DrugDashboards

levofloxacin

levofloxacin · LEVOFLOXACIN 500 mg/100mL · Injection, Solution · Intravenous · Gland Pharma Limited

NDC 68083-0415-01 · 1 BAG in 1 POUCH / 100 mL in 1 BAG · ANDA · View full market →

The short version

6 companies supply this market — a reasonable cushion if one runs into trouble.

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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

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
ANDA206908
TE code
AP
Approval date
Dec 30, 2020
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of levofloxacin (Injection, Solution)

LabelerStrengthFirst seenLast seen
Gland Pharma LimitedLEVOFLOXACIN 25 mg/mLJul 15, 2026Sep 3, 2026
Hikma Pharmaceuticals USA Inc.LEVOFLOXACIN 750 mg/150mLJul 15, 2026Sep 3, 2026
Hikma Pharmaceuticals USA Inc.LEVOFLOXACIN 500 mg/100mLJul 15, 2026Sep 3, 2026
WG Critical Care, LLCLEVOFLOXACIN 5 mg/mLJul 15, 2026Sep 3, 2026
Baxter Healthcare CorporationLEVOFLOXACIN 25 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedLEVOFLOXACIN 500 mg/100mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedLEVOFLOXACIN 750 mg/150mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedLEVOFLOXACIN 250 mg/50mLJul 15, 2026Sep 2, 2026
Hospira, IncLEVOFLOXACIN 750 mg/150mLJul 15, 2026Sep 2, 2026
Hospira, IncLEVOFLOXACIN 250 mg/50mLJul 15, 2026Sep 2, 2026
Hospira, IncLEVOFLOXACIN 500 mg/100mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsLEVOFLOXACIN 5 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.LEVOFLOXACIN 250 mg/50mLJul 15, 2026Aug 29, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "levofloxacin — NDC 68083-0415-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68083041501.

Free to cite with attribution — see how the data is put together.