Xenleta (lefamulin acetate) NDC 71288-037

NDC codes

FDA NDC Directory

Product NDC (as listed)71288-037Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71288-0037Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
71288-037-10	71288003710	10 TABLET, COATED in 1 BLISTER PACK (71288-037-10)Marketed from Sep 9, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Xenleta
Generic name (nonproprietary): lefamulin acetate
Active ingredients: Lefamulin acetate — 600 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Meitheal Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 211672
Marketing start: Sep 9, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Diterpenes (Chemical structure)
Identifiers: Product ID 71288-037_b9951406-492b-4420-89cc-24fd655824b3SPL ID b9951406-492b-4420-89cc-24fd655824b3SPL set ID eb972ea8-7502-422e-84bb-66cb8e93ca06RxCUI 2198948, 2198953, 2198961, 2198966, 2747671, 2747672UNII XF417D3PSL, HDN0B924X4
Pharmacologic class: Pleuromutilin Antibacterial

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N471288003710 followed by a unit qualifier and the quantity

Package 71288-0037-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 22, 2026.

Indications (excerpt from the label)

XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. ( 1.1 ) To reduce the development of drug resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Community-Acquired Bacterial Pneumonia (CABP) 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-sus…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)