DrugDashboards

Lamotrigine Extended Release

lamotrigine extended release · LAMOTRIGINE 250 mg/1 · Tablet · Oral · Par Health USA, LLC

NDC 49884-0604-11 · 30 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price has held steady around $1.25 per unit over the past year. One of its named manufacturing plants, Zhejiang Huahai Pharmaceutical Co., Ltd., failed FDA inspectionwithin the last two years — the agency’s most serious outcome. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

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

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

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

  • Pharmacies pay (NADAC)$1.25per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicaid generic ceiling (FUL)$3.82per TABweighted avg manufacturer price $2.1853 · Aug 1, 2026305% of what pharmacies pay — higher than 90% of drugs with this benchmark

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

$0$10.00$20.00May 2013Sep 2026$1.25
144 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$37.60
#90 count
$112.79

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$433,671
2,930 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

40● Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 1 active manufacturer+30
  • manufacturer plans to discontinue+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.2%chance of a new FDA shortage posting for lamotrigine (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 →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA201791
TE code
—
Approval date
Jan 18, 2013
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation — Lamotrigine, Tablet, Extended Release, 25 mg (NDC 49884-561-11)Apr 29, 2026
  • Planned discontinuation — Lamotrigine, Tablet, Extended Release, 250 mg (NDC 49884-604-11)Apr 29, 2026
  • Planned discontinuation — Lamotrigine, Tablet, Extended Release, 300 mg (NDC 49884-605-11)Apr 29, 2026

Recalls (this NDC)

  • Class II · TerminatedMar 15, 2021
    Cardinal Health Inc. — CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Manufacturers of lamotrigine extended release (Tablet)

LabelerStrengthFirst seenLast seen
Par Health USA, LLCLAMOTRIGINE 25 mg/1Jul 15, 2026Sep 2, 2026
Par Health USA, LLCLAMOTRIGINE 250 mg/1Jul 15, 2026Sep 2, 2026
Par Health USA, LLCLAMOTRIGINE 300 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Lamotrigine Extended Release — NDC 49884-0604-11," retrieved September 3, 2026, https://drugdashboards.com/drug/49884060411.

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