Omega-3-acid ethyl esters
- Product NDC
- 0254-3010
- 11-digit product format
- 002543010
- Labeler code
- 0254
- Product ID
- 0254-3010_9b349968-03b7-4a4f-ab40-976570f5e398
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omega-3-acid ethyl esters
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Par Pharmaceutical Inc.
- Application
- ANDA203893
- Marketing category
- ANDA
- Marketing start
- 2017-09-19
- Substance
- OMEGA-3-ACID ETHYL ESTERS
- Active strength
- 900 mg/1
- Pharmacologic classes
- Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omega-3-acid ethyl esters
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEGA-3-ACID ETHYL ESTERS | 900 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D87YGH4Z0Q |
| Rxcui | 577208 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0254-3010-08 | Omega-3-acid ethyl esters | 120 in 1 BOTTLE | CAPSULE | 120 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0254-3010 | OMEGA-3-ACID ETHYL ESTERS CAPSULE [PAR PHARMACEUTICAL INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20170925_b53f1c14-43da-4e05-8c80-a0a455dd41cf.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 |
|---|
| 0254-3010-08 | 00254301008 | 120 CAPSULE in 1 BOTTLE (0254-3010-08) | 120 capsule | 2017-09-19 | 0000-00-00 | No | No | Current |