Icosapent Ethyl
- Product NDC
- 0480-0127
- 11-digit product format
- 004800127
- Labeler code
- 0480
- Product ID
- 0480-0127_0d2afdd4-3333-47dc-9653-0b63e478b36d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icosapent Ethyl
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA209525
- Marketing category
- ANDA
- Marketing start
- 2022-12-15
- 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ICOSAPENT ETHYL | 1 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GC8A4PAYH |
| Rxcui | 1304979, 1811180 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0480-0127-89 | Icosapent Ethyl | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-0127 | ICOSAPENT ETHYL CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250112_de7049ae-d1d6-4267-a93b-dd5039c50c2c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0480-0127-89 | 00480012789 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-0127-89) | 2022-12-15 | 0000-00-00 | No | No | Current |