Prescription drug · ANDA
Icosapent ethyl NDC 69238-2597
Icosapent ethyl .5 g/1 · Capsule · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-2597-7 | 69238259707 | 240 CAPSULE in 1 BOTTLE (69238-2597-7)Marketed from Nov 1, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Icosapent ethyl
- Generic name (nonproprietary)
- icosapent ethyl
- Active ingredients
- Icosapent ethyl — .5 g/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217844
- Marketing start
- Listing expires
- Identifiers
- Product ID 69238-2597_9e7d9563-10a7-4c29-bf92-6086c3ba0ae9SPL ID 9e7d9563-10a7-4c29-bf92-6086c3ba0ae9SPL set ID fd2b5373-1ddd-46c0-a579-d5a4f289d79fRxCUI 1304979, 1811180UNII 6GC8A4PAYHUPC 0369238259773, 0369238259889
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
N469238259707followed by a unit qualifier and the quantityPackage 69238-2597-07. 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)
Icosapent ethyl capsules are indicated: as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Limitations of Use: The effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined . Icosapent ethyl capsules are an ethyl ester of eicosapentaenoic acid (EPA) indicated: as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. (1) Limitations of Use: The effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217844
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 |
|---|---|---|---|---|
| Icosapent ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 69238-2598 |