Dalbavancin
- Product NDC
- 0480-3325
- 11-digit product format
- 004803325
- Labeler code
- 0480
- Product ID
- 0480-3325_7fddacee-2401-4514-acf0-3847da11c6e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dalbavancin
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA219465
- Marketing category
- ANDA
- Marketing start
- 2025-10-29
- Substance
- DALBAVANCIN HYDROCHLORIDE
- Active strength
- 500 mg/25mL
- Pharmacologic classes
- Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 33WDQ7T81E | DALBAVANCIN HYDROCHLORIDE | | DALBAVANCIN HYDROCHLORIDE |
| 808UI9MS5K | DALBAVANCIN | 171500-79-1 | Dalbavancin |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0480-3325-01 | 00480332501 | 1 VIAL in 1 CARTON (0480-3325-01) / 25 mL in 1 VIAL | 1 vial | 2025-10-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Dalbavancin | Teva Pharmaceuticals, Inc. | 2025-10-06 | HUMAN PRESCRIPTION DRUG LABEL | 3 |