Dexmedetomidine
- Product NDC
- 68083-527
- 11-digit product format
- 680830527
- Labeler code
- 68083
- Product ID
- 68083-527_daec1549-17b5-483b-8efe-55b936be5174
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmedetomidine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA202126
- Marketing category
- ANDA
- Marketing start
- 2021-06-28
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexmedetomidine
- Listing expiration
- 2027-12-31
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 |
|---|
| 68083-527-25 | Dexmedetomidine | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 4 |
| 68083-527-25 | Dexmedetomidine | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-527 | DEXMEDETOMIDINE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 1 | Current NDC, 2 package rows | 20230625_714cc0d2-8a4c-40c0-8ef0-dcfde4c46989.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 |
|---|
| 68083-527-25 | 68083052725 | 25 VIAL in 1 CARTON (68083-527-25) / 2 mL in 1 VIAL | 25 vial | 2021-06-28 | No | No | Current |