Dexmedetomidine Hydrochloride
- Product NDC
- 42023-187
- 11-digit product format
- 420230187
- Labeler code
- 42023
- Product ID
- 42023-187_54174211-6684-4fb9-a605-be12b94e2948
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmedetomidine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Par Health USA, LLC
- Application
- ANDA208266
- Marketing category
- ANDA
- Marketing start
- 2020-12-04
- 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
- 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 | 4 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1018WH7F9I |
| Rxcui | 309710, 1718906, 1718909 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42023-187-10 | Dexmedetomidine Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 34 |
| 42023-187-10 | Dexmedetomidine Hydrochloride | 100 mL in 1 VIAL | INJECTION, SOLUTION | 100 | | 34 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Dexmedetomidine Hydrochloride | ACTIVE INGREDIENT | 1018WH7F9I | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [PAR PHARMACEUTICAL, INC.] | 3 | |
| Dexmedetomidine | ACTIVE MOIETY | 67VB76HONO | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [PAR PHARMACEUTICAL, INC.] | 3 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [PAR PHARMACEUTICAL, INC.] | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [PAR PHARMACEUTICAL, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42023-187 | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [ENDO USA, INC.] | 29 | Current NDC, Legacy NDC, 2 package rows | 20240425_1ee59985-4c1d-48f7-b8f9-5584c2d55e08.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 |
|---|
| 42023-187-10 | 42023018710 | 10 VIAL in 1 CARTON (42023-187-10) / 100 mL in 1 VIAL | 10 vial | 2020-12-04 | 0000-00-00 | No | No | Current |