Prescription drug · NDA
Vascepa (Icosapent ethyl) NDC 63629-8247
Icosapent ethyl 1000 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8247-1 | 6362982470163629824701 | 30 CAPSULE in 1 BOTTLE (63629-8247-1)Marketed from Apr 7, 2026 | |
| 63629-8247-2 | 6362982470263629824702 | 60 CAPSULE in 1 BOTTLE (63629-8247-2)Marketed from Apr 7, 2026 | |
| 63629-8247-3 | 6362982470363629824703 | 120 CAPSULE in 1 BOTTLE (63629-8247-3)Marketed from Apr 7, 2026 | |
| 63629-8247-4 | 6362982470463629824704 | 90 CAPSULE in 1 BOTTLE (63629-8247-4)Marketed from Apr 7, 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)
- Vascepa
- Generic name (nonproprietary)
- icosapent ethyl
- Active ingredients
- Icosapent ethyl — 1000 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202057
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-8247_322776f8-84f9-4198-b95c-353e9df6c70dSPL ID 322776f8-84f9-4198-b95c-353e9df6c70dSPL set ID d245ddab-d81b-44bd-90d7-0e4d446d9bf5RxCUI 1304979, 1304985UNII 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
N463629824701followed by a unit qualifier and the quantityPackage 63629-8247-01. 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)
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 63629-8247
- What is NDC 63629-8247?
- 63629-8247 is the product NDC for Vascepa (icosapent ethyl), Icosapent ethyl 1000 mg/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?
- Vascepa (Icosapent ethyl).
- What is the active ingredient?
- Icosapent ethyl.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 500 mg/1 | CapsuleOral | Amarin Pharma Inc. | 52937-003 | 52937-0003-1652937-0003-40 |
| 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 |
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 500 mg/1 | CapsuleOral | Amarin Pharma Inc. | 52937-003 |
| 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 |