Prescription drug · ANDA
Icosapent Ethyl NDC 60505-4033
Icosapent ethyl 1 g/1 · Capsule · Oral · Apotex Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-4033-1 | 6050540330160505403301 | 120 CAPSULE in 1 BOTTLE (60505-4033-1)Marketed from Dec 16, 2021 |
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
- Apotex CorpNDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209437
- Marketing start
- Marketing end
- Identifiers
- Product ID 60505-4033_131d2bd6-c27a-36af-da0f-2102b32e1e06SPL ID 131d2bd6-c27a-36af-da0f-2102b32e1e06
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
N460505403301followed by a unit qualifier and the quantityPackage 60505-4033-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 60505-4033
- What is NDC 60505-4033?
- 60505-4033 is the product NDC for Icosapent Ethyl, Icosapent ethyl 1 g/1 capsule, listed with the FDA by Apotex Corp. It has 1 package NDC, 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?
- Apotex Corp, NDC labeler code 60505. 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 209437
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 | Golden State Medical Supply, Inc. | 60429-005 |
| Icosapent Ethyl | Icosapent ethyl 1 g/1 | CapsuleOral | American Health Packaging | 60687-764 |