DALBAVANCIN HYDROCHLORIDE 500 mg/25mL
DALBAVANCIN HYDROCHLORIDE · INJECTION, POWDER, FOR SOLUTION · Fresenius Kabi USA, LLC
DALBAVANCIN HYDROCHLORIDE is a injection, powder, for solution containing dalbavancin hydrochloride at 500 mg/25mL, taken intravenous. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- DALBAVANCIN HYDROCHLORIDE
- Generic Name
- DALBAVANCIN HYDROCHLORIDE
- NDC Code (Product)
65219-120- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 500 mg/25mL
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA217591
- Marketing Start
- 11/10/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes , Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus ) and Enterococcus faecalis (vancomycin susce…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Dosage in Adult Patients ( 2.1 , 2.3 ) : Estimated Creatinine Clearance (CLcr) Single Dose Regimen 30 mL/min and above or on regular hemodialysis 1,500 mg Less than 30 mL/min and not on regular hemodialysis 1,125 mg • Administer by intravenous infusion over 30 minutes ( 2.1 , 2.4 ) • See Full Prescribing Information for instructions on reconstitution of lyophilized powder and preparation of injection ( 2.4 ) Dosage in Pediatric Patients with CLcr 30 mL/min/1.73m 2 and above ( 2.2 ) Age Range Dosage (Single Dose Regimen) Birth to less than 6 years 22.5 mg/kg (maximum of 1,500 mg) 6 to less than 18 years 18 mg/kg (maximum of 1,500 mg) • Dosage adjustment in pediatric patients with CLcr less than 30 mL/min has not been studied. 2.1 Recommended Dosage Regimen in Adult Patients with CLcr 30 mL/min and Above The recommended dosage regimen of dalbavancin for injection in adult patients with CLcr 30 mL/min and above is 1,500 mg, administered as a single dose regimen. Administer dalbavancin for injection over 30 minutes by intravenous infusion. For adult patients with CLcr less than 30 mL/min, dosage adjustment is required [see Dosage and Administration ( 2.3 ) a…
Contraindications
4 CONTRAINDICATIONS Dalbavancin for injection is contraindicated in patients with known hypersensitivity to dalbavancin. Known hypersensitivity to dalbavancin ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Drug-Laboratory Test Interactions Drug-laboratory test interactions have not been reported. Dalbavancin for injection at therapeutic concentrations does not artificially prolong prothrombin time (PT) or activated partial thromboplastin time (aPTT). 7.2 Drug-Drug Interactions No clinical drug-drug interaction studies have been conducted with dalbavancin for injection. There is minimal potential for drug-drug interactions between dalbavancin for injection and cytochrome P450 (CYP450) substrates, inhibitors, or inducers [see Clinical Pharmacology ( 12.3 )] .
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are also discussed elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Infusion Related Reactions [see Warnings and Precautions ( 5.2 )] • Hepatic Effects [see Warnings and Precautions ( 5.3 )] • Clostridioides difficile -associated Diarrhea [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring in >4% of adult patients treated with dalbavancin for injection were nausea, headache, and diarrhea. The most common adverse reaction that occurred in >1% of pediatric patients was pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of dalbavancin for injection cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. Clinical Trials Experience in Adult Patients Adverse reactions were evaluated for 2,473 patients treated with d…
Frequently Asked Questions
What is DALBAVANCIN HYDROCHLORIDE used for?
DALBAVANCIN HYDROCHLORIDE contains DALBAVANCIN HYDROCHLORIDE. It is a injection, powder, for solution taken intravenous. Consult your doctor for specific uses.
Is DALBAVANCIN HYDROCHLORIDE a controlled substance?
DALBAVANCIN HYDROCHLORIDE is not classified as a controlled substance by the DEA.
What is the generic name for DALBAVANCIN HYDROCHLORIDE?
The generic name for DALBAVANCIN HYDROCHLORIDE is DALBAVANCIN HYDROCHLORIDE. There are 1 other brand versions of DALBAVANCIN HYDROCHLORIDE.
What is the NDC code for DALBAVANCIN HYDROCHLORIDE 500 mg/25mL?
The NDC (National Drug Code) for DALBAVANCIN HYDROCHLORIDE 500 mg/25mL is 65219-120, listed by Fresenius Kabi USA, LLC.