Prescription drug · ANDA
Omega-3-Acid Ethyl Esters NDC 42806-552
Omega-3-acid ethyl esters 1 g/1 · Capsule, Liquid filled · Oral · EPIC PHARMA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-552-12 | 42806055212 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42806-552-12)Marketed from Jul 2, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Omega-3-Acid Ethyl Esters
- Generic name (nonproprietary)
- omega-3-acid ethyl esters
- Active ingredients
- Omega-3-acid ethyl esters — 1 g/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- EPIC PHARMA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210093
- Marketing start
- Listing expires
- Other FDA classes
- Omega-3 (Chemical structure)
- Identifiers
- Product ID 42806-552_2b206d7a-b677-757e-e063-6294a90a9c0dSPL ID 2b206d7a-b677-757e-e063-6294a90a9c0dSPL set ID 787f9929-ef31-42a7-a305-8ba343e39672RxCUI 577208UNII D87YGH4Z0Q
- Pharmacologic class
- Omega-3 Fatty Acid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N442806055212followed by a unit qualifier and the quantityPackage 42806-0552-12. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients,…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210093
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Omega-3-Acid Ethyl Esters | Omega-3-acid ethyl esters 1 g/1 | Capsule, Liquid filledOral | REMEDYREPACK INC. | 70518-3040 |
| Omega-3-Acid Ethyl Esters | Omega-3-acid ethyl esters 1 g/1 | Capsule, Liquid filledOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-350 |
| Omega-3-Acid Ethyl Esters | Omega-3-acid ethyl esters 1 g/1 | Capsule, Liquid filledOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8550 |
| Omega-3-Acid Ethyl Esters | Omega-3-acid ethyl esters 1 g/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 71335-2024 |
| Omega-3-Acid Ethyl Esters | Omega-3-acid ethyl esters 1 g/1 | Capsule, Liquid filledOral | A-S Medication Solutions | 50090-6692 |
| Omega-3-Acid Ethyl Esters | Omega-3-acid ethyl esters 1 g/1 | Capsule, Liquid filledOral | A-S Medication Solutions | 50090-6691 |