Icosapent Ethyl
- Product NDC
- 60505-4033
- 11-digit product format
- 605054033
- Labeler code
- 60505
- Product ID
- 60505-4033_e0a75c2f-7422-2c9c-a132-3cc51dde6021
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icosapent Ethyl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Apotex Corp
- Application
- ANDA209437
- Marketing category
- ANDA
- Marketing start
- 2021-12-16
- Marketing end
- 2027-08-31
- Substance
- ICOSAPENT ETHYL
- Active strength
- 1 g/1
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Icosapent Ethyl
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 |
|---|
| 60505-4033-1 | Icosapent Ethyl | 120 in 1 BOTTLE | CAPSULE | 120 | | 6 |
| 60505-4033-3 | Icosapent Ethyl | 30 in 1 BOTTLE | CAPSULE | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-4033 | ICOSAPENT ETHYL CAPSULE [APOTEX CORP] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250529_886aa8d8-b293-258f-b16d-be40418787a8.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 |
|---|
| 60505-4033-1 | 60505403301 | 120 CAPSULE in 1 BOTTLE (60505-4033-1) | 120 capsule | 2021-12-16 | 2027-08-31 | No | No | Current |
| 60505-4033-3 | 60505403303 | 30 CAPSULE in 1 BOTTLE (60505-4033-3) | 30 capsule | 2021-12-16 | 0000-00-00 | No | No | Current |