omega-3-acid ethyl esters
- Product NDC
- 60687-846
- 11-digit product format
- 606870846
- Labeler code
- 60687
- Product ID
- 60687-846_33eafe56-2385-cd60-e063-6294a90a5f4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omega-3-acid ethyl esters
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA203893
- Marketing category
- ANDA
- Marketing start
- 2025-04-29
- 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 |
|---|
| 60687-846-11 | omega-3-acid ethyl esters | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 2 |
| 60687-846-65 | omega-3-acid ethyl esters | 50 in 1 CARTON | CAPSULE | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-846 | OMEGA-3-ACID ETHYL ESTERS CAPSULE [AMERICAN HEALTH PACKAGING] | 2 | Current NDC, 2 package rows | 20250430_294ee73f-849c-4c3d-a415-d66138c91f53.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 |
|---|
| 60687-846-11 | 60687084611 | 1 in 1 BLISTER PACK | | | | | Historical |
| 60687-846-65 | 60687084665 | 50 BLISTER PACK in 1 CARTON (60687-846-65) / 1 CAPSULE in 1 BLISTER PACK (60687-846-11) | 50 blister pack | 2025-04-29 | No | No | Historical |