Dexmedetomidine Hydrochloride
- Product NDC
- 0143-9198
- 11-digit product format
- 001439198
- Labeler code
- 0143
- Product ID
- 0143-9198_b39a45b9-3b3d-4719-8dfe-da16fd55ac10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmedetomidine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA206407
- Marketing category
- ANDA
- Marketing start
- 2026-03-03
- 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 Hydrochloride
- 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, 2396891 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9198-01 | Dexmedetomidine Hydrochloride | 250 mL in 1 BAG | INJECTION, SOLUTION | 250 | | 15 |
| 0143-9198-10 | Dexmedetomidine Hydrochloride | 10 in 1 CASE | INJECTION, SOLUTION | 10 | | 15 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0143-9198-01 | 00143919801 | 250 mL in 1 BAG | 250 ml | | | | Historical |
| 0143-9198-10 | 00143919810 | 10 BAG in 1 CASE (0143-9198-10) / 250 mL in 1 BAG (0143-9198-01) | 10 bag | 2026-03-03 | No | No | Current |