Dexmedetomidine in Dextrose
- Product NDC
- 44567-603
- 11-digit product format
- 445670603
- Labeler code
- 44567
- Product ID
- 44567-603_39d2f5dc-b34e-4c4b-9c54-3c8fb2c20589
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmedetomidine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- WG Critical Care, LLC
- Application
- NDA206628
- Marketing category
- NDA
- Marketing start
- 2016-04-19
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexmedetomidine in Dextrose
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | 4 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1018WH7F9I |
| Rxcui | 1718906, 1718909, 1788947 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 44567-603-24 | Dexmedetomidine in Dextrose | 24 in 1 CARTON | INJECTION | 24 | | 13 |
| 44567-603-24 | Dexmedetomidine in Dextrose | 100 mL in 1 BAG | INJECTION | 100 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44567-603 | DEXMEDETOMIDINE INJECTION, SOLUTION, CONCENTRATE DEXMEDETOMIDINE IN DEXTROSE (DEXMEDETOMIDINE) INJECTION [WG CRITICAL CARE, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250315_0d2710f2-ee47-4114-ab5c-8dca74cdcb8d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 44567-603-24 | 44567060324 | 24 BAG in 1 CARTON (44567-603-24) / 100 mL in 1 BAG | 24 bag | 2018-10-18 | 0000-00-00 | No | No | Current |