Prescription drug · ANDA
Icosapent Ethyl NDC 0054-0508
Icosapent ethyl 1 g/1 · Capsule · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0508-23 | 00054050823 | 120 CAPSULE in 1 BOTTLE (0054-0508-23)Marketed from Nov 4, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209457
- Marketing start
- Listing expires
- Identifiers
- Product ID 0054-0508_8963be4d-11e2-42c9-af2f-410b99a4694fSPL ID 8963be4d-11e2-42c9-af2f-410b99a4694fSPL set ID e3d38d1d-fbe7-413d-849a-675e7dfa9b0aRxCUI 1304979, 1811180UNII 6GC8A4PAYHUPC 0300540621278, 0300540508234
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
N400054050823followed by a unit qualifier and the quantityPackage 00054-0508-23. 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 | Bryant Ranch Prepack | 72162-1000 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Northstar Rx LLC | 72603-129 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9311 |