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
| 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 | |
| >Company | >Tradename | >Ingredient | >NDC | >Excipient | >Potential Generic Entry |
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 |
| >Company | >Ingredient | >NDC | >Excipient |
Detailed excipient profiles for OMEGA-3-ACID ETHYL ESTERS
Excipient focus: .ALPHA.-TOCOPHEROL
OMEGA-3-ACID ETHYL ESTERS drug variants containing .ALPHA.-TOCOPHEROL
| Company | Ingredient | NDC |
|---|---|---|
| GlaxoSmithKline LLC | omega-3-acid ethyl esters | 0173-0783 |
| Major Pharmaceuticals | omega-3-acid ethyl esters | 0904-6706 |
| Major Pharmaceuticals | omega-3-acid ethyl esters capsules | 0904-7495 |
| Atlantic Biologicals Corps | omega-3-acid ethyl esters | 17856-0034 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing .ALPHA.-TOCOPHEROL
Excipient focus: ALCOHOL
OMEGA-3-ACID ETHYL ESTERS drug variants containing ALCOHOL
| Company | Ingredient | NDC |
|---|---|---|
| Procaps S A | omega-3-acid ethyl esters | 49264-4274 |
| Par Pharmaceutical Inc | omega-3-acid ethyl esters | 49884-019 |
| A-S Medication Solutions | omega-3-acid ethyl esters | 50090-3956 |
| A-S Medication Solutions | omega-3-acid ethyl esters | 50090-3957 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing ALCOHOL
Excipient focus: ALPHA-TOCOPHEROL
OMEGA-3-ACID ETHYL ESTERS drug variants containing ALPHA-TOCOPHEROL
| Company | Ingredient | NDC |
|---|---|---|
| Teva Pharmaceuticals USA Inc | omega-3-acid ethyl esters | 0093-5401 |
| NorthStar Rx LLC | omega-3-acid ethyl esters | 16714-660 |
| Rebel Distributors Corp | omega-3-acid ethyl esters | 21695-795 |
| Camber Pharmaceuticals Inc | omega-3-acid ethyl esters | 31722-936 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing ALPHA-TOCOPHEROL
| Company | Ingredient | NDC |
|---|---|---|
| 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 |
Excipient focus: AMMONIA
OMEGA-3-ACID ETHYL ESTERS drug variants containing AMMONIA
| Company | Ingredient | NDC |
|---|---|---|
| Major Pharmaceuticals | omega-3-acid ethyl esters | 0904-6706 |
| AvKARE | omega-3-acid ethyl esters | 42291-657 |
| Procaps S A | omega-3-acid ethyl esters | 49264-4274 |
| Par Pharmaceutical Inc | omega-3-acid ethyl esters | 49884-019 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing AMMONIA
Excipient focus: BUTYL ALCOHOL
OMEGA-3-ACID ETHYL ESTERS drug variants containing BUTYL ALCOHOL
| Company | Ingredient | NDC |
|---|---|---|
| Par Pharmaceutical Inc | omega-3-acid ethyl esters | 0254-3010 |
| AvPAK | omega-3-acid ethyl esters | 50268-676 |
| American Health Packaging | omega-3-acid ethyl esters | 60687-846 |
| Strides Pharma Science Limited | omega-3-acid ethyl esters | 64380-761 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing BUTYL ALCOHOL
Excipient focus: DIMETHICONE
OMEGA-3-ACID ETHYL ESTERS drug variants containing DIMETHICONE
| Company | Ingredient | NDC |
|---|---|---|
| Par Pharmaceutical Inc | omega-3-acid ethyl esters | 0254-3010 |
| Major Pharmaceuticals | omega-3-acid ethyl esters | 0904-6706 |
| AvKARE | omega-3-acid ethyl esters | 42291-657 |
| A-S Medication Solutions | omega-3-acid ethyl esters | 50090-3421 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing DIMETHICONE
| Company | Ingredient | NDC |
|---|---|---|
| Teva Pharmaceuticals USA Inc | omega-3-acid ethyl esters | 0093-5401 |
| GlaxoSmithKline LLC | omega-3-acid ethyl esters | 0173-0783 |
| NCS HealthCare of KY LLC dba Vangard Labs | omega-3-acid ethyl esters | 0615-8550 |
| NorthStar Rx LLC | omega-3-acid ethyl esters | 16714-660 |
| >Company | >Ingredient | >NDC |
Excipient focus: ETHYL ACETATE
OMEGA-3-ACID ETHYL ESTERS drug variants containing ETHYL ACETATE
| Company | Ingredient | NDC |
|---|---|---|
| Procaps S A | omega-3-acid ethyl esters | 49264-4274 |
| Chartwell RX LLC | omega-3-acid ethyl esters | 62135-780 |
| ANI Pharmaceuticals Inc | omega-3-acid ethyl esters | 62559-410 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing ETHYL ACETATE
Excipient focus: GELATIN
OMEGA-3-ACID ETHYL ESTERS drug variants containing GELATIN
OMEGA-3-ACID ETHYL ESTERS drug variants not containing GELATIN
| Company | Ingredient | NDC |
|---|---|---|
| >Company | >Ingredient | >NDC |
Excipient focus: GLYCERIN
OMEGA-3-ACID ETHYL ESTERS drug variants containing GLYCERIN
OMEGA-3-ACID ETHYL ESTERS drug variants not containing GLYCERIN
| Company | Ingredient | NDC |
|---|---|---|
| >Company | >Ingredient | >NDC |
Excipient focus: HYPROMELLOSE
OMEGA-3-ACID ETHYL ESTERS drug variants containing HYPROMELLOSE
| Company | Ingredient | NDC |
|---|---|---|
| Teva Pharmaceuticals USA Inc | omega-3-acid ethyl esters | 0093-5401 |
| QPharma Inc | omega-3-acid ethyl esters | 42708-067 |
| A-S Medication Solutions | omega-3-acid ethyl esters | 50090-5799 |
| A-S Medication Solutions | omega-3-acid ethyl esters | 50090-5800 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing HYPROMELLOSE
| Company | Ingredient | NDC |
|---|---|---|
| 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 |
Excipient focus: HYPROMELLOSES
OMEGA-3-ACID ETHYL ESTERS drug variants containing HYPROMELLOSES
| Company | Ingredient | NDC |
|---|---|---|
| Camber Pharmaceuticals Inc | omega-3-acid ethyl esters | 31722-936 |
| XLCare Pharmaceuticals Inc | omega-3-acid ethyl esters | 72865-139 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing HYPROMELLOSES
Excipient focus: ISOPROPYL ALCOHOL
OMEGA-3-ACID ETHYL ESTERS drug variants containing ISOPROPYL ALCOHOL
| Company | Ingredient | NDC |
|---|---|---|
| Procaps S A | omega-3-acid ethyl esters | 49264-4274 |
| Par Pharmaceutical Inc | omega-3-acid ethyl esters | 49884-019 |
| A-S Medication Solutions | omega-3-acid ethyl esters | 50090-3956 |
| A-S Medication Solutions | omega-3-acid ethyl esters | 50090-3957 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing ISOPROPYL ALCOHOL
Excipient focus: LECITHIN, SOYBEAN
OMEGA-3-ACID ETHYL ESTERS drug variants containing LECITHIN, SOYBEAN
| Company | Ingredient | NDC |
|---|---|---|
| Par Pharmaceutical Inc | omega-3-acid ethyl esters | 0254-3010 |
| AvPAK | omega-3-acid ethyl esters | 50268-676 |
| Strides Pharma Science Limited | omega-3-acid ethyl esters | 64380-761 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing LECITHIN, SOYBEAN
Excipient focus: MEDIUM-CHAIN TRIGLYCERIDES
OMEGA-3-ACID ETHYL ESTERS drug variants containing MEDIUM-CHAIN TRIGLYCERIDES
| Company | Ingredient | NDC |
|---|---|---|
| Chartwell RX LLC | omega-3-acid ethyl esters | 62135-780 |
| ANI Pharmaceuticals Inc | omega-3-acid ethyl esters | 62559-410 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing MEDIUM-CHAIN TRIGLYCERIDES
Excipient focus: POLYETHYLENE GLYCOL
OMEGA-3-ACID ETHYL ESTERS drug variants containing POLYETHYLENE GLYCOL
| Company | Ingredient | NDC |
|---|---|---|
| Procaps S A | omega-3-acid ethyl esters | 49264-4274 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing POLYETHYLENE GLYCOL
Excipient focus: POLYETHYLENE GLYCOL 400
OMEGA-3-ACID ETHYL ESTERS drug variants containing POLYETHYLENE GLYCOL 400
| Company | Ingredient | NDC |
|---|---|---|
| Chartwell RX LLC | omega-3-acid ethyl esters | 62135-780 |
| ANI Pharmaceuticals Inc | omega-3-acid ethyl esters | 62559-410 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing POLYETHYLENE GLYCOL 400
Excipient focus: POLYVINYL ACETATE PHTHALATE
OMEGA-3-ACID ETHYL ESTERS drug variants containing POLYVINYL ACETATE PHTHALATE
| Company | Ingredient | NDC |
|---|---|---|
| Procaps S A | omega-3-acid ethyl esters | 49264-4274 |
| Chartwell RX LLC | omega-3-acid ethyl esters | 62135-780 |
| ANI Pharmaceuticals Inc | omega-3-acid ethyl esters | 62559-410 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing POLYVINYL ACETATE PHTHALATE
Excipient focus: PROPYLENE GLYCOL
OMEGA-3-ACID ETHYL ESTERS drug variants containing PROPYLENE GLYCOL
OMEGA-3-ACID ETHYL ESTERS drug variants not containing PROPYLENE GLYCOL
| Company | Ingredient | NDC |
|---|---|---|
| GlaxoSmithKline LLC | omega-3-acid ethyl esters | 0173-0783 |
| Par Pharmaceutical Inc | omega-3-acid ethyl esters | 0254-3010 |
| NorthStar Rx LLC | omega-3-acid ethyl esters | 16714-660 |
| Atlantic Biologicals Corps | omega-3-acid ethyl esters | 17856-0034 |
| >Company | >Ingredient | >NDC |
Excipient focus: SHELLAC
OMEGA-3-ACID ETHYL ESTERS drug variants containing SHELLAC
OMEGA-3-ACID ETHYL ESTERS drug variants not containing SHELLAC
| Company | Ingredient | NDC |
|---|---|---|
| Teva Pharmaceuticals USA Inc | omega-3-acid ethyl esters | 0093-5401 |
| GlaxoSmithKline LLC | omega-3-acid ethyl esters | 0173-0783 |
| NorthStar Rx LLC | omega-3-acid ethyl esters | 16714-660 |
| Atlantic Biologicals Corps | omega-3-acid ethyl esters | 17856-0034 |
| >Company | >Ingredient | >NDC |
Excipient focus: SILICON DIOXIDE
OMEGA-3-ACID ETHYL ESTERS drug variants containing SILICON DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Major Pharmaceuticals | omega-3-acid ethyl esters | 0904-6706 |
| AvKARE | omega-3-acid ethyl esters | 42291-657 |
| A-S Medication Solutions | omega-3-acid ethyl esters | 50090-3421 |
| A-S Medication Solutions | omega-3-acid ethyl esters | 50090-3742 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing SILICON DIOXIDE
Excipient focus: SOYBEAN LECITHIN
OMEGA-3-ACID ETHYL ESTERS drug variants containing SOYBEAN LECITHIN
| Company | Ingredient | NDC |
|---|---|---|
| American Health Packaging | omega-3-acid ethyl esters | 60687-846 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing SOYBEAN LECITHIN
Excipient focus: SOYBEAN OIL
OMEGA-3-ACID ETHYL ESTERS drug variants containing SOYBEAN OIL
| Company | Ingredient | NDC |
|---|---|---|
| Camber Pharmaceuticals Inc | omega-3-acid ethyl esters | 31722-936 |
| A-S Medication Solutions | omega-3-acid ethyl esters | 50090-5799 |
| A-S Medication Solutions | omega-3-acid ethyl esters | 50090-5800 |
| A-S Medication Solutions | omega-3-acid ethyl esters | 50090-6822 |
| >Company | >Ingredient | >NDC |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing SOYBEAN OIL
Excipient focus: TITANIUM DIOXIDE
OMEGA-3-ACID ETHYL ESTERS drug variants containing TITANIUM DIOXIDE
OMEGA-3-ACID ETHYL ESTERS drug variants not containing TITANIUM DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| GlaxoSmithKline LLC | omega-3-acid ethyl esters | 0173-0783 |
| NorthStar Rx LLC | omega-3-acid ethyl esters | 16714-660 |
| Atlantic Biologicals Corps | omega-3-acid ethyl esters | 17856-0034 |
| Atlantic Biologicals Corps | omega-3-acid ethyl esters | 17856-0084 |
| >Company | >Ingredient | >NDC |
Excipient focus: WATER
OMEGA-3-ACID ETHYL ESTERS drug variants containing WATER
| Company | Ingredient | NDC |
|---|---|---|
| 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 |
OMEGA-3-ACID ETHYL ESTERS drug variants not containing WATER
| Company | Ingredient | NDC |
|---|---|---|
| Teva Pharmaceuticals USA Inc | omega-3-acid ethyl esters | 0093-5401 |
| QPharma Inc | omega-3-acid ethyl esters | 42708-067 |
| >Company | >Ingredient | >NDC |
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