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NDC 65162-0034-06 Omega-3-Acid Ethyl Esters 1 g/1 Details
Omega-3-Acid Ethyl Esters 1 g/1
Omega-3-Acid Ethyl Esters is a ORAL CAPSULE, LIQUID FILLED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is OMEGA-3-ACID ETHYL ESTERS.
MedlinePlus Drug Summary
Omega-3 fatty acids are used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of triglycerides (a fat-like substance) in the blood in people with very high triglycerides. Omega-3 fatty acids are in a class of medications called antilipemic or lipid-regulating agents. Omega-3 fatty acids may work by decreasing the amount of triglycerides and other fats made in the liver.
Related Packages: 65162-0034-06Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Omega-3 Fatty Acids
Product Information
| NDC | 65162-0034 |
|---|---|
| Product ID | 65162-034_37a1442a-5885-498b-b970-e3b1773c8e8b |
| Associated GPIs | 39500045200130 |
| GCN Sequence Number | 058486 |
| GCN Sequence Number Description | omega-3 acid ethyl esters CAPSULE 1 G ORAL |
| HIC3 | M4E |
| HIC3 Description | LIPOTROPICS |
| GCN | 23929 |
| HICL Sequence Number | 026793 |
| HICL Sequence Number Description | OMEGA-3 ACID ETHYL ESTERS |
| Brand/Generic | Generic |
| Proprietary Name | Omega-3-Acid Ethyl Esters |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Omega-3-Acid Ethyl Esters |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | g/1 |
| Substance Name | OMEGA-3-ACID ETHYL ESTERS |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204940 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0034-06 (65162003406)
| NDC Package Code | 65162-034-06 |
|---|---|
| Billing NDC | 65162003406 |
| Package | 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-06) |
| Marketing Start Date | 2015-11-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |