Prescription drug · NDA
Xenleta (Lefamulin acetate) NDC 71288-039
Lefamulin acetate 150 mg/15mL · Injection, Solution · Intravenous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-039-16 | 7128800391671288003916 | 6 VIAL, SINGLE-USE in 1 CARTON (71288-039-16) / 15 mL in 1 VIAL, SINGLE-USE (71288-039-15)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 — 150 mg/15mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Meitheal Pharmaceuticals Inc.NDC labeler code 71288
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211673
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Diterpenes (Chemical structure)
- Identifiers
- Product ID 71288-039_b9951406-492b-4420-89cc-24fd655824b3SPL ID b9951406-492b-4420-89cc-24fd655824b3SPL set ID eb972ea8-7502-422e-84bb-66cb8e93ca06RxCUI 2198948, 2198953, 2198961, 2198966, 2747671, 2747672UNII HDN0B924X4, XF417D3PSL
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N471288003916followed by a unit qualifier and the quantityPackage 71288-0039-16. 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 .
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.
About NDC 71288-039
- What is NDC 71288-039?
- 71288-039 is the product NDC for Xenleta (lefamulin acetate), Lefamulin acetate 150 mg/15mL injection, solution, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xenleta (Lefamulin acetate).
- What is the active ingredient?
- Lefamulin acetate.
- Who is the labeler?
- Meitheal Pharmaceuticals Inc., NDC labeler code 71288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xenleta?
- 1 other product NDC are listed under this name. See all Xenleta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xenleta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xenletalefamulin acetate | Lefamulin acetate 600 mg/1 | Tablet, CoatedOral | Meitheal Pharmaceuticals Inc. | 71288-037 | 71288-0037-10 |
Other NDCs under NDA 211673
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Citric Buffered Normal Salineanhydrous citric acid | Anhydrous citric acid 166 mg/270mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-040 |