ICOSAPENT ETHYL
- Product NDC
- 16714-636
- 11-digit product format
- 167140636
- Labeler code
- 16714
- Product ID
- 16714-636_ad34781b-7624-4344-a31f-83ef471da07b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icosapent ethyl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Northstar Rx LLC
- Application
- ANDA216811
- Marketing category
- ANDA
- Marketing start
- 2025-07-01
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-636-01 | ICOSAPENT ETHYL | 120 in 1 BOTTLE | CAPSULE | 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 |
|---|
| 16714-636-01 | 16714063601 | 120 CAPSULE in 1 BOTTLE (16714-636-01) | 120 capsule | 2025-07-01 | No | No | Historical |