Icosapent ethyl
- Product NDC
- 64380-285
- 11-digit product format
- 643800285
- Labeler code
- 64380
- Product ID
- 64380-285_7569c8d6-9fbf-4428-b274-6a803b3718a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icosapent ethyl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA217844
- Marketing category
- ANDA
- Marketing start
- 2026-05-22
- Substance
- ICOSAPENT ETHYL
- Active strength
- 1 g/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f6766515-27b8-72de-2010-167151236ace | Product name | 7 | 20251021 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64380-285-01 | Icosapent ethyl | 120 in 1 BOTTLE | CAPSULE | 120 | 3 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1811180 | icosapent ethyl 0.5 GM Oral Capsule | PSN | 1a50bc22-bbdf-4ba8-b162-0e12f3e9d160 | 3 |
| 1304979 | icosapent ethyl 1 GM Oral Capsule | PSN | 1a50bc22-bbdf-4ba8-b162-0e12f3e9d160 | 3 |
| 1304979 | icosapent ethyl 1000 MG Oral Capsule | SCD | 1a50bc22-bbdf-4ba8-b162-0e12f3e9d160 | 3 |
| 1811180 | icosapent ethyl 500 MG Oral Capsule | SCD | 1a50bc22-bbdf-4ba8-b162-0e12f3e9d160 | 3 |
| 1811180 | icosapent ethyl 0.5 GM Oral Capsule | SY | 1a50bc22-bbdf-4ba8-b162-0e12f3e9d160 | 3 |
| 1304979 | icosapent ethyl 1 GM Oral Capsule | SY | 1a50bc22-bbdf-4ba8-b162-0e12f3e9d160 | 3 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1811180 | icosapent ethyl 0.5 GM Oral Capsule | PSN | 1a50bc22-bbdf-4ba8-b162-0e12f3e9d160 | 3 |
| 1304979 | icosapent ethyl 1 GM Oral Capsule | PSN | 1a50bc22-bbdf-4ba8-b162-0e12f3e9d160 | 3 |
| 1304979 | icosapent ethyl 1000 MG Oral Capsule | SCD | 1a50bc22-bbdf-4ba8-b162-0e12f3e9d160 | 3 |
| 1811180 | icosapent ethyl 500 MG Oral Capsule | SCD | 1a50bc22-bbdf-4ba8-b162-0e12f3e9d160 | 3 |
| 1811180 | icosapent ethyl 0.5 GM Oral Capsule | SY | 1a50bc22-bbdf-4ba8-b162-0e12f3e9d160 | 3 |
| 1304979 | icosapent ethyl 1 GM Oral Capsule | SY | 1a50bc22-bbdf-4ba8-b162-0e12f3e9d160 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64380-285-01 | 64380028501 | 120 CAPSULE in 1 BOTTLE (64380-285-01) | 120 capsule | 2026-05-22 | No | No | Historical |