Icosapent Ethyl
- Product NDC
- 43598-746
- 11-digit product format
- 435980746
- Labeler code
- 43598
- Product ID
- 43598-746_c23214a0-3fde-a1b2-d1ed-e7f120af949a
- 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
- 2023-04-17
- Substance
- ICOSAPENT ETHYL
- Active strength
- 500 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 Ethyl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ICOSAPENT ETHYL | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GC8A4PAYH |
| Rxcui | 1811180 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-746-72 | Icosapent Ethyl | 240 in 1 BOTTLE | CAPSULE | 240 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-746 | ICOSAPENT ETHYL CAPSULE [DR. REDDY'S LABORATORIES, INC.] | 4 | Current NDC, 1 package rows | 20230419_cdcee03e-5df1-a8fc-7490-dfdc624ce6d6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 43598-746-72 | 43598074672 | 240 CAPSULE in 1 BOTTLE (43598-746-72) | 240 capsule | 2023-04-17 | No | No | Current |