NDC 62332-0245-30 — Fenofibric Acid 135 mg, 30-count

🆔 Identity & classification

FDA NDC (as labeled) 62332-245-30

Product NDC 62332-245

11-digit billing NDC 62332024530

RxCUI 828373, 828379

UNII BGF9MN2HU1

Application # ANDA208705

SPL Set ID 8ffcb173-095a-4550-84f2-18959ad2aab8

Established class (EPC) Peroxisome Proliferator Receptor alpha Agonist

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2017-05-15

Route ORAL

Dosage form CAPSULE, DELAYED RELEASE

Substance FENOFIBRIC ACID

GPI-14 39200006006540

GPI class Fenofibric Acid

GCN Seq No 064677

GCN 16105

HICL code 036019

Ingredient (HICL) Fenofibric Acid (Choline)

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 24:06.06.00

AHFS class Fibric Acid Derivatives

FDB label name FENOFIBRIC ACID DR 135 MG CAP

FDB brand name Fenofibric Acid

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 62332-245-30 — 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 → 62332-0245-30. 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.

🏷️ RxNorm drug class

This medicine belongs to the Peroxisome Proliferator-activated Receptor alpha Agonist class.

Pharmacologic class Peroxisome Proliferator-activated Receptor alpha Agonist

Drug family (ATC) Fibrates

How it works Peroxisome Proliferator-activated Receptor alpha Agonists

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAlembic Pharmaceuticals Inc.

Application holderALEMBIC PHARMACEUTICALS LTD

FDA applicationANDA208705 (ANDA)

Labeler code62332

First marketedMay 2017

Product typeHuman Prescription Drug

Portfolio491 products on file

🔎 All NDCs from Alembic Pharmaceuticals Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name FENOFIBRIC ACID DR 135 MG CAP Ingredient Fenofibric Acid (Choline)

📗 Our plain-language guide HelloPharmacist

Fenofibrate helps bring your blood lipid levels into a healthier range. Depending on your situation, that might mean lowering your triglycerides, bringing down your LDL (bad) chole...
What exactly is fenofibrate supposed to do for me?
It depends on which form you have. Lipofen capsules should be taken with food. Antara capsules and most fenofibrate tablets can be taken with or without food. Some film-coated feno...
Does it matter if I take this with food or on an empty stomach?

📖 Read our full Fenofibrate guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 What it looks like

Color Brown / Blue

ShapeCapsule

ImprintA;139

Size21 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.

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

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 system	Per each	Per 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	$0.5579	$16.74 / 30 capsules

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Fenofibric Acid 135 mg 00115-1325-10	Amneal	90 capsules	$0.295	AB	Availability likely	—
Fenofibric Acid 135 mg 00115-1555-10	Amneal	90 capsules	$0.295	—	Discontinued	—
Fenofibric Acid 135 mg 59651-0217-90	Aurobindo	90 capsules	$0.295	AB	Availability likely	—
Fenofibric Acid 135 mg 69315-0282-09	Leading	90 capsules	$0.295	AB	Availability likely	—
Fenofibric acid 135 mg 33342-0295-10	Macleods	90 capsules	—	—	FDA listed	—
Fenofibric Acid Delayed-Release 135 mg 42385-0945-11	Laurus	1000 capsules	—	AB	Discontinued	—
Fenofibric acid 135 mg 42571-0348-05	Micro	500 capsules	—	AB	Discontinued	—
Fenofibric Acid 135 mg 46708-0245-30	Alembic	30 capsules	—	AB	FDA listed	—
Fenofibric Acid 135 mgthis 62332-0245-30	Alembic	30 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

🏛️

2017

On the market since

May 2017

📍

2026

Currently FDA-listed

9 years listed

🔓

·

Generic on the market

this product is a generic

✅This is a generic drug

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

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

90 capsules62332-0245-90 1,755 Rx · $41,922

30 capsules this page62332-0245-30 No Medicaid data

1000 capsules62332-0245-91 No Medicaid data

Drug total (last 4 qtrs): 1,755 Rx · 80,334 units · $41,922 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Fenofibric Acid — the program that covers self-administered drugs. 6 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 Fenofibric Acid. 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

$1.62M

Claims incl. refills

37.2K

Beneficiaries

30.5K

Spend / beneficiary

$52.97

Spend / claim

$43.49

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Fatigue67

Nausea56

Diarrhoea50

Pain42

Dyspnoea37

Headache37

Arthralgia34

Age at onset

Adult81

Elderly74

Reporter sex

Male · 55%

Female · 45%

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
62332-0245-30 You're viewing this	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-245-30)	—	—	2017-05-15	Active
62332-0245-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-245-90)	$0.2947 / ea	$26.52	2017-05-15	Active
62332-0245-91	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-245-91)	—	—	2017-05-15	Active

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

This pack shows little to no recent Medicaid volume — the 90 capsules pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 62332-0245-30?

NDC 62332-0245-30 is a 30-count package — 30 capsule, delayed release in 1 bottle.

What is the difference between NDC 62332-0245-30 and NDC 62332-0245-90?

Both are Fenofibric Acid 135 mg Capsule, Delayed Release — the drug itself is identical. NDC 62332-0245-30 is the 30-count package, while NDC 62332-0245-90 is the 90 capsules package.

What NDC number is used to bill for this package of Fenofibric Acid 135 mg Capsule, Delayed Release?

Bill NDC 62332-0245-30 — the 11-digit billing format is 62332024530. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

🧭 About this NDC listing & data coverage

Finished prescription product

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)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 62332-245-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 62332-0245-30, written without dashes as 62332024530. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 62332-0245-30, the first segment (62332) is the labeler code FDA assigned to Alembic Pharmaceuticals Inc.; the middle segment (0245) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alembic Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 2 other package presentations of this same product, including 90 capsules (62332-0245-90), 1000 capsules (62332-0245-91). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Alembic Pharmaceuticals 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Fenofibric acid delayed-release capsules indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use • Markedly elevated levels of serum TG (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis.

The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)]. • Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)]. Fenofibric acid delayed-release capsules are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunct to diet: • to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL) (1). • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible (1).

Limitations of Use: • Markedly elevated levels of serum TG (e.g., >2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined (1). • Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus (1).

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Severe hypertriglyceridemia: 45 to 135 mg orally once daily; the dosage should be adjusted according to patient response (2.2). Primary hyperlipidemia: 135 mg orally once daily (2.2). Administer as a single dose, at any time of day, with or without food (2.2).

Assess TG when clinically appropriate, as early as 4 to 8 weeks after initiating fenofibric acid delayed-release capsules. Discontinue fenofibric acid delayed-release capsules in patients who do not have an adequate response after 2 months of treatment (2.2). Swallow capsules whole.

Do not crush, break, dissolve, or chew (2.2). Renal impairment: Initial dosage of 45 mg orally once daily (2.3). Geriatric patients: Select the dosage on the basis of renal function (2.4).

2.1Prior to Initiation of Fenofibric Acid Delayed-Release Capsules • Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high TG levels and manage as appropriate. • Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibric acid delayed-release capsules, and should continue this diet during treatment with fenofibric acid delayed-release capsules. • In patients with diabetes and fasting chylomicronemia, improve glycemic control prior to considering starting fenofibric acid delayed-release capsules.

2.2Recommended Dosage and Administration • Severe hypertriglyceridemia: o The recommended dosage of fenofibric acid delayed-release capsule is 45 mg or 135 mg orally once daily. o Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. • Primary hyperlipidemia: o The recommended dosage of fenofibric acid delayed-release capsule is 135 mg orally once daily. • Administer fenofibric acid delayed-release capsule as a single dose at any time of day, with or without food. • Advise patients to swallow fenofibric acid delayed-release capsules whole.

Do not crush, break, dissolve, or chew capsules. • Assess TG when clinically appropriate, as early as 4 to 8 weeks after initiating fenofibric acid delayed-release capsules. Discontinue fenofibric acid delayed-release capsules in patients who do not have an adequate response after two months of treatment. • If a dose is missed, advise patients not to take an extra dose. Resume treatment with the next dose. • Advise patients to take fenofibric acid delayed-release capsules at least 1 hour before or 4 hours to 6 hours after a bile acid binding resin to avoid impeding its absorption.

2.3Recommended Dosage in Patients with Renal Impairment • Assess renal function prior to initiation of fenofibric acid delayed-release capsules and periodically thereafter [see Warnings and Precautions (5.4)] . • Treatment with fenofibric acid delayed-release capsules should be initiated at a dosage of 45 mg orally once daily in patients with mild to moderately impaired renal function (eGFR 30 to <60 mL/min/1.73m 2 ), and increased only after evaluation of the effects on renal function and TG levels at this dosage. • Fenofibric acid delayed-release capsule is contraindicated in patients with severe renal impairment (eGFR <30 mL/min/1.73m 2 ), including those with end-stage renal disease (ESRD) and those receiving dialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

2.4Recommended Dosage in Geriatric Patients Dosage selection for geriatric patients should be made on the basis of renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

💊 Dosage Forms and Strengths 98 words ▾

3 DOSAGE FORMS AND STRENGTHS • 45 mg capsules with a brown opaque cap/ yellow opaque body size ‘3’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘138’ on the body in black ink, filled with white to off white mini tablets. • 135 mg capsules with a blue opaque cap/ yellow opaque body size ‘0’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘139’ on the body in black ink, filled with white to off white mini tablets. Delayed Release Capsules: 45 mg and 135 mg (3)

⛔ Contraindications 134 words ▾

4 CONTRAINDICATIONS Fenofibric acid delayed-release capsules are contraindicated in patients with: Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis [see Clinical Pharmacology (12.3)]. Active liver disease, including those with unexplained persistent liver function abnormalities [see Warnings and Precautions (5.2)] . Pre-existing gallbladder disease [see Warnings and Precautions (5.5)] .

Hypersensitivity to fenofibric acid, fenofibrate, or any of the excipients in fenofibric acid delayed-release capsules. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with fenofibrate [see Warnings and Precautions (5.9)]. Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis (4).

Active liver disease including those with unexplained persistent liver function abnormalities (4). Pre-existing gallbladder disease (4). Hypersensitivity to fenofibric acid, fenofibrate, or any of the excipients in fenofibric acid delayed-release capsules (4).

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Serious drug-induced liver injury, including liver transplantation and death, has been reported with fenofibrates, including fenofibric acid delayed-release capsules. Monitor patient’s liver function, including serum ALT, AST, and total bilirubin, at baseline and periodically for the duration of therapy. Discontinue if signs or symptoms of liver injury develop or if elevated enzyme levels persist (5.2).

Myopathy and Rhabdomyolysis : Have been reported in patients taking fenofibrate. Risks are increased during co-administration with a statin, in geriatric patients, and in patients with renal impairment or hypothyroidism. Discontinue fenofibric acid delayed-release capsulesif markedly elevated CK levels occur or if myopathy is either diagnosed or suspected.

Temporarily discontinue fenofibric acid delayed-release capsulesin patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the fenofibric acid delayed-release capsulesdosage. Instruct patients to promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever (5.3).

Increases in Serum Creatinine: Monitor renal function in patients with renal impairment taking fenofibric acid delayed-release capsules. Consider monitoring renal function in patients at risk for renal impairment (5.4). Cholelithiasis: Fenofibrate may increase cholesterol excretion into the bile, leading to cholelithiasis.

If cholelithiasis is suspected, gallbladder studies are indicated (5.5). Hypersensitivity Reactions: Acute hypersensitivity reactions, including anaphylaxis and angioedema, and delayed hypersensitivity reactions, including severe cutaneous adverse drug reactions have been reported postmarketing. Some cases were life-threatening and required emergency treatment.

Discontinue fenofibric acid delayed-release capsulesand treat patients appropriately if reactions occur (5.9).

5.1Mortality and Coronary Heart Disease Morbidity Fenofibrate did not reduce cardiovascular disease morbidity or mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Clinical Studies ( 14.4)] . Because of chemical, pharmacological, and clinical similarities between fenofibrates, including fenofibric acid delayed-release capsules; pemafibrate; clofibrate; and gemfibrozil; the findings in 5 large randomized, placebo-controlled clinical trials with these other fibrate drugs may also apply to fenofibric acid delayed-release capsules.

Pemafibrate did not reduce cardiovascular disease morbidity or mortality in a large, randomized, placebo-controlled trial of patients with type 2 diabetes mellitus on background statin therapy [see Clinical Studies ( 14.4)] . In the Coronary Drug Project, a large trial conducted from 1965 to 1985 in men post myocardial infarction, there was no difference in mortality or nonfatal myocardial infarction between the clofibrate group and the placebo group after 5 years of treatment (NCT00000482). In a trial conducted by the World Health Organization (WHO) from 1965 to 1976, men without known coronary artery disease were treated with placebo or clofibrate for 5 years and followed for an additional 1 year.

There was a statistically significant, higher age-adjusted all-cause mortality in the clofibrate group compared with the placebo group (5.7% vs. 3.96%, p ≤ 0.01). Excess mortality was due to a 33% increase in non-cardiovascular causes, including malignancy, post-cholecystectomy complications, and pancreatitis.

The Helsinki Heart Study, conducted from 1982 to 1987, was a large (N = 4,081) trial of middle-aged men without a history of coronary artery disease. Subjects received either placebo or gemfibrozil for 5 years, with a 3.5-year open extension afterward. Total mortality was numerically but not statistically highe…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Mortality and coronary heart disease morbidity [see Warnings and Precautions (5.1)] Hepatoxicity [see Warnings and Precautions (5.2)] Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.3)] Increases in Serum Creatinine [see Warnings and Precautions (5.4)] Cholelithiasis [see Warnings and Precautions (5.5)] Increased Bleeding Risk with Coumarin Anticoagulants [see Warnings and Precautions (5.6)] Pancreatitis [see Warnings and Precautions (5.7)] Hematologic Changes [see Warnings and Precautions (5.8)] Hypersensitivity reactions [see Warnings and Precautions (5.9)] Venothromboembolic disease [see Warnings and Precautions (5.10)] Paradoxical Decreases in HDL Cholesterol Levels [see Warnings and Precautions (5.11)] Adverse reactions (≥ 2% and greater than placebo): abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 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 to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of fenofibric acid delayed-release capsules has been established in adults with hypertriglyceridemia or primary hyperlipidemia based on adequate and well-controlled trials of other formulations of fenofibrate, referenced below as “fenofibrate” [see Clinical Studies (14)].

Dosages of fenofibrate used in these trials were comparable to fenofibric acid delayed-release capsules 135 mg per day [see Clinical Pharmacology (12.3)]. Adverse reactions reported by 2% or more of patients treated with fenofibrate (and greater than placebo) during the double-blind, placebo-controlled trials are listed in Table 1. Adverse reactions led to discontinuation of treatment in 5% of patients treated with fenofibrate and in 3% treated with placebo.

Increases in liver function tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials. Table 1. Adverse Reactions Reported by 2% or More of Patients Treated with Fenofibrate and Greater than Placebo During the Double-Blind, Placebo-Controlled Trials Adverse Reaction Placebo (N = 365) Fenofibrate (N = 439) Abnormal Liver Tests 1% 8% Abdominal Pain 4% 5% Increased ALT 2% 3% Increased AST 1% 3% Increased Creatine Phosphokinase 1% 3% Constipation 1% 2% Rhinitis 1% 2% Other Adverse Reactions Urticaria Urticaria was seen in 1.1% vs.

0%, and rash in 1.4% vs. 0.8% of fenofibrate and placebo patients respectively in controlled trials. Increases in Liver Enzymes In a pooled analysis of three 12-week, double-blind, controlled studies of fenofibric acid delayed-release capsules, increases in ALT and AST > 3 times the upper limit of normal on two consecutive occasions occurred in 1.9% and 0.2%, respectively, of patients receiving fenofibric acid delayed-release capsules 135 mg daily and placebo, without other lipid-altering drugs.

In a pooled analysis of 10 placebo-controlled trials, increases to > 3 times the upper limit of normal in ALT occurred in 5.3% of patients taking either an intermediate or maximum recommended daily dosage of fenofibrate versus 1.1% of patients treated with placebo. In an 8-week trial, the incidence of ALT or AST elevations ≥ 3 times the upper limit of normal was 13% in patients receiving an intermediate daily dosage or the maximum recommended daily dosage of fenofibrate and was 0% in those receiving the lowest recommended daily dosage of fenofibrate or placebo [see Warnings and Precautions 5.2].

Clinical trials with fenofibric acid delayed-release capsules did not include a placebo-control arm. However, the ad…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 2 presents clinically important drug interactions with fenofibric acid delayed-release capsules. Table 2. Clinically Important Drug Interactions with Fenofibric Acid Delayed-Release Capsules Statins Clinical Impact: Fibrates may cause myopathy when given alone.

The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins. Intervention: Consider if the benefit of using fenofibric acid delayed-release capsules concomitantly with statin therapy outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dosage titration of statin therapy.

Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with fenofibrates. Intervention: Consider if the benefit of using colchicine concomitantly with fenofibric acid delayed-release capsules outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dosage titration of colchicine.

Coumarin Anticoagulants Clinical Impact: Fibrates may cause potentiation of coumarin-type anticoagulant effects with prolongation of the PT/INR. Intervention: Caution should be exercised when coumarin anticoagulants are given in conjunction with fenofibric acid delayed-release capsules. The dosage of the anticoagulants should be reduced to maintain the PT/INR at the desired level to prevent bleeding complications.

Frequent PT/INR determinations are advisable until it has been definitely determined that the PT/INR has stabilized Immunosuppressants Clinical Impact: Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including fenofibric acid delayed-release capsules, there is a risk that an interaction will lead to deterioration of renal function. Intervention: The benefits and risks of using fenofibric acid delayed-release capsules with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dosage employed and renal function monitored.

Bile-Acid Binding Resins Clinical Impact: Bile-acid binding resins may bind other drugs given concurrently. Intervention: In patients taking a bile acid resin, administer fenofibric acid delayed-release capsules at least 1 hour before or 4 to 6 hours after the bile acid resin to avoid impeding its absorption. Consider if the benefit of concomitant use of statins or colchicine outweighs the increased risk of myopathy and rhabdomyolysis.

Monitor patients for signs and symptoms of myopathy (7). Exercise caution in concomitant treatment with coumarin anticoagulants. Reduce the dosage of coumarin to maintain the PT/INR at the desired level to prevent bleeding complications (7).

Consider the benefits and risks of concomitant use with immunosuppressants and other potentially nephrotoxic agents. Use the lowest effective dosage and monitor renal function (7). Administer fenofibric acid delayed-release capsules at least 1 hour before or 4 to 6 hours after a bile acid resin to avoid impeding its absorption (7).

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or comparable to the maximum recommended clinical dosage of 135 mg of fenofibric acid delayed-release capsules daily, based on body surface area (mg/m 2 ).

Adverse reproductive outcomes occurred at higher doses in the presence of maternal toxicity (see Data). Fenofibric acid delayed-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In pregnant rats given oral dietary doses of 14 mg/kg/day, 127 mg/kg/day, and 361 mg/kg/day from gestation day 6 to 15 during the period of organogenesis, no adverse developmental findings were observed at 14 mg/kg/day (less than the clinical exposure at the maximum recommended human dose [MRHD] of 300 mg fenofibrate daily, comparable to 135 mg fenofibric acid delayed-release capsule daily, based on body surface area comparisons).

Increased fetal skeletal malformations were observed at maternally toxic doses (361 mg/kg/day, corresponding to 12 times the clinical exposure at the MRHD) that significantly suppressed maternal body weight gain. In pregnant rabbits given oral gavage doses of 15 mg/kg/day, 150 mg/kg/day, and 300 mg/kg/day from gestation day 6 to 18 during the period of organogenesis and allowed to deliver, no adverse developmental findings were observed at 15 mg/kg/day (a dose that approximates the clinical exposure at the MRHD, based on body surface area comparisons).

Aborted litters were observed at maternally toxic doses (≥ 150 mg/kg/day, corresponding to ≥ 10 times the clinical exposure at the MRHD) that suppressed maternal body weight gain. In pregnant rats given oral dietary doses of 15 mg/kg/day, 75 mg/kg/day, and 300 mg/kg/day from gestation day 15 through lactation day 21 (weaning), no adverse developmental effects were observed at 15 mg/kg/day (less than the clinical exposure at the MRHD, based on body surface area comparisons), despite maternal toxicity (decreased weight gain).

Post-implantation loss was observed at ≥ 75 mg/kg/day (≥ 2 times the clinical exposure at the MRHD) in the presence of maternal toxicity (decreased weight gain). Decreased pup survival was noted at 300 mg/kg/day (10 times the clinical exposure at the MRHD), which was associated with decreased maternal body weight gain/maternal neglect.

8.2Lactation Risk Summary There is no available information on the presence of fenofibrate in human milk, effects of the drug on the breastfed infant, or the effects on milk production. Fenofibrate is present in the milk of rats and is therefore likely to be present in human milk. Because of the potential for serious adverse reactions in breastfed infants, such as disruption of infant lipid metabolism, women should not breastfeed during treatment with fenofibric acid delayed-release capsules and for 5 days after the final dose.

8.4Pediatric Use The safety and effectiveness of fenofibric acid delayed-release capsules have not been established in pediatric patients with severe hypertriglyceridemia or primary hyperlipidemia.

8.5Geriatric Use Assess renal function in geriatric patients and follow contraindications and dosing recommendations for patients with renal impairment [see Contraindications (4), Warnings and Precautions (5.3, 5.4), and Use in Specific Populations (8.6)] . Whi…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or comparable to the maximum recommended clinical dosage of 135 mg of fenofibric acid delayed-release capsules daily, based on body surface area (mg/m 2 ).

Adverse reproductive outcomes occurred at higher doses in the presence of maternal toxicity (see Data). Fenofibric acid delayed-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In pregnant rats given oral dietary doses of 14 mg/kg/day, 127 mg/kg/day, and 361 mg/kg/day from gestation day 6 to 15 during the period of organogenesis, no adverse developmental findings were observed at 14 mg/kg/day (less than the clinical exposure at the maximum recommended human dose [MRHD] of 300 mg fenofibrate daily, comparable to 135 mg fenofibric acid delayed-release capsule daily, based on body surface area comparisons).

Increased fetal skeletal malformations were observed at maternally toxic doses (361 mg/kg/day, corresponding to 12 times the clinical exposure at the MRHD) that significantly suppressed maternal body weight gain. In pregnant rabbits given oral gavage doses of 15 mg/kg/day, 150 mg/kg/day, and 300 mg/kg/day from gestation day 6 to 18 during the period of organogenesis and allowed to deliver, no adverse developmental findings were observed at 15 mg/kg/day (a dose that approximates the clinical exposure at the MRHD, based on body surface area comparisons).

Aborted litters were observed at maternally toxic doses (≥ 150 mg/kg/day, corresponding to ≥ 10 times the clinical exposure at the MRHD) that suppressed maternal body weight gain. In pregnant rats given oral dietary doses of 15 mg/kg/day, 75 mg/kg/day, and 300 mg/kg/day from gestation day 15 through lactation day 21 (weaning), no adverse developmental effects were observed at 15 mg/kg/day (less than the clinical exposure at the MRHD, based on body surface area comparisons), despite maternal toxicity (decreased weight gain).

Post-implantation loss was observed at ≥ 75 mg/kg/day (≥ 2 times the clinical exposure at the MRHD) in the presence of maternal toxicity (decreased weight gain). Decreased pup survival was noted at 300 mg/kg/day (10 times the clinical exposure at the MRHD), which was associated with decreased maternal body weight gain/maternal neglect.

🧒 Pediatric Use 25 words ▾

8.4Pediatric Use The safety and effectiveness of fenofibric acid delayed-release capsules have not been established in pediatric patients with severe hypertriglyceridemia or primary hyperlipidemia.

🧓 Geriatric Use 79 words ▾

8.5Geriatric Use Assess renal function in geriatric patients and follow contraindications and dosing recommendations for patients with renal impairment [see Contraindications (4), Warnings and Precautions (5.3, 5.4), and Use in Specific Populations (8.6)] . While fenofibric acid exposure is not influenced by age, geriatric patients are more likely to have renal impairment, and fenofibric acid is substantially excreted by the kidney [see Clinical Pharmacology (12.3)] . Consider monitoring renal function in geriatric patients taking fenofibric acid delayed-release capsules.

🆘 Overdosage 102 words ▾

10 OVERDOSAGE In the event of an overdose of fenofibric acid delayed-release capsules, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. There is no specific treatment for overdose with fenofibric acid delayed-release capsules. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur.

If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibric acid delayed-release capsules are highly bound to plasma proteins, hemodialysis should not be considered.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The active moiety of fenofibric acid delayed-release capsule is fenofibric acid. The pharmacological effects of fenofibric acid in both animals and humans have been studied through oral administration of fenofibrate. The lipid-modifying effects of fenofibric acid seen in clinical practice have been explained in vivo in transgenic mice and in vitro in human hepatocyte cultures by the activation of PPAR alpha receptor.

Through this mechanism, fenofibric acid increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III (an inhibitor of lipoprotein lipase activity).

12.2Pharmacodynamics Fenofibric acid, the active metabolite of fenofibrate, produces reductions in total cholesterol (Total-C), total triglycerides, and triglyceride rich lipoprotein (VLDL) in treated patients with severe hypertriglyceridemia.

12.3Pharmacokinetics Fenofibric acid delayed-release capsules contain fenofibric acid, which is the circulating pharmacologically active moiety in plasma after oral administration of fenofibric acid delayed-release capsules. Fenofibric acid is also the circulating pharmacologically active moiety in plasma after oral administration of fenofibrate, the ester of fenofibric acid. Absorption Fenofibric acid is well absorbed throughout the gastrointestinal tract.

The absolute bioavailability of fenofibric acid is approximately 81%. Peak plasma levels of fenofibric acid occur within 4 to 5 hours after a single dose administration of fenofibric acid delayed-release capsule under fasting conditions. Effect of Food Fenofibric acid exposure in plasma, as measured by C max and AUC, is not significantly different when a single 135 mg dose of fenofibric acid delayed-release capsule is administered under fasting or nonfasting conditions.

Distribution Upon multiple dosing of fenofibric acid delayed-release capsules, fenofibric acid levels reach steady state within 8 days. Plasma concentrations of fenofibric acid at steady state are approximately double those following a single dose. Serum protein binding was approximately 99% in normal and dyslipidemic subjects.

Elimination Fenofibric acid is eliminated with a half-life of approximately 20 hours, allowing once daily administration of fenofibric acid delayed-release capsules. Metabolism Fenofibric acid is primarily conjugated with glucuronic acid and then excreted in urine. A small amount of fenofibric acid is reduced at the carbonyl moiety to a benzhydrol metabolite which is, in turn, conjugated with glucuronic acid and excreted in urine.

In vivo metabolism data after fenofibrate administration indicate that fenofibric acid does not undergo oxidative metabolism (e.g., cytochrome P450) to a significant extent. Excretion After absorption, fenofibric acid delayed-release capsules are primarily excreted in the urine in the form of fenofibric acid and fenofibric acid glucuronide. Specific Populations Geriatrics Patients In geriatrics volunteers 77 to 87 years of age, the oral clearance of fenofibric acid following a single oral dose of fenofibrate was

1.2 L/h, which compares to

1.1L/h in young adults. This indicates that a similar dosage regimen can be used in geriatric patients with normal renal function, without increasing accumulation of the drug or metabolites [see Dosage and Administration (2.4) and Use in Specific Populations (8.5)] . Pediatric Patients The pharmacokinetics of fenofibric acid delayed-release capsules has not been studied in pediatric populations.

Male and Female Patients No pharmacokinetic difference between males and females has been observed for fenofibric acid. Racial and Ethnic Groups The influence of race on the pharmacokinetics of fenofibric acid has not been studied; however, fenofibric acid is not metabolized by enzymes known for exhibiting inter-ethnic variability. Patients with Renal Impairment The pharmacokinetics of feno…

🧬 Mechanism of Action 96 words ▾

12.1Mechanism of Action The active moiety of fenofibric acid delayed-release capsule is fenofibric acid. The pharmacological effects of fenofibric acid in both animals and humans have been studied through oral administration of fenofibrate. The lipid-modifying effects of fenofibric acid seen in clinical practice have been explained in vivo in transgenic mice and in vitro in human hepatocyte cultures by the activation of PPAR alpha receptor.

Through this mechanism, fenofibric acid increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III (an inhibitor of lipoprotein lipase activity).

📦 How Supplied / Storage and Handling 163 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Fenofibric acid delayed-release capsules 45 mg have a brown opaque cap/ yellow opaque body size ‘3’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘138’ on the body in black ink, filled with white to off white mini tablets. NDC 62332-244-30 30 Capsules HDPE Bottle Pack NDC 62332-244-90 90 Capsules HDPE Bottle Pack NDC 62332-244-91 1000 Capsules HDPE Bottle Pack Fenofibric acid delayed-release capsules 135 mg have a blue opaque cap/ yellow opaque body size ‘0’ hard gelatin capsule imprinted with ‘A’ on the cap in white ink and ‘139’ on the body in black ink, filled with white to off white mini tablets.

NDC 62332-245-30 30 Capsules HDPE Bottle Pack NDC 62332-245-90 90 Capsules HDPE Bottle Pack NDC 62332-245-91 1000 Capsules HDPE Bottle Pack Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.

📋 Description ~1 min read ▾

11 DESCRIPTION Fenofibric acid delayed-release capsules are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as delayed release capsules for oral administration. Fenofibric acid delayed-release capsules are a lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid.

The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula: The empirical formula is C 22 H 28 ClNO 5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water and methanol. The melting point is approximately 210°C.

Choline fenofibrate is a white to off-white crystalline powder, which is stable under ordinary conditions. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: colloidal silicon dioxide, hydroxylpropyl cellulose, hypromellose, methacrylic acid copolymer, povidone, sodium stearyl fumarate, talc, triethyl citrate, water. The capsule shell of the 45 mg capsule contains the following inactive ingredients: gelatin, iron oxide red, iron oxide yellow and titanium dioxide.

The capsule shell of the 135 mg capsule contains the following inactive ingredients: FD&C Blue #2, gelatin, iron oxide yellow and titanium dioxide. The capsule shells are printed with edible black ink and white ink. The edible white ink contains potassium hydroxide, propylene glycol, shellac and titanium dioxide and the edible black ink contains iron oxide black, potassium hydroxide, propylene glycol and shellac. structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Hepatotoxicity Inform patients that fenofibric acid delayed-release capsules may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Contraindications (4) and Warnings and Precautions (5.2)] . Myopathy and Rhabdomyolysis Advise patients that fenofibric acid delayed-release capsules may cause myopathy and rhabdomyolysis.

Inform patients that the risk is also increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patients to inform other healthcare providers prescribing a new medication or increasing the dosage of an existing medication that they are taking fenofibric acid delayed-release capsules. Instruct patients to promptly report any unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.3) and Drug Interactions (7)] .

Increased Bleeding Risk with Coumarin Anticoagulants Inform patients that the concomitant use of fenofibric acid delayed-release capsules with coumarin-type anticoagulants may increase the risk of bleeding. Advise patients if they are taking or planning to take coumarin-type anticoagulants to inform their healthcare providers and that increased monitoring may be necessary [see Warnings and Precautions (5.6) and Drug Interactions (7)] . Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions, such as anaphylaxis and angioedema, have been reported with fenofibrates.

Advise patients to report immediately any signs or symptoms suggesting allergic reaction, and to discontinue drug until they have consulted prescribing physicians [see Warnings and Precautions (5.9)] . Pregnancy Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if fenofibric acid delayed-release capsules should be discontinued [see Use in Specific Populations (8.1)] . Lactation Advise patients that breastfeeding during treatment with fenofibric acid delayed-release capsule is not recommended [see Use in Specific Populations (8.2)].

Missed Doses If a dose is missed, advise patients to not take an extra dose and to resume treatment with the next dose. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For more information call Alembic Pharmaceuticals Limited at 1-866-210-9797. Brands listed are the trademarks of their respective owners. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc.

Bedminster, NJ 07921, USA Revised: 07/2025

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adjunctive therapy: A medicine added alongside a main treatment to help it work better.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

cholelithiasis: Gallstones; hardened deposits that form inside the gallbladder.

CK: A protein measured in a blood test that rises when muscle is being damaged.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

delayed-release: A pill coated so it does not release its medicine until after it has passed through the stomach.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

eGFR: Estimated glomerular filtration rate, a blood-test-based estimate of how well the kidneys filter; lower numbers mean weaker function.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

end-stage renal disease: The most advanced, permanent stage of kidney failure, usually needing dialysis or a kidney transplant.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertriglyceridemia: A higher-than-normal level of triglycerides, a type of fat, in the blood.

hypothyroidism: A condition where the thyroid gland makes too little thyroid hormone, which can slow the body down.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

INR: A blood test result that shows how quickly blood clots, often used to monitor blood-thinning medicines.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

myopathy: A disease of the muscles that can make them weak, painful, or tender.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

nephrotoxicity: Damage to the kidneys caused by a medicine or other substance.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

pooled analysis: Combining the results of several separate studies into one larger group to look at the overall pattern.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal excretion: Removal of a medicine from the body through the kidneys into the urine.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

rhabdomyolysis: A serious condition where damaged muscle breaks down and releases material into the blood that can harm the kidneys.

serum creatinine: A waste product measured in a blood test; higher levels can mean the kidneys are not filtering as well as normal.

statistically significant: A result unlikely to be due to chance alone, suggesting a real difference between the groups being compared.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

upper limit of normal: The highest value considered normal for a lab test; results above it are flagged as elevated.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

🔗 Related NDC lookups

🧪 All Fenofibric Acid NDCsSame ingredient 🏭 All Alembic labeler NDCsLabeler code 62332 📚 All Peroxisome Proliferator Receptor alpha Agonist NDCsDrug class 📖 Read the Fenofibric Acid drug informationUses, warnings & side effects

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Fenofibric Acid 135 mg Capsule, Delayed Release, 30-count

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🧪 Inactive Ingredients / Excipients

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💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

💊 Medicaid utilization by pack size

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

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

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📦 Packaging — all sizes for this product

Pack size FAQ

🧭 About this NDC listing & data coverage

Questions about this listing

📄 Full prescribing information FDA SPL

8 USE IN SPECIFIC POPULATIONS

12 CLINICAL PHARMACOLOGY

1.2 L/h, which compares to

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