Icosapent Ethyl
- Product NDC
- 42291-046
- 11-digit product format
- 422910046
- Labeler code
- 42291
- Product ID
- 42291-046_484c1be6-d44c-23ed-e063-6394a90acd5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icosapent Ethyl
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA209525
- Marketing category
- ANDA
- Marketing start
- 2023-12-05
- 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 |
|---|
| 42291-046-12 | Icosapent Ethyl | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-046 | ICOSAPENT ETHYL CAPSULE, LIQUID FILLED [AVKARE] | 1 | Current NDC, 1 package rows | 20231206_0bc72bd8-1f33-b01c-e063-6394a90a77ea.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-046-12 | 42291004612 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-046-12) | 2023-12-05 | No | No | Historical |