Prescription drug · ANDA
icosapent ethyl NDC 70710-1592
Icosapent ethyl 1 g/1 · Capsule · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1592-7 | 70710159207 | 120 CAPSULE in 1 BOTTLE (70710-1592-7)Marketed from Aug 4, 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 — 1 g/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217656
- Marketing start
- Listing expires
- Identifiers
- Product ID 70710-1592_fc13bee2-0828-4bc5-b967-b47e368f0a24SPL ID fc13bee2-0828-4bc5-b967-b47e368f0a24SPL set ID 5910742b-c5e6-4029-9a19-97669e3808bcRxCUI 1304979, 1811180UNII 6GC8A4PAYHUPC 0370710159276
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
N470710159207followed by a unit qualifier and the quantityPackage 70710-1592-07. 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 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 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 217656
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 .5 g/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1738 |
| icosapent ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Softgel Healthcare Private Limited | 35916-1592 |
| icosapent ethyl | Icosapent ethyl .5 g/1 | CapsuleOral | Softgel Healthcare Private Limited | 35916-1738 |