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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| D87YGH4Z0Q | OMEGA-3-ACID ETHYL ESTERS | 308081-97-2 | OMEGA-3-ACID ETHYL ESTERS |
Packages
| 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 | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| OMEGA-3-ACID ETHYL ESTERS | NCS HealthCare of KY, LLC dba Vangard Labs | 2024-10-18 | HUMAN PRESCRIPTION DRUG LABEL | 1 |