DrugDashboards

Spritam

levetiracetam · LEVETIRACETAM 500 mg/1 · Tablet, For Suspension · Oral · Aprecia Pharmaceuticals, LLC

NDC 43485-0102-03 · 6 BLISTER PACK in 1 CARTON / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK · NDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 66993-0101-60) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$9.78per unit
middle half $9.60$10.24 · 4,873 plans · Apr 1, 2026
Est. net of rebates
$5.87–$7.33
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
89%of plans cover it
tier 4 · prior auth 9% · step therapy 23% · qty limit 74%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 1 quarter since 2024.

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.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for levetiracetam (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

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 $987.31 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA207958
TE code
Approval date
Jul 31, 2015
Patents / exclusivity
12 patents, 0 exclusivities
TypeNumber / codeExpires
patent9339489Mar 14, 2034
patent9339489Mar 14, 2034
patent9339489Mar 14, 2034
patent9669009Mar 14, 2034
patent9669009Mar 14, 2034
patent9669009Mar 14, 2034
patent9339489Mar 14, 2034
patent9669009Mar 14, 2034
patent11160786Mar 14, 2034
patent11160786Mar 14, 2034
patent11160786Mar 14, 2034
patent11160786Mar 14, 2034

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of levetiracetam (Tablet, For Suspension)

LabelerStrengthFirst seenLast seen
Aprecia Pharmaceuticals, LLCLEVETIRACETAM 1000 mg/1Jul 15, 2026Sep 2, 2026
Aprecia Pharmaceuticals, LLCLEVETIRACETAM 250 mg/1Jul 15, 2026Sep 2, 2026
Aprecia Pharmaceuticals, LLCLEVETIRACETAM 500 mg/1Jul 15, 2026Sep 2, 2026
Aprecia Pharmaceuticals, LLCLEVETIRACETAM 750 mg/1Jul 15, 2026Sep 2, 2026
Prasco LaboratoriesLEVETIRACETAM 250 mg/1Jul 15, 2026Sep 2, 2026
Prasco LaboratoriesLEVETIRACETAM 500 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Spritam — NDC 43485-0102-03," retrieved September 3, 2026, https://drugdashboards.com/drug/43485010203.

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