icosapent ethyl
- Product NDC
- 35916-1738
- 11-digit product format
- 359161738
- Labeler code
- 35916
- Product ID
- 35916-1738_51ab40c9-9b15-4fa3-a355-6ac5d36552ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- icosapent ethyl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Softgel Healthcare Private Limited
- Application
- ANDA217656
- Marketing category
- ANDA
- Marketing start
- 2025-03-01
- Substance
- ICOSAPENT ETHYL
- Active strength
- .5 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 | .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 |
|---|
| 35916-1738-1 | icosapent ethyl | 240 in 1 BOTTLE | CAPSULE | 240 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35916-1738 | ICOSAPENT ETHYL CAPSULE [SOFTGEL HEALTHCARE PRIVATE LIMITED] | 1 | Current NDC, 1 package rows | 20250302_6f5838cd-4d17-401d-8e2a-652d0e73c1e9.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 |
|---|
| 35916-1738-1 | 35916173801 | 240 CAPSULE in 1 BOTTLE (35916-1738-1) | 240 capsule | 2025-03-01 | No | No | Current |