Prescription drug · ANDA
Icosapent Ethyl NDC 71335-2989
Icosapent ethyl 1 g/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2989-1 | 7133529890171335298901 | 30 CAPSULE in 1 BOTTLE (71335-2989-1)Marketed from Feb 4, 2026 | |
| 71335-2989-2 | 7133529890271335298902 | 60 CAPSULE in 1 BOTTLE (71335-2989-2)Marketed from Feb 4, 2026 | |
| 71335-2989-3 | 7133529890371335298903 | 120 CAPSULE in 1 BOTTLE (71335-2989-3)Marketed from Feb 4, 2026 | |
| 71335-2989-4 | 7133529890471335298904 | 90 CAPSULE in 1 BOTTLE (71335-2989-4)Marketed from Feb 4, 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 PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216811
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-2989_9df091ac-075e-456c-9f09-faf11d1c4b0aSPL ID 9df091ac-075e-456c-9f09-faf11d1c4b0aSPL set ID b4a1ca8a-2d22-4c54-9193-eab4e75ba7dbRxCUI 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
N471335298901followed by a unit qualifier and the quantityPackage 71335-2989-01. 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 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.
About NDC 71335-2989
- What is NDC 71335-2989?
- 71335-2989 is the product NDC for Icosapent Ethyl, Icosapent ethyl 1 g/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Icosapent Ethyl.
- What is the active ingredient?
- Icosapent ethyl.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Icosapent Ethyl?
- 32 other product NDCs are listed under this name. See all Icosapent Ethyl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Icosapent Ethyl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Icosapent ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-812 | 59651-0812-08 |
| Icosapent Ethylicosapent ethyl capsules | Icosapent ethyl 1 g/g | Capsule, Liquid filledOral | Torrent Pharmaceuticals Limited | 13668-761 | 13668-0761-12 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Vitruvias Therapeutics, Inc. | 69680-186 | 69680-0186-92 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Northstar Rx LLC | 16714-636 | 16714-0636-01 |
| icosapent ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Softgel Healthcare Private Limited | 35916-1592 | 35916-1592-01 |
| icosapent ethyl | Icosapent ethyl .5 g/1 | CapsuleOral | Softgel Healthcare Private Limited | 35916-1738 | 35916-1738-01 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Qilu Pharmaceutical Co., Ltd. | 67184-0582 | 67184-0582-01 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | American Health Packaging | 60687-764 | 60687-0764-21 |
| Icosapent Ethyl | Icosapent ethyl .5 g/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-298 | 31722-0298-24 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-299 | 31722-0299-12 |
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 | Camber Pharmaceuticals, Inc. | 31722-298 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-299 |
| 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 |