ICOSAPENT ETHYL
- Product NDC
- 42806-560
- 11-digit product format
- 428060560
- Labeler code
- 42806
- Product ID
- 42806-560_61751e3a-6f7b-4725-9d8b-7dc9c7d8558e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- icosapent ethyl
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- EPIC PHARMA, LLC
- Application
- ANDA217919
- Marketing category
- ANDA
- Marketing start
- 2023-12-22
- 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, 1811180 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42806-560-12 | ICOSAPENT ETHYL | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-560 | ICOSAPENT ETHYL CAPSULE, LIQUID FILLED [EPIC PHARMA, LLC] | 3 | Current NDC, 1 package rows | 20240815_6db749b9-c817-41cd-909f-dd60a90c9f73.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42806-560-12 | 42806056012 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-560-12) | 2023-12-22 | No | No | Current |