The short version
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Levetiracetam
Levetiracetam Injection · LEVETIRACETAM 15 mg/mL · Injection · Intravenous · Dr.Reddy's Laboratories Inc
NDC 43598-0637-10 · 10 BAG in 1 CARTON / 100 mL in 1 BAG · 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.
Estimated fill cost
WAC per package, as filed
$400.00
Reported to Texas DSHS · 2026 annual filing · Dr. Reddy's Laboratories, Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 10 MG
$0.032
HCPCS J1953 · Jul 1, 2026 quarter · typically ASP + 6%
Medicaid spend (2025)
$2,988
137 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Gland Pharma LimitedIndiaanalysis · manufacture
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
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA206880
- TE code
- AP
- Approval date
- Oct 25, 2017
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class I · OngoingMar 13, 2025Dr. Reddy's Laboratories, Inc. — LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
- Class I · TerminatedOct 26, 2018Dr. Reddy's Laboratories, Inc. — Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
Manufacturers of Levetiracetam Injection (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Dr.Reddy's Laboratories Inc | LEVETIRACETAM 10 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Dr.Reddy's Laboratories Inc | LEVETIRACETAM 15 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Dr.Reddy's Laboratories Inc | LEVETIRACETAM 5 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Levetiracetam — NDC 43598-0637-10," retrieved September 3, 2026, https://drugdashboards.com/drug/43598063710.
Free to cite with attribution — see how the data is put together.