Drug
Who makes dexmedetomidine hydrochloride?
18 companies list dexmedetomidine hydrochloride as a human prescription drug, including under the names Precedex. Forms: injection; injection, solution; injection, solution, concentrate. Routes: intravenous.
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 dexmedetomidine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Hospira, Inc.United States | injection, solution; injection, solution, concentrate | NDANDA021038 | 13 | 7 |
| Baxter Healthcare CorporationUnited States | injection; injection, solution, concentrate | ANDAANDA208103, ANDA208532 | 5 | 16 |
| Par Health USA, LLCIndia | injection, solution; injection, solution, concentrate | ANDAANDA203972, ANDA208266 | 3 | 5 |
| GLAND PHARMA LIMITEDIndia | injection | ANDAANDA209307 | 3 | 4 |
| Hikma Pharmaceuticals USA Inc.United States | injection, solution | ANDAANDA206407 | 3 | 4 |
| Medical Purchasing Solutions, LLCUnited States | injection, solution | ANDAANDA202126, ANDA204023, ANDA205867 | 3 | 1 |
| Precision Dose Inc.United States | injection, solution | ANDAANDA212857 | 3 | 1 |
| Dr. Reddy's Laboratories LimitedIndia | injection, solution | ANDAANDA209307 | 2 | 15 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDAANDA201072 | 2 | 6 |
| Amneal Ireland LimitedIreland | injection, solution | ANDAANDA207551 | 2 | 1 |
| Civica, Inc. dba CivicaRxUnited States | injection | ANDAANDA212791 | 2 | 1 |
| Piramal Critical Care IncUnited States | injection | ANDAANDA209307 | 2 | 1 |
| Somerset Therapeutics Private LimitedIndia | injection, solution | ANDAANDA218112 | 2 | 1 |
| Mylan Institutional Inc. | injection, solution | ANDAANDA212571 | 2 | 0 |
| Sagent Pharmaceuticals | injection; injection, solution | ANDAANDA209307, ANDA217308 | 2 | 0 |
| Wilshire Pharmaceuticals, Inc. | injection | ANDAANDA212791 | 2 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | injection, solution | ANDAANDA202126 | 1 | 13 |
| Henry Schein, Inc.United States | injection, solution, concentrate | NDANDA021038 | 1 | 1 |
Bulk ingredient listings
- NORCHIMFrance · 2 NDC
- Asymchem Laboratories (Tianjin) Co., Ltd. · 1 NDC
- Chongqing Biocare Pharmaceutical Ltd.China · 1 NDC
- Edmond Pharma S.r.lItaly · 1 NDC
- Emcure Pharmaceuticals LimitedIndia · 1 NDC
- Fermion OyFinland · 1 NDC
- Guangan Kingday Pharma & Chem Co., Ltd. · 1 NDC
- Jiangsu Hengrui Pharmaceuticals Co., Ltd.China · 1 NDC
- Maithri Drugs Private LimitedIndia · 1 NDC
- Sterling Pharmaceutical Services, LLCUnited States · 1 NDC
- Strem Chemicals, Inc.United States · 1 NDC
- Wuhan Biocause Pharmaceutical Development Co., Ltd · 1 NDC
Orange Book patents
29 unexpired patents list dexmedetomidine hydrochloride as the active ingredient, expiring between Jan 2032 and Jan 2043. Application holders: BIOXCEL THERAPEUTICS INC, HOSPIRA INC, HQ SPECIALTY PHARMA CORP.
Enquiry
Common questions
- Who makes dexmedetomidine hydrochloride?
- 18 companies list dexmedetomidine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Hospira, Inc., Baxter Healthcare Corporation, Par Health USA, LLC, GLAND PHARMA LIMITED, Hikma Pharmaceuticals USA Inc.. 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 Precedex?
- 16 companies list dexmedetomidine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies dexmedetomidine hydrochloride active ingredient?
- 12 companies list dexmedetomidine hydrochloride as a bulk ingredient, including NORCHIM, Asymchem Laboratories (Tianjin) Co., Ltd., Chongqing Biocare Pharmaceutical Ltd., Edmond Pharma S.r.l.