The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Xenleta
lefamulin acetate · LEFAMULIN ACETATE 600 mg/1 · Tablet, Coated · Oral · Meitheal Pharmaceuticals Inc.
NDC 71288-0037-10 · 10 TABLET, COATED in 1 BLISTER PACK · NDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Regulatory
- Application
- NDA211672
- TE code
- —
- Approval date
- Aug 19, 2019
- Patents / exclusivity
- 3 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | GAIN | Aug 19, 2029 |
| exclusivity | NCE | Aug 19, 2024 |
| patent | 8071643 | Mar 25, 2033 |
| patent | 9120727 | May 23, 2031 |
| patent | 8153689 | Mar 19, 2028 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of lefamulin acetate (Tablet, Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Meitheal Pharmaceuticals Inc. | LEFAMULIN ACETATE 600 mg/1 | Jul 24, 2026 | Aug 28, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Xenleta — NDC 71288-0037-10," retrieved September 3, 2026, https://drugdashboards.com/drug/71288003710.
Free to cite with attribution — see how the data is put together.