Icosapent
- Product NDC
- 43598-267
- 11-digit product format
- 435980267
- Labeler code
- 43598
- Product ID
- 43598-267_d6afc522-23f4-025c-df81-109460653b4d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icosapent Ethyl
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories, Inc.
- 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 |
|---|
| 43598-267-04 | Icosapent | 120 in 1 BOTTLE | CAPSULE | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-267 | ICOSAPENT (ICOSAPENT ETHYL) CAPSULE [DR. REDDY'S LABORATORIES, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20210928_1aca884c-c464-900d-ac06-33aee7118df8.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 |
|---|
| 43598-267-04 | 43598026704 | 120 CAPSULE in 1 BOTTLE (43598-267-04) | 120 capsule | 2021-06-21 | 0000-00-00 | No | No | Current |