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NDC 00480-0126-49 Icosapent Ethyl 500 mg/1 Details
Icosapent Ethyl 500 mg/1
Icosapent Ethyl is a ORAL CAPSULE, LIQUID FILLED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Teva Pharmaceuticals, Inc.. The primary component is ICOSAPENT ETHYL.
MedlinePlus Drug Summary
Icosapent ethyl is used together with lifestyle changes (diet, weight loss, exercise) to reduce the amount of triglycerides (a fat-like substance) in the blood. It is also used along with cholesterol-lowering medications (statins) to decrease the risk of a heart attack, a stroke, or other heart problems that require hospitalization in certain adults with high triglyceride levels and heart disease or diabetes with 2 or more other heart disease risk factors. Icosapent ethyl is in a class of medications called antilipemic or lipid-regulating agents. Icosapent ethyl may work by decreasing the amount of triglycerides and other fats made in the liver.
Related Packages: 00480-0126-49Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Icosapent Ethyl
Product Information
| NDC | 00480-0126 |
|---|---|
| Product ID | 0480-0126_a1df4757-8d08-49a7-ac6a-f4cc9cf8f481 |
| Associated GPIs | |
| GCN Sequence Number | 076660 |
| GCN Sequence Number Description | icosapent ethyl CAPSULE 0.5 GRAM ORAL |
| HIC3 | M4E |
| HIC3 Description | LIPOTROPICS |
| GCN | 42365 |
| HICL Sequence Number | 039613 |
| HICL Sequence Number Description | ICOSAPENT ETHYL |
| Brand/Generic | Generic |
| Proprietary Name | Icosapent Ethyl |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Icosapent Ethyl |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | ICOSAPENT ETHYL |
| Labeler Name | Teva Pharmaceuticals, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209525 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00480-0126-49 (00480012649)
| NDC Package Code | 0480-0126-49 |
|---|---|
| Billing NDC | 00480012649 |
| Package | 240 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-0126-49) |
| Marketing Start Date | 2022-09-09 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1.05992 |
| Pricing Unit | EA |
| Effective Date | 2023-09-20 |
| NDC Description | ICOSAPENT ETHYL 500 MG CAPSULE |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |