Dexmedetomidine
- Product NDC
- 66794-238
- 11-digit product format
- 667940238
- Labeler code
- 66794
- Product ID
- 66794-238_e26b89c7-8f28-0c94-e053-2a95a90a6113
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmedetomidine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Piramal Critical Care Inc
- Application
- ANDA214794
- Marketing category
- ANDA
- Marketing start
- 2020-04-24
- Marketing end
- 0000-00-00
- Substance
- DEXMEDETOMIDINE HYDROCHLORIDE
- Active strength
- 100 ug/mL
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66794-238 | DEXMEDETOMIDINE INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC] | 3 | Legacy NDC | 20220629_cbf32b97-d2a1-71bd-e053-2a95a90a3df7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 66794-238-41 | 66794023841 | 25 VIAL in 1 CARTON (66794-238-41) > 2 mL in 1 VIAL (66794-238-02) | 25 vial | 2020-04-24 | 0000-00-00 | No | No | Current |
| 66794-238-43 | 66794023843 | 10 VIAL in 1 CARTON (66794-238-43) > 2 mL in 1 VIAL (66794-238-02) | 10 vial | 2020-04-24 | 0000-00-00 | No | No | Current |