Dexmedetomidine Hydrochloride
- Product NDC
- 71872-7031
- 11-digit product format
- 718727031
- Labeler code
- 71872
- Product ID
- 71872-7031_fd1604d4-5081-7e98-e053-6394a90af8aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmedetomidine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Medical Purchasing Solutions, LLC
- Application
- ANDA205867
- Marketing category
- ANDA
- Marketing start
- 2016-03-17
- 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 | 309710 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71872-7031-1 | Dexmedetomidine Hydrochloride | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 3 |
| 71872-7031-1 | Dexmedetomidine Hydrochloride | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71872-7031 | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230602_a268e759-9a3e-1d7b-e053-2a95a90a335b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71872-7031-1 | 71872703101 | 1 VIAL in 1 BAG (71872-7031-1) / 2 mL in 1 VIAL | 1 vial | 2020-03-02 | 0000-00-00 | No | No | Current |