ICOSAPENT ETHYL
- Product NDC
- 71335-2989
- 11-digit product format
- 713352989
- Labeler code
- 71335
- Product ID
- 71335-2989_9df091ac-075e-456c-9f09-faf11d1c4b0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icosapent ethyl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA216811
- Marketing category
- ANDA
- Marketing start
- 2024-02-16
- Substance
- ICOSAPENT ETHYL
- Active strength
- 1 g/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ICOSAPENT ETHYL
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ICOSAPENT ETHYL | 1 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GC8A4PAYH |
| Rxcui | 1304979 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2989-1 | ICOSAPENT ETHYL | 30 in 1 BOTTLE | CAPSULE | 30 | | 1 |
| 71335-2989-2 | ICOSAPENT ETHYL | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
| 71335-2989-3 | ICOSAPENT ETHYL | 120 in 1 BOTTLE | CAPSULE | 120 | | 1 |
| 71335-2989-4 | ICOSAPENT ETHYL | 90 in 1 BOTTLE | CAPSULE | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2989-1 | 71335298901 | 30 CAPSULE in 1 BOTTLE (71335-2989-1) | 30 capsule | 2026-02-04 | No | No | Current |
| 71335-2989-2 | 71335298902 | 60 CAPSULE in 1 BOTTLE (71335-2989-2) | 60 capsule | 2026-02-04 | No | No | Current |
| 71335-2989-3 | 71335298903 | 120 CAPSULE in 1 BOTTLE (71335-2989-3) | 120 capsule | 2026-02-04 | No | No | Current |
| 71335-2989-4 | 71335298904 | 90 CAPSULE in 1 BOTTLE (71335-2989-4) | 90 capsule | 2026-02-04 | No | No | Current |