Icosapent Ethyl
- Product NDC
- 71335-2842
- 11-digit product format
- 713352842
- Labeler code
- 71335
- Product ID
- 71335-2842_d97ec6a3-1912-4a16-b85a-ff78fd692e35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icosapent Ethyl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209457
- Marketing category
- ANDA
- Marketing start
- 2020-11-04
- Substance
- ICOSAPENT ETHYL
- Active strength
- 1 g/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-2842_d97ec6a3-1912-4a16-b85a-ff78fd692e35
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Icosapent Ethyl
- Generic name
- Icosapent Ethyl
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing start
- 2020-11-04
- Marketing category
- ANDA
- Application number
- ANDA209457
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| ICOSAPENT ETHYL | 1 g/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 6GC8A4PAYH |
| Rxcui | 1304979 |
| Spl Set Id | 582638e5-9881-409d-a455-041b5ba6892a |
| Manufacturer Name | Bryant Ranch Prepack |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 6GC8A4PAYH | ICOSAPENT ETHYL | 86227-47-6 | ICOSAPENT ETHYL |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2842-1 | 71335284201 | 120 CAPSULE in 1 BOTTLE (71335-2842-1) | 120 capsule | 2025-10-21 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Icosapent Ethyl | Bryant Ranch Prepack | 2025-10-21 | HUMAN PRESCRIPTION DRUG LABEL | 100 |