Icosapent Ethyl
- Product NDC
- 13668-761
- 11-digit product format
- 136680761
- Labeler code
- 13668
- Product ID
- 13668-761_6400c781-77e1-49a5-91e4-0fb8ccc2bfb8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icosapent Ethyl Capsules
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA218994
- Marketing category
- ANDA
- Marketing start
- 2026-04-22
- Substance
- ICOSAPENT ETHYL
- Active strength
- 1 g/g
- 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/g |
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 |
|---|
| 13668-761-12 | Icosapent Ethyl | 120 g in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 13668-761-12 | 13668076112 | 120 g in 1 BOTTLE (13668-761-12) | 120 g | 2026-04-22 | No | No | Historical |