Dexmedetomidine Hydrochloride
- Product NDC
- 65219-642
- 11-digit product format
- 652190642
- Labeler code
- 65219
- Product ID
- 65219-642_1896a96e-25f8-494e-9a96-6463b52fb102
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dexmedetomidine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA201072
- Marketing category
- ANDA
- Marketing start
- 2015-09-18
- 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
- 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 | 100 ug/mL |
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 |
|---|
| 65219-642-01 | Dexmedetomidine Hydrochloride | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 1 |
| 65219-642-02 | Dexmedetomidine Hydrochloride | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 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 |
|---|
| 65219-642-01 | 65219064201 | 2 mL in 1 VIAL | 2 ml | | | | Historical |
| 65219-642-02 | 65219064202 | 25 VIAL in 1 TRAY (65219-642-02) / 2 mL in 1 VIAL (65219-642-01) | 25 vial | 2024-12-13 | No | No | Current |