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Last Updated: December 11, 2025

List of Excipients in API omega-3-acid ethyl esters


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Excipients in NDA-approved (novel) drugs containing omega-3-acid ethyl esters

Glossary
Company Tradename Ingredient NDC Excipient Potential Generic Entry
GlaxoSmithKline LLC LOVAZA omega-3-acid ethyl esters 0173-0783 .ALPHA.-TOCOPHEROL
GlaxoSmithKline LLC LOVAZA omega-3-acid ethyl esters 0173-0783 GELATIN
GlaxoSmithKline LLC LOVAZA omega-3-acid ethyl esters 0173-0783 GLYCERIN
GlaxoSmithKline LLC LOVAZA omega-3-acid ethyl esters 0173-0783 WATER
Atlantic Biologicals Corps LOVAZA omega-3-acid ethyl esters 17856-0084 .ALPHA.-TOCOPHEROL
>Company >Tradename >Ingredient >NDC >Excipient >Potential Generic Entry

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Excipients in ANDA-approved (generic) drugs containing omega-3-acid ethyl esters

Company Ingredient NDC Excipient
Teva Pharmaceuticals USA Inc omega-3-acid ethyl esters 0093-5401 ALPHA-TOCOPHEROL
Teva Pharmaceuticals USA Inc omega-3-acid ethyl esters 0093-5401 GELATIN
Teva Pharmaceuticals USA Inc omega-3-acid ethyl esters 0093-5401 GLYCERIN
Teva Pharmaceuticals USA Inc omega-3-acid ethyl esters 0093-5401 HYPROMELLOSE
Teva Pharmaceuticals USA Inc omega-3-acid ethyl esters 0093-5401 PROPYLENE GLYCOL
>Company >Ingredient >NDC >Excipient

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Detailed excipient profiles for omega-3-acid ethyl esters

Excipient focus: .ALPHA.-TOCOPHEROL

Excipient focus: ALCOHOL

Excipient focus: ALPHA-TOCOPHEROL

Excipient focus: AMMONIA

Excipient focus: BUTYL ALCOHOL

Excipient focus: DIMETHICONE

Excipient focus: ETHYL ACETATE

Excipient focus: GELATIN

Excipient focus: GLYCERIN

Excipient focus: HYPROMELLOSE

Excipient focus: HYPROMELLOSES

Excipient focus: ISOPROPYL ALCOHOL

Excipient focus: LECITHIN, SOYBEAN

Excipient focus: MEDIUM-CHAIN TRIGLYCERIDES

omega-3-acid ethyl esters drug variants not containing MEDIUM-CHAIN TRIGLYCERIDES

Company Ingredient NDC
Teva Pharmaceuticals USA Inc omega-3-acid ethyl esters 0093-5401
GlaxoSmithKline LLC omega-3-acid ethyl esters 0173-0783
Par Pharmaceutical Inc omega-3-acid ethyl esters 0254-3010
NCS HealthCare of KY LLC dba Vangard Labs omega-3-acid ethyl esters 0615-8550
Major Pharmaceuticals omega-3-acid ethyl esters 0904-6706
>Company >Ingredient >NDC

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Excipient focus: POLYETHYLENE GLYCOL

Excipient focus: POLYETHYLENE GLYCOL 400

omega-3-acid ethyl esters drug variants not containing POLYETHYLENE GLYCOL 400

Company Ingredient NDC
Teva Pharmaceuticals USA Inc omega-3-acid ethyl esters 0093-5401
GlaxoSmithKline LLC omega-3-acid ethyl esters 0173-0783
Par Pharmaceutical Inc omega-3-acid ethyl esters 0254-3010
NCS HealthCare of KY LLC dba Vangard Labs omega-3-acid ethyl esters 0615-8550
Major Pharmaceuticals omega-3-acid ethyl esters 0904-6706
>Company >Ingredient >NDC

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Excipient focus: POLYVINYL ACETATE PHTHALATE

omega-3-acid ethyl esters drug variants not containing POLYVINYL ACETATE PHTHALATE

Company Ingredient NDC
Teva Pharmaceuticals USA Inc omega-3-acid ethyl esters 0093-5401
GlaxoSmithKline LLC omega-3-acid ethyl esters 0173-0783
Par Pharmaceutical Inc omega-3-acid ethyl esters 0254-3010
NCS HealthCare of KY LLC dba Vangard Labs omega-3-acid ethyl esters 0615-8550
Major Pharmaceuticals omega-3-acid ethyl esters 0904-6706
>Company >Ingredient >NDC

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Excipient focus: PROPYLENE GLYCOL

omega-3-acid ethyl esters drug variants containing PROPYLENE GLYCOL

Company Ingredient NDC
Teva Pharmaceuticals USA Inc omega-3-acid ethyl esters 0093-5401
NCS HealthCare of KY LLC dba Vangard Labs omega-3-acid ethyl esters 0615-8550
Major Pharmaceuticals omega-3-acid ethyl esters 0904-6706
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS omega-3-acid ethyl esters 24658-350
Camber Pharmaceuticals Inc omega-3-acid ethyl esters 31722-936
>Company >Ingredient >NDC

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Excipient focus: SHELLAC

Excipient focus: SILICON DIOXIDE

Excipient focus: SOYBEAN LECITHIN

Excipient focus: SOYBEAN OIL

Excipient focus: TITANIUM DIOXIDE

omega-3-acid ethyl esters drug variants containing TITANIUM DIOXIDE

Company Ingredient NDC
Teva Pharmaceuticals USA Inc omega-3-acid ethyl esters 0093-5401
Par Pharmaceutical Inc omega-3-acid ethyl esters 0254-3010
NCS HealthCare of KY LLC dba Vangard Labs omega-3-acid ethyl esters 0615-8550
Major Pharmaceuticals omega-3-acid ethyl esters 0904-6706
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS omega-3-acid ethyl esters 24658-350
>Company >Ingredient >NDC

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Excipient focus: WATER

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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