Prescription drug · ANDA
Icosapent Ethyl NDC 72603-129
Icosapent ethyl 1 g/1 · Capsule · Oral · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-129-01 | 72603012901 | 120 CAPSULE in 1 BOTTLE (72603-129-01)Marketed from Jan 31, 2022 |
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)
- Icosapent Ethyl
- Generic name (nonproprietary)
- icosapent ethyl
- Active ingredients
- Icosapent ethyl — 1 g/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Northstar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209457
- Marketing start
- Marketing end
- Identifiers
- Product ID 72603-129_a5ce71bd-452c-4c3a-b53b-58500307f1bbSPL ID a5ce71bd-452c-4c3a-b53b-58500307f1bbSPL set ID 45f8bb41-bdb1-4afc-83ec-9dc69720ee9cRxCUI 1304979UNII 6GC8A4PAYHUPC 0372603129014
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
N472603012901followed by a unit qualifier and the quantityPackage 72603-0129-01. 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 | Bryant Ranch Prepack | 63629-9311 |