Vascepa
- Product NDC
- 52937-101
- 11-digit product format
- 529370101
- Labeler code
- 52937
- Product ID
- 52937-101_86b35fe3-d1cf-478e-849b-2ea0c87bda33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- icosapent ethyl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amarin Pharma Inc.
- Application
- NDA202057
- Marketing category
- NDA
- Marketing start
- 2012-10-01
- Substance
- ICOSAPENT ETHYL
- Active strength
- 1000 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Vascepa
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ICOSAPENT ETHYL | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GC8A4PAYH |
| Rxcui | 1304979, 1304985, 1811180, 1811182 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52937-101-08 | Vascepa | 8 in 1 BLISTER PACK | CAPSULE | 8 | | 21 |
| 52937-101-08 | Vascepa | 1 in 1 CARTON | CAPSULE | 1 | | 21 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52937-101 | VASCEPA (ICOSAPENT ETHYL) CAPSULE [AMARIN PHARMA INC.] | 19 | Current NDC, Legacy NDC, 2 package rows | 20230426_9c1a2828-1583-4414-ab22-a60480e8e508.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 |
|---|
| 52937-101-08 | 52937010108 | 1 BLISTER PACK in 1 CARTON (52937-101-08) / 8 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2012-10-01 | 0000-00-00 | No | No | Current |