DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
- Product NDC
- 84549-493
- 11-digit product format
- 845490493
- Labeler code
- 84549
- Product ID
- 84549-493_42caba25-dd88-040c-e063-6294a90a7a12
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- ProPharma Distribution
- Application
- ANDA209065
- Marketing category
- ANDA
- Marketing start
- 2020-06-12
- 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 IN 0.9% SODIUM CHLORIDE
- 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 | 1718900 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84549-493-95 | DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | 20 mL in 1 VIAL | INJECTION | 20 | | 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 |
|---|
| 84549-493-95 | 84549049395 | 20 mL in 1 VIAL (84549-493-95) | 20 ml | 2025-10-10 | No | No | Historical |