Dexmedetomidine Hydrochloride Injection
Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.) · Available
Open FDA's page for this record- Update type
- Reverified
- Initial posting date
- 04/10/2020
- Package NDC
- 83634-600-02
- Generic name
- Dexmedetomidine Hydrochloride Injection
- Contact info
- See Related Information section below for customer service information
- Availability
- Available
- Related info
- Distributed by Avenacy; Contact information: 877-283-6229
- Update date
- 09/08/2026
- Dosage form
- Injection
- Presentation
- Dexmedetomidine Hydrochloride, Injection, 200 mcg/2 mL (NDC 83634-600-02)
- Company name
- Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.)
- Status
- Current
- Therapeutic category
- Anesthesia
- Harmonized identifiers (openFDA)
- Application number
- ANDA209065
- Brand name
- DEXMEDETOMIDINE
- Generic name
- DEXMEDETOMIDINE
- Manufacturer name
- Avenacy Inc.
- Product NDC
- 83634-600
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Substance name
- DEXMEDETOMIDINE HYDROCHLORIDE
- RxCUI
- 309710
- SPL ID
- f036291f-40af-44b9-8a7f-d4475788ea63
- SPL set ID
- eee6145b-d83f-4596-92d3-733934d8a3a4
- Package NDC
- 83634-600-41, 83634-600-02
- UNII
- 1018WH7F9I