Home › NDC Lookup › Ingredients › Omega-3 Acid Ethyl Esters › 65162-0034-16
💊image loading
(from DailyMed)

Omega-3-Acid Ethyl Esters 1 g Capsule, Liquid Filled, 120-count

by Amneal Pharmaceuticals LLC · 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-16)
NDC 65162-0034-16
🏷️ FDA NDC (as labeled) 65162-034-16 billing pads the product segment with a zero
This package
Contains120-count Cost per ea$0.1726 NADAC Per package$20.71 / 120 capsules Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.2831/unit — full pricing hub ↓
Also comes in: 60 capsules 65162-0034-06 360 capsules 65162-0034-32
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 2, 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 Omega-3-acid Ethyl Esters (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 · Apr 9, 2026 — Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. (The Harvard Drug Group LLC) · FDA recall D-0493-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 65162-034-16
Product NDC 65162-034
11-digit billing NDC 65162003416
NCPDP billing unit EA — each (per item)
RxCUI 577208
UNII D87YGH4Z0Q
UPC 0365162034066
Application # ANDA204940
SPL Set ID 530161f4-26a0-4cb0-8a01-a18cfd36d88c
Established class (EPC) Fatty Acids; Omega-3 Fatty Acid
Chemical class Omega-3
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 2015-11-30
Marketing end 2026-07-01
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance OMEGA-3-ACID ETHYL ESTERS
GPI-14 39500045200130
GPI class Omega-3-acid Ethyl Esters
GCN Seq No 058486
GCN 23929
HICL code 026793
Ingredient (HICL) Omega-3 Acid Ethyl Esters
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M4
Therapeutic class — intermediate (HIC2) Affect Blood Lipids/Sugar/Amino Acids
HIC3 code M4E
Therapeutic class — specific (HIC3) Lipotropics
AHFS code 24:06.12.00
AHFS class Omega-3-Mediated Antilipemics
FDB label name OMEGA-3 ETHYL ESTERS 1 GM CAP
FDB brand name Omega-3 Acid Ethyl Esters
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 65162-034-16 — a 5-3-2 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 product segment → 65162-0034-16. 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

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL PHARMACEUTICALS OF NEW YORK LLC
FDA applicationANDA204940 (ANDA)
Labeler code65162
First marketedNov 2015
Product typeHuman Prescription Drug
Portfolio467 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

Label name OMEGA-3 ETHYL ESTERS 1 GM CAP Ingredient Omega-3 Acid Ethyl Esters
📗 Our plain-language guide HelloPharmacist
  • Great question. Omega-3-acid ethyl esters capsules — including the brand Lovaza — are a prescription-strength, highly concentrated form of omega-3 fatty acids. They're specifically...
  • What exactly is this medication for — isn't fish oil something you can just buy at the store?
  • Yes, absolutely. This medication is meant to work alongside a triglyceride-lowering diet — not replace it. You should start the diet before beginning treatment and continue it the...
  • Do I still need to follow a diet even though I'm taking this medication?
📖 Read our full Omega-3-Acid Ethyl Esters guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.173 $20.71 / 120 capsules
Medicaid paysCMS SDUD · 12 mo $0.2831 $33.97 / 120 capsules
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.189 $0.166
▲ Up 3% over the last 24 months.
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
Omega-3-Acid Ethyl Esters 1 g 00904-7495-06 Major 1 capsule $0.173 AB Availability likely —
Omega-3-Acid Ethyl Esters 1 g 24658-0350-12 PURACAP 120 capsules $0.173 AB Availability likely —
Omega-3-Acid Ethyl Esters 1 g 42806-0552-12 EPIC 120 capsules $0.173 AB Availability likely —
omega-3-acid ethyl esters 900 mg 60687-0846-65 American 50 capsules $0.173 AB Availability likely —
omega-3-acid ethyl esters 900 mg 62135-0780-12 Chartwell 120 capsules $0.173 AB Availability likely —
Omega-3-Acid Ethyl Esters 1 gthis 65162-0034-16 Amneal 120 capsules $0.173 — Discontinued —
Omega-3-Acid Ethyl Esters 1 g 70756-0423-22 Lifestar 120 capsules $0.173 AB Availability likely —
Omega-3-acid ethyl esters 900 mg 00254-3010-08 Par 120 capsules — AB FDA listed —
Omega-3-Acid Ethyl Esters 1 g 00615-8550-39 NCS 30 capsules — AB FDA listed —
Omega-3-acid ethyl esters 1 g 31722-0936-05 Camber 500 capsules — AB FDA listed —
Omega-3-acid ethyl esters 1 g 50090-5799-00 A-S 120 capsules — AB FDA listed —
Omega-3-acid ethyl esters 1 g 50090-5800-02 A-S 1440 capsules — AB FDA listed —
Omega-3-Acid Ethyl Esters 1 g 50090-6691-00 A-S 120 capsules — AB FDA listed —
Omega-3-Acid Ethyl Esters 1 g 50090-6692-00 A-S 120 capsules — AB FDA listed —
Omega-3-acid ethyl esters 1 g 50090-6822-00 A-S 120 capsules — AB FDA listed —
Omega-3-Acid Ethyl Esters 1 g 51407-0763-12 Golden 120 capsules — AB FDA listed —
Omega-3-acid ethyl esters 1 g 63629-1918-01 Bryant 120 capsules — AB FDA listed —
omega-3-acid ethyl esters 900 mg 64380-0761-02 Strides 50 capsules — AB FDA listed —
Omega-3-Acid Ethyl Ester 900 mg 69452-0175-17 Bionpharma 60 capsules — AB FDA listed —
Omega-3-Acid Ethyl Esters 1 g 70518-3040-00 REMEDYREPACK 180 capsules — AB FDA listed —
Omega-3-Acid Ethyl Esters 1 g 71335-2024-01 Bryant 90 capsules — AB FDA listed —
Omega-3-acid ethyl esters 1 g 72162-1310-02 Bryant 120 capsules — AB FDA listed —
Omega-3-acid ethyl esters 1 g 72865-0139-05 XLCare 500 capsules — AB FDA listed —
Omega-3-Acid Ethyl Esters 1 g 72998-0850-12 KD 120 capsules — AB FDA listed —
Omega-3-Acid Ethyl Esters 1 g 72998-0851-12 KD 120 capsules — AB FDA listed —
Lovaza 1 g 80725-0420-12 Waylis 120 capsules — AB Discontinued —
Omega-3-acid ethyl esters 1 g 70518-4744-00 REMEDYREPACK 180 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2015
On the market since
Nov 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 65162-0034-16, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
12.8K
Units reimbursed last 4 qtrs
1.5M
Gross reimbursed last 4 qtrs
$411.9K
Avg / prescription
$32.15
Avg / unit
$0.2831
Latest quarter Q4 2025
3.5KRx
Medicaid pays / ea
$0.2831
gross reimbursed
vs
NADAC / ea
$0.1726
acquisition cost
=
Spread
+$0.1105
+64% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
81% FFS 19% MCO
Fee-for-service · 10,442 Rx Managed care · 2,371 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 3,832 units · 49.1 per 100k residents WA Idaho: 3,000 units · 153 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 1,800 units · 30.5 per 100k residents WI Michigan: no data reported MI New York: 450,106 units · 2,300 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 12,924 units · 405 per 100k residents NV Wyoming: no data reported WY South Dakota: 2,070 units · 225 per 100k residents SD Iowa: 304 units · 9.5 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 8,918 units · 75.7 per 100k residents OH Pennsylvania: 68,332 units · 527 per 100k residents PA New Jersey: 52,454 units · 565 per 100k residents NJ Massachusetts: 4,284 units · 61.2 per 100k residents MA California: 734,311 units · 1,885 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 50,854 units · 1,124 per 100k residents KY West Virginia: no data reported WV Virginia: 2,790 units · 32.0 per 100k residents VA Maryland: 930 units · 15.0 per 100k residents MD Connecticut: 3,060 units · 84.6 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,260 units · 17.0 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 1,590 units · 14.4 per 100k residents GA D.C.: 960 units · 141 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: 27,673 units · 122 per 100k residents FL
Units reimbursed · per 100k residents
9.52,300
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 2,300 /100k
2 California 1,885 /100k
3 Kentucky 1,124 /100k
4 New Jersey 565 /100k
5 Pennsylvania 527 /100k
6 Nevada 405 /100k
7 South Dakota 225 /100k
8 Idaho 153 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
120 capsules this page65162-0034-16 12,813 Rx · $411,915
60 capsules65162-0034-06 No Medicaid data
360 capsules65162-0034-32 No Medicaid data
Drug total (last 4 qtrs): 12,813 Rx · 1,455,122 units · $411,915 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Omega-3 Acid Ethyl Esters — the program that covers self-administered drugs. 10 manufacturers.
⚠️ 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 Omega-3 Acid Ethyl Esters. 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
$13.44M
Claims incl. refills
298.2K
Beneficiaries
181.8K
Spend / beneficiary
$73.93
Spend / claim
$45.08
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for OMEGA-3-ACID ETHYL ESTERS — the ingredient across all brands.

Top reported reactions

Product Odour Abnormal96
Chest Pain83
Diarrhoea78
Nausea76
Malaise67
Pain67
Fatigue65

Age at onset

Neonate2
Child2
Adolescent2
Adult125
Elderly180

Reporter sex

1,919 reports
Male · 56%
Female · 44%
Unknown · 0%

Serious outcomes

Hospitalization970
Death96
Life-threatening52
Disabling44
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 145 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
65162-0034-06 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-06) — — 2015-11-30 Discontinued by firm
65162-0034-16 You're viewing this 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-16) $0.1726 / ea $20.71 2015-11-30 Discontinued by firm
65162-0034-32 360 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-034-32) — — 2015-11-30 Discontinued by firm

You're viewing one of 3 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 65162-0034-16?
NDC 65162-0034-16 is a 120-count package — 120 capsule, liquid filled in 1 bottle.
What is the difference between NDC 65162-0034-16 and NDC 65162-0034-06?
Both are Omega-3-Acid Ethyl Esters 1 g Capsule, Liquid Filled — the drug itself is identical. NDC 65162-0034-16 is the 120-count package, while NDC 65162-0034-06 is the 60 capsules package.
What NDC number is used to bill for this package of Omega-3-Acid Ethyl Esters 1 g Capsule, Liquid Filled?
Bill NDC 65162-0034-16 — the 11-digit billing format is 65162003416. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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) ✓ Available
“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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 65162-034-16, 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: 65162-0034-16, written without dashes as 65162003416. 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 65162-0034-16, the first segment (65162) is the labeler code FDA assigned to Amneal Pharmaceuticals LLC; the middle segment (0034) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 capsules (65162-0034-06), 360 capsules (65162-0034-32). 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?
Amneal Pharmaceuticals LLC 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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules.

Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed, if possible, prior to consideration of TG-lowering drug therapy. Limitations of Use: The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined.

The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined. Omega-3-acid ethyl esters capsules are a combination of ethyl esters of omega 3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. (1) Limitations of Use: The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined.

(1) The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined. (1)

⏱️ Dosage and Administration 188 words ▾

2 DOSAGE AND ADMINISTRATION Assess TG levels carefully before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high TG levels and manage as appropriate [see Indications and Usage (1) ] . Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules.

In clinical studies, omega-3-acid ethyl esters capsules were administered with meals. The daily dose of omega-3-acid ethyl esters capsules is 4 grams per day. The daily dose may be taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily).

Patients should be advised to swallow omega-3-acid ethyl esters capsules whole. Do not break open, crush, dissolve, or chew omega-3-acid ethyl esters capsules. The daily dose of omega-3-acid ethyl esters capsules is 4 grams per day taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily).

(2) Patients should be advised to swallow omega-3-acid ethyl esters capsules whole. Do not break open, crush, dissolve, or chew omega-3-acid ethyl esters capsules. (2)

💊 Dosage Forms and Strengths 32 words ▾

3 DOSAGE FORMS AND STRENGTHS Omega-3-acid ethyl esters capsules, USP are supplied as 1 gram transparent, soft-gelatin capsules filled with light-yellow oil and imprinted with “AN34”. 1 gram transparent soft-gelatin capsules. (3)

⛔ Contraindications 49 words ▾

4 CONTRAINDICATIONS Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components. Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components. (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy. (5.1) Omega-3-acid ethyl esters may increase levels of low-density lipoprotein (LDL). Monitor LDL levels periodically during therapy.

(5.1 ) Use with caution in patients with known hypersensitivity to fish and/or shellfish. (5.2) There is a possible association between omega-3-acid ethyl esters and more frequent recurrences of symptomatic atrial fibrillation or flutter in patients with paroxysmal or persistent atrial fibrillation, particularly within the first months of initiating therapy. (5.3)

5.1Monitoring: Laboratory Tests In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with omega-3-acid ethyl esters. In some patients, increases in ALT levels without a concurrent increase in AST levels were observed. In some patients, omega-3-acid ethyl esters increase low-density lipoprotein cholesterol (LDL-C) levels.

LDL-C levels should be monitored periodically during therapy with omega-3-acid ethyl esters. Laboratory studies should be performed periodically to measure the patient’s TG levels during therapy with omega-3-acid ethyl esters.

5.2Fish Allergy Omega-3-acid ethyl esters capsules contain ethyl esters of omega-3 fatty acids (EPA and DHA) obtained from the oil of several fish sources. It is not known whether patients with allergies to fish and/or shellfish, are at increased risk of an allergic reaction to omega-3-acid ethyl esters. Omega-3-acid ethyl esters should be used with caution in patients with known hypersensitivity to fish and/or shellfish.

5.3Recurrent Atrial Fibrillation (AF) or Flutter In a double-blind, placebo-controlled trial of 663 subjects with symptomatic paroxysmal AF (n = 542) or persistent AF (n = 121), recurrent AF or flutter was observed in subjects randomized to omega-3-acid ethyl esters who received 8 grams/day for 7 days and 4 grams/day thereafter for 23 weeks at a higher rate relative to placebo. Subjects in this trial had median baseline TG levels of 127 mg/dL, had no substantial structural heart disease, were taking no anti-arrhythmic therapy (rate control permitted), and were in normal sinus rhythm at baseline.

At 24 weeks, in the paroxysmal AF stratum, there were 129 (47%) first recurrent symptomatic AF or flutter events on placebo and 141 (53%) on omega-3-acid ethyl esters (primary endpoint, HR: 1.19; 95% CI: 0.93, 1.35). In the persistent AF stratum, there were 19 (35%) events on placebo and 34 (52%) events on omega-3-acid ethyl esters (HR: 1.63; 95% CI: 0.91, 2.18). For both strata combined, the HR was 1.25; 95% CI: 1, 1.4.

Although the clinical significance of these results is uncertain, there is a possible association between omega-3-acid ethyl esters and more frequent recurrences of symptomatic AF or flutter in patients with paroxysmal or persistent AF, particularly within the first 2 to 3 months of initiating therapy. Omega-3-acid ethyl esters are not indicated for the treatment of AF or flutter.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia, and taste perversion. (6) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions reported in at least 3% of subjects treated with omega-3-acid ethyl esters and at a greater rate than placebo based on pooled data across 23 clinical trials are listed in Table 1. Table 1.

Adverse Reactions Occurring at Incidence ≥3% and Greater than Placebo in Clinical Trials of Omega-3-acid ethyl esters Adverse Reaction a Omega-3-acid ethyl esters (n = 655) Placebo (n = 370) n % n % Eructation 29 4 5 1 Dyspepsia 22 3 6 2 Taste perversion 27 4 1 <1 a Trials included subjects with hypertriglyceridemia and severe hypertriglyceridemia. Additional adverse reactions from clinical trials are listed below: Digestive System Constipation, gastrointestinal disorder, and vomiting. Metabolic and Nutritional Disorders Increased ALT and increased AST.

Skin Pruritus and rash.

6.2Postmarketing Experience In addition to adverse reactions reported from clinical trials, the events described below have been identified during post-approval use of omega-3-acid ethyl esters. Because these events are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or to always establish a causal relationship to drug exposure. The following events have been reported: anaphylactic reaction, hemorrhagic diathesis, urticaria.

🔄 Drug Interactions 107 words ▾

7 DRUG INTERACTIONS Omega-3-acids may prolong bleeding time. Patients taking omega-3-acid ethyl esters and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically. (7.1)

7.1Anticoagulants or Other Drugs Affecting Coagulation Some trials with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in these trials has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical trials have not been done to thoroughly examine the effect of omega-3-acid ethyl esters and concomitant anticoagulants.

Patients receiving treatment with omega-3-acid ethyl esters and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.

👥 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 omega-3-acid ethyl esters in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, omega-3-acid ethyl esters given orally to female rats prior to mating through lactation did not have adverse effects on reproduction or development when given at doses 5 times the maximum recommended human dose (MRHD) of 4 grams/day, based on a body surface area comparison.

Omega-3-acid ethyl esters given orally to rats and rabbits during organogenesis was not teratogenic at clinically relevant exposures, based on body surface area comparison (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data: In female rats given oral doses of omega-3-acid ethyl esters (100, 600, or 2,000 mg/kg/day) beginning 2 weeks prior to mating through lactation, no adverse effects were observed at 2,000 mg/kg/day (5 times the MRHD based on body surface area [mg/m 2 ]). In a dose-ranging study, female rats given oral doses of omega-3-acid ethyl esters (1,000, 3,000, or 6,000 mg/kg/day) beginning 2 weeks prior to mating through Postpartum Day 7 had decreased live births (20% reduction) and pup survival to Postnatal Day 4 (40% reduction) at or greater than 3,000 mg/kg/day in the absence of maternal toxicity at 3,000 mg/kg/day (7 times the MRHD based on body surface area [mg/m 2 ]).

In pregnant rats given oral doses of omega-3-acid ethyl esters (1,000, 3,000, or 6,000 mg/kg/day) during organogenesis, no adverse effects were observed in fetuses at a maternally toxic dose (increased food consumption) of 6,000 mg/kg/day (14 times the MRHD based on body surface area [mg/m 2 ]). In pregnant rats given oral doses of omega-3-acid ethyl esters (100, 600, or 2,000 mg/kg/day) from Gestation Day 14 through Lactation Day 21, no adverse effects were observed at 2,000 mg/kg/day (5 times the MRHD based on body surface area [mg/m 2 ]).

In pregnant rabbits given oral doses of omega-3-acid ethyl esters (375, 750, or 1,500 mg/kg/day) during organogenesis, no adverse effects were observed in fetuses given 375 mg/kg/day (2 times the MRHD based on body surface area [mg/m 2 ]). However, at higher doses, increases in fetal skeletal variations and reduced fetal growth were evident at maternally toxic doses (reduced food consumption and body weight gain) greater than or equal to 750 mg/kg/day (4 times the MRHD), and embryolethality was evident at 1,500 mg/kg/day (7 times the MRHD).

8.2Lactation Risk Summary Published studies have detected omega-3 fatty acids, including EPA and DHA, 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 available on the effects of omega-3 fatty acid ethyl esters on the breastfed infant or on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for omega-3-acid ethyl esters and any potential adverse effects on the breastfed child from omega-3-acid ethyl esters or from the underlying maternal condition.

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

8.5Geriatric Use A limited number of subjects older than 65 years were enrolled in the clinical trials of omega-3-acid ethyl esters. Safety and efficacy findings in subjects older than 60 years did not appear to differ from those of subjects younger than 60 years.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of omega-3-acid ethyl esters is not completely understood. Potential mechanisms of action include inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal β-oxidation in the liver, decreased lipogenesis in the liver, and increased plasma lipoprotein lipase activity. Omega-3-acid ethyl esters may reduce the synthesis of TG in the liver because EPA and DHA are poor substrates for the enzymes responsible for TG synthesis, and EPA and DHA inhibit esterification of other fatty acids.

12.3Pharmacokinetics Absorption In healthy volunteers and in subjects with hypertriglyceridemia, EPA and DHA were absorbed when administered as ethyl esters orally. Omega-3-acids administered as ethyl esters (omega-3-acid ethyl esters capsules) induced significant dose-dependent increases in serum phospholipid EPA content, though increases in DHA content were less marked and not dose-dependent when administered as ethyl esters. Specific Populations Age: Uptake of EPA and DHA into serum phospholipids in subjects treated with omega-3-acid ethyl esters was independent of age (younger than 49 years versus 49 years and older).

Male and Female Patients : Females tended to have more uptake of EPA into serum phospholipids than males. The clinical significance of this is unknown. Pediatric Patients : Pharmacokinetics of omega-3-acid ethyl esters have not been studied.

Patients with Renal or Hepatic Impairment: Omega-3-acid ethyl esters have not been studied in patients with renal or hepatic impairment. Drug Interaction Studies Simvastatin: In a 14-day trial of 24 healthy adult subjects, daily co-administration of simvastatin 80 mg with omega-3-acid ethyl esters 4 grams did not affect the extent (AUC) or rate (C max ) of exposure to simvastatin or the major active metabolite, beta-hydroxy simvastatin, at steady-state. Atorvastatin: In a 14-day trial of 50 healthy adult subjects, daily co-administration of atorvastatin 80 mg with omega-3-acid ethyl esters 4 grams did not affect AUC or C max of exposure to atorvastatin, 2-hydroxyatorvastatin, or 4-hydroxyatorvastatin at steady-state.

Rosuvastatin: In a 14-day trial of 48 healthy adult subjects, daily co-administration of rosuvastatin 40 mg with omega-3-acid ethyl esters 4 grams did not affect AUC or C max of exposure to rosuvastatin at steady-state. In vitro studies using human liver microsomes indicated that clinically significant cytochrome P450-mediated inhibition by EPA/DHA combinations are not expected in humans.

📦 How Supplied / Storage and Handling 86 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Omega-3-acid ethyl esters capsules USP, are supplied as 1 gram, transparent, soft-gelatin capsules filled with light-yellow oil and imprinted with “AN34”. They are available as follows: Bottles of 60: NDC 65162-034-06 Bottles of 120: NDC 65162-034-16 Bottles of 360: NDC 65162-034-32 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

Dispense in a tight, light-resistant container. Protect from light. Keep out of reach of children.

📋 Description 159 words ▾

11 DESCRIPTION Omega-3-acid ethyl esters, USP, a lipid-regulating agent, are supplied as a liquid-filled gel capsule for oral administration. Each 1 gram capsule of omega-3-acid ethyl esters, USP contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg).

The empirical formula of EPA ethyl ester is C 22 H 34 O 2 , and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is: The empirical formula of DHA ethyl ester is C 24 H 36 O 2 , and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is: Omega-3-acid ethyl esters capsules, USP also contain the following inactive ingredients: alpha-tocopherol, gelatin, glycerin and purified water (components of the capsule shell).

400f230c-figure-01 400f230c-figure-02

💬 Information for Patients 147 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) . Information for Patients Omega-3-acid ethyl esters should be used with caution in patients with known sensitivity or allergy to fish and/or shellfish [see Warnings and Precautions (5.2) ] . Advise patients that use of lipid-regulating agents does not reduce the importance of adhering to diet [see Dosage and Administration (2) ] .

Advise patients not to alter omega-3-acid ethyl esters capsules in any way and to ingest intact capsules only [see Dosage and Administration (2) ] . Instruct patients to take omega-3-acid ethyl esters as prescribed. If a dose is missed, advise patients to take it as soon as they remember.

However, if they miss one day of omega-3-acid ethyl esters, they should not double the dose when they take it. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 09-2020-02

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65162-0033-10 · Amneal 65162-0036-02 · Amneal →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.