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NDC 72000-0110-30 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: 72000-0110-30Last 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 72000-0110-30 (72000011030)
| NDC Package Code | 72000-110-30 |
|---|---|
| Billing NDC | 72000011030 |
| Package | 30 TABLET, COATED in 1 BOTTLE (72000-110-30) |
| Marketing Start Date | 2019-09-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |