Dexmedetomidine Hydrochloride
- Product NDC
- 70069-759
- 11-digit product format
- 700690759
- Labeler code
- 70069
- Product ID
- 70069-759_6a1a2c33-1467-4eb0-adc6-6e21771fbf6b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmedetomidine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA218112
- Marketing category
- ANDA
- Marketing start
- 2024-09-26
- 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 Hydrochloride
- 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 | 1788947 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70069-759-04 | Dexmedetomidine Hydrochloride | 4 in 1 CARTON | INJECTION, SOLUTION | 4 | | 5 |
| 70069-759-04 | Dexmedetomidine Hydrochloride | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-759 | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] | 5 | Current NDC, 2 package rows | 20240927_649e777b-9b30-4f1e-9fb9-6bba57580976.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70069-759-04 | 70069075904 | 4 VIAL in 1 CARTON (70069-759-04) / 10 mL in 1 VIAL | 4 vial | 2024-09-26 | No | No | Historical |