Drugplain

DALBAVANCIN HYDROCHLORIDE 500 mg/25mL

DALBAVANCIN HYDROCHLORIDE · INJECTION, POWDER, FOR SOLUTION · Fresenius Kabi USA, LLC

No Recall History
Plain English

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 History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use23 reports
acute kidney injury19 reports
decreased appetite13 reports
pyrexia13 reports
vomiting13 reports
malaise12 reports
hypertension9 reports
neutropenia9 reports
pallor9 reports
presyncope9 reports

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.

Product NDC

65219-120

Package NDC

65219-120-12

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)