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Vascepa icosapent ethyl 1000 mg Capsule, 120-count — NDC 63629-8247-03 package photo

Vascepa icosapent ethyl 1000 mg Capsule, 120-count

by Bryant Ranch Prepack · 120 CAPSULE in 1 BOTTLE (63629-8247-3)
NDC 63629-8247-03
🏷️ FDA NDC (as labeled) 63629-8247-3 billing pads the package segment with a zero
This package
Contains120-count Pack sizes4 compare ↓
Also priced by: Part D plans $1.66/unit — full pricing hub ↓
Also comes in: 30 capsules 63629-8247-01 60 capsules 63629-8247-02 90 capsules 63629-8247-04
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Icosapent Ethyl (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 9, 2026 — Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0400-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 63629-8247-3
Product NDC 63629-8247
11-digit billing NDC 63629824703
RxCUI 1304979, 1304985
UNII 6GC8A4PAYH
Application # NDA202057
SPL Set ID d245ddab-d81b-44bd-90d7-0e4d446d9bf5
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-10-01
Route ORAL
Dosage form CAPSULE
Substance ICOSAPENT ETHYL
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 63629-8247-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 63629-8247-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderAMARIN PHARMACEUTICALS IRELAND LTD
FDA applicationNDA202057 (NDA)
Labeler code63629
First marketedOct 2012
Product typeHuman Prescription Drug
Portfolio4,433 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Icosapent ethyl is a highly purified omega-3 fatty acid that helps lower very high triglyceride levels in your blood. Depending on the specific product and your health situation, y...
  • What exactly does icosapent ethyl do, and why has my doctor prescribed it?
  • Take them twice a day with food — that's how they were used in all the clinical studies, and food helps your body absorb the medicine properly. Swallow the capsules whole every tim...
  • How should I take my icosapent ethyl capsules?
📖 Read our full Icosapent Ethyl guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Yellow
ShapeOval
ImprintVascepa
Size25 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII D65DG142WK
    Maltitol is a sugar alcohol made by hydrogenating maltose. It's used as a sweetener and filler in medicines to improve taste and add bulk to tablets and capsules.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 2 mg UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1.66 $199.12 / 120 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Icosapent Ethyl 1 g 00054-0508-23 Hikma 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 00480-0127-89 Teva 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 16714-0636-01 Northstar 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 31722-0299-12 Camber 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 42806-0560-12 EPIC 120 capsules $0.441 AB Availability likely —
Icosapent 1000 mg 43598-0267-04 Dr. 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 60505-4033-01 Apotex 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 60687-0764-21 American 30 capsules $0.441 AB Availability likely —
Icosapent ethyl 1 g 69238-2598-08 Amneal 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 69680-0186-92 Vitruvias 120 capsules $0.441 AB Availability likely —
icosapent ethyl 1 g 70710-1592-07 Zydus 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 72603-0129-01 Northstar 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g/g 13668-0761-12 Torrent 120 g — AB FDA listed —
icosapent ethyl 1 g 35916-1592-01 Softgel 120 capsules — AB FDA listed —
Icosapent Ethyl 1 g 42291-0046-12 AvKARE 120 capsules — AB Discontinued —
Icosapent Ethyl 1 g 42806-0576-12 EPIC 120 capsules — AB FDA listed —
Vascepa 1000 mg 52937-0001-04 Amarin 4 capsules — AB Discontinued —
Vascepa 1000 mg 52937-0005-20 Amarin 120 capsules — AB FDA listed —
Vascepa 1000 mg 52937-0101-08 Amarin 8 capsules — AB FDA listed —
Icosapent Ethyl 1 g 60429-0005-12 Golden 120 capsules — AB FDA listed —
Vascepa 1000 mgthis 63629-8247-03 Bryant 120 capsules — AB FDA listed —
Icosapent Ethyl 1 g 63629-9311-01 Bryant 120 capsules — AB FDA listed —
Icosapent 1000 mg 63629-9312-01 Bryant 120 capsules — AB FDA listed —
Icosapent Ethyl 1 g 67184-0582-01 Qilu 120 capsules — AB FDA listed —
Icosapent Ethyl 1 g 71335-2842-01 Bryant 120 capsules — AB FDA listed —
Icosapent Ethyl 1 g 71335-2989-01 Bryant 30 capsules — AB FDA listed —
Icosapent Ethyl 1 g 71335-3072-01 Bryant 30 capsules — AB FDA listed —
Icosapent Ethyl 1 g 71335-3148-01 Bryant 30 capsules — AB FDA listed —
Icosapent Ethyl 1 g 72162-1000-02 Bryant 120 capsules — AB FDA listed —
Icosapent Ethyl 1 g 72865-0290-12 XLCare 120 capsules — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2012
First FDA approval
Jul 2012
📍
2026
Currently FDA-listed
14 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 26, 2012 AB TE-rated RLD RS ⏳ ~6.8 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8501225 — method of use (U-1287)
US 8524698 — method of use (U-1287)
US 8546372 — method of use (U-1287)
US 8445013 — method of use (U-1287)
US 8518929 — method of use (U-1287)
US 8399446 — method of use (U-1287)
US 8546372 — method of use (U-1287)
US 8617594 — method of use (U-1287)
US 8445003 — method of use (U-1287)
US 8426399 — method of use (U-1287)
US 8623406 — method of use (U-1287)
US 8617593 — method of use (U-1478)
US 8617594 — method of use (U-1287)
US 8617593 — method of use (U-1287)
US 8445003 — method of use (U-1287)
US 9700537 — method of use (U-2707)
US 9198892 — method of use (U-2706)
US 9198892 — method of use (U-2706)
US 9700537 — method of use (U-2707)
US 8410086 — method of use (U-2688)
US 8454994 — method of use (U-2689)
US 8410086 — method of use (U-2688)
US 8454994 — method of use (U-2689)
US 8455472 — method of use (U-2690)
US 8617593 — method of use (U-2691)
US 8617593 — method of use (U-2691)
US 8618166 — method of use (U-2689)
US 8623406 — method of use (U-2692)
US 8623406 — method of use (U-2692)
US 8642077 — method of use (U-2693)
US 8642077 — method of use (U-2693)
US 8669245 — method of use (U-2694)
US 8669245 — method of use (U-2694)
US 8680144 — method of use (U-2695)
US 8680144 — method of use (U-2695)
US 8703185 — method of use (U-2691)
US 8691871 — method of use (U-2689)
US 8709475 — method of use (U-2689)
US 8703185 — method of use (U-2691)
US 8709475 — method of use (U-2689)
US 8691871 — method of use (U-2689)
US 8710041 — method of use (U-2690)
US 8710041 — method of use (U-2690)
US 9603826 — method of use (U-2696)
US 9603826 — method of use (U-2696)
US 9610272 — method of use (U-2697)
US 9610272 — method of use (U-2697)
US 9623001 — method of use (U-2698)
US 9693984 — method of use (U-2697)
US 9693984 — method of use (U-2697)
US 9623001 — method of use (U-2698)
US 9693985 — method of use (U-2696)
US 9693986 — method of use (U-2698)
US 9693985 — method of use (U-2696)
US 9693986 — method of use (U-2698)
US 10010517 — method of use (U-2690)
US 9918954 — method of use (U-2699)
US 10010517 — method of use (U-2690)
US 9918954 — method of use (U-2699)
US 10278935 — method of use (U-2701)
US 10265287 — method of use (U-2700)
US 10278935 — method of use (U-2701)
US 10265287 — method of use (U-2700)
US 10278937 — method of use (U-2703)
US 10278936 — method of use (U-2702)
US 10278936 — method of use (U-2702)
US 10278937 — method of use (U-2703)
US 10383840 — method of use (U-2704)
US 10383840 — method of use (U-2704)
US 8426399 — method of use (U-1287)
US 10555925 — method of use (U-2744)
US 10555924 — method of use (U-2743)
US 10555924 — method of use (U-2743)
US 10555925 — method of use (U-2744)
US 8415335 — method of use (U-1287)
US 8501225 — method of use (U-1287)
US 8524698 — method of use (U-1287)
US 8563608 — method of use (U-1287)
US 8563608 — method of use (U-1287)
US 11369582 — method of use (U-2841)
US 11369582 — method of use (U-2841)
US 11298333 — method of use (U-3358)
US 11298333 — method of use (U-3358)
US 12171738 — method of use (U-4105)
US 12171738 — method of use (U-4105)
US 11154526 — method of use (U-3240)
US 11154526 — method of use (U-3240)
US 10568861 — method of use (U-2756)
US 10568861 — method of use (U-2756)
US 10668042 — method of use (U-2841)
US 10668042 — method of use (U-2841)
US 10576054 — method of use (U-2762)
US 10576054 — method of use (U-2762)
US 11717504 — method of use (U-3669)
US 11717504 — method of use (U-3669)
US 10792270 — method of use (U-2962)
US 10786478 — method of use (U-2959)
US 10786478 — method of use (U-2960)
US 10792267 — method of use (U-2961)
US 10792270 — method of use (U-2962)
US 10786478 — method of use (U-2959)
US 10786478 — method of use (U-2960)
US 10792267 — method of use (U-2961)
US 10842768 — method of use (U-2688)
US 10842766 — method of use (U-2997)
US 10842766 — method of use (U-2997)
US 10842768 — method of use (U-2688)
US 10881632 — method of use (U-3052)
US 10881632 — method of use (U-3052)
US 10894028 — method of use (U-3053)
US 10894028 — method of use (U-3053)
US 11103477 — method of use (U-3209)
US 11103477 — method of use (U-3209)
US 11000499 — method of use (U-3126)
US 11000499 — method of use (U-3126)
US 8623406 — method of use (U-1478)
US 8415335 — method of use (U-1287)
US 11116742 — method of use (U-3221)
US 11116742 — method of use (U-3221)
US 8445013 — method of use (U-1287)
US 8518929 — method of use (U-1287)
US 11213504 — method of use (U-3292)
US 11213504 — method of use (U-3292)
US 8298554 — drug product
US 8298554 — drug product
2012 2014 2016 2018 2020 2022 2024 2026 2028 2030 2032
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (125)
PatentTypeUse codeExpires
US 8501225 ↗ Method of use U-1287 Apr 29, 2030
US 8524698 ↗ Method of use U-1287 Feb 9, 2030
US 8546372 ↗ Method of use U-1287 Feb 9, 2030
US 8445013 ↗ Method of use U-1287 Apr 29, 2030
US 8518929 ↗ Method of use U-1287 Feb 9, 2030
US 8399446 ↗ Method of use U-1287 Feb 9, 2030
US 8546372 ↗ Method of use U-1287 Feb 9, 2030
US 8617594 ↗ Method of use U-1287 Apr 29, 2030
US 8445003 ↗ Method of use U-1287 Apr 29, 2030
US 8426399 ↗ Method of use U-1287 Feb 9, 2030
US 8623406 ↗ Method of use U-1287 Apr 29, 2030
US 8617593 ↗ Method of use U-1478 Apr 29, 2030
US 8617594 ↗ Method of use U-1287 Apr 29, 2030
US 8617593 ↗ Method of use U-1287 Apr 29, 2030
US 8445003 ↗ Method of use U-1287 Apr 29, 2030
US 9700537 ↗ Method of use U-2707 May 31, 2027
US 9198892 ↗ Method of use U-2706 Sep 25, 2027
US 9198892 ↗ Method of use U-2706 Sep 25, 2027
US 9700537 ↗ Method of use U-2707 May 31, 2027
US 8410086 ↗ Method of use U-2688 Jun 15, 2030
US 8454994 ↗ Method of use U-2689 Apr 29, 2030
US 8410086 ↗ Method of use U-2688 Jun 15, 2030
US 8454994 ↗ Method of use U-2689 Apr 29, 2030
US 8455472 ↗ Method of use U-2690 Jun 15, 2030
US 8617593 ↗ Method of use U-2691 Apr 29, 2030
US 8617593 ↗ Method of use U-2691 Apr 29, 2030
US 8618166 ↗ Method of use U-2689 Apr 29, 2030
US 8623406 ↗ Method of use U-2692 Apr 29, 2030
US 8623406 ↗ Method of use U-2692 Apr 29, 2030
US 8642077 ↗ Method of use U-2693 Apr 29, 2030
US 8642077 ↗ Method of use U-2693 Apr 29, 2030
US 8669245 ↗ Method of use U-2694 Jun 15, 2030
US 8669245 ↗ Method of use U-2694 Jun 15, 2030
US 8680144 ↗ Method of use U-2695 Feb 9, 2030
US 8680144 ↗ Method of use U-2695 Feb 9, 2030
US 8703185 ↗ Method of use U-2691 Apr 29, 2030
US 8691871 ↗ Method of use U-2689 Apr 29, 2030
US 8709475 ↗ Method of use U-2689 Apr 29, 2030
US 8703185 ↗ Method of use U-2691 Apr 29, 2030
US 8709475 ↗ Method of use U-2689 Apr 29, 2030
US 8691871 ↗ Method of use U-2689 Apr 29, 2030
US 8710041 ↗ Method of use U-2690 Jun 15, 2030
US 8710041 ↗ Method of use U-2690 Jun 15, 2030
US 9603826 ↗ Method of use U-2696 Jun 28, 2033
US 9603826 ↗ Method of use U-2696 Jun 28, 2033
US 9610272 ↗ Method of use U-2697 Jun 28, 2033
US 9610272 ↗ Method of use U-2697 Jun 28, 2033
US 9623001 ↗ Method of use U-2698 Jun 28, 2033
US 9693984 ↗ Method of use U-2697 Jun 28, 2033
US 9693984 ↗ Method of use U-2697 Jun 28, 2033
US 9623001 ↗ Method of use U-2698 Jun 28, 2033
US 9693985 ↗ Method of use U-2696 Jun 28, 2033
US 9693986 ↗ Method of use U-2698 Jun 28, 2033
US 9693985 ↗ Method of use U-2696 Jun 28, 2033
US 9693986 ↗ Method of use U-2698 Jun 28, 2033
US 10010517 ↗ Method of use U-2690 Apr 29, 2030
US 9918954 ↗ Method of use U-2699 Jun 28, 2033
US 10010517 ↗ Method of use U-2690 Apr 29, 2030
US 9918954 ↗ Method of use U-2699 Jun 28, 2033
US 10278935 ↗ Method of use U-2701 Jun 28, 2033
US 10265287 ↗ Method of use U-2700 Apr 29, 2030
US 10278935 ↗ Method of use U-2701 Jun 28, 2033
US 10265287 ↗ Method of use U-2700 Apr 29, 2030
US 10278937 ↗ Method of use U-2703 Jun 28, 2033
US 10278936 ↗ Method of use U-2702 Jun 28, 2033
US 10278936 ↗ Method of use U-2702 Jun 28, 2033
US 10278937 ↗ Method of use U-2703 Jun 28, 2033
US 10383840 ↗ Method of use U-2704 Jun 28, 2033
US 10383840 ↗ Method of use U-2704 Jun 28, 2033
US 8426399 ↗ Method of use U-1287 Feb 9, 2030
US 10555925 ↗ Method of use U-2744 Jun 28, 2033
US 10555924 ↗ Method of use U-2743 Jun 28, 2033
US 10555924 ↗ Method of use U-2743 Jun 28, 2033
US 10555925 ↗ Method of use U-2744 Jun 28, 2033
US 8415335 ↗ Method of use U-1287 Feb 9, 2030
US 8501225 ↗ Method of use U-1287 Apr 29, 2030
US 8524698 ↗ Method of use U-1287 Feb 9, 2030
US 8563608 ↗ Method of use U-1287 Apr 29, 2030
US 8563608 ↗ Method of use U-1287 Apr 29, 2030
US 11369582 ↗ Method of use U-2841 Jun 28, 2033
US 11369582 ↗ Method of use U-2841 Jun 28, 2033
US 11298333 ↗ Method of use U-3358 Jun 28, 2033
US 11298333 ↗ Method of use U-3358 Jun 28, 2033
US 12171738 ↗ Method of use U-4105 Feb 9, 2030
US 12171738 ↗ Method of use U-4105 Feb 9, 2030
US 11154526 ↗ Method of use U-3240 Apr 29, 2030
US 11154526 ↗ Method of use U-3240 Apr 29, 2030
US 10568861 ↗ Method of use U-2756 Jun 28, 2033
US 10568861 ↗ Method of use U-2756 Jun 28, 2033
US 10668042 ↗ Method of use U-2841 Jun 28, 2033
US 10668042 ↗ Method of use U-2841 Jun 28, 2033
US 10576054 ↗ Method of use U-2762 Jun 28, 2033
US 10576054 ↗ Method of use U-2762 Jun 28, 2033
US 11717504 ↗ Method of use U-3669 Apr 29, 2030
US 11717504 ↗ Method of use U-3669 Apr 29, 2030
US 10792270 ↗ Method of use U-2962 Jun 28, 2033
US 10786478 ↗ Method of use U-2959 Jun 28, 2033
US 10786478 ↗ Method of use U-2960 Jun 28, 2033
US 10792267 ↗ Method of use U-2961 Apr 29, 2030
US 10792270 ↗ Method of use U-2962 Jun 28, 2033
US 10786478 ↗ Method of use U-2959 Jun 28, 2033
US 10786478 ↗ Method of use U-2960 Jun 28, 2033
US 10792267 ↗ Method of use U-2961 Apr 29, 2030
US 10842768 ↗ Method of use U-2688 Jun 15, 2030
US 10842766 ↗ Method of use U-2997 Apr 29, 2030
US 10842766 ↗ Method of use U-2997 Apr 29, 2030
US 10842768 ↗ Method of use U-2688 Jun 15, 2030
US 10881632 ↗ Method of use U-3052 Apr 29, 2030
US 10881632 ↗ Method of use U-3052 Apr 29, 2030
US 10894028 ↗ Method of use U-3053 Jun 28, 2033
US 10894028 ↗ Method of use U-3053 Jun 28, 2033
US 11103477 ↗ Method of use U-3209 Apr 29, 2030
US 11103477 ↗ Method of use U-3209 Apr 29, 2030
US 11000499 ↗ Method of use U-3126 Jun 28, 2033
US 11000499 ↗ Method of use U-3126 Jun 28, 2033
US 8623406 ↗ Method of use U-1478 Apr 29, 2030
US 8415335 ↗ Method of use U-1287 Feb 9, 2030
US 11116742 ↗ Method of use U-3221 Jun 28, 2033
US 11116742 ↗ Method of use U-3221 Jun 28, 2033
US 8445013 ↗ Method of use U-1287 Apr 29, 2030
US 8518929 ↗ Method of use U-1287 Feb 9, 2030
US 11213504 ↗ Method of use U-3292 Apr 29, 2030
US 11213504 ↗ Method of use U-3292 Apr 29, 2030
US 8298554 ↗ Drug product — Apr 29, 2030
US 8298554 ↗ Drug product — Apr 29, 2030
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Vascepa — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Vascepa. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$144.95M
Claims incl. refills
288.1K
Beneficiaries
173K
Spend / beneficiary
$837.66
Spend / claim
$503.10
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63629-8247-01 30 CAPSULE in 1 BOTTLE (63629-8247-1) 2019-09-19 Active
63629-8247-02 60 CAPSULE in 1 BOTTLE (63629-8247-2) 2019-11-19 Active
63629-8247-03 You're viewing this 120 CAPSULE in 1 BOTTLE (63629-8247-3) 2023-03-10 Active
63629-8247-04 90 CAPSULE in 1 BOTTLE (63629-8247-4) 2026-04-07 Active

You're viewing the largest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 63629-8247-03?
NDC 63629-8247-03 is a 120-count package — 120 capsule in 1 bottle.
What is the difference between NDC 63629-8247-03 and NDC 63629-8247-01?
Both are Vascepa icosapent ethyl 1000 mg Capsule — the drug itself is identical. NDC 63629-8247-03 is the 120-count package, while NDC 63629-8247-01 is the 30 capsules package.
What NDC number is used to bill for this package of Vascepa icosapent ethyl 1000 mg Capsule?
Bill NDC 63629-8247-03 — the 11-digit billing format is 63629824703. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 63629-8247-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63629-8247-03, written without dashes as 63629824703. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 63629-8247-03, the first segment (63629) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (8247) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 30 capsules (63629-8247-01), 60 capsules (63629-8247-02), 90 capsules (63629-8247-04). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 208 words ▾

1 INDICATIONS AND USAGE 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 eicosapentaenoic acid (EPA) 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.

( 1 ) as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. ( 1 ) Limitations of Use: The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. ( 1 )

⏱️ Dosage and Administration 196 words ▾

2 DOSAGE AND ADMINISTRATION Assess lipid levels before initiating therapy. Identify other causes of high triglyceride levels and manage as appropriate. ( 2.1 ) Patients should engage in appropriate nutritional intake and physical activity before receiving VASCEPA, which should continue during treatment.

( 2.1 ) The daily dose of VASCEPA is 4 grams per day taken as either four 0.5 gram capsules twice daily with food or two 1 gram capsules twice daily with food. ( 2.2 ) Advise patients to swallow capsules whole. Do not break open, crush, dissolve, or chew VASCEPA.

( 2.2 )

2.1Prior to Initiation of VASCEPA Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. Patients should engage in appropriate nutritional intake and physical activity before receiving VASCEPA, which should continue during treatment with VASCEPA.

2.2Dosage and Administration The daily dose of VASCEPA is 4 grams per day taken as either: four 0.5 gram capsules twice daily with food; or as two 1 gram capsules twice daily with food. Advise patients to swallow VASCEPA capsules whole. Do not break open, crush, dissolve, or chew VASCEPA.

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS AND STRENGTHS VASCEPA capsules are supplied as: 0.5 gram amber-colored, oval, soft-gelatin capsules imprinted with V500 1 gram amber-colored, oblong, soft-gelatin capsules imprinted with VASCEPA Capsules: 0.5 gram and 1 gram ( 3 )

⛔ Contraindications 41 words ▾

4 CONTRAINDICATIONS VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Atrial Fibrillation/Flutter: VASCEPA was associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. ( 5.1 ) Potential for Allergic Reactions in Patients with Fish Allergy: VASCEPA contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish.

It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to VASCEPA. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions and advise them to discontinue VASCEPA and seek medical attention if any reactions occur. ( 5.2 ) Bleeding: VASCEPA was associated with an increased risk of bleeding in a double-blind, placebo-controlled trial.

The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin. ( 5.3 )

5.1Atrial Fibrillation/Flutter VASCEPA is associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization. In a double-blind, placebo-controlled trial of 8,179 statin-treated subjects with established cardiovascular disease (CVD) or diabetes plus an additional risk factor for CVD, adjudicated atrial fibrillation or atrial flutter requiring hospitalization for 24 or more hours occurred in 127 (3%) patients treated with VASCEPA compared to 84 (2%) patients receiving placebo [HR= 1.5 (95% CI 1.14, 1.98)].

The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.

5.2Potential for Allergic Reactions in Patients with Fish Allergy VASCEPA contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish. It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to VASCEPA. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions to VASCEPA and advise them to discontinue VASCEPA and seek medical attention if any reactions occur.

5.3Bleeding VASCEPA is associated with an increased risk of bleeding. In a double-blind, placebo-controlled cardiovascular outcomes trial of 8,179 patients, 482 (12%) patients receiving VASCEPA experienced a bleeding event compared to 404 (10%) patients receiving placebo. Serious bleeding events occurred in 111 (3%) of patients on VASCEPA vs.

85 (2%) of patients receiving placebo. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Atrial Fibrillation or Atrial Flutter [see Warnings and Precautions ( 5.1 )] Potential for Allergic Reactions in Patients with Fish Allergy [see Warnings and Precautions ( 5.2 )] Bleeding [see Warnings and Precautions ( 5.3 )] Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation ( 6.1 ) Common adverse reactions in the hypertriglyceridemia trials (incidence ≥1% more frequent than placebo): arthralgia and oropharyngeal pain.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amarin Pharma, Inc. at 1-855-VASCEPA (1-855-827-2372) or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Cardiovascular Outcomes Trial In a double-blind, randomized, placebo-controlled cardiovascular outcomes trial, 8,179 statin-stabilized patients were randomized to receive VASCEPA or placebo and followed for a median of 4.9 years [see Clinical Studies ( 14.1 )] .

The median age at baseline was 64 years, 29% were women, 90% White, 5% Asian, 2% were Black, and 4% identified as Hispanic ethnicity. Common adverse reactions (incidence ≥3% on VASCEPA and ≥1% more frequent than placebo) included musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. Hypertriglyceridemia Trials In two randomized, double-blind, placebo-controlled trials in patients with triglyceride levels between 200 and 2000 mg/dL treated for 12 weeks, adverse reactions reported with VASCEPA at an incidence ≥1% more frequent than placebo based on pooled data included arthralgia and oropharyngeal pain.

6.2Postmarketing Experience Additional adverse reactions have been identified during post-approval use of VASCEPA. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Diarrhea Blood triglycerides increased Abdominal discomfort Pain in the extremities

🔄 Drug Interactions 95 words ▾

7 DRUG INTERACTIONS Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents: Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. Monitor patients receiving VASCEPA and concomitant anticoagulants and/or antiplatelet agents for bleeding. ( 7 )

7.1Increased Bleeding Risk with Anticoagulants and Antiplatelet Agents Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in those studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Monitor patients receiving VASCEPA and concomitant anticoagulants and/or antiplatelet agents for bleeding.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary The available data from published case reports and the pharmacovigilance database on the use of VASCEPA in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies in pregnant rats, non-dose-related imbalances for some minor developmental findings were observed with oral administration of icosapent ethyl during organogenesis at exposures that were equivalent to the clinical exposure at the human dose of 4 g/day, based on body surface area comparisons.

In a study in pregnant rabbits orally administered icosapent ethyl during organogenesis, there were no clinically relevant adverse developmental effects at exposures that were 5 times the clinical exposure, based on body surface area comparisons ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In pregnant rats given oral gavage doses of 0.3, 1 and 2 g/kg/day icosapent ethyl from gestation through organogenesis all drug treated groups had non-dose-related imbalances in visceral and skeletal findings, including 13 th reduced ribs, additional liver lobes, testes medially displaced and/or not descended, at human systemic exposures following a maximum oral dose of 4 g/day based on body surface comparisons.

In a multigenerational developmental study in pregnant rats given doses of 0.3, 1, 3 g/kg/day icosapent ethyl by oral gavage from gestation day 7-17, icosapent ethyl did not affect viability in fetuses (F 1 or F 2 ). Non-dose-related imbalances in findings of absent optic nerves and unilateral testes atrophy at human exposures based on the maximum dose of 4 g/day and on body surface area comparisons. Additional variations consisting of early incisor eruption and increased percent cervical ribs were observed at the same exposures.

Pups from high dose treated dams exhibited decreased copulation rates, delayed estrus, decreased implantations and decreased surviving fetuses (F2) suggesting potential multigenerational effects of icosapent ethyl at 7 times human systemic exposure following 4 g/day dose based on body surface area comparisons across species. In pregnant rabbits given oral gavage doses of 0.1, 0.3, and 1 g/kg/day icosapent ethyl from gestation through organogenesis, a decrease in body weight and food consumption was observed at the high dose of 1 g/kg/day (5 times the human exposure at the maximum dose of 4 g/day, based on body surface area comparisons).

Slight increases in resorbed and dead fetuses were noted in the 1 g/kg/day group, but these were not significantly different from the control group. There were no differences between the icosapent ethyl groups and control group as to the number of corpora lutea , number of implantations, number of surviving fetuses, sex ratio, body weight of female fetuses or placental weight. There were no treatment-related malformations or skeletal anomalies.

In pregnant rats given icosapent ethyl from gestation day 17 through lactation day 20 at 0.3, 1, 3 g/kg/day no adverse maternal or developmental effects were observed. However, complete litter loss (not dose-related) was noted in 2/23 litters at the low dose and 1/23 mid-dose dams by post-natal day 4 at human exposures at a maximum dose of 4 g/day, based on body surface area comparisons.

8.2Lactation Risk Summary Published studies have detected omega-3 fatty acids, including EPA, in human milk. Lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk. There are no data on the effects of…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary The available data from published case reports and the pharmacovigilance database on the use of VASCEPA in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies in pregnant rats, non-dose-related imbalances for some minor developmental findings were observed with oral administration of icosapent ethyl during organogenesis at exposures that were equivalent to the clinical exposure at the human dose of 4 g/day, based on body surface area comparisons.

In a study in pregnant rabbits orally administered icosapent ethyl during organogenesis, there were no clinically relevant adverse developmental effects at exposures that were 5 times the clinical exposure, based on body surface area comparisons ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In pregnant rats given oral gavage doses of 0.3, 1 and 2 g/kg/day icosapent ethyl from gestation through organogenesis all drug treated groups had non-dose-related imbalances in visceral and skeletal findings, including 13 th reduced ribs, additional liver lobes, testes medially displaced and/or not descended, at human systemic exposures following a maximum oral dose of 4 g/day based on body surface comparisons.

In a multigenerational developmental study in pregnant rats given doses of 0.3, 1, 3 g/kg/day icosapent ethyl by oral gavage from gestation day 7-17, icosapent ethyl did not affect viability in fetuses (F 1 or F 2 ). Non-dose-related imbalances in findings of absent optic nerves and unilateral testes atrophy at human exposures based on the maximum dose of 4 g/day and on body surface area comparisons. Additional variations consisting of early incisor eruption and increased percent cervical ribs were observed at the same exposures.

Pups from high dose treated dams exhibited decreased copulation rates, delayed estrus, decreased implantations and decreased surviving fetuses (F2) suggesting potential multigenerational effects of icosapent ethyl at 7 times human systemic exposure following 4 g/day dose based on body surface area comparisons across species. In pregnant rabbits given oral gavage doses of 0.1, 0.3, and 1 g/kg/day icosapent ethyl from gestation through organogenesis, a decrease in body weight and food consumption was observed at the high dose of 1 g/kg/day (5 times the human exposure at the maximum dose of 4 g/day, based on body surface area comparisons).

Slight increases in resorbed and dead fetuses were noted in the 1 g/kg/day group, but these were not significantly different from the control group. There were no differences between the icosapent ethyl groups and control group as to the number of corpora lutea , number of implantations, number of surviving fetuses, sex ratio, body weight of female fetuses or placental weight. There were no treatment-related malformations or skeletal anomalies.

In pregnant rats given icosapent ethyl from gestation day 17 through lactation day 20 at 0.3, 1, 3 g/kg/day no adverse maternal or developmental effects were observed. However, complete litter loss (not dose-related) was noted in 2/23 litters at the low dose and 1/23 mid-dose dams by post-natal day 4 at human exposures at a maximum dose of 4 g/day, based on body surface area comparisons.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 54 words ▾

8.5Geriatric Use Of the total number of patients in well-controlled clinical studies of VASCEPA, 45% were 65 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger groups. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Studies suggest that EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles. Potential mechanisms of action include increased β-oxidation; inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity. The mechanisms of action contributing to reduction of cardiovascular events with VASCEPA (icosapent ethyl) are not completely understood but are likely multi-factorial.

Increased EPA lipid composition from carotid plaque specimens and increased circulating EPA/arachidonic acid ratio have been observed following EPA treatment. EPA inhibits platelet aggregation under some ex vivo conditions. However, the direct clinical meaning of individual findings is not clear.

12.2Pharmacodynamics In a 12-week, dose-ranging study in patients with severe hypertriglyceridemia and in the event-driven REDUCE-IT ® trial, VASCEPA 4 grams per day reduced median TG from baseline relative to placebo [see Clinical Studies ( 14 )].

12.3Pharmacokinetics Absorption After oral administration, VASCEPA is de-esterified during the absorption process and the active metabolite EPA is absorbed in the small intestine and enters the systemic circulation mainly via the thoracic duct lymphatic system. Peak plasma concentrations of EPA were reached approximately 5 hours following oral doses of VASCEPA. VASCEPA was administered with or following a meal in all clinical studies; no food effect studies were performed.

Take VASCEPA with or following a meal. Distribution The mean volume of distribution at steady state of EPA is approximately 88 liters. The majority of EPA circulating in plasma is incorporated in phospholipids, triglycerides and cholesteryl esters, and <1% is present as the unesterified fatty acid.

Greater than 99% of unesterified EPA is bound to plasma proteins. Elimination Metabolism EPA is mainly metabolized by the liver via beta-oxidation similar to dietary fatty acids. Beta oxidation splits the long carbon chain of EPA into acetyl Coenzyme A, which is converted into energy via the Krebs cycle.

Cytochrome P450-mediated metabolism is a minor pathway of elimination of EPA. Excretion The total plasma clearance of EPA at steady state is 684 mL/hr. The plasma elimination half-life (t 1/2 ) of EPA is approximately 89 hours.

VASCEPA does not undergo renal excretion. Specific Populations Gender When administered VASCEPA in clinical trials, plasma total EPA concentrations did not differ significantly between men and women. Pediatric The pharmacokinetics of VASCEPA have not been studied in pediatric patients.

Hepatic or Renal Impairment VASCEPA has not been studied in patients with renal or hepatic impairment. Drug Interaction Studies Omeprazole In a drug-drug interaction study with 28 healthy adult subjects, VASCEPA 4 g/day at steady-state did not significantly change the steady-state AUC τ or C max of omeprazole when co-administered at 40 mg/day to steady-state. Rosiglitazone In a drug-drug interaction study with 28 healthy adult subjects, VASCEPA 4 g/day at steady-state did not significantly change the single dose AUC or C max of rosiglitazone at 8 mg.

Warfarin In a drug-drug interaction study with 25 healthy adult subjects, VASCEPA 4 g/day at steady-state did not significantly change the single dose AUC or C max of R - and S -warfarin or the anti-coagulation pharmacodynamics of warfarin when co-administered as racemic warfarin at 25 mg. Atorvastatin In a drug-drug interaction study of 26 healthy adult subjects, VASCEPA 4 g/day at steady-state did not significantly change the steady-state AUC τ or C max of atorvastatin, 2-hydroxyatorvastatin, or 4-hydroxyatorvastatin when co-administered with atorvastatin 80 mg/day at steady-state.

🧬 Mechanism of Action ~2 min read ▾

12.1Mechanism of Action Studies suggest that EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles. Potential mechanisms of action include increased β-oxidation; inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity. The mechanisms of action contributing to reduction of cardiovascular events with VASCEPA (icosapent ethyl) are not completely understood but are likely multi-factorial.

Increased EPA lipid composition from carotid plaque specimens and increased circulating EPA/arachidonic acid ratio have been observed following EPA treatment. EPA inhibits platelet aggregation under some ex vivo conditions. However, the direct clinical meaning of individual findings is not clear.

12.2Pharmacodynamics In a 12-week, dose-ranging study in patients with severe hypertriglyceridemia and in the event-driven REDUCE-IT ® trial, VASCEPA 4 grams per day reduced median TG from baseline relative to placebo [see Clinical Studies ( 14 )].

14.2Severe Hypertriglyceridemia The effects of VASCEPA 4 grams per day were assessed in a randomized, placebo-controlled, double-blind, parallel-group study of adult patients (76 on VASCEPA, 75 on placebo) with severe hypertriglyceridemia. Patients whose baseline TG levels were between 500 and 2,000 mg/dL were enrolled in this study for 12 weeks. The median baseline TG and LDL-C levels in these patients were 684 mg/dL and 86 mg/dL, respectively.

Median baseline HDL-C level was 27 mg/dL. The randomized population in this study was mostly Caucasian (88%) and male (76%). The mean age was 53 years and the mean body mass index was 31 kg/m 2 .

Twenty-five percent of patients were on concomitant statin therapy, 28% were diabetics, and 39% of the patients had TG levels >750 mg/dL. The changes in the major lipoprotein lipid parameters for the groups receiving VASCEPA or placebo are shown in Table 2 . Table 2.

Median Baseline and Percent Change from Baseline in Lipid Parameters in Patients with Severe Hypertriglyceridemia (≥500 mg/dL) % Change= Median Percent Change from Baseline Difference= Median of [VASCEPA % Change – Placebo % Change] (Hodges-Lehmann Estimate) p-values from Wilcoxon rank-sum test * p-value < 0.001 (primary efficacy endpoint) ** p-value < 0.05 (key secondary efficacy endpoints determined to be statistically significant according to the pre-specified multiple comparison procedure) Parameter VASCEPA 4 g/day N=76 Placebo N=75 Difference (95% Confidence Interval) Baseline % Change Baseline % Change TG (mg/dL) 680 -27 703 +10 -33 * (-47, -22) LDL-C (mg/dL) 91 -5 86 -3 -2 (-13, +8) Non-HDL-C (mg/dL) 225 -8 229 +8 -18 (-25, -11) TC (mg/dL) 254 -7 256 +8 -16 (-22, -11) HDL-C (mg/dL) 27 -4 27 0 -4 (-9, +2) VLDL-C (mg/dL) 123 -20 124 +14 -29 ** (-43, -14) Apo B (mg/dL) 121 -4 118 +4 -9 ** (-14, -3) VASCEPA 4 grams per day reduced median TG, VLDL-C, and Apo B levels from baseline relative to placebo.

The reduction in TG observed with VASCEPA was not associated with elevations in LDL-C levels relative to placebo.

📦 How Supplied / Storage and Handling 81 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING VASCEPA (icosapent ethyl) capsules are supplied as 1 gram capsules, amber-colored soft-gelatin capsules imprinted with VASCEPA. NDC 63629-8247-1: 30 Capsules in a BOTTLE NDC 63629-8247-2: 60 Capsules in a BOTTLE NDC 63629-8247-3: 120 Capsules in a BOTTLE NDC 63629-8247-4: 90 Capsules in a BOTTLE Store at 20° to 25° C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description 114 words ▾

11 DESCRIPTION VASCEPA, a lipid-regulating agent, is supplied as either a 0.5 gram or a 1 gram amber-colored, liquid-filled soft gelatin capsule for oral use. Each VASCEPA capsule contains either 0.5 grams of icosapent ethyl (in a 0.5 gram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA).

The empirical formula of icosapent ethyl is C 22 H 34 O 2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure: VASCEPA capsules also contain the following inactive ingredients: tocopherol, gelatin, glycerin, maltitol, sorbitol, and purified water.

💬 Information for Patients 180 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling before starting VASCEPA (Patient Information). Inform patients that VASCEPA may increase their risk for atrial fibrillation or atrial flutter [see Warnings and Precautions ( 5.1 )] . Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions to VASCEPA and advise them to discontinue VASCEPA and seek medical attention if any reactions occur [see Warnings and Precautions ( 5.2 )] .

Inform patients that VASCEPA may increase their risk for bleeding, especially if they are receiving other antithrombotic agents [see Warnings and Precautions ( 5.3 )] . Advise patients to swallow VASCEPA capsules whole. Do not break open, crush, dissolve, or chew VASCEPA [see Dosage and Administration ( 2.2 )] .

Instruct patients to take VASCEPA as prescribed. If a dose is missed, patients should take it as soon as they remember. However, if they miss one day of VASCEPA, they should not double the dose when they take it.

For more information about VASCEPA, go to www.VASCEPA.com or call 1-855-VASCEPA (1-855-827-2372).

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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