Omega-3-Acid Ethyl Esters
- Product NDC
- 65162-034
- 11-digit product format
- 651620034
- Labeler code
- 65162
- Product ID
- 65162-034_605495d0-a1f3-490f-b32d-0ac015c034a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omega-3-Acid Ethyl Esters
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA204940
- Marketing category
- ANDA
- Marketing start
- 2015-11-30
- Marketing end
- 2026-07-01
- Substance
- OMEGA-3-ACID ETHYL ESTERS
- Active strength
- 1 g/1
- Pharmacologic classes
- Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omega-3-Acid Ethyl Esters
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEGA-3-ACID ETHYL ESTERS | 1 g/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 |
|---|
| 65162-034-06 | Omega-3-Acid Ethyl Esters | 60 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 60 | | 14 |
| 65162-034-16 | Omega-3-Acid Ethyl Esters | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | | 14 |
| 65162-034-32 | Omega-3-Acid Ethyl Esters | 360 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 360 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-034 | OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS LLC] | 13 | Current NDC, Legacy NDC, 3 package rows | 20241031_530161f4-26a0-4cb0-8a01-a18cfd36d88c.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 |
|---|
| 65162-034-06 | 65162003406 | 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-06) | 2015-11-30 | 2026-07-01 | No | No | Current |
| 65162-034-16 | 65162003416 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-16) | 2015-11-30 | 2026-07-01 | No | No | Current |
| 65162-034-32 | 65162003432 | 360 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-32) | 2015-11-30 | 2026-07-01 | No | No | Current |