Prescription drug · NDA
Vascepa (Icosapent ethyl) NDC 52937-003
Icosapent ethyl 500 mg/1 · Capsule · Oral · Amarin Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52937-003-16 | 5293700031652937000316 | 1 BLISTER PACK in 1 CARTON (52937-003-16) / 16 CAPSULE in 1 BLISTER PACKMarketed from Sep 16, 2016 | |
| 52937-003-40 | 5293700034052937000340 | 240 CAPSULE in 1 BOTTLE (52937-003-40)Marketed from Sep 16, 2016 |
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)
- Vascepa
- Generic name (nonproprietary)
- icosapent ethyl
- Active ingredients
- Icosapent ethyl — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amarin Pharma Inc.NDC labeler code 52937
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202057
- Marketing start
- Listing expires
- Identifiers
- Product ID 52937-003_86b35fe3-d1cf-478e-849b-2ea0c87bda33SPL ID 86b35fe3-d1cf-478e-849b-2ea0c87bda33SPL set ID 9c1a2828-1583-4414-ab22-a60480e8e508RxCUI 1304979, 1304985, 1811180, 1811182UNII 6GC8A4PAYHUPC 0352937001200
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
N452937000316followed by a unit qualifier and the quantityPackage 52937-0003-16. 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)
VASCEPA ® (icosapent ethyl) is indicated: as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Limitations of Use: The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. VASCEPA is an ethyl ester of eico…
Excerpt only. Read the full label for complete information.
About NDC 52937-003
- What is NDC 52937-003?
- 52937-003 is the product NDC for Vascepa (icosapent ethyl), Icosapent ethyl 500 mg/1 capsule, listed with the FDA by Amarin Pharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vascepa (Icosapent ethyl).
- What is the active ingredient?
- Icosapent ethyl.
- Who is the labeler?
- Amarin Pharma Inc., NDC labeler code 52937. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vascepa?
- 4 other product NDCs are listed under this name. See all Vascepa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vascepa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vascepaicosapent ethyl | Icosapent ethyl 1000 mg/1 | CapsuleOral | Amarin Pharma Inc. | 52937-005 | 52937-0005-20 |
| Vascepaicosapent ethyl | Icosapent ethyl 1000 mg/1 | CapsuleOral | Amarin Pharma Inc. | 52937-001 | 52937-0001-20 |
| Vascepaicosapent ethyl | Icosapent ethyl 1000 mg/1 | CapsuleOral | Amarin Pharma Inc. | 52937-101 | 52937-0101-08 |
| Vascepaicosapent ethyl | Icosapent ethyl 1000 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8247 | 63629-8247-0163629-8247-0263629-8247-03+1 more |
Other NDCs under NDA 202057
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 |
|---|---|---|---|---|
| Vascepaicosapent ethyl | Icosapent ethyl 1000 mg/1 | CapsuleOral | Amarin Pharma Inc. | 52937-001 |
| Vascepaicosapent ethyl | Icosapent ethyl 1000 mg/1 | CapsuleOral | Amarin Pharma Inc. | 52937-005 |
| Vascepaicosapent ethyl | Icosapent ethyl 1000 mg/1 | CapsuleOral | Amarin Pharma Inc. | 52937-101 |
| Vascepaicosapent ethyl | Icosapent ethyl 1000 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8247 |