Dexmedetomidine Hydrochloride in Sodium Chloride
- Product NDC
- 51224-215
- 11-digit product format
- 512240215
- Labeler code
- 51224
- Product ID
- 51224-215_b654e5e9-102d-4623-80ad-5af3372427b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmedetomidine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- TAGI Pharma, Inc.
- Application
- ANDA212857
- Marketing category
- ANDA
- Marketing start
- 2020-11-23
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51224-215-10 | 51224021510 | 10 BOTTLE in 1 CARTON (51224-215-10) > 100 mL in 1 BOTTLE (51224-215-01) | 10 bottle | 2020-11-23 | 0000-00-00 | No | No | Current |