Prescription drug · ANDA
Icosapent Ethyl NDC 63629-9311
Icosapent ethyl 1 g/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-9311-1 | 63629931101 | 120 CAPSULE in 1 BOTTLE (63629-9311-1)Marketed from Aug 10, 2026 |
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 — 1 g/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209457
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-9311_f85fe370-c8e6-40b5-a44b-64ec7446b13eSPL ID f85fe370-c8e6-40b5-a44b-64ec7446b13eSPL set ID f9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4cRxCUI 1304979UNII 6GC8A4PAYH
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
N463629931101followed by a unit qualifier and the quantityPackage 63629-9311-01. 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 is indicated: • as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Limitations of Use The effect of icosapent ethyl 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 triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. ( 1 ) Limitations of Use: • The effect of icosapent ethyl 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 209457
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 | Bryant Ranch Prepack | 71335-2842 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3072 |
| Icosapent Ethyl | Icosapent ethyl .5 g/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc. | 0054-0621 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc. | 0054-0508 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1000 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Northstar Rx LLC | 72603-129 |