Prescription drug · ANDA
Icosapent Ethyl NDC 31722-298
Icosapent ethyl .5 g/1 · Capsule · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-298-24 | 31722029824 | 240 CAPSULE in 1 BOTTLE (31722-298-24)Marketed from Feb 16, 2024 |
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 — .5 g/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216811
- Marketing start
- Listing expires
- Identifiers
- Product ID 31722-298_293101bd-609b-40d0-8ed4-953ebb8b5072SPL ID 293101bd-609b-40d0-8ed4-953ebb8b5072SPL set ID 3e3498ab-f35e-4597-8556-89bf9fdd1406RxCUI 1304979, 1811180UNII 6GC8A4PAYHUPC 0331722299121, 0331722298247
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
N431722029824followed by a unit qualifier and the quantityPackage 31722-0298-24. 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 triglyceride (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 triglyceride (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 216811
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 | Northstar Rx LLC | 16714-636 |
| Icosapent Ethyl | Icosapent ethyl .5 g/1 | CapsuleOral | XLCare Pharmaceuticals, Inc. | 72865-289 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | XLCare Pharmaceuticals, Inc. | 72865-290 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2989 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-299 |