Prescription drug · ANDA
Dalbavancin NDC 0480-3325
Dalbavancin hydrochloride 500 mg/25mL · Injection, Powder, For solution · Intravenous · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-3325-01 | 00480332501 | 1 VIAL in 1 CARTON (0480-3325-01) / 25 mL in 1 VIALMarketed from Oct 29, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Dalbavancin
- Generic name (nonproprietary)
- dalbavancin
- Active ingredients
- Dalbavancin hydrochloride — 500 mg/25mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Teva Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219465
- Marketing start
- Listing expires
- Other FDA classes
- Lipoglycopeptides (Chemical structure)
- Identifiers
- Product ID 0480-3325_7fddacee-2401-4514-acf0-3847da11c6e5SPL ID 7fddacee-2401-4514-acf0-3847da11c6e5SPL set ID 1f4a5924-96d7-445a-b75f-2c0e1ffd2deaRxCUI 1539243UNII 33WDQ7T81E
- Pharmacologic class
- Lipoglycopeptide Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400480332501followed by a unit qualifier and the quantityPackage 00480-3325-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
1 INDICATION AND USAGE Dalbavancin for injection is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of dalbavancin for injection and other antibacterial drugs, dalbavancin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.2 ) 1.1 Acute Bacterial Skin and Skin Structure Infections Dalbavancin for injection is indicated for the t…
Excerpt only. Read the full label for complete information.