Xenleta
NDC 72000-120
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Xenleta is a NDA-approved product labeled by Nabriva Therapeutics Us, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 72000-120 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
72000-120
Proprietary Name:
Xenleta
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
72000
Product Label ID:
FDA Application Number: [6]
NDA211673
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
09-09-2019
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 72000-120?
The NDC code 72000-120 is assigned by the FDA to the product Xenleta. This pharmaceutical product is labeled by Nabriva Therapeutics Us, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 72000-120-06. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
XENLETA is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- LEFAMULIN ACETATE (UNII: HDN0B924X4)
- LEFAMULIN (UNII: 21904A5386) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- WATER (UNII: 059QF0KO0R)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 2198948 - lefamulin 150 MG in 15 ML Injection
- RxCUI: 2198948 - 15 ML lefamulin 10 MG/ML Injection
- RxCUI: 2198948 - lefamulin 150 MG per 15 ML Injection
- RxCUI: 2198953 - Xenleta 150 MG in 15 ML Injection
- RxCUI: 2198953 - 15 ML lefamulin 10 MG/ML Injection [Xenleta]
* Please review the full disclaimer at the bottom of this page.
Patient Education
Lefamulin Injection
Lefamulin injection 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 injection 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 injection will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
