ICOSAPENT ETHYL
- Product NDC
- 72865-289
- 11-digit product format
- 728650289
- Labeler code
- 72865
- Product ID
- 72865-289_e78f8ff5-3e0a-44d1-b64f-19a912bd0a34
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icosapent ethyl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- XLCare Pharmaceuticals, Inc.
- Application
- ANDA216811
- Marketing category
- ANDA
- Marketing start
- 2024-02-16
- Substance
- ICOSAPENT ETHYL
- Active strength
- .5 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 | .5 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 |
|---|
| 72865-289-24 | ICOSAPENT ETHYL | 240 in 1 BOTTLE | CAPSULE | 240 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72865-289 | ICOSAPENT ETHYL CAPSULE [XLCARE PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20240322_019cc0ac-0c2f-426d-996a-6d932f954443.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72865-289-24 | 72865028924 | 240 CAPSULE in 1 BOTTLE (72865-289-24) | 240 capsule | 2024-02-16 | No | No | Historical |