Icosapent
- Product NDC
- 63629-9312
- 11-digit product format
- 636299312
- Labeler code
- 63629
- Product ID
- 63629-9312_8988eb81-87de-4d83-8d5a-f9e0d2863618
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icosapent Ethyl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209499
- Marketing category
- ANDA
- Marketing start
- 2021-06-21
- Substance
- ICOSAPENT ETHYL
- Active strength
- 1000 mg/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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ICOSAPENT ETHYL | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GC8A4PAYH |
| Rxcui | 1304979 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-9312-1 | Icosapent | 120 in 1 BOTTLE | CAPSULE | 120 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-9312 | ICOSAPENT (ICOSAPENT ETHYL) CAPSULE [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 1 package rows | 20240116_cc28828d-beab-45cc-a3b6-151c5fee3924.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 |
|---|
| 63629-9312-1 | 63629931201 | 120 CAPSULE in 1 BOTTLE (63629-9312-1) | 120 capsule | 2022-07-06 | 0000-00-00 | No | No | Current |