DALBAVANCIN HYDROCHLORIDE
- Product NDC
- 65219-120
- 11-digit product format
- 652190120
- Labeler code
- 65219
- Product ID
- 65219-120_e9e7ab64-7f96-41c4-abb4-f71b77e60245
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DALBAVANCIN HYDROCHLORIDE
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA217591
- Marketing category
- ANDA
- Marketing start
- 2025-11-10
- Substance
- DALBAVANCIN HYDROCHLORIDE
- Active strength
- 500 mg/25mL
- Pharmacologic classes
- Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DALBAVANCIN HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DALBAVANCIN HYDROCHLORIDE | 500 mg/25mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 33WDQ7T81E |
| Rxcui | 1539243 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-120-12 | DALBAVANCIN HYDROCHLORIDE | 25 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 25 | | 2 |
| 65219-120-12 | DALBAVANCIN HYDROCHLORIDE | 1 in 1 PACKAGE | INJECTION, POWDER, FOR SOLUTION | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-120-12 | 65219012012 | 1 VIAL in 1 PACKAGE (65219-120-12) / 25 mL in 1 VIAL | 1 vial | 2025-11-10 | No | No | Current |