DrugDashboards

Lamotrigine Extended Release

lamotrigine extended release · LAMOTRIGINE 25 mg/1 · Tablet · Oral · Par Health USA, LLC

NDC 49884-0561-11 · 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 fallen 41% in a year, to $0.2540 per unit — and generics that get this cheap tend to get abandoned rather than defended. 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: this is a fragile supply — if anything else goes wrong, there is very little slack to absorb it.

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)$0.2540per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicaid generic ceiling (FUL)$0.7510per TABweighted avg manufacturer price $0.4291 · Aug 1, 2026296% 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$2.00$4.00$6.00Jul 2013Sep 2026$0.254
122 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$7.62
#90 count
$22.86

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

Medicaid spend (2025)

$1,218
41 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

55High risk

Several kinds of pressure are visible at once — each line below is a condition that historically precedes supply trouble, and this market is stacking them.

  • 1 active manufacturer+30
  • price down 51% year over year+15
  • 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 49884-0561-11," retrieved September 3, 2026, https://drugdashboards.com/drug/49884056111.

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