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icosapent ethyl

icosapent ethyl · ICOSAPENT ETHYL .5 g/1 · Capsule · Oral · Softgel Healthcare Private Limited

NDC 35916-1738-01 · 240 CAPSULE in 1 BOTTLE · ANDA · View full market →

The short version

21 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 icosapent ethyl (oral solid) in the next 90 days

sole-source market · 1 Class I/II recall(s) in 12 months

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 →

Regulatory

Application
ANDA217656
TE code
AB
Approval date
Apr 20, 2023
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation — Icosapent Ethyl, Capsule, 1 g (NDC 60429-005-12)Apr 1, 2026

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of icosapent ethyl (Capsule)

LabelerStrengthFirst seenLast seen
Amarin Pharma Inc.ICOSAPENT ETHYL 1000 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackICOSAPENT ETHYL 1000 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 3, 2026
Catalent Pharma Solutions, LLCICOSAPENT 500 mg/1Jul 15, 2026Sep 3, 2026
Northstar Rx LLCICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 3, 2026
Patheon Softgels Inc.ICOSAPENT ETHYL 500 mg/1Jul 15, 2026Sep 3, 2026
Patheon Softgels Inc.ICOSAPENT ETHYL 1000 mg/1Jul 15, 2026Sep 3, 2026
Amarin Pharma Inc.ICOSAPENT ETHYL 500 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCICOSAPENT ETHYL .5 g/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Apotex CorpICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.ICOSAPENT ETHYL .5 g/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.ICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCICOSAPENT 1000 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCICOSAPENT ETHYL 1000 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories, Inc.ICOSAPENT ETHYL 500 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories, Inc.ICOSAPENT ETHYL 1000 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.ICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.ICOSAPENT ETHYL .5 g/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.ICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
NextPharma PloermelICOSAPENT ETHYL 1000 mg/1Jul 15, 2026Sep 2, 2026
Patheon Softgels B.V.ICOSAPENT ETHYL 500 mg/1Jul 15, 2026Sep 2, 2026
Patheon Softgels B.V.ICOSAPENT ETHYL 1000 mg/1Jul 15, 2026Sep 2, 2026
Qilu Pharmaceutical Co., Ltd.ICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Softgel Healthcare Private LimitedICOSAPENT ETHYL .5 g/1Jul 15, 2026Sep 2, 2026
Softgel Healthcare Private LimitedICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Vitruvias Therapeutics, Inc.ICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
XLCare Pharmaceuticals, Inc.ICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
XLCare Pharmaceuticals, Inc.ICOSAPENT ETHYL .5 g/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.ICOSAPENT ETHYL 1 g/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.ICOSAPENT ETHYL .5 g/1Jul 15, 2026Sep 2, 2026
Patheon Softgels, Inc.ICOSAPENT ETHYL 998 mg/1Jul 15, 2026Aug 19, 2026

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

Cite this page

DrugDashboards, "icosapent ethyl — NDC 35916-1738-01," retrieved September 3, 2026, https://drugdashboards.com/drug/35916173801.

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