The short version
6 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Levofloxacin
levofloxacin · LEVOFLOXACIN 25 mg/mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC 36000-0045-01 · 20 mL in 1 VIAL, SINGLE-USE · ANDA · 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.
Where it's made
- analysis · label · manufacture · pack · sterilize
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $5.97 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA091436
- TE code
- —
- Approval date
- Jun 5, 2013
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class III · TerminatedSep 25, 2018Baxter Healthcare Corporation — Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- Class III · TerminatedAug 1, 2018Baxter Healthcare Corporation — Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- Class III · TerminatedAug 1, 2018Baxter Healthcare Corporation — Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- Class III · TerminatedAug 1, 2018Baxter Healthcare Corporation — Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- Class II · TerminatedMar 10, 2017Claris Lifesciences Inc — Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Manufacturers of levofloxacin (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Gland Pharma Limited | LEVOFLOXACIN 25 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Hikma Pharmaceuticals USA Inc. | LEVOFLOXACIN 750 mg/150mL | Jul 15, 2026 | Sep 3, 2026 |
| Hikma Pharmaceuticals USA Inc. | LEVOFLOXACIN 500 mg/100mL | Jul 15, 2026 | Sep 3, 2026 |
| WG Critical Care, LLC | LEVOFLOXACIN 5 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Baxter Healthcare Corporation | LEVOFLOXACIN 25 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Gland Pharma Limited | LEVOFLOXACIN 500 mg/100mL | Jul 15, 2026 | Sep 2, 2026 |
| Gland Pharma Limited | LEVOFLOXACIN 750 mg/150mL | Jul 15, 2026 | Sep 2, 2026 |
| Gland Pharma Limited | LEVOFLOXACIN 250 mg/50mL | Jul 15, 2026 | Sep 2, 2026 |
| Hospira, Inc | LEVOFLOXACIN 750 mg/150mL | Jul 15, 2026 | Sep 2, 2026 |
| Hospira, Inc | LEVOFLOXACIN 250 mg/50mL | Jul 15, 2026 | Sep 2, 2026 |
| Hospira, Inc | LEVOFLOXACIN 500 mg/100mL | Jul 15, 2026 | Sep 2, 2026 |
| Sagent Pharmaceuticals | LEVOFLOXACIN 5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Hikma Pharmaceuticals USA Inc. | LEVOFLOXACIN 250 mg/50mL | Jul 15, 2026 | Aug 29, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Levofloxacin — NDC 36000-0045-01," retrieved September 3, 2026, https://drugdashboards.com/drug/36000004501.
Free to cite with attribution — see how the data is put together.