Prescription drug · ANDA
Icosapent (Icosapent ethyl) NDC 43598-267
Icosapent ethyl 1000 mg/1 · Capsule · Oral · Dr. Reddy's Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-267-04 | 4359802670443598026704 | 120 CAPSULE in 1 BOTTLE (43598-267-04)Marketed from Jun 21, 2021 |
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
- Generic name (nonproprietary)
- icosapent ethyl
- Active ingredients
- Icosapent ethyl — 1000 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories, Inc.NDC labeler code 43598
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209499
- Marketing start
- Marketing end
- Identifiers
- Product ID 43598-267_548bf172-d774-f1cf-d856-5638eb43bf24SPL ID 548bf172-d774-f1cf-d856-5638eb43bf24SPL set ID 1aca884c-c464-900d-ac06-33aee7118df8RxCUI 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
N443598026704followed by a unit qualifier and the quantityPackage 43598-0267-04. 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 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 TG levels in adultpatients 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 43598-267
- What is NDC 43598-267?
- 43598-267 is the product NDC for Icosapent (icosapent ethyl), Icosapent ethyl 1000 mg/1 capsule, listed with the FDA by Dr. Reddy's Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Icosapent (Icosapent Ethyl).
- What is the active ingredient?
- Icosapent ethyl.
- Who is the labeler?
- Dr. Reddy's Laboratories, Inc., NDC labeler code 43598. 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?
- 1 other product NDC are listed under this name. See all Icosapent NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Icosapent products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Icosapenticosapent ethyl | Icosapent ethyl 1000 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9312 | 63629-9312-01 |
Other NDCs under ANDA 209499
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 |
|---|---|---|---|---|
| Icosapenticosapent ethyl | Icosapent ethyl 1000 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9312 |
| Icosapent Ethyl | Icosapent ethyl 500 mg/1 | CapsuleOral | Dr. Reddy's Laboratories, Inc. | 43598-746 |