Dexmedetomidine
- Product NDC
- 66794-230
- 11-digit product format
- 667940230
- Labeler code
- 66794
- Product ID
- 66794-230_3f76a806-297b-184b-e063-6394a90a7404
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmedetomidine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Piramal Critical Care Inc
- Application
- ANDA202126
- Marketing category
- ANDA
- Marketing start
- 2021-01-19
- Substance
- DEXMEDETOMIDINE HYDROCHLORIDE
- Active strength
- 200 ug/2mL
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexmedetomidine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | 200 ug/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1018WH7F9I |
| Rxcui | 309710 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66794-230-02 | Dexmedetomidine | 2 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 2 | | 6 |
| 66794-230-42 | Dexmedetomidine | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66794-230 | DEXMEDETOMIDINE INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240528_b93a71ed-0f9e-1ff9-e053-2995a90a789d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 66794-230-02 | 66794023002 | 2 mL in 1 VIAL, GLASS | 2 ml | | | | | Historical |
| 66794-230-42 | 66794023042 | 25 VIAL, GLASS in 1 CARTON (66794-230-42) / 2 mL in 1 VIAL, GLASS (66794-230-02) | | 2021-01-19 | 0000-00-00 | No | No | Current |