Icosapent Ethyl
- Product NDC
- 0054-0508
- 11-digit product format
- 000540508
- Labeler code
- 0054
- Product ID
- 0054-0508_2417e4be-d579-4c3d-8ec0-a42dc51aabf5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icosapent Ethyl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Icosapent Ethyl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ICOSAPENT ETHYL | 1 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GC8A4PAYH |
| Rxcui | 1304979, 1811180 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0508-23 | Icosapent Ethyl | 120 in 1 BOTTLE | CAPSULE | 120 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0508 | ICOSAPENT ETHYL CAPSULE [HIKMA PHARMACEUTICALS USA INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20230314_e3d38d1d-fbe7-413d-849a-675e7dfa9b0a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0508-23 | 00054050823 | 120 CAPSULE in 1 BOTTLE (0054-0508-23) | 120 capsule | 2020-11-04 | 0000-00-00 | No | No | Current |