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Carvedilol 6.25 mg Tablet, Film Coated, 60-count — NDC 63187-0424-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Carvedilol 6.25 mg Tablet, Film Coated, 60-count — NDC 63187-424-60 (Billing 63187-0424-60)

by Proficient Rx LP · 60 TABLET, FILM COATED in 1 BOTTLE

This is a package of 60 tablets of Carvedilol 6.25 mg Tablet, Film Coated from Proficient Rx LP, marketed since Sep 2007 and currently FDA-listed.

NDC 63187-0424-60
🏷️ FDA NDC (as labeled) 63187-424-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.0650/unit — full pricing hub ↓
Product page 63187-0424-30 Also comes in: 30 tablets 63187-424-30
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Carvedilol (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 20, 2025 — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm (The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories) · FDA recall D-0594-2025
Class II · Aug 7, 2025 — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0578-2025
Class II · Aug 7, 2025 — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0577-2025
Class II · Aug 7, 2025 — CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0579-2025
Class II · Aug 6, 2025 — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0588-2025
Class II · Aug 6, 2025 — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0587-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63187-424-60
Product NDC 63187-424
11-digit billing NDC 63187042460
RxCUI 200031
UNII 0K47UL67F2
Application # ANDA077614
SPL Set ID d5822e3c-413c-4c7e-bbec-d0d42d2028ba
Established class (EPC) alpha-Adrenergic Blocker; beta-Adrenergic Blocker
Mechanism of action Adrenergic alpha-Antagonists; Adrenergic beta1-Antagonists; Adrenergic beta2-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-09-05
Route ORAL
Dosage form TABLET, FILM COATED
Substance CARVEDILOL
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 028109
GCN 01554
HICL code 013795
Ingredient (HICL) Carvedilol
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J7
Therapeutic class — intermediate (HIC2) Antiadrenergics
HIC3 code J7A
Therapeutic class — specific (HIC3) Alpha/Beta-Adrenergic Blocking Agents
AHFS code 12:16.04.12
AHFS class Selective Alpha-1-Adrenergic Block.agent
FDB label name CARVEDILOL 6.25 MG TABLET
FDB brand name Carvedilol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 028109
  • GCN: 01554
  • HICL (First Databank): 013795
  • AHFS class code: 12:16.04.12
  • RxCUI (RxNorm): 200031
Why two NDCs? The FDA registers this code as 63187-424-60 — 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 → 63187-0424-60. 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 alpha-Adrenergic Blocker class.

Pharmacologic class alpha-Adrenergic Blocker, beta-Adrenergic Blocker
Drug family (ATC) Alpha and beta blocking agents
How it works Adrenergic alpha-Antagonists, Adrenergic beta1-Antagonists, Adrenergic beta2-Antagonists
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.

Clinical

Label name CARVEDILOL 6.25 MG TABLET Ingredient Carvedilol
📖 What it is MedlinePlus · NLM

Carvedilol is used to treat heart failure (condition in which the heart cannot pump enough blood to all parts of the body) and high blood pressure. It also is used to improve survival after a heart attack.  Carvedilol is in a class of medications called beta-blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Carvedilol works in two ways at once. It blocks beta receptors, which slows your heart rate and reduces how hard your heart has to work. It also blocks alpha-1 receptors, which rel...
  • What is carvedilol actually doing for my heart?
  • Yes, it really does matter. Taking carvedilol with food slows down how fast it's absorbed into your bloodstream. That slower absorption significantly reduces the chance of feeling...
  • Why do I have to take it with food? Does it matter?
📖 Read our full Carvedilol guide →
1
Nutrient depletion considerations

Carvedilol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Carvedilol nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0650 $3.90 / 60 tablets
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
63187-0424-60 You're viewing this 60 TABLET, FILM COATED in 1 BOTTLE 2018-12-01 — Active
63187-0424-30 63187-424-30 Main listing 30 TABLET, FILM COATED in 1 BOTTLE 2025-12-05 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet, film coated in 1 bottle.
How does this package differ from NDC 63187-0424-30?
Both are Carvedilol 6.25 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 60-count one, while NDC 63187-0424-30 is the 30 tablets package.
What NDC number is used to bill for this package of Carvedilol 6.25 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Carvedilol 6.25 mg 00093-0135-01 Teva 100 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 00904-7306-61 Major 1 tablet $0.018 AB Availability likely —
Carvedilol 6.25 mg 65862-0143-01 Aurobindo 100 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 68001-0154-00 BluePoint 100 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 68084-0854-01 American 1 tablet $0.018 AB Availability likely —
Carvedilol 6.25 mg 68382-0093-01 Zydus 100 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 68462-0163-01 Glenmark 100 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 72888-0035-00 Advagen 1000 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 72888-0500-01 Advagen 100 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 82009-0126-05 Quallent 500 tablets $0.018 AB Availability likely —
Carvedilol 6.25 mg 00615-8388-30 NCS 5 tablets — AB Discontinued —
Carvedilol 6.25 mg 43063-0833-60 PD-Rx 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 50090-2175-00 A-S 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 50090-6742-00 A-S 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 50090-6865-00 A-S 90 tablets — AB FDA listed —
Carvedilol 6.25 mg 50090-7786-00 A-S 90 tablets — AB FDA listed —
Carvedilol 6.25 mg 51407-0040-01 Golden 100 tablets — AB FDA listed —
Carvedilol 6.25 mg 51655-0029-25 Northwind 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 51655-0943-18 Northwind 180 tablets — AB FDA listed —
Carvedilol 6.25 mg 55111-0253-01 Dr. 100 tablets — AB FDA listed —
Carvedilol 6.25 mg 55154-2649-00 Cardinal 1 tablet — AB FDA listed —
Carvedilol 6.25 mg 58657-0751-01 Method 100 tablets — AB FDA listed —
Carvedilol 6.25 mg 60760-0582-60 St. 60 tablets — AB FDA listed —
Carvedilol 6.25 mgthis 63187-0424-60 Proficient 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 63187-0946-30 Proficient 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 65841-0617-01 Zydus 100 tablets — AB FDA listed —
Carvedilol 6.25 mg 67046-0336-03 Coupler 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 68071-2780-08 NuCare 180 tablets — AB FDA listed —
Carvedilol 6.25 mg 68071-4600-03 NuCare 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 68071-4816-03 NuCare 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 68071-5275-08 NuCare 180 tablets — AB FDA listed —
Carvedilol 6.25 mg 68788-9789-01 Preferred 100 tablets — AB FDA listed —
Carvedilol 6.25 mg 70518-0426-00 REMEDYREPACK 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 70518-0840-02 REMEDYREPACK 1 tablet — AB FDA listed —
Carvedilol 6.25 mg 71335-1457-01 Bryant 30 tablets — AB Discontinued —
Carvedilol 6.25 mg 71335-1937-01 Bryant 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 71335-2033-01 Bryant 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 71335-2101-01 Bryant 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 71610-0063-30 Aphena 30 tablets — AB FDA listed —
Carvedilol 6.25 mg 72189-0664-60 Direct_Rx 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 72789-0431-60 PD-Rx 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 76385-0111-01 UNICHEM 100 tablets — AB FDA listed —
Coreg 6.25 mg 80725-0140-20 Waylis 100 tablets — AB FDA listed —
Carvedilol 6.25 mg 82804-0270-60 Proficient 60 tablets — AB FDA listed —
Carvedilol 6.25 mg 68071-5311-08 NuCare 180 tablets — AB FDA listed —
Carvedilol 6.25 mg 67296-2298-06 Redpharm 60 tablets — 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

🏛️
2007
On the market since
Sep 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

What it looks like

Color White
ShapeRound
ImprintZC40
Size6 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 V35KBM8JGR
    A compound derived from an amino acid that acts as a photosensitizing agent. In topical medicines, it helps the active ingredient become activated by light during treatment of certain skin conditions.
  • UNII PPM8SX5Q3V
    A chemical compound used in pharmaceuticals as a buffering agent and pH regulator. It helps maintain stable acidity or alkalinity in the medicine to protect the active ingredient and improve how the body absorbs it.
  • UNII 20P9NI883O
    Aminopentamide sulfate is an anticholinergic compound used as an active pharmaceutical ingredient in some veterinary medicines. In formulations, it may serve as a therapeutic agent rather than a traditional inactive excipient, helping to reduce smooth muscle contractions in animals.
  • UNII 27Y3KJK423
    Aminophylline is a combination of the drug theophylline with ethylenediamine. In formulations, it acts as a solubilizer and buffer, helping the medicine dissolve properly and maintain stable pH levels in the product.
  • UNII S9SDD93U5U
    A synthetic compound used as a stabilizer or preservative in pharmaceutical formulations. It helps protect the active ingredients from degradation and extends the product's shelf life.
  • UNII 9KWA4W69IW
    Aminopromazine maleate is a synthetic compound belonging to the phenothiazine class. In this medication, it typically serves as an active pharmaceutical ingredient rather than an inactive excipient, though formulation context may vary.
  • UNII FZU1QI13O9
    A folate antagonist compound used as an active pharmaceutical ingredient in certain cancer medications. It works to disrupt cell division and is not classified as an excipient or inactive ingredient.
  • UNII 27RL57FCYM
    A synthetic compound used as a preservative and antimicrobial agent in medications. It helps prevent bacterial and fungal growth, extending shelf life and maintaining product safety during storage.
  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 3UN285QN0C
    Visnaga daucoides fruit is a plant extract used in some formulations. It may serve as a flavoring agent or natural additive to support product taste and sensory characteristics.

18 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

LabelerProficient Rx LP
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA077614 (ANDA)
Labeler code63187
First marketedSep 2007
Product typeHuman Prescription Drug
Portfolio1,729 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. 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 120 words ▾

1. INDICATIONS AND USAGE Carvedilol tablets, USP is an alpha/beta-adrenergic blocking agent indicated for the treatment of: • Left ventricular dysfunction following myocardial infarction in clinically stable patients( 1.1 ) • Hypertension( 1.2 )

1.1Left Ventricular Dysfunction Following Myocardial Infarction Carvedilol tablets, USP are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤40% (with or without symptomatic heart failure) [see Clinical Studies (14.1)].

1.2Hypertension Carvedilol tablets, USP are indicated for the management of essential hypertension [see Clinical Studies (14.2)] . It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)].

⏱️ Dosage and Administration ~2 min read ▾

2. DOSAGE AND ADMINISTRATION Take with food. Individualize dosage and monitor during up-titration.

( 2 ) • Left ventricular dysfunction following myocardial infarction: Start at 6.25 mg twice daily and increase to 12.5 mg then 25 mg twice daily after intervals of 3 to 10 days. A lower starting dose or slower titration may be used.( 2.1 ) • Hypertension: Start at 6.25 mg twice daily and increase if needed for blood pressure control to 12.5 mg then 25 mg twice daily over intervals of 1 to 2 weeks.( 2.2 ) Carvedilol should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.

2.1Left Ventricular Dysfunction Following Myocardial Infarction DOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION. Treatment with carvedilol tablets may be started as an inpatient or outpatient and should be started after the patient is hemodynamically stable and fluid retention has been minimized. It is recommended that carvedilol tablets be started at 6.25 mg twice daily and increased after 3 to 10 days, based on tolerability, to 12.5 mg twice daily, then again to the target dose of 25 mg twice daily.

A lower starting dose may be used (3.125 mg twice daily) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are not tolerated. The recommended dosing regimen need not be altered in patients who received treatment with an IV or oral β-blocker during the acute phase of the myocardial infarction.

2.2Hypertension DOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of carvedilol tablets is 6.25 mg twice daily. If this dose is tolerated, using standing systolic pressure measured about 1 hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 12.5 mg twice daily if needed, based on trough blood pressure, again using standing systolic pressure one hour after dosing as a guide for tolerance.

This dose should also be maintained for 7 to 14 days and can then be adjusted upward to 25 mg twice daily if tolerated and needed. The full antihypertensive effect of carvedilol tablet is seen within 7 to 14 days. Total daily dose should not exceed 50 mg.

Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic component of carvedilol action.

2.3Hepatic Impairment Carvedilol tablets should not be given to patients with severe hepatic impairment [see CONTRAINDICATIONS (4)].

💊 Dosage Forms and Strengths 47 words ▾

3. DOSAGE FORMS AND STRENGTHS Tablets: 3.125, 6.25, 12.5, 25 mg ( 3 ) The white to off-white, round, film-coated tablets are available in the following strengths: 3.125 mg– debossed with Z and 1, 6.25 mg–debossed with ZC40, 12.5 mg–debossed with ZC41 and 25 mg–debossed with ZC42.

⛔ Contraindications 200 words ▾

4. CONTRAINDICATIONS • Bronchial asthma or related bronchospastic conditions ( 4 ) • Second- or third-degree AV block ( 4 ) • Sick sinus syndrome ( 4 ) • Severe bradycardia (unless permanent pacemaker in place) ( 4 ) • Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy. ( 4 ) • Severe hepatic impairment ( 2.3 , 4 ) • History of serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to carvedilol, any of the components of carvedilol ( 4 ) Carvedilol tablets are contraindicated in the following conditions: • Bronchial asthma or related bronchospastic conditions.

Deaths from status asthmaticus have been reported following single doses of carvedilol tablets. • Second- or third-degree AV block • Sick sinus syndrome • Severe bradycardia (unless a permanent pacemaker is in place) • Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. Such patients should first be weaned from intravenous therapy before initiating carvedilol tablets • Patients with severe hepatic impairment • Patients with a history of a serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to carvedilol, any of the components of carvedilol tablets.

⚠️ Warnings and Cautions ~3 min read ▾

5. WARNINGS AND PRECAUTIONS • Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. ( 5.1 ) • Bradycardia, hypotension, worsening heart failure/fluid retention may occur.

Reduce the dose as needed. ( 5.2 , 5.3 , 5.4 ) • Non-allergic bronchospasm (e.g., chronic bronchitis and emphysema): Avoid β-blockers. ( 4 ) However, if deemed necessary, use with caution and at lowest effective dose.

( 5.5 ) • Diabetes: Monitor glucose as β-blockers may mask symptoms of hypoglycemia or worsen hyperglycemia. ( 5.6 )

5.1Cessation of Therapy Patients with coronary artery disease, who are being treated with carvedilol tablets, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in angina patients following the abrupt discontinuation of therapy with β-blockers. The last 2 complications may occur with or without preceding exacerbation of the angina pectoris.

As with other β-blockers, when discontinuation of carvedilol tablets is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. Carvedilol tablets should be discontinued over 1 to 2 weeks whenever possible. If the angina worsens or acute coronary insufficiency develops, it is recommended that carvedilol tablets be promptly reinstituted, at least temporarily.

Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue therapy with carvedilol abruptly even in patients treated only for hypertension or heart failure.

5.2Bradycardia In clinical trials, carvedilol tablets caused bradycardia in about 2% of hypertensive patients, and 6.5% of myocardial infarction patients with left ventricular dysfunction. If pulse rate drops below 55 beats/minute, the dosage should be reduced.

5.3Hypotension Postural hypotension occurred in 1.8% and syncope in 0.1% of hypertensive patients, primarily following the initial dose or at the time of dose increase and was a cause for discontinuation of therapy in 1% of patients. In the CAPRICORN study of survivors of an acute myocardial infarction, hypotension or postural hypotension occurred in 20.2% of patients receiving carvedilol tablets compared to 12.6% of placebo patients. Syncope was reported in 3.9% and 1.9% of patients, respectively.

These events were a cause for discontinuation of therapy in 2.5% of patients receiving carvedilol tablets, compared to 0.2% of placebo patients. Starting with a low dose, administration with food, and gradual up-titration should decrease the likelihood of syncope or excessive hypotension [see DOSAGE AND ADMINISTRATION (2.1, 2.2)]. During initiation of therapy, the patient should be cautioned to avoid situations such as driving or hazardous tasks, where injury could result should syncope occur.

5.4Heart Failure/Fluid Retention Worsening heart failure or fluid retention may occur during up-titration of carvedilol. If such symptoms occur, diuretics should be increased and the carvedilol dose should not be advanced until clinical stability resumes [see DOSAGE AND ADMINISTRATION ( 2 ) ]. Occasionally it is necessary to lower the carvedilol dose or temporarily discontinue it.

Such episodes do not preclude subsequent successful titration of, or a favorable response to, carvedilol.

5.5Non-allergic Bronchospasm Patients with bronchospastic disease (e.g., chronic bronchitis and emphysema) should, in general, not receive β-blockers. Carvedilol tablets may be used with caution, however, in patients who do not respond to, or cannot tolerate, other antihypertensive agents. It is prudent, if carvedilol tablets are used, to use the smallest effective dose, so that inhibition of endogenous or exogenous β-agonists is minimized.

In clinical trials, patients with bronchospastic disease were enrolled if they did not require oral or inhaled medication to treat their bronchospastic dise…

🤒 Adverse Reactions ~3 min read ▾

6. ADVERSE REACTIONS Most common adverse events ( 6.1 ): • Left ventricular dysfunction following myocardial infarction (≥10%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase • Hypertension (≥5%): Dizziness To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals USA Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Carvedilol tablets have been evaluated for safety in patients with left ventricular dysfunction following myocardial infarction and in hypertensive patients. The observed adverse event profile was consistent with the pharmacology of the drug and the health status of the patients in the clinical trials. Adverse events reported for each of these patient populations are provided below.

Excluded are adverse events considered too general to be informative, and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population. Rates of adverse events were generally similar across demographic subsets (men and women, elderly and non-elderly, blacks and non-blacks). Left Ventricular Dysfunction Following Myocardial Infarction: Carvedilol tablets have been evaluated for safety in survivors of an acute myocardial infarction with left ventricular dysfunction in the CAPRICORN trial which involved 969 patients who received carvedilol tablets and 980 who received placebo.

Approximately 75% of the patients received carvedilol tablets for at least 6 months and 53% received carvedilol tablets for at least 12 months. Patients were treated for an average of 12.9 months and 12.8 months with carvedilol tablets and placebo, respectively. The following adverse events were reported with a frequency of >1% but ≤3% and more frequently with carvedilol tablets: flu syndrome, cerebrovascular accident, peripheral vascular disorder, hypotonia, depression, gastrointestinal pain, arthritis, and gout.

The overall rates of discontinuations due to adverse events were similar in both groups of patients. In this database, the only cause of discontinuation >1%, and occurring more often on carvedilol was hypotension (1.5% on carvedilol, 0.2% on placebo). Hypertension: Carvedilol tablets have been evaluated for safety in hypertension in more than 2,193 patients in US clinical trials and in 2,976 patients in international clinical trials.

Approximately 36% of the total treated population received carvedilol tablets for at least 6 months. Most adverse events reported during therapy with carvedilol tablets were of mild to moderate severity. In US controlled clinical trials directly comparing carvedilol tablets in doses up to 50 mg (n = 1,142) to placebo (n = 462), 4.9% of patients receiving carvedilol tablets discontinued for adverse events versus 5.2% of placebo patients.

Although there was no overall difference in discontinuation rates, discontinuations were more common in the carvedilol group for postural hypotension (1% versus 0). The overall incidence of adverse events in US placebo-controlled trials increased with increasing dose of carvedilol tablets. For individual adverse events this could only be distinguished for dizziness, which increased in frequency from 2% to 5% as total daily dose increased from 6.25 mg to 50 mg.

Table 1 shows adverse events in US placebo-controlled clinical trials for hypertension that occurred with an incidence of >1% regardless of causality, and that were more frequent in drug-treated patients than placebo-treated patients. Table 1 Adverse Events (%) Occurring in US Placebo-Controlled Hypertension Trials (Incidence ≥1%, Regardless of Causality) Shown are events with rate >1% rounded to nearest integer. Carvedilol Tablets Placebo (n = 1,142) (n = 462) Cardiovascular Bradycardia 2 - Postural hypotension 2 - Peripheral edema 1 - Central Nervous System Dizziness 6 5 Insomnia 2 1 Gastrointestinal Diarrhea 2 1 Hematolo…

🔄 Drug Interactions ~3 min read ▾

7. DRUG INTERACTIONS • CYP P450 2D6 enzyme inhibitors may increase and rifampin may decrease carvedilol levels. ( 7.1 , 7.5 ) • Hypotensive agents (e.g., reserpine, MAO inhibitors, clonidine) may increase the risk of hypotension and/or severe bradycardia.

( 7.2 ) • Cyclosporine or digoxin levels may increase. ( 7.3 , 7.4 ) • Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

( 7.4 ) • Amiodarone may increase carvedilol levels resulting in further slowing of the heart rate or cardiac conduction. ( 7.6 ) • Verapamil- or diltiazem-type calcium channel blockers may affect ECG and/or blood pressure. (7.6) • Insulin and oral hypoglycemics action may be enhanced.

(7.7)

7.1CYP2D6 Inhibitors and Poor Metabolizers Interactions of carvedilol with potent inhibitors of CYP2D6 isoenzyme (such as quinidine, fluoxetine, paroxetine, and propafenone) have not been studied, but these drugs would be expected to increase blood levels of the R(+) enantiomer of carvedilol [see CLINICAL PHARMACOLOGY (12.3)]. Retrospective analysis of side effects in clinical trials showed that poor 2D6 metabolizers had a higher rate of dizziness during up-titration, presumably resulting from vasodilating effects of the higher concentrations of the α-blocking R(+) enantiomer.

7.2Hypotensive Agents Patients taking both agents with β-blocking properties and a drug that can deplete catecholamines (e.g., reserpine and monoamine oxidase inhibitors) should be observed closely for signs of hypotension and/or severe bradycardia. Concomitant administration of clonidine with agents with β-blocking properties may potentiate blood-pressure and heart-rate-lowering effects. When concomitant treatment with agents with β-blocking properties and clonidine is to be terminated, the β-blocking agent should be discontinued first.

Clonidine therapy can then be discontinued several days later by gradually decreasing the dosage.

7.3Cyclosporine Modest increases in mean trough cyclosporine concentrations were observed following initiation of carvedilol treatment in 21 renal transplant patients suffering from chronic vascular rejection. In about 30% of patients, the dose of cyclosporine had to be reduced in order to maintain cyclosporine concentrations within the therapeutic range, while in the remainder no adjustment was needed. On the average for the group, the dose of cyclosporine was reduced about 20% in these patients.

Due to wide interindividual variability in the dose adjustment required, it is recommended that cyclosporine concentrations be monitored closely after initiation of carvedilol therapy and that the dose of cyclosporine be adjusted as appropriate.

7.4Digitalis Glycosides Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Digoxin concentrations are increased by about 15% when digoxin and carvedilol are administered concomitantly. Therefore, increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing Carvedilol tablets [see CLINICAL PHARMACOLOGY (12.5) ].

7.5Inducers/Inhibitors of Hepatic Metabolism Rifampin reduced plasma concentrations of carvedilol by about 70% [see CLINICAL PHARMACOLOGY (12.5) ]. Cimetidine increased AUC by about 30% but caused no change in C max [see CLINICAL PHARMACOLOGY (12.5) ].

7.6Amiodarone Amiodarone, and its metabolite desethyl amiodarone, inhibitors of CYP2C9 and P385 glycoprotein, increased concentrations of the S(-) enantiomer of carvedilol by at least 2-fold [see CLINICAL PHARMACOLOGY (12.5)]. The concomitant administration of amiodarone or other CYP2C9 inhibitors such as fluconazole with carvedilol may enhance the β-blocking properties of carvedilol resulting in further slowing of the heart rate or cardiac conduction. Patients should be observed for signs of bradycardia or heart block, particularly when one…

👥 Use in Specific Populations ~3 min read ▾

8. USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category C. Studies performed in pregnant rats and rabbits given carvedilol revealed increased post-implantation loss in rats at doses of 300 mg/kg/day (50 times the maximum recommended human dose [MRHD] as mg/m 2 ) and in rabbits at doses of 75 mg/kg/day (25 times the MRHD as mg/m 2 ). In the rats, there was also a decrease in fetal body weight at the maternally toxic dose of 300 mg/kg/day (50 times the MRHD as mg/m 2 ), which was accompanied by an elevation in the frequency of fetuses with delayed skeletal development (missing or stunted 13th rib).

In rats the no-observed-effect level for developmental toxicity was 60 mg/kg/day (10 times the MRHD as mg/m 2 ); in rabbits it was 15 mg/kg/day (5 times the MRHD as mg/m 2 ). There are no adequate and well-controlled studies in pregnant women. Carvedilol tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3Nursing Mothers It is not known whether this drug is excreted in human milk. Studies in rats have shown that carvedilol and/or its metabolites (as well as other β-blockers) cross the placental barrier and are excreted in breast milk. There was increased mortality at one week post-partum in neonates from rats treated with 60 mg/kg/day (10 times the MRHD as mg/m 2 ) and above during the last trimester through day 22 of lactation.

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from β-blockers, especially bradycardia, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The effects of other α- and β-blocking agents have included perinatal and neonatal distress.

8.4Pediatric Use Effectiveness of carvedilol tablets in patients younger than 18 years of age has not been established. In a double-blind trial, 161 children (mean age 6 years, range 2 months to 17 years; 45% less than 2 years old) with chronic heart failure [NYHA class II-IV, left ventricular ejection fraction <40% for children with a systemic left ventricle (LV), and moderate-severe ventricular dysfunction qualitatively by echo for those with a systemic ventricle that was not an LV] who were receiving standard background treatment were randomized to placebo or to 2 dose levels of carvedilol.

These dose levels produced placebo-corrected heart rate reduction of 4-6 heart beats per minute, indicative of β-blockade activity. Exposure appeared to be lower in pediatric subjects than adults. After 8 months of follow-up, there was no significant effect of treatment on clinical outcomes.

Adverse reactions in this trial that occurred in greater than 10% of patients treated with carvedilol and at twice the rate of placebo-treated patients included chest pain (17% versus 6%), dizziness (13% versus 2%), and dyspnea (11% versus 0%).

8.5Geriatric Use Of the 975 myocardial infarction patients randomized to carvedilol tablets in the CAPRICORN trial, 48% (468) were 65 years of age or older, and 11% (111) were 75 years of age or older. Of the 2,065 hypertensive patients in US clinical trials of efficacy or safety who were treated with carvedilol tablets, 21% (436) were 65 years of age or older. Of 3,722 patients receiving carvedilol tablets in hypertension clinical trials conducted worldwide, 24% were 65 years of age or older.

With the exception of dizziness in hypertensive patients (incidence 8.8% in the elderly versus 6% in younger patients), no overall differences in the safety or effectiveness (see Figure 2 ) were observed between the older subjects and younger subjects in each of these populations. Similarly, other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

🤰 Pregnancy 163 words ▾

8.1Pregnancy Pregnancy Category C. Studies performed in pregnant rats and rabbits given carvedilol revealed increased post-implantation loss in rats at doses of 300 mg/kg/day (50 times the maximum recommended human dose [MRHD] as mg/m 2 ) and in rabbits at doses of 75 mg/kg/day (25 times the MRHD as mg/m 2 ). In the rats, there was also a decrease in fetal body weight at the maternally toxic dose of 300 mg/kg/day (50 times the MRHD as mg/m 2 ), which was accompanied by an elevation in the frequency of fetuses with delayed skeletal development (missing or stunted 13th rib).

In rats the no-observed-effect level for developmental toxicity was 60 mg/kg/day (10 times the MRHD as mg/m 2 ); in rabbits it was 15 mg/kg/day (5 times the MRHD as mg/m 2 ). There are no adequate and well-controlled studies in pregnant women. Carvedilol tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 178 words ▾

8.4Pediatric Use Effectiveness of carvedilol tablets in patients younger than 18 years of age has not been established. In a double-blind trial, 161 children (mean age 6 years, range 2 months to 17 years; 45% less than 2 years old) with chronic heart failure [NYHA class II-IV, left ventricular ejection fraction <40% for children with a systemic left ventricle (LV), and moderate-severe ventricular dysfunction qualitatively by echo for those with a systemic ventricle that was not an LV] who were receiving standard background treatment were randomized to placebo or to 2 dose levels of carvedilol.

These dose levels produced placebo-corrected heart rate reduction of 4-6 heart beats per minute, indicative of β-blockade activity. Exposure appeared to be lower in pediatric subjects than adults. After 8 months of follow-up, there was no significant effect of treatment on clinical outcomes.

Adverse reactions in this trial that occurred in greater than 10% of patients treated with carvedilol and at twice the rate of placebo-treated patients included chest pain (17% versus 6%), dizziness (13% versus 2%), and dyspnea (11% versus 0%).

🧓 Geriatric Use 156 words ▾

8.5Geriatric Use Of the 975 myocardial infarction patients randomized to carvedilol tablets in the CAPRICORN trial, 48% (468) were 65 years of age or older, and 11% (111) were 75 years of age or older. Of the 2,065 hypertensive patients in US clinical trials of efficacy or safety who were treated with carvedilol tablets, 21% (436) were 65 years of age or older. Of 3,722 patients receiving carvedilol tablets in hypertension clinical trials conducted worldwide, 24% were 65 years of age or older.

With the exception of dizziness in hypertensive patients (incidence 8.8% in the elderly versus 6% in younger patients), no overall differences in the safety or effectiveness (see Figure 2 ) were observed between the older subjects and younger subjects in each of these populations. Similarly, other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage ~1 min read ▾

10. OVERDOSAGE Overdosage may cause severe hypotension, bradycardia, cardiac insufficiency, cardiogenic shock, and cardiac arrest. Respiratory problems, bronchospasms, vomiting, lapses of consciousness, and generalized seizures may also occur.

The patient should be placed in a supine position and, where necessary, kept under observation and treated under intensive-care conditions. Gastric lavage or pharmacologically induced emesis may be used shortly after ingestion. The following agents may be administered: for excessive bradycardia: Atropine, 2 mg IV. to support cardiovascular function: Glucagon, 5 to 10 mg IV rapidly over 30 seconds, followed by a continuous infusion of 5 mg/hour; sympathomimetics (dobutamine, isoprenaline, adrenaline) at doses according to body weight and effect.

If peripheral vasodilation dominates, it may be necessary to administer adrenaline or noradrenaline with continuous monitoring of circulatory conditions. For therapy-resistant bradycardia, pacemaker therapy should be performed. For bronchospasm, β-sympathomimetics (as aerosol or IV) or aminophylline IV should be given.

In the event of seizures, slow IV injection of diazepam or clonazepam is recommended. NOTE: In the event of severe intoxication where there are symptoms of shock, treatment with antidotes must be continued for a sufficiently long period of time consistent with the 7- to 10-hour half-life of carvedilol. Cases of overdosage with carvedilol tablets alone or in combination with other drugs have been reported.

Quantities ingested in some cases exceeded 1,000 milligrams. Symptoms experienced included low blood pressure and heart rate. Standard supportive treatment was provided and individuals recovered.

🧬 Clinical Pharmacology ~3 min read ▾

12. CLINICAL PHARMACOLOGY

12.1Mechanism of Action Carvedilol is a racemic mixture in which nonselective β-adrenoreceptor blocking activity is present in the S(-) enantiomer and α 1 -adrenergic blocking activity is present in both R(+) and S(-) enantiomers at equal potency. carvedilol has no intrinsic sympathomimetic activity.

12.2Pharmacodynamics Left Ventricular Dysfunction Following Myocardial Infarction: The basis for the beneficial effects of carvedilol tablets in patients with left ventricular dysfunction following an acute myocardial infarction is not established. Hypertension: The mechanism by which β-blockade produces an antihypertensive effect has not been established. β-adrenoreceptor blocking activity has been demonstrated in animal and human studies showing that carvedilol (1) reduces cardiac output in normal subjects; (2) reduces exercise- and/or isoproterenol-induced tachycardia; and (3) reduces reflex orthostatic tachycardia.

Significant β-adrenoreceptor blocking effect is usually seen within 1 hour of drug administration. α 1 -adrenoreceptor blocking activity has been demonstrated in human and animal studies, showing that carvedilol (1) attenuates the pressor effects of phenylephrine; (2) causes vasodilation; and (3) reduces peripheral vascular resistance. These effects contribute to the reduction of blood pressure and usually are seen within 30 minutes of drug administration. Due to the α 1 -receptor blocking activity of carvedilol, blood pressure is lowered more in the standing than in the supine position, and symptoms of postural hypotension (1.8%), including rare instances of syncope, can occur.

Following oral administration, when postural hypotension has occurred, it has been transient and is uncommon when carvedilol tablets is administered with food at the recommended starting dose and titration increments are closely followed [see DOSAGE AND ADMINISTRATION (2)]. In hypertensive patients with normal renal function, therapeutic doses of carvedilol tablets decreased renal vascular resistance with no change in glomerular filtration rate or renal plasma flow. Changes in excretion of sodium, potassium, uric acid, and phosphorus in hypertensive patients with normal renal function were similar after carvedilol tablets and placebo.

Carvedilol tablets have little effect on plasma catecholamines, plasma aldosterone, or electrolyte levels, but it does significantly reduce plasma renin activity when given for at least 4 weeks. It also increases levels of atrial natriuretic peptide.

12.3Pharmacokinetics Carvedilol is rapidly and extensively absorbed following oral administration, with absolute bioavailability of approximately 25% to 35% due to a significant degree of first-pass metabolism. Following oral administration, the apparent mean terminal elimination half-life of carvedilol generally ranges from 7 to 10 hours. Plasma concentrations achieved are proportional to the oral dose administered.

When administered with food, the rate of absorption is slowed, as evidenced by a delay in the time to reach peak plasma levels, with no significant difference in extent of bioavailability. Taking carvedilol tablets with food should minimize the risk of orthostatic hypotension. Carvedilol is extensively metabolized.

Following oral administration of radiolabelled carvedilol to healthy volunteers, carvedilol accounted for only about 7% of the total radioactivity in plasma as measured by area under the curve (AUC). Less than 2% of the dose was excreted unchanged in the urine. Carvedilol is metabolized primarily by aromatic ring oxidation and glucuronidation.

The oxidative metabolites are further metabolized by conjugation via glucuronidation and sulfation. The metabolites of carvedilol are excreted primarily via the bile into the feces. Demethylation and hydroxylation at the phenol ring produce 3 active metabolites with β-receptor blocking activity.

Based on preclinical studies, the 4'-hydroxyphenyl metabolite is approximately…

🧬 Mechanism of Action 44 words ▾

12.1Mechanism of Action Carvedilol is a racemic mixture in which nonselective β-adrenoreceptor blocking activity is present in the S(-) enantiomer and α 1 -adrenergic blocking activity is present in both R(+) and S(-) enantiomers at equal potency. carvedilol has no intrinsic sympathomimetic activity.

📦 How Supplied / Storage and Handling 71 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING Carvedilol Tablets USP, 6.25 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with 'ZC40' on one side and plain on other side and are supplied as follows: NDC-63187-424-30 in bottles of 30 tablets NDC-63187-424-60 in bottles of 60 tablets Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.

Dispense in a tight, light-resistant container.

📋 Description 158 words ▾

11. DESCRIPTION Carvedilol is a nonselective β-adrenergic blocking agent with α 1 -blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol.

Carvedilol is a racemic mixture with the following structure: Carvedilol, USP is a white to almost white crystalline powder with a molecular weight of 406.5 and a molecular formula of C 24 H 26 N 2 O 4 . It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Each carvedilol tablet, USP intended for oral administration contains 3.125 mg or 6.25 mg or 12.5 mg or 25 mg of carvedilol.

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, and titanium dioxide. The product meets USP Dissolution Test 3. structured formula for carvedilol

💬 Information for Patients 163 words ▾

17. PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling []

17.1Patient Advice Patients taking carvedilol tablets should be advised of the following: • Patients should take carvedilol tablets with food. • Patients should not interrupt or discontinue using carvedilol tablets without a physician’s advice. • Patients should consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath. • Patients may experience a drop in blood pressure when standing, resulting in dizziness and, rarely, fainting. Patients should sit or lie down when these symptoms of lowered blood pressure occur. • If experiencing dizziness or fatigue, patients should avoid driving or hazardous tasks. • Patients should consult a physician if they experience dizziness or faintness, in case the dosage should be adjusted. • Diabetic patients should report any changes in blood sugar levels to their physician. • Contact lens wearers may experience decreased lacrimation.

17.2FDA-Approved Patient Labeling Patient labeling is provided separately.

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 Carvedilol — the program that covers self-administered drugs. 15 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 Carvedilol. 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
$36.64M
Claims incl. refills
3.9M
Beneficiaries
2.8M
Spend / beneficiary
$12.90
Spend / claim
$9.29
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

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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
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“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 Proficient Rx LP. 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 1 other package presentation of this same product, including 30 tablets (63187-0424-30). 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?
Proficient Rx LP 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.
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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.