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Omega-3-Acid Ethyl Esters 1 g Capsule, 120-count — NDC 51407-0763-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Omega-3-Acid Ethyl Esters 1 g Capsule, 120-count — NDC 51407-763-12 (Billing 51407-0763-12)

by Golden State Medical Supply, Inc. · 120 CAPSULE in 1 BOTTLE, PLASTIC

This is a package of 120 capsules of Omega-3-Acid Ethyl Esters 1 g Capsule from Golden State Medical Supply, Inc., marketed since Apr 2014 and currently FDA-listed. It is this product's only package size.

NDC 51407-0763-12
🏷️ FDA NDC (as labeled) 51407-763-12 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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 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 ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51407-763-12
Product NDC 51407-763
11-digit billing NDC 51407076312
NCPDP billing unit EA — each (per item)
RxCUI 577208
UNII D87YGH4Z0Q
Application # ANDA091028
SPL Set ID 11d744aa-cc06-1206-e063-6294a90a49c9
Established class (EPC) Fatty Acids; Omega-3 Fatty Acid
Chemical class Omega-3
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-04-07
Route ORAL
Dosage form CAPSULE
Substance OMEGA-3-ACID ETHYL ESTERS
TE code (Orange Book) AB · RLD · RS

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

GPI-14 39500045200130
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 51407-763-12 — 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 → 51407-0763-12. 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
📖 What it is MedlinePlus · NLM

Omega-3 fatty acids are used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of triglycerides (a fat-like substance) in the blood in people with very high triglycerides. Omega-3 fatty acids are in a class of medications called antilipemic or lipid-regulating agents. Omega-3 fatty acids may work by decreasing the amount of triglycerides and other fats made in the liver.

Read the full MedlinePlus article ↗
📗 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 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 $0.2792 $33.50 / 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51407-0763-12 You're viewing this Main listing 120 CAPSULE in 1 BOTTLE, PLASTIC 2023-12-19 — Active

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 gthis 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 g 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

🏛️
2014
On the market since
Apr 2014
📍
2026
Currently FDA-listed
12 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.

What it looks like

Color white
ShapeCapsule
ImprintGLW
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 H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • 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 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.

4 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.

Manufacturer & labeler

LabelerGolden State Medical Supply, Inc.
Application holderGLW PHARMA GMBH
FDA applicationANDA091028 (ANDA)
Labeler code51407
First marketedApr 2014
Product typeHuman Prescription Drug
Portfolio671 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.

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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 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 per dL) hypertriglyceridemia (HTG). 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 (HTG).

( 1 ) Limitations of Use: The effect of omega-3-acid ethyl esters on the risk for pancreatitis has not been determined. ( 1 ) The effect of omega-3-acid ethyl esters on cardiovascular mortality and morbidity has not been determined. ( 1 ) Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters and should continue this diet during treatment with omega-3-acid ethyl esters.

Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. 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 triglyceride-lowering drug therapy.

Limitations of Use: The effect of omega-3-acid ethyl esters on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters on cardiovascular mortality and morbidity has not been determined.

⏱️ Dosage and Administration 181 words ▾

2 DOSAGE AND ADMINISTRATION Assess triglyceride levels carefully before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, medications) of high triglyceride 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, and should continue this diet during treatment with omega-3-acid ethyl esters.

In clinical studies, omega-3-acid ethyl esters was administered with meals. The daily dose of omega-3-acid ethyl esters 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 whole. Do not break open, crush, dissolve, or chew omega-3-acid ethyl esters. The daily dose of omega-3-acid ethyl esters 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 whole. Do not break open, crush, dissolve, or chew omega-3-acid ethyl esters. ( 2 )

💊 Dosage Forms and Strengths 42 words ▾

3 DOSAGE FORMS AND STRENGTHS Omega-3-acid ethyl esters capsules USP are supplied as 1-gram oblong, clear, soft gel capsules filled with slightly yellow to yellow liquid and imprinted with "GLW" in white ink across one side. Capsules: 1 gram ( 3 )

⛔ Contraindications 49 words ▾

4 CONTRAINDICATIONS Omega-3-acid ethyl esters 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 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 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 increases 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 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 per day for 7 days and 4 grams per day thereafter for 23 weeks at a higher rate relative to placebo. Subjects in this trial had median baseline triglycerides of 127 mg per 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: 1.00, 1.40.

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 atrial fibrillation or flutter in patients with paroxysmal or persistent atrial fibrillation, particularly within the first 2 or 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 KD Pharma USA at 1-877-241-7978 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 with omega-3-acid ethyl esters based on pooled data across 23 clinical trials are listed in Table 1. Adverse Reaction Trials included subjects with HTG and severe HTG.

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 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 109 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 Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. ( 8.1 )

8.1Pregnancy Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. It is unknown whether omega-3-acid ethyl esters can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.Omega-3-acid ethyl esters should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Animal Data Omega-3-acid ethyl esters have been shown to have an embryocidal effect in pregnant rats when given in doses resulting in exposures 7 times the recommended human dose of 4 grams per day based on a body surface area comparison.

In female rats given oral gavage doses of 100, 600, and 2,000 mg per kg per day beginning 2 weeks prior to mating and continuing through gestation and lactation, no adverse effects were observed in the high-dose group (5 times human systemic exposure following an oral dose of 4 grams per day based on body surface area comparison). In pregnant rats given oral gavage doses of 1,000, 3,000, and 6,000 mg per kg per day from gestation Day 6 through 15, no adverse effects were observed (14 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

In pregnant rats given oral gavage doses of 100, 600, and 2,000 mg per kg per day from gestation Day 14 through lactation Day 21, no adverse effects were seen at 2,000 mg per kg per day (5 times the human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison). However, decreased live births (20% reduction) and decreased survival to postnatal Day 4 (40% reduction) were observed in a dose-ranging study using higher doses of 3,000 mg per kg per day (7 times the human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

In pregnant rabbits given oral gavage doses of 375, 750, and 1,500 mg per kg per day from gestation Day 7 through 19, no findings were observed in the fetuses in groups given 375 mg per kg per day (2 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison). However, at higher doses, evidence of maternal toxicity was observed (4 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

8.3Nursing Mothers Studies with omega-3-acid ethyl esters have demonstrated excretion in human milk. The effect of this excretion on the infant of a nursing mother is unknown; caution should be exercised when omega-3-acid ethyl esters are administered to a nursing mother. An animal study in lactating rats given oral gavage 14C-ethyl EPA demonstrated that drug levels were 6 to 14 times higher in milk than in plasma.

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.

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. It is unknown whether omega-3-acid ethyl esters can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.Omega-3-acid ethyl esters should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Animal Data Omega-3-acid ethyl esters have been shown to have an embryocidal effect in pregnant rats when given in doses resulting in exposures 7 times the recommended human dose of 4 grams per day based on a body surface area comparison.

In female rats given oral gavage doses of 100, 600, and 2,000 mg per kg per day beginning 2 weeks prior to mating and continuing through gestation and lactation, no adverse effects were observed in the high-dose group (5 times human systemic exposure following an oral dose of 4 grams per day based on body surface area comparison). In pregnant rats given oral gavage doses of 1,000, 3,000, and 6,000 mg per kg per day from gestation Day 6 through 15, no adverse effects were observed (14 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

In pregnant rats given oral gavage doses of 100, 600, and 2,000 mg per kg per day from gestation Day 14 through lactation Day 21, no adverse effects were seen at 2,000 mg per kg per day (5 times the human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison). However, decreased live births (20% reduction) and decreased survival to postnatal Day 4 (40% reduction) were observed in a dose-ranging study using higher doses of 3,000 mg per kg per day (7 times the human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

In pregnant rabbits given oral gavage doses of 375, 750, and 1,500 mg per kg per day from gestation Day 7 through 19, no findings were observed in the fetuses in groups given 375 mg per kg per day (2 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison). However, at higher doses, evidence of maternal toxicity was observed (4 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

🧒 Pediatric Use 13 words ▾

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

🧓 Geriatric Use 45 words ▾

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 triglycerides 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) 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. Special 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 has 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 coadministration 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 coadministration 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 coadministration 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.

🧬 Mechanism of Action 80 words ▾

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 triglycerides 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.

📦 How Supplied / Storage and Handling 82 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Omega-3-Acid Ethyl Esters Capsules USP are available as follows: 1 gram – slightly yellow to yellow liquid, oblong, clear, soft gel capsules, imprinted with "GLW" in white ink across one side. Bottles of 120: NDC 51407-763-12 Store at 20°-25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

📦 Storage and Handling 41 words ▾

Store at 20°-25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

📋 Description 159 words ▾

11 DESCRIPTION Omega-3-acid ethyl esters, USP, lipid-regulating agents, 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 (EP — 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: 4 mg alpha-tocopherol, gelatin, glycerin, hypromellose, propylene glycol, and titanium dioxide.

Chemical Structure Chemical Structure

💬 Information for Patients 135 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 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.

🍼 Nursing Mothers 68 words ▾

8.3Nursing Mothers Studies with omega-3-acid ethyl esters have demonstrated excretion in human milk. The effect of this excretion on the infant of a nursing mother is unknown; caution should be exercised when omega-3-acid ethyl esters are administered to a nursing mother. An animal study in lactating rats given oral gavage 14C-ethyl EPA demonstrated that drug levels were 6 to 14 times higher in milk than in plasma.

🧬 Pharmacokinetics ~1 min read ▾

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) 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. Special 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 has 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 coadministration 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 coadministration 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 coadministration 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.

🔬 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, doubleblind, parallel-group trials of 84 adult subjects (42 on omega-3-acid ethyl esters, 42 on placebo) with very high triglyceride levels. Subjects whose baseline triglyceride levels were between 500 and 2,000 mg per dL were enrolled in these 2 trials of 6 and 16 weeks' duration. The median triglyceride and LDL-C levels in these subjects were 792 mg per dL and 100 mg per dL, respectively.

Median high-density lipoprotein cholesterol (HDL-C) level was 23.0 mg per 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 per dL) Parameter Omega-3-acid ethyl esters n=42 Placebo n=42 Difference BL % Change BL % Change BL = Baseline (mg per dL); % Change = Median Percent Change from Baseline; Difference = Omega-3-acid ethyl esters Median % Change – Placebo Median % Change; VLDL-C = Very-low-density lipoprotein (VLDL) cholesterol. 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 -8.0 VLDL-C 175 -41.7 175 -0.9 -40.8 HDL-C 22 +9.1 24 0.0 +9.1 LDL-C 89 +44.5 108 -4.8 +49.3 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.

🔒 Drug Abuse and Dependence 18 words ▾

9 DRUG ABUSE AND DEPENDENCE Omega-3-acid ethyl esters do not have any known drug abuse or withdrawal effects.

🧪 Nonclinical Toxicology 211 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 per kg per 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 per 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 gavage doses of 100, 600, and 2,000 mg per kg per day, males were treated for 10 weeks prior to mating and females were treated for 2 weeks prior to and throughout mating, gestation, and lactation. No adverse effect on fertility was observed at 2,000 mg per kg per day (5 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 208 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a rat carcinogenicity study with oral gavage doses of 100, 600, and 2,000 mg per kg per 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 per 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 gavage doses of 100, 600, and 2,000 mg per kg per day, males were treated for 10 weeks prior to mating and females were treated for 2 weeks prior to and throughout mating, gestation, and lactation. No adverse effect on fertility was observed at 2,000 mg per kg per day (5 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison).

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP (oh may' ga as' id eth' il es' ters). What are OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP? OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP are 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 CAPSULES, USP change your risk of having inflammation of your pancreas (pancreatitis). It is not known if OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP prevent you from having a heart attack or stroke. It is not known if OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP are safe and effective in children.

Who should not take OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP? Do not take OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP if you are allergic to omega-3-acid ethyl esters or any of the ingredients in OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP. See the end of this leaflet for a complete list of ingredients in OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP.

Before taking OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP, 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 CAPSULES, USP. are pregnant or plan to become pregnant.

It is not known if OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP will harm your unborn baby. are breastfeeding or plan to breastfeed. OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP 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 CAPSULES, USP.

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 CAPSULES, USP can interact with certain other medicines that you are taking. Using OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP with medicines that affect blood clotting (anticoagulants or blood thinners) may cause serious side effects.

How should I take OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP? Take OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP exactly as your healthcare provider tells you to take them. You should not take more than 4 capsules of OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP 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 CAPSULES, USP without talking to your healthcare provider. Take OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP with food.

Take OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP whole. Do not break, open, crush, dissolve, or chew OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP before swallowing. If you cannot swallow OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP whole, tell your healthcare provider.

You may need a different medicine. If you miss a dose of OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP, take the missed dose as soon as you remember. If you miss one day of OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP, 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 CAPSULES, USP. Stay on this diet while taking OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP. 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 CAPSULES, USP.

What are the possible side effects of OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP? OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP may cause serious side effects, including: changes in certain blood tests. OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP may cause an increase in the results of blood tests used to check your liver function and your ba… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 30 words ▾

PRINCIPAL DISPLAY PANEL - 120 Capsule Bottle Label NDC 51407-763-12 Omega-3-Acid Ethyl Esters Capsules, USP 1 gram* Swallow capsules whole. Rx Only 120 Capsules 51407-763-12OL - Omega-3-acid - Rev. 0325.pdf.jpg

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

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
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 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.
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 Golden State Medical Supply, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Golden State Medical Supply, Inc. 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.
← 51407-0762-01 · Golden 51407-0765-90 · Golden →
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.