OMEGA-3-ACID ETHYL ESTERS
- Product NDC
- 0904-7495
- 11-digit product format
- 009047495
- Labeler code
- 0904
- Product ID
- 0904-7495_b4dad9e0-98b3-4538-bc99-e390185bf642
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omega-3-acid ethyl esters
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA215458
- Marketing category
- ANDA
- Marketing start
- 2024-12-13
- 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
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OMEGA-3-ACID ETHYL ESTERS
- Listing expiration
- 2027-12-31
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 |
|---|
| 0904-7495-06 | OMEGA-3-ACID ETHYL ESTERS | 1 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 1 | | 4 |
| 0904-7495-06 | OMEGA-3-ACID ETHYL ESTERS | 50 in 1 CARTON | CAPSULE, LIQUID FILLED | 50 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7495 | OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS CAPSULES) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] | 1 | Current NDC, 2 package rows | 20241215_e40d55f2-db9f-4a48-8639-9aa7491e4de5.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 |
|---|
| 0904-7495-06 | 00904749506 | 50 BLISTER PACK in 1 CARTON (0904-7495-06) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 50 blister pack | 2024-12-13 | No | No | Current |