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Omega-3-Acid Ethyl Esters 1 g Capsule, Liquid Filled, 60-count — NDC 65162-034-06 (Billing 65162-0034-06)

by Amneal Pharmaceuticals LLC · 60 CAPSULE, LIQUID FILLED in 1 BOTTLE

This is a package of 60 capsules of Omega-3-Acid Ethyl Esters 1 g Capsule, Liquid Filled from Amneal Pharmaceuticals LLC, no longer marketed (first marketed Nov 2015), no longer in the FDA NDC Directory, this package's marketing ended Jul 2026.

NDC 65162-0034-06
🏷️ FDA NDC (as labeled) 65162-034-06 billing pads the product segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Product page 65162-0034-16 Also comes in: 120 capsules 65162-034-16 360 capsules 65162-034-32
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 65162-034-06 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
65162 labeler · 034 product · 06 package
Package marketed since
Nov 30, 2015
Package marketing ended
Jul 1, 2026
Sample package
No — commercial package
Barcode (UPC)
0365162034066
FDA record last changed
Jul 2, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65162-034-06
Product NDC 65162-034
11-digit billing NDC 65162003406
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

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

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
Quick answers
  • GSN (GCN sequence number): 058486
  • GCN: 23929
  • GPI-14 (Medi-Span): 39500045200130
  • HICL (First Databank): 026793
  • AHFS class code: 24:06.12.00
  • RxCUI (RxNorm): 577208
Why two NDCs? The FDA registers this code as 65162-034-06 — 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 → 65162-0034-06. 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.

Clinical

Label name OMEGA-3 ETHYL ESTERS 1 GM CAP Ingredient Omega-3 Acid Ethyl Esters
📗 Our plain-language guide HelloPharmacist
  • This medication is specifically approved for adults with severely high triglyceride levels — 500 mg/dL or above. It's a prescription-strength omega-3 fatty acid, quite different fr...
  • What exactly is this medication for? My doctor said my triglycerides were very high.
  • Prescription omega-3-acid ethyl esters like Lovaza are not the same as over-the-counter fish oil. They contain standardized, concentrated amounts of EPA and DHA and have been teste...
  • Can I just take regular fish oil from the store instead?
📖 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.

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 mLPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 120 capsules 360 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
65162-0034-06 You're viewing this 60 CAPSULE, LIQUID FILLED in 1 BOTTLE — — 2015-11-30 Jul 1, 2026 Discontinued by firm
65162-0034-16 65162-034-16 Main listing 120 CAPSULE, LIQUID FILLED in 1 BOTTLE $0.1711 / ea $20.53 2015-11-30 Jul 1, 2026 Discontinued by firm
65162-0034-32 65162-034-32 360 CAPSULE, LIQUID FILLED in 1 BOTTLE — — 2015-11-30 Jul 1, 2026 Discontinued by firm

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

This pack shows little to no recent Medicaid volume — the 120 capsules pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 capsule, liquid filled in 1 bottle.
How does this package differ from NDC 65162-0034-16?
Both are Omega-3-Acid Ethyl Esters 1 g Capsule, Liquid Filled — the drug itself is identical. This page's package is the 60-count one, while NDC 65162-0034-16 is the 120 capsules package.
What NDC number is used to bill for this package of Omega-3-Acid Ethyl Esters 1 g Capsule, Liquid Filled?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Omega-3-Acid Ethyl Esters 1 g 00904-7495-06 Major 1 capsule $0.171 AB Availability likely —
Omega-3-Acid Ethyl Esters 1 g 24658-0350-12 PURACAP 120 capsules $0.171 AB Availability likely —
Omega-3-Acid Ethyl Esters 1 g 42806-0552-12 EPIC 120 capsules $0.171 AB Availability likely —
omega-3-acid ethyl esters 900 mg 60687-0846-65 American 50 capsules $0.171 AB Availability likely —
omega-3-acid ethyl esters 900 mg 62135-0780-12 Chartwell 120 capsules $0.171 AB Availability likely —
Omega-3-Acid Ethyl Esters 1 g 70756-0423-22 Lifestar 120 capsules $0.171 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 Esters 1 gthis 65162-0034-06 Amneal 60 capsules — — Discontinued —
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.

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.

🧪 Avoiding an ingredient? See Omega-3-Acid Ethyl Esters inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL PHARMACEUTICALS OF NEW YORK LLC
FDA applicationANDA204940 (ANDA)
Labeler code65162
First marketedNov 2015
Product typeHuman Prescription Drug
Portfolio490 products on file

More NDCs from Amneal Pharmaceuticals LLC labeler code 65162

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 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

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES

14.1Severe Hypertriglyceridemia The effects of omega-3-acid ethyl esters 4 grams per day were assessed in 2 randomized, placebo-controlled, double-blind, parallel-group trials of 84 adult subjects (42 on omega-3-acid ethyl esters, 42 on placebo) with very high TG levels. Subjects whose baseline TG levels were between 500 and 2,000 mg/dL were enrolled in these 2 trials of 6 and 16 weeks’ duration. The median TG and LDL-C levels in these subjects were 792 mg/dL and 100 mg/dL, respectively.

Median high-density lipoprotein cholesterol (HDL-C) level was 23 mg/dL. The changes in the major lipoprotein lipid parameters for the groups receiving omega-3-acid ethyl esters or placebo are shown in Table 2. Table 2.

Median Baseline and Percent Change from Baseline in Lipid Parameters in Subjects with Severe Hypertriglyceridemia (≥500 mg/dL) Parameter Omega-3-acid ethyl esters n = 42 Placebo n = 42 Difference BL % Change BL % Change TG 816 -44.9 788 +6.7 -51.6 Non-HDL-C 271 -13.8 292 -3.6 -10.2 TC 296 -9.7 314 -1.7 -8 VLDL-C 175 -41.7 175 -0.9 -40.8 HDL-C 22 +9.1 24 0 +9.1 LDL-C 89 +44.5 108 -4.8 +49.3 BL = Baseline (mg/dL); % Change = Median Percent Change from Baseline; Difference = Omega-3-acid ethyl esters Median % Change – Placebo Median % Change.

TC = Total cholesterol. VLDL-C = Very-low-density lipoprotein (VLDL) cholesterol. Omega-3-acid ethyl esters 4 grams per day reduced median TG, VLDL-C, and non-HDL-C levels and increased median HDL-C from baseline relative to placebo.

Treatment with omega-3-acid ethyl esters to reduce very high TG levels may result in elevations in LDL-C and non-HDL-C in some individuals. Patients should be monitored to ensure that the LDL-C level does not increase excessively. The effect of omega-3-acid ethyl esters on the risk of pancreatitis has not been determined.

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

🧪 Nonclinical Toxicology 188 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a rat carcinogenicity study with oral gavage doses of 100, 600, and 2,000 mg/kg/day, males were treated with omega-3-acid ethyl esters for 101 weeks and females for 89 weeks without an increased incidence of tumors (up to 5 times human systemic exposures following an oral dose of 4 grams/day based on a body surface area comparison). Standard lifetime carcinogenicity bioassays were not conducted in mice. Omega-3-acid ethyl esters were not mutagenic or clastogenic with or without metabolic activation in the bacterial mutagenesis (Ames) test with Salmonella typhimurium and Escherichia coli or in the chromosomal aberration assay in Chinese hamster V79 lung cells or human lymphocytes.

Omega-3-acid ethyl esters were negative in the in vivo mouse micronucleus assay. In a rat fertility study with oral doses of 100, 600, and 2,000 mg/kg/day, males were treated for 10 weeks prior to mating and females were treated for 2 weeks prior to mating and through lactation. No adverse effect on fertility was observed at 2,000 mg/kg/day (5 times the MRHD of 4 grams/day based on body surface area [mg/m 2 ]).

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Omega-3-Acid Ethyl Esters (oh-MAY-ga 3 AS-id eth-il es-ters) Capsules What are omega-3-acid ethyl esters? Omega-3-acid ethyl esters is a prescription medicine used along with a low-fat and low-cholesterol diet to lower very high triglyceride (fat) levels in adults. It is not known if omega-3-acid ethyl esters changes your risk of having inflammation of your pancreas (pancreatitis).

It is not known if omega-3-acid ethyl esters prevents you from having a heart attack or stroke. It is not known if omega-3-acid ethyl esters are safe and effective in children. Who should not take omega-3-acid ethyl esters?

Do not take omega-3-acid ethyl esters if you are allergic to omega-3-acid ethyl esters or any of the ingredients in omega-3-acid ethyl esters capsules. See the end of this leaflet for a complete list of ingredients in omega-3-acid ethyl esters capsules. Before taking omega-3-acid ethyl esters, tell your healthcare provider about all of your medical conditions, including if you: have diabetes. have a low thyroid problem (hypothyroidism). have a liver problem. have a pancreas problem. have a certain heart rhythm problem called atrial fibrillation or flutter. are allergic to fish or shellfish.

It is not known if people who are allergic to fish or shellfish are also allergic to omega-3-acid ethyl esters. are pregnant or plan to become pregnant. It is not known if omega-3-acid ethyl esters will harm your unborn baby. are breastfeeding or plan to breastfeed. Omega-3-acid ethyl esters can pass into your breast milk.

Talk to your healthcare provider about the best way to feed your baby if you take omega-3-acid ethyl esters. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Omega-3-acid ethyl esters can interact with certain other medicines that you are taking.

Using omega-3-acid ethyl esters with medicines that affect blood clotting (anticoagulants or blood thinners) may cause serious side effects. How should I take omega-3-acid ethyl esters? Take omega-3-acid ethyl esters exactly as your healthcare provider tells you to take it.

You should not take more than 4 capsules of omega-3-acid ethyl esters each day. Either take all 4 capsules at one time or 2 capsules two times a day. Do not change your dose or stop omega-3-acid ethyl esters without talking to your healthcare provider.

Take omega-3-acid ethyl esters capsules with food. Take omega-3-acid ethyl esters capsules whole. Do not break, open, crush, dissolve, or chew omega-3-acid ethyl esters capsules before swallowing.

If you cannot swallow omega-3-acid ethyl esters capsules whole, tell your healthcare provider. You may need a different medicine. If you miss a dose of omega-3-acid ethyl esters, take the missed dose as soon as you remember.

If you miss one day of omega-3-acid ethyl esters, do not double your dose the next time you take it. Your healthcare provider may start you on a cholesterol-lowering diet before giving you omega-3-acid ethyl esters. Stay on this diet while taking omega-3-acid ethyl esters.

Your healthcare provider should do blood tests to check your triglyceride, bad cholesterol (LDL-C), and liver function (ALT and AST) levels while you take omega-3-acid ethyl esters. What are the possible side effects of omega-3-acid ethyl esters? Omega-3-acid ethyl esters may cause serious side effects, including: changes in certain blood tests.

Omega-3-acid ethyl esters may cause an increase in the results of blood tests used to check your liver function and your bad cholesterol levels. increased risk of a heart rhythm problem in people who have a heart rhythm problem. Omega-3-acid ethyl esters may cause an increase in the frequency of a heart rhythm problem (atrial fibrillation or flutter), especially in the first few months of taking omega-3-acid ethyl esters, if you already have a heart rhythm problem. The most common side effects of omega-3-acid ethyl este… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 19 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65162-034-06 Omega-3-Acid Ethyl Esters Capsules, USP Rx Only Container Label Amneal Pharmaceuticals LLC 10

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

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 capsules65162-0034-16 13,400 Rx · $417,956
60 capsules this page65162-0034-06 No Medicaid data
360 capsules65162-0034-32 No Medicaid data
Drug total (last 4 qtrs): 13,400 Rx · 1,534,857 units · $417,956 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.

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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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) — 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.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 120 capsules (65162-0034-16), 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.
← 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.