Omega-3-Acid Ethyl Ester
- Product NDC
- 69452-175
- 11-digit product format
- 694520175
- Labeler code
- 69452
- Product ID
- 69452-175_c1aebacc-8c18-3f0d-e053-2a95a90ab85a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omega-3-acid ethyl esters
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA206455
- Marketing category
- ANDA
- Marketing start
- 2017-01-15
- 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 Ester
- 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 |
|---|
| 69452-175-17 | Omega-3-Acid Ethyl Ester | 60 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 60 | | 6 |
| 69452-175-22 | Omega-3-Acid Ethyl Ester | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-175 | OMEGA-3-ACID ETHYL ESTER (OMEGA-3-ACID ETHYL ESTERS) CAPSULE, LIQUID FILLED [BIONPHARMA INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20210508_91ef2e89-e816-4494-9558-2f647b7452f8.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 |
|---|
| 69452-175-17 | 69452017517 | 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-17) | 2017-01-15 | 0000-00-00 | No | No | Current |
| 69452-175-22 | 69452017522 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-22) | 2017-01-15 | 0000-00-00 | No | No | Current |