Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride
- Product NDC
- 25021-615
- 11-digit product format
- 250210615
- Labeler code
- 25021
- Product ID
- 25021-615_18a919fe-92bd-4e01-a966-7334eb31b844
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dexmedetomidine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA217308
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- Substance
- DEXMEDETOMIDINE HYDROCHLORIDE
- Active strength
- 4 ug/mL
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 1018WH7F9I | DEXMEDETOMIDINE HYDROCHLORIDE | 145108-58-3 | DEXMEDETOMIDINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 25021-615-50 | 25021061550 | 10 BOTTLE in 1 CARTON (25021-615-50) / 50 mL in 1 BOTTLE | 10 bottle | 2024-02-15 | No | No | Historical |
| 25021-615-51 | 25021061551 | 10 BOTTLE in 1 CARTON (25021-615-51) / 100 mL in 1 BOTTLE | 10 bottle | 2024-02-15 | No | No | Historical |