Dexmedetomidine Hydrochloride
- Product NDC
- 25021-617
- 11-digit product format
- 250210617
- Labeler code
- 25021
- Product ID
- 25021-617_56ca6ba0-864c-4360-8791-0bd8399b2a2b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmedetomidine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA209307
- Marketing category
- ANDA
- Marketing start
- 2025-07-15
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexmedetomidine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | 4 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1018WH7F9I |
| Rxcui | 1718909 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25021-617-82 | Dexmedetomidine Hydrochloride | 20 in 1 CARTON | INJECTION | 20 | | 1 |
| 25021-617-82 | Dexmedetomidine Hydrochloride | 100 mL in 1 BAG | INJECTION | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 25021-617-82 | 25021061782 | 20 BAG in 1 CARTON (25021-617-82) / 100 mL in 1 BAG | 20 bag | 2025-07-15 | No | No | Historical |