Prescription medicine
Dalbavancin Brand names: Dalvance
Dalbavancin (Dalvance) is a prescription medicine with an FDA approval on record since 2014. FDA's NDC Directory lists it from 6 generic labelers.
- Generic listed
Check it at the source: the dalbavancin FDA label on DailyMed (effective January 13, 2025, Allergan, Inc.); the NDA 21883 record on Drugs@FDA; every dalbavancin label on DailyMed.
Highlights of the record
FDA label of January 13, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDALVANCE 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.
Forms and strengths
- 500 mg
- 500 mg/25ml
Injection (powder) for solution; injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- May 23, 2014 Dalvance, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first October 23, 2025; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 6 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 23, 2028 Dalvance injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,183 through July 30, 2026
What is dalbavancin used for?
From the label: indications and usageDALVANCE 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 DALVANCE and other antibacterial drugs, DALVANCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. […]
FDA pharmacologic class: Lipoglycopeptide Antibacterial.
Source: FDA drug label (DALVANCE), NDA021883 (Abbvie), as published by Allergan, Inc., effective January 13, 2025 (SPL set 4b4674d8-4d1e-4728-8465-d42ada33fa5c), via openFDA; the full label on DailyMed
Is there a generic for dalbavancin (Dalvance)?
The FDA approved the first generic dalbavancin on October 23, 2025. 5 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dalbavancin from 6 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Dalvance injection, the last expiring on May 23, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2025 first generic approved
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for dalbavancin?
The FDA Adverse Event Reporting System holds 1,183 reports that list dalbavancin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 36 are coded as a death and 322 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other lipoglycopeptide antibacterials
- the pharmacologic class, with prices and generics
- Dalbavancin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other