, ANDA077901 | 3 | 34 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA070886 | 3 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet; tablet, extended release | ANDAANDA070974, ANDA070975, ANDA209686 | 3 | 5 |
| Unichem Laboratories Limited, IndiaIndia | tablet | ANDAANDA078895 | 3 | 5 |
| Coupler LLCUnited States | tablet | ANDAANDA070975, ANDA091368, ANDA202297 | 3 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet | ANDAANDA070974, ANDA070975, ANDA070976 | 3 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet | ANDAANDA078895, ANDA091368 | 3 | 1 |
| AvPAK | tablet | ANDAANDA078895 | 3 | 0 |
| Method Pharmaceuticals, LLC. | tablet | ANDAANDA202297 | 3 | 0 |
| Hikma Pharmaceuticals USA Inc.United States | injection, solution | ANDAANDA200300 | 2 | 4 |
| RedPharm DrugUnited States | tablet | ANDAANDA078895, ANDA091368 | 2 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet | ANDAANDA078895, ANDA091368 | 2 | 1 |
| Unit Dose Solutions, Inc.United States | tablet | ANDAANDA070923, ANDA070975 | 2 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet | ANDAANDA070923, ANDA070976 | 2 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA077901 | 2 | 0 |
| VerityRx | tablet | ANDAANDA078895, ANDA091368 | 2 | 0 |
| Lupin LimitedIndia | tablet, extended release | ANDAANDA209285 | 1 | 14 |
| Ajanta Pharma LimitedIndia | tablet, extended release | ANDAANDA209686 | 1 | 2 |
| CMP Pharma, Inc.United States | solution | NDANDA221094 | 1 | 1 |
| Somerset Therapeutics Private LimitedIndia | tablet, extended release | ANDAANDA211433 | 1 | 1 |
| Xiamen LP Pharmaceutical Co., Ltd.China | tablet, extended release | ANDAANDA209757 | 1 | 1 |
| DirectRx | tablet | ANDAANDA091368 | 1 | 0 |
| Mylan Institutional Inc. | injection, solution | NDANDA020615 | 1 | 0 |
| NextWave Pharmaceuticals, Inc | suspension, extended release | NDANDA217645 | 1 | 0 |
Bulk ingredient listings
- Enaltec Labs Private LimitedIndia · 1 NDC
- Galenova IncCanada · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
- XENEX LABORATORIES INCCanada · 1 NDC
- YUNG ZIP CHEMICAL INDUSTRIAL .CO., LTD. · 1 NDC
Orange Book patents
6 unexpired patents list clonidine hydrochloride as the active ingredient, expiring between Mar 2029 and Aug 2045. Application holders: AZURITY PHARMACEUTICALS INC, CMP DEVELOPMENT LLC, TRIS PHARMA INC.
Enquiry
Common questions
- Who makes clonidine hydrochloride?
- 37 companies list clonidine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, RemedyRepack, Inc, International Medication Systems, Ltd., NuCare Pharmaceuticals,Inc., Alembic Pharmaceuticals Limited. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Duraclon?
- 34 companies list clonidine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies clonidine hydrochloride active ingredient?
- 9 companies list clonidine hydrochloride as a bulk ingredient, including Enaltec Labs Private Limited, Galenova Inc, LETCO MEDICAL, LLC, MEDISCA Inc..