icosapent ethyl
- Product NDC
- 70710-1592
- 11-digit product format
- 707101592
- Labeler code
- 70710
- Product ID
- 70710-1592_b292c3ea-8ce0-471f-8c44-57d1c4df9bf5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- icosapent ethyl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA217656
- Marketing category
- ANDA
- Marketing start
- 2023-08-04
- Substance
- ICOSAPENT ETHYL
- Active strength
- 1 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 | 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 |
|---|
| 70710-1592-7 | icosapent ethyl | 120 in 1 BOTTLE | CAPSULE | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1592 | ICOSAPENT ETHYL CAPSULE [ZYDUS PHARMACEUTICALS USA INC.] | 3 | Current NDC, 1 package rows | 20250227_5910742b-c5e6-4029-9a19-97669e3808bc.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 |
|---|
| 70710-1592-7 | 70710159207 | 120 CAPSULE in 1 BOTTLE (70710-1592-7) | 120 capsule | 2023-08-04 | No | No | Current |