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NDC 72000-0110-10 Xenleta 600 mg/1 Details

Xenleta 600 mg/1

Xenleta is a ORAL TABLET, COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Nabriva Therapeutics US, Inc.. The primary component is LEFAMULIN ACETATE.

MedlinePlus Drug Summary

Lefamulin is used to treat community acquired pneumonia (a lung infection that developed in a person who was not in the hospital) caused by certain types of bacteria. Lefamulin is in a class of medications called pleuromutilin antibiotics. It works by slowing the growth or killing bacteria that cause infections. Antibiotics such as lefamulin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Related Packages: 72000-0110-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lefamulin

Product Information

NDC	72000-0110
Product ID	72000-110_772b4b36-4627-4087-8a16-c1ed771939c4
Associated GPIs	16240040100320
GCN Sequence Number	080129
GCN Sequence Number Description	lefamulin acetate TABLET 600 MG ORAL
HIC3	W9E
HIC3 Description	PLEUROMUTILIN DERIVATIVES
GCN	46826
HICL Sequence Number	045961
HICL Sequence Number Description	LEFAMULIN ACETATE
Brand/Generic	Brand
Proprietary Name	Xenleta
Proprietary Name Suffix	n/a
Non-Proprietary Name	lefamulin acetate
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	600
Active Ingredient Units	mg/1
Substance Name	LEFAMULIN ACETATE
Labeler Name	Nabriva Therapeutics US, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA211672
Listing Certified Through	2024-12-31

Package

NDC 72000-0110-10 (72000011010)

Pricing Information	N/A
NDC Package Code	72000-110-10
Billing NDC	72000011010
Package	10 TABLET, COATED in 1 BLISTER PACK (72000-110-10)
Marketing Start Date	2019-09-09
NDC Exclude Flag	N