Dalbavancin Hydrochloride NDC 65219-120

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-120Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0120Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65219-120-12	65219012012	1 VIAL in 1 PACKAGE (65219-120-12) / 25 mL in 1 VIALMarketed from Nov 10, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 Hydrochloride
Generic name (nonproprietary): dalbavancin hydrochloride
Active ingredients: Dalbavancin hydrochloride — 500 mg/25mL
Dosage form: Injection, Powder, For solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217591
Marketing start: Nov 10, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Lipoglycopeptides (Chemical structure)
Identifiers: Product ID 65219-120_e9e7ab64-7f96-41c4-abb4-f71b77e60245SPL ID e9e7ab64-7f96-41c4-abb4-f71b77e60245SPL set ID 2c2ec45e-48a2-4887-8ab0-9244eb39a394RxCUI 1539243UNII 33WDQ7T81EUPC 0365219120124
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.

How CPT relates to drug billing

NDC on a medical claim

N465219012012 followed by a unit qualifier and the quantity

Package 65219-0120-12. 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 Apr 2, 2026.

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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)