Dalbavancin
- Product NDC
- 71288-034
- 11-digit product format
- 712880034
- Labeler code
- 71288
- Product ID
- 71288-034_eb1f6798-3443-4fa7-95fc-fe4a387de46d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dalbavancin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc
- Application
- ANDA218929
- Marketing category
- ANDA
- Marketing start
- 2025-11-26
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dalbavancin
- Listing expiration
- 2026-12-31
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 |
|---|
| 71288-034-50 | Dalbavancin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
| 71288-034-50 | Dalbavancin | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 25 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71288-034-50 | 71288003450 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-034-50) / 25 mL in 1 VIAL, SINGLE-DOSE | 2025-11-26 | No | No | Current |