OMEGA-3-ACID ETHYL ESTERS
- Product NDC
- 0615-8550
- 11-digit product format
- 006158550
- Labeler code
- 0615
- Product ID
- 0615-8550_57a3c56b-8da3-4ec0-a45c-cd15f8173f43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OMEGA-3-ACID ETHYL ESTERS
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA210093
- Marketing category
- ANDA
- Marketing start
- 2020-07-02
- 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
- 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 | 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 |
|---|
| 0615-8550-39 | OMEGA-3-ACID ETHYL ESTERS | 30 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8550 | OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 1 | Current NDC, 1 package rows | 20241020_c293de7f-b4b6-461b-a0eb-470e5b84618d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8550-39 | 00615855039 | 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0615-8550-39) | 2024-10-15 | No | No | Current |