DrugDashboards

Entacapone

Entacapone · ENTACAPONE 200 mg/1 · Tablet, Film Coated · Oral · Aurobindo Pharma Limited

NDC 65862-0654-99 · 1000 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply.

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

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.

90-day shortage risk (model v2)

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

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
ANDA203437
TE code
AB
Approval date
Jun 19, 2015
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 Entacapone (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Alembic Pharmaceuticals Inc.ENTACAPONE 200 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedENTACAPONE 200 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingENTACAPONE 200 mg/1Jul 15, 2026Sep 2, 2026
Aphena Pharma Solutions - Tennessee, LLCENTACAPONE 200 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedENTACAPONE 200 mg/1Jul 15, 2026Sep 2, 2026
AvPAKENTACAPONE 200 mg/1Jul 15, 2026Sep 2, 2026
Lannett Company, Inc.ENTACAPONE 200 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsENTACAPONE 200 mg/1Jul 15, 2026Sep 2, 2026
Orion Corporation, Orion PharmaENTACAPONE 200 mg/1Jul 15, 2026Sep 2, 2026
Rising Pharma Holdings, Inc.ENTACAPONE 200 mg/1Jul 15, 2026Sep 2, 2026
Sandoz IncENTACAPONE 200 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.ENTACAPONE 200 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Entacapone — NDC 65862-0654-99," retrieved September 3, 2026, https://drugdashboards.com/drug/65862065499.

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