DEXMEDETOMIDINE
- Product NDC
- 84549-505
- 11-digit product format
- 845490505
- Labeler code
- 84549
- Product ID
- 84549-505_42dab90e-68c2-bed1-e063-6294a90a4b0c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEXMEDETOMIDINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- ProPharma Distribution
- Application
- ANDA204843
- Marketing category
- ANDA
- Marketing start
- 2019-01-18
- 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
- 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 | 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 |
|---|
| 84549-505-03 | DEXMEDETOMIDINE | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 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 |
|---|
| 84549-505-03 | 84549050503 | 2 mL in 1 VIAL, SINGLE-DOSE (84549-505-03) | 2 ml | 2025-10-10 | No | No | Historical |