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Icosapent Ethyl 1 g/g Capsule, Liquid Filled, 120 g — NDC 13668-0761-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Icosapent Ethyl 1 g/g Capsule, Liquid Filled, 120 g — NDC 13668-761-12 (Billing 13668-0761-12)

by Torrent Pharmaceuticals Limited · 120 g in 1 BOTTLE

This is a package of 120 g of Icosapent Ethyl 1 g/g Capsule, Liquid Filled from Torrent Pharmaceuticals Limited, marketed since Apr 2026 and currently FDA-listed. It is this product's only package size.

NDC 13668-0761-12
🏷️ FDA NDC (as labeled) 13668-761-12 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 →

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 13668-761-12
Product NDC 13668-761
11-digit billing NDC 13668076112
RxCUI 1304979
UNII 6GC8A4PAYH
Application # ANDA218994
SPL Set ID 24105b33-bbb7-4349-a5d0-8fe4af7e4994
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-22
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance ICOSAPENT ETHYL
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1304979
Why two NDCs? The FDA registers this code as 13668-761-12 — 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 → 13668-0761-12. 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

📖 What it is MedlinePlus · NLM

Icosapent ethyl is used to reduce the amount of triglycerides (a fat-like substance) in the blood. It is also used to decrease the risk of a heart attack, a stroke, or other heart problems that require hospitalization in certain adults. Icosapent ethyl is in a class of medications called antilipemic or lipid-regulating agents. Icosapent ethyl 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
  • All icosapent ethyl capsules are used with diet to lower very high triglycerides, 500 mg/dL or higher, in adults. Vascepa is also approved, along with a statin, to lower the risk o...
  • Take it by mouth twice a day with food, exactly as your label says. Swallow the capsules whole. Don't crush, chew, dissolve or open them.
  • Some people notice muscle or joint aches, constipation, leg swelling, gout or a sore throat. Let me or your doctor know if these bother you.
  • Call about a racing, fluttering or irregular heartbeat, or any unusual bleeding. Stop the medicine and get help right away if you have signs of an allergic reaction.
📖 Read our full Icosapent Ethyl 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 · Q2 2026 $1.12 —
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
13668-0761-12 You're viewing this Main listing 120 g in 1 BOTTLE 2026-04-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Icosapent Ethyl 1 g 00054-0508-23 Hikma 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 00480-0127-89 Teva 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 16714-0636-01 Northstar 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 31722-0299-12 Camber 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 42806-0560-12 EPIC 120 capsules $0.441 AB Availability likely —
Icosapent 1000 mg 43598-0267-04 Dr. 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 60505-4033-01 Apotex 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 60687-0764-21 American 30 capsules $0.441 AB Availability likely —
Icosapent ethyl 1 g 69238-2598-08 Amneal 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 69680-0186-92 Vitruvias 120 capsules $0.441 AB Availability likely —
icosapent ethyl 1 g 70710-1592-07 Zydus 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g 72603-0129-01 Northstar 120 capsules $0.441 AB Availability likely —
Icosapent Ethyl 1 g/gthis 13668-0761-12 Torrent 120 g — AB FDA listed —
icosapent ethyl 1 g 35916-1592-01 Softgel 120 capsules — AB FDA listed —
Icosapent Ethyl 1 g 42291-0046-12 AvKARE 120 capsules — AB Discontinued —
Icosapent Ethyl 1 g 42806-0576-12 EPIC 120 capsules — AB FDA listed —
Vascepa 1000 mg 52937-0001-04 Amarin 4 capsules — AB Discontinued —
Vascepa 1000 mg 52937-0005-20 Amarin 120 capsules — AB FDA listed —
Vascepa 1000 mg 52937-0101-08 Amarin 8 capsules — AB FDA listed —
Icosapent Ethyl 1 g 60429-0005-12 Golden 120 capsules — AB FDA listed —
Vascepa 1000 mg 63629-8247-01 Bryant 30 capsules — AB FDA listed —
Icosapent Ethyl 1 g 63629-9311-01 Bryant 120 capsules — AB FDA listed —
Icosapent 1000 mg 63629-9312-01 Bryant 120 capsules — AB FDA listed —
Icosapent Ethyl 1 g 67184-0582-01 Qilu 120 capsules — AB FDA listed —
Icosapent Ethyl 1 g 71335-2842-01 Bryant 120 capsules — AB FDA listed —
Icosapent Ethyl 1 g 71335-2989-01 Bryant 30 capsules — AB FDA listed —
Icosapent Ethyl 1 g 71335-3072-01 Bryant 30 capsules — AB FDA listed —
Icosapent Ethyl 1 g 71335-3148-01 Bryant 30 capsules — AB FDA listed —
Icosapent Ethyl 1 g 72162-1000-02 Bryant 120 capsules — AB FDA listed —
Icosapent Ethyl 1 g 72865-0290-12 XLCare 120 capsules — AB FDA listed —
About this product: this is 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

🏛️
2026
On the market since
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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 yellow
ShapeCapsule
Imprint0958
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 7QWA1RIO01
    A synthetic form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the formulation from breaking down, helping the drug remain stable and effective during storage.
  • UNII AV0YTZ4E6J
    A chemical compound derived from sorbitol, a natural sugar alcohol. It acts as an emulsifier and surfactant to help blend oil and water-based ingredients in medicines, ensuring uniform texture and stability.
  • 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerTorrent Pharmaceuticals Limited
Application holderTORRENT PHARMA INC
FDA applicationANDA218994 (ANDA)
Labeler code13668
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio182 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 📋 Description 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 112 words ▾

1 INDICATIONS AND USAGE Icosapent ethyl capsules are indicated: as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL)hypertriglyceridemia. Limitations of Use: The effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Icosapent ethyl capsules are an ethyl ester of eicosapentaenoic acid (EPA) 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 icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. ( 1 )

⏱️ Dosage and Administration 193 words ▾

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

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

( 2.2 )

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

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

💊 Dosage Forms and Strengths 45 words ▾

3 DOSAGE FORMS AND STRENGTHS Icosapent ethyl capsules are supplied as: 1 gram amber – coloured, oblong shaped soft gelatin capsules filled with colorless to light yellow liquid and bearing the designation “0958” on one side of the capsules. Capsules: 1 gram ( 3 )

⛔ Contraindications 47 words ▾

4 CONTRAINDICATIONS Icosapent ethyl capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components. Icosapent ethyl capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

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

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

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

5.1Atrial Fibrillation/Flutter Icosapent ethyl capsules are associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization. In a double-blind, placebo-controlled trial of 8,179 subjects, adjudicated atrial fibrillation or atrial flutter requiring hospitalization for 24 or more hours occurred in 127 (3%) patients treated with icosapent ethyl capsules compared to 84 (2%) patients receiving placebo [HR=1.5 (95% Cl 1.14, 1.98)]. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.

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

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

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

🤒 Adverse Reactions ~1 min read ▾

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

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Common adverse reactions (incidence ≥3% on icosapent ethyl capsules and ≥1% more frequent than placebo) included musculoskeletal pain, peripheral edema, constipation, gout and atrial fibrillation. Hypertriglyceridemia Trials In two randomized, double-blind, placebo-controlled trials in patients with triglyceride levels between 200 and 2000 mg/dL treated for 12 weeks, adverse reactions reported with icosapent ethyl capsules at an incidence ≥1% more frequent than placebo based on pooled data included arthralgia and oropharyngeal pain.

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

🔄 Drug Interactions 99 words ▾

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

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

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

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

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

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and15-20%, respectively. Data Animal Data In pregnant rats given oral gavage doses of 0.3, 1 and 2 g/kg/day icosapent ethyl from gestation through organogenesis all drug treated groups had non-dose-related imbalances in visceral and skeletal findings, including 13th reduced ribs, additional liver lobes, testes medially displaced and/or not descended, at human systemic exposures following a maximum oral dose of 4 g/day based on body surface comparisons.

In a multigenerational developmental study in pregnant rats given doses of 0.3, 1, 3 g/kg/day icosapent ethyl by oral gavage from gestation day 7-17, icosapent ethyl did not affect viability in fetuses (F1 or F2). Non-dose-related imbalances in findings of absent optic nerves and unilateral testes atrophy at human exposures based on the maximum dose of 4 g/day and on body surface area comparisons.Additional variations consisting of early incisor eruption and increased percent cervical ribs were observed at the same exposures.

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

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

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

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

🤰 Pregnancy ~3 min read ▾

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

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

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and15-20%, respectively. Data Animal Data In pregnant rats given oral gavage doses of 0.3, 1 and 2 g/kg/day icosapent ethyl from gestation through organogenesis all drug treated groups had non-dose-related imbalances in visceral and skeletal findings, including 13th reduced ribs, additional liver lobes, testes medially displaced and/or not descended, at human systemic exposures following a maximum oral dose of 4 g/day based on body surface comparisons.

In a multigenerational developmental study in pregnant rats given doses of 0.3, 1, 3 g/kg/day icosapent ethyl by oral gavage from gestation day 7-17, icosapent ethyl did not affect viability in fetuses (F1 or F2). Non-dose-related imbalances in findings of absent optic nerves and unilateral testes atrophy at human exposures based on the maximum dose of 4 g/day and on body surface area comparisons.Additional variations consisting of early incisor eruption and increased percent cervical ribs were observed at the same exposures.

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

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

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

🧒 Pediatric Use 13 words ▾

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

🧓 Geriatric Use 55 words ▾

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

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Studies suggest that EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles. Potential mechanisms of action include increased β-oxidation; inhibition of acyl-CoA: 1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity.

12.2Pharmacodynamics In a 12-week, dose-ranging study in patients with severe hypertriglyceridemia, icosapent ethyl capsules 4 grams per day reduced median TG from baseline relative to placebo [ see Clinical Studies ( 14 ) ].

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

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

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

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

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

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

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

🧬 Mechanism of Action 50 words ▾

12.1Mechanism of Action Studies suggest that EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles. Potential mechanisms of action include increased β-oxidation; inhibition of acyl-CoA: 1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity.

📦 How Supplied / Storage and Handling 93 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Icosapent ethyl capsules are supplied as: Strength Quantity Description NDC 1 gram capsules Bottles of 120 Amber – coloured, oblong shaped soft gelatin capsules filled with colorless to light yellow liquid and bearing the designation “0958” on one side of the capsules 13668-761-12 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

📋 Description 106 words ▾

11 DESCRIPTION Icosapent ethyl, a lipid-regulating agent, is supplied as a 1 gram liquid-filled soft gelatin capsule for oral administration. Each icosapent ethyl capsule contains 1 gram of icosapent ethyl. Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA).

The empirical formula of icosapent ethyl is C 22 H 34 O 2 and the molecular weight is 330.5. The chemical name for icosapent ethyl is (5Z, 8Z, 11Z, 14Z, 17Z)-Eicosa-5, 8, 11, 14, 17-Pentaenoic Acid Ethyl Ester with the following chemical structure: Icosapent ethyl capsules contain the following inactive ingredients: dl-alpha tocopherol, gelatin, glycerin, sorbitol sorbitan solution, and purified water. Structure

🍼 Nursing Mothers 97 words ▾

8.2Lactation Risk Summary Published studies have detected omega-3 fatty acids, including EPA, in human milk. Lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk. There are no data on the effects of 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 icosapent ethyl capsules and any potential adverse effects on the breastfed child from icosapent ethyl capsules or from the underlying maternal condition.

🧬 Pharmacokinetics ~2 min read ▾

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

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

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

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

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

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

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

🧬 Pharmacodynamics 35 words ▾

12.2Pharmacodynamics In a 12-week, dose-ranging study in patients with severe hypertriglyceridemia, icosapent ethyl capsules 4 grams per day reduced median TG from baseline relative to placebo [ see Clinical Studies ( 14 ) ].

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES

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

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

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

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

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

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year rat carcinogenicity study with oral gavage doses of 0.09, 0.27, and 0.91 g/kg/day icosapent ethyl, respectively, males did not exhibit drug-related neoplasms. Hemangiomas and hemangiosarcomas of the mesenteric lymph node, the site of drug absorption, were observed in females at clinically relevant exposures based on body surface area comparisons across species relative to the maximum clinical dose of 4 g/day. Overall incidence of hemangiomas and hemangiosarcomas in all vascular tissues did not increase with treatment.

In a 6-month carcinogenicity study in Tg.rasH2 transgenic mice with oral gavage doses of 0.5, 1, 2, and 4.6 g/kg/day icosapent ethyl, drug-related incidences of benign squamous cell papilloma in the skin and subcutis of the tail was observed in high dose male mice. The papillomas were considered to develop secondary to chronic irritation of the proximal tail associated with fecal excretion of oil and therefore not clinically relevant. Drug-related neoplasms were not observed in female mice.

Icosapent ethyl was not mutagenic with or without metabolic activation in the bacterial mutagenesis (Ames) assay or in the in vivo mouse micronucleus assay. A chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells was positive for clastogenicity with and without metabolic activation. In an oral gavage rat fertility study, ethyl-EPA, administered at doses of 0.3, 1, and 3 g/kg/day to male rats for 9 weeks before mating and to female rats for 14 days before mating through day 7 of gestation, increased anogenital distance in female pups and increased cervical ribs were observed at 3 g/kg/day (7 times human systemic exposure with 4 g/day clinical dose based on a body surface area comparison).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year rat carcinogenicity study with oral gavage doses of 0.09, 0.27, and 0.91 g/kg/day icosapent ethyl, respectively, males did not exhibit drug-related neoplasms. Hemangiomas and hemangiosarcomas of the mesenteric lymph node, the site of drug absorption, were observed in females at clinically relevant exposures based on body surface area comparisons across species relative to the maximum clinical dose of 4 g/day. Overall incidence of hemangiomas and hemangiosarcomas in all vascular tissues did not increase with treatment.

In a 6-month carcinogenicity study in Tg.rasH2 transgenic mice with oral gavage doses of 0.5, 1, 2, and 4.6 g/kg/day icosapent ethyl, drug-related incidences of benign squamous cell papilloma in the skin and subcutis of the tail was observed in high dose male mice. The papillomas were considered to develop secondary to chronic irritation of the proximal tail associated with fecal excretion of oil and therefore not clinically relevant. Drug-related neoplasms were not observed in female mice.

Icosapent ethyl was not mutagenic with or without metabolic activation in the bacterial mutagenesis (Ames) assay or in the in vivo mouse micronucleus assay. A chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells was positive for clastogenicity with and without metabolic activation. In an oral gavage rat fertility study, ethyl-EPA, administered at doses of 0.3, 1, and 3 g/kg/day to male rats for 9 weeks before mating and to female rats for 14 days before mating through day 7 of gestation, increased anogenital distance in female pups and increased cervical ribs were observed at 3 g/kg/day (7 times human systemic exposure with 4 g/day clinical dose based on a body surface area comparison).

📄 Patient Package Insert ~3 min read ▾

Icosapent Ethyl Capsules (eye koe’ sa pent eth’il) What are icosapent ethyl capsules? Icosapent ethyl capsules are prescription medicine used: along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults. It is not known if icosapent ethyl capsules changes your risk of having inflammation of your pancreas (pancreatitis).

It is not known if icosapent ethyl capsulesare safe and effective in children. Do not take icosapent ethyl capsules if you are allergic to icosapent ethyl or any of the ingredients in icosapent ethyl capsules. See the end of this leaflet for a complete list of ingredients in icosapent ethyl capsules.

Before taking icosapent ethyl capsules, tell your doctor 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. are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish are also allergic to icosapent ethyl capsules. are pregnant, or planning to become pregnant. It is not known if icosapent ethyl capsules will harm your unborn baby. are breastfeeding or plan to breastfeed.

Icosapent ethyl can pass into your breast milk, and may harm your baby. Talk to your doctor about the best way to feed your baby if you take icosapent ethyl capsules. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and dietary or herbal supplements.

Icosapent ethyl capsules can interact with certain other medicines that you are taking. Especially tell your doctor if you take medicines that affect your blood clotting (anticoagulants or blood thinners). How should I take icosapent ethyl capsules?

Take icosapent ethyl capsules exactly as your doctor tells you to take it. Do not change your dose or stop taking icosapent ethyl capsules without talking to your doctor. Do not take more capsules than what is prescribed by your doctor.

If you are prescribed the 1-gram capsules, you should not take more than 4 capsules each day with food. Take icosapent ethyl capsules whole. Do not break, crush, dissolve, or chew icosapent ethyl capsules before swallowing.

If you miss a dose of icosapent ethyl capsules, take it as soon as you remember. However, if you miss one day of icosapent ethyl capsules, do not double your dose when you take it. Your doctor may start you on a diet that is low in saturated fat, cholesterol, carbohydrates, and low in added sugars before giving you icosapent ethyl capsules.

Stay on this diet while taking icosapent ethyl capsules. Your doctor may do blood tests to check your triglyceride and other lipid levels while you take icosapent ethyl capsules. What are the possible side effects of icosapent ethyl capsules?

Icosapent ethyl capsules may cause serious side effects, including: Heart rhythm problems (atrial fibrillation and atrial flutter). Heart rhythm problems which can be serious and cause hospitalization have happened in people who take icosapent ethyl capsules, especially in people who have heart (cardiovascular) disease or diabetes with a risk factor for heart (cardiovascular) disease, or who have had heart rhythm problems in the past. Tell your doctor if you get any symptoms of heart rhythm problems such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort, or you faint.

Possible allergic reactions if you are allergic to fish or shellfish. Stop taking icosapent ethyl capsules and tell your doctor right away or get emergency medical help if you have any signs or symptoms of an allergic reaction. Bleeding.

Serious bleeding can happen in people who take icosapent ethyl capsules. Your risk of bleeding may increase if you are also taking a blood thinner medicine. If you have liver problems and are taking icosapent ethyl capsules, your doctor should do blood tests during treatment.

The most common side effects o… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 4 words ▾

Icosapent Ethyl Capsule: label

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 Icosapent Ethyl — the program that covers self-administered drugs. 12 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 Icosapent Ethyl. 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
$40.25M
Claims incl. refills
227.1K
Beneficiaries
148.8K
Spend / beneficiary
$270.50
Spend / claim
$177.26
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 Torrent Pharmaceuticals Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Torrent Pharmaceuticals Limited 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.
← 13668-0760-60 · Torrent 13668-0775-30 · TORRENT →
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.