FDA LABEL RECORD

Vancocin

VANCOMYCIN HYDROCHLORIDE. FDA prescribing information for this product, as published on the retrieval date below.

AS THE LABEL RECORDS IT

Product details

Brand nameVancocin
Generic nameVANCOMYCIN HYDROCHLORIDE
LabellerANI Pharmaceuticals, Inc.
RouteORAL
Label version12
Effective2025-12-22
Retrieved by this site2026-10-03
Full labelhttps://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a078d9c2-f89c-4f9f-8ded-60ffb2983c3f

INDICATIONS AND USAGE

Quoted from the FDA label

1 INDICATIONS AND USAGE VANCOCIN is indicated for the treatment of Clostridioides difficil e-associated diarrhea. VANCOCIN is also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use • Parenteral administration of vancomycin is not effective for the above infections; therefore, VANCOCIN must be given orally for these infections. • Orally administered VANCOCIN is not effective for other types of infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VANCOCIN and other antibacterial drugs, VANCOCIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. VANCOCIN is a glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: ( 1 ) • Clostridioides difficile -associated diarrhea • Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) Limitations of Use: ( 1 ) ( 5.1 ) • Parenteral administration of vancomycin is not effective for the above infections; therefore, vancocin must be given orally for these infections. • Orally administered VANCOCIN is not effective for other types of infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VANCOCIN and other antibacterial drugs, VANCOCIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 )

What this page is

A reproduction of a public FDA label record. Everything quoted above is the labeller's wording as published by the FDA, not this site's. Nothing here is regulatory, legal or medical advice, and a label being reproduced says nothing about whether a product is available in any particular country. Labels are revised often; the retrieval date above says when this copy was taken, and the full current label is at the link.

All labels · Method

WEEKLY

Register Watch, weekly

New trials, approvals and enforcement actions. One email a week.