Icosapent Ethyl
- Product NDC
- 60687-764
- 11-digit product format
- 606870764
- Labeler code
- 60687
- Product ID
- 60687-764_47a64acc-3806-d861-e063-6394a90a8d02
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icosapent Ethyl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA209437
- Marketing category
- ANDA
- Marketing start
- 2024-02-21
- Marketing end
- 2027-05-31
- Substance
- ICOSAPENT ETHYL
- Active strength
- 1 g/1
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Icosapent Ethyl
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 |
|---|
| 60687-764-11 | Icosapent Ethyl | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 5 |
| 60687-764-21 | Icosapent Ethyl | 30 in 1 CARTON | CAPSULE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-764 | ICOSAPENT ETHYL CAPSULE [AMERICAN HEALTH PACKAGING] | 3 | Current NDC, 2 package rows | 20240328_fd28217d-5817-43b0-8185-7c7ec6da83f3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60687-764-11 | 60687076411 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 60687-764-21 | 60687076421 | 30 BLISTER PACK in 1 CARTON (60687-764-21) / 1 CAPSULE in 1 BLISTER PACK (60687-764-11) | 30 blister pack | 2024-02-21 | 2027-05-31 | No | No | Historical |