HomeNDC LookupIngredientsVerapamil Hydrochloride › 71335-1004-02
VERAPAMIL HYDROCHLORIDE 120 mg Tablet, 90-count — NDC 71335-1004-02 package photo

VERAPAMIL HYDROCHLORIDE 120 mg Tablet, 90-count

by Bryant Ranch Prepack · 90 TABLET in 1 BOTTLE (71335-1004-2)
NDC 71335-1004-02
🏷️ FDA NDC (as labeled) 71335-1004-2 billing pads the package segment with a zero
This package
Contains90-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1177/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Verapamil Hydrochloride (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Jul 2, 2024 — Cross contamination with other products. (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0592-2024
Class III · Jul 2, 2024 — Cross contamination with other products. (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0593-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71335-1004-2
Product NDC 71335-1004
11-digit billing NDC 71335100402
RxCUI 897666
UNII V3888OEY5R
Application # ANDA071881
SPL Set ID 660a83a9-60be-42d5-bc70-fe384e93beaa
Established class (EPC) Calcium Channel Blocker
Mechanism of action Calcium Channel Antagonists; Cytochrome P450 3A Inhibitors; Cytochrome P450 3A4 Inhibitors; P-Glycoprotein Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-20
Route ORAL
Dosage form TABLET
Substance VERAPAMIL HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71335-1004-2 — a 5-4-1 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 package segment → 71335-1004-02. 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 Calcium Channel Blocker class.

Pharmacologic class Calcium Channel Blocker
Drug family (ATC) Phenylalkylamine derivatives, ACE inhibitors and calcium channel blockers
How it works Calcium Channel Antagonists, Cytochrome P450 3A4 Inhibitors, P-Glycoprotein Inhibitors, Cytochrome P450 3A Inhibitors
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

LabelerBryant Ranch Prepack
Application holderHERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC
FDA applicationANDA071881 (ANDA)
Labeler code71335
First marketedJul 2018
Product typeHuman Prescription Drug
Portfolio4,433 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • That depends on why your doctor prescribed it. Verapamil can treat three main problems: high blood pressure, angina (chest pain from the heart not getting enough blood), and certai...
  • What exactly is verapamil treating in my body?
  • Yes, and it depends on your specific formulation. If you have the extended-release tablets, take them in the morning with food. If you have the extended-release PM capsules, take t...
  • Does it matter when I take verapamil or whether I take it with food?
📖 Read our full Verapamil guide →
2
Nutrient depletion considerations

Verapamil may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

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.

💊 What it looks like

Color White
ShapeRound
ImprintHP;27
Size1 mm
ScoringScored — splits in 2
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 O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • 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.

9 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 DailyMedingredient 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.

💲 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 $0.1177 $10.59 / 90 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Verapamil Hydrochloride 120 mg 00591-0345-01 Actavis 100 tablets $0.087 AB Availability likely
Verapamil Hydrochloride 120 mg 23155-0486-01 Heritage 100 tablets $0.087 AB Availability likely
Verapamil Hydrochloride 120 mg 62135-0745-90 Chartwell 90 tablets $0.087 AB Availability likely
Verapamil hydrochloride 120 mg 68382-0561-01 Zydus 100 tablets $0.180 AB Availability likely
Verapamil Hydrochloride 120 mg 42291-0855-01 AvKARE 100 tablets AB FDA listed
Verapamil Hydrochloride 120 mg 50090-4013-00 A-S 100 tablets AB FDA listed
Verapamil Hydrochloride 120 mg 51407-0964-01 Golden 100 tablets AB FDA listed
Verapamil Hydrochloride 120 mg 51655-0315-26 Northwind 90 tablets AB FDA listed
Verapamil Hydrochloride 120 mg 51655-0957-26 Northwind 90 tablets AB FDA listed
Verapamil Hydrochloride 120 mg 63629-4337-01 Bryant 30 tablets AB FDA listed
Verapamil Hydrochloride 120 mg 68071-4635-09 NuCare 90 tablets AB FDA listed
Verapamil Hydrochloride 120 mg 68788-8338-03 Preferred 30 tablets AB FDA listed
Verapamil Hydrochloride 120 mg 71205-0129-30 Proficient 30 tablets AB FDA listed
Verapamil Hydrochloride 120 mgthis 71335-1004-02 Bryant 90 tablets AB FDA listed
Verapamil Hydrochloride 120 mg 68788-8696-01 Preferred 100 tablets AB FDA listed
Verapamil hydrochloride 120 mg 70771-1953-01 Zydus 100 tablets AB FDA listed
Verapamil Hydrochloride 120 mg 71335-2375-01 Bryant 30 tablets AB FDA listed
Verapamil Hydrochloride 120 mg 50090-7311-01 A-S 90 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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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.

🔬 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 Verapamil Hydrochloride — the ingredient across all brands.

Top reported reactions

Dyspnoea352
Nausea351
Drug Interaction317
Dizziness295
Hypotension293
Fatigue275
Diarrhoea271

Reporter sex

4,297 reports
Male · 41%
Female · 59%
Unknown · 1%

Serious outcomes

Death969
Life-threatening437
Disabling147
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 285 0
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 NDCDescription Marketing startStatus
71335-1004-01 30 TABLET in 1 BOTTLE (71335-1004-1) 2018-11-15 Active
71335-1004-02 You're viewing this 90 TABLET in 1 BOTTLE (71335-1004-2) 2021-06-21 Active
71335-1004-03 100 TABLET in 1 BOTTLE (71335-1004-3) 2024-10-24 Active

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

Pack size FAQ

What quantity is in NDC 71335-1004-02?
NDC 71335-1004-02 is a 90-count package — 90 tablet in 1 bottle.
What is the difference between NDC 71335-1004-02 and NDC 71335-1004-01?
Both are VERAPAMIL HYDROCHLORIDE 120 mg Tablet — the drug itself is identical. NDC 71335-1004-02 is the 90-count package, while NDC 71335-1004-01 is the 30 tablets package.
What NDC number is used to bill for this package of VERAPAMIL HYDROCHLORIDE 120 mg Tablet?
Bill NDC 71335-1004-02 — the 11-digit billing format is 71335100402. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71335-1004-2, 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: 71335-1004-02, written without dashes as 71335100402. 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 71335-1004-02, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (1004) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Bryant Ranch Prepack. 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 30 tablets (71335-1004-01), 100 tablets (71335-1004-03). 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?
Bryant Ranch Prepack 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 ~2 min read

INDICATIONS AND USAGE Verapamil hydrochloride tablets, USP are indicated for the treatment of the following: Angina 1. Angina at rest including: - Vasospastic (Prinzmetal's variant) angina - Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina) Arrhythmias In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS : Accessory bypass tract) Prophylaxis of repetitive paroxysmal supraventricular tachycardia Essential hypertension Verapamil hydrochloride is indicated for the treatment of hypertension, to lower blood pressure.

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.

Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits.

The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

⏱️ Dosage and Administration ~1 min read

DOSAGE AND ADMINISTRATION The dose of verapamil must be individualized by titration. The usefulness and safety of dosages exceeding 480 mg/day have not been established; therefore, this daily dosage should not be exceeded. Since the half-life of verapamil increases during chronic dosing, maximum response may be delayed.

Angina: Clinical trials show that the usual dose is 80 mg to 120 mg three times a day. However, 40 mg three times a day may be warranted in patients who may have an increased response to verapamil (e.g., decreased hepatic function, elderly, etc). Upward titration should be based on therapeutic efficacy and safety evaluated approximately eight hours after dosing.

Dosage may be increased at daily (e.g., patients with unstable angina) or weekly intervals until optimum clinical response is obtained. Arrhythmias: The dosage in digitalized patients with chronic atrial fibrillation ( see PRECAUTIONS ) ranges from 240 to 320 mg/day in divided (t.i.d. or q.i.d.) doses. The dosage for prophylaxis of PSVT (non-digitalized patients) ranges from 240 to 480 mg/day in divided (t.i.d. or q.i.d.) doses.

In general, maximum effects for any given dosage will be apparent during the first 48 hours of therapy. Essential hypertension: Dose should be individualized by titration. The usual initial monotherapy dose in clinical trials was 80 mg three times a day (240 mg/ day).

Daily dosages of 360 and 480 mg have been used but there is no evidence that dosages beyond 360 mg provided added effect. Consideration should be given to beginning titration at 40 mg three times per day in patients who might respond to lower doses, such as the elderly or people of small stature. The antihypertensive effects of verapamil hydrochloride are evident within the first week of therapy.

Upward titration should be based on therapeutic efficacy, assessed at the end of the dosing interval.

Contraindications 78 words

CONTRAINDICATIONS Verapamil HCl tablets are contraindicated in: Severe left ventricular dysfunction ( see WARNINGS ) Hypotension (systolic pressure less than 90 mm Hg) or cardiogenic shock Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker) Second-or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker) Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) ( see WARNINGS ) Patients with known hypersensitivity to verapamil hydrochloride

⚠️ Warnings ~3 min read

WARNINGS Heart failure: Verapamil has a negative inotropic effect, which in most patients is compensated by its afterload reduction (decreased systemic vascular resistance) properties without a net impairment of ventricular performance. In clinical experience with 4,954 patients, 87 (1.8%) developed congestive heart failure or pulmonary edema. Verapamil should be avoided in patients with severe left ventricular dysfunction (e.g., ejection fraction less than 30%) or moderate to severe symptoms of cardiac failure and in patients with any degree of ventricular dysfunction if they are receiving a beta-adrenergic blocker ( see PRECAUTIONS , Drug interactions ).

Patients with milder ventricular dysfunction should, if possible, be controlled with optimum doses of digitalis and/or diuretics before verapamil treatment. (Note interactions with digoxin under PRECAUTIONS ) Hypotension: Occasionally, the pharmacologic action of verapamil may produce a decrease in blood pressure below normal levels, which may result in dizziness or symptomatic hypotension. The incidence of hypotension observed in 4,954 patients enrolled in clinical trials was 2.5%.

In hypertensive patients, decreases in blood pressure below normal are unusual. Tilt-table testing (60 degrees) was not able to induce orthostatic hypotension. Elevated liver enzymes: Elevations of transaminases with and without concomitant elevations in alkaline phosphatase and bilirubin have been reported.

Such elevations have sometimes been transient and may disappear even with continued verapamil treatment. Several cases of hepatocellular injury related to verapamil have been proven by rechallenge; half of these had clinical symptoms (malaise, fever, and/or right upper quadrant pain), in addition to elevation of SGOT, SGPT, and alkaline phosphatase. Periodic monitoring of liver function in patients receiving verapamil is therefore prudent.

Accessory bypass tract (Wolff-Parkinson-White or Lown-Ganong-Levine): Some patients with paroxysmal and/or chronic atrial fibrillation or atrial flutter and a coexisting accessory AV pathway have developed increased antegrade conduction across the accessory pathway bypassing the AV node, producing a very rapid ventricular response or ventricular fibrillation after receiving intravenous verapamil (or digitalis). Although a risk of this occurring with oral verapamil has not been established, such patients receiving oral verapamil may be at risk and its use in these patients is contraindicated ( see CONTRAINDICATIONS ).

Treatment is usually DC-cardioversion. Cardioversion has been used safely and effectively after oral verapamil hydrochloride. Atrioventricular block: The effect of verapamil on AV conduction and the SA node may cause asymptomatic first-degree AV block and transient bradycardia, sometimes accompanied by nodal escape rhythms.

PR-interval prolongation is correlated with verapamil plasma concentrations especially during the early titration phase of therapy. Higher degrees of AV block, however, were infrequently (0.8%) observed. Marked first-degree block or progressive development to second-or third-degree AV block requires a reduction in dosage or, in rare instances, discontinuation of verapamil HCl and institution of appropriate therapy, depending on the clinical situation.

Patients with hypertrophic cardiomyopathy (IHSS): In 120 patients with hypertrophic cardiomyopathy (most of them refractory or intolerant to propranolol) who received therapy with verapamil at doses up to 720 mg/day, a variety of serious adverse effects were seen. Three patients died in pulmonary edema; all had severe left ventricular outflow obstruction and a past history of left ventricular dysfunction. Eight other patients had pulmonary edema and/or severe hypotension; abnormally high (greater than 20 mm Hg) pulmonary wedge pressure and a marked left ventricular outflow obstruction were present in most of these patients.

Concomitant administration of quinidine ( see PRECAUTI…

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS Serious adverse reactions are uncommon when verapamil hydrochloride therapy is initiated with upward dose titration within the recommended single and total daily dose. See WARNINGS for discussion of heart failure, hypotension, elevated liver enzymes, AV block, and rapid ventricular response. Reversible (upon discontinuation of verapamil) non-obstructive, paralytic ileus has been infrequently reported in association with the use of verapamil.

The following reactions to orally administered verapamil occurred at rates greater than 1.0% or occurred at lower rates but appeared clearly drug-related in clinical trials in 4,954 patients: Constipation 7.30% Dyspnea 1.40% Dizziness 3.30% Bradycardia (HR <50/min) 1.40% Nausea 2.70% AV block total (1°, 2°, 3°) 1.20% Hypotension 2.50% 2° and 3° 0.80% Headache 2.20% Rash 1.20% Edema 1.90% Flushing 0.60% CHF, Pulmonary edema 1.80% Fatigue 1.70% Elevated liver enzymes (see WARNINGS ) In clinical trials related to the control of ventricular response in digitalized patients who had atrial fibrillation or flutter, ventricular rates below 50 at rest occurred in 15% of patients and asymptomatic hypotension occurred in 5% of patients.

The following reactions, reported in 1.0% or less of patients, occurred under conditions (open trials, marketing experience) where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship: Cardiovascular: angina pectoris, atrioventricular dissociation, chest pain, claudication, myocardial infarction, palpitations, purpura (vasculitis), syncope. Digestive system : diarrhea, dry mouth, gastrointestinal distress, gingival hyperplasia. Hemic and lymphatic: ecchymosis or bruising.

Nervous system: cerebrovascular accident, confusion, equilibrium disorders, insomnia, muscle cramps, paresthesia, psychotic symptoms, shakiness, somnolence, extrapyramidal symptoms. Skin: arthralgia and rash, exanthema, hair loss, hyperkeratosis, macules, sweating, urticaria, Stevens-Johnson syndrome, erythema multiforme. Special senses: blurred vision, tinnitus.

Urogenital: gynecomastia, galactorrhea/hyperprolactinemia, increased urination, spotty menstruation, impotence. Treatment of acute cardiovascular adverse reactions: The frequency of cardiovascular adverse reactions that require therapy is rare; hence, experience with their treatment is limited. Whenever severe hypotension or complete AV block occurs following oral administration of verapamil, the appropriate emergency measures should be applied immediately; e.g., intravenously administered norepinephrine bitartrate, atropine sulfate, isoproterenol HCl (all in the usual doses), or calcium gluconate (10% solution).

In patients with hypertrophic cardiomyopathy (IHSS), alphaadrenergic agents (phenylephrine HCl, metaraminol bitartrate, or methoxamine HCl) should be used to maintain blood pressure, and isoproterenol and norepinephrine should be avoided. If further support is necessary, dopamine HCl or dobutamine HCl may be administered. Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician.

To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 160 words

OVERDOSAGE Treat all verapamil overdoses as serious and maintain observation for at least 48 hours (especially Verapamil Hydrochloride Tablets SR), preferably under continuous hospital care. Delayed pharmacodynamic consequences may occur with the sustained-release formulation. Verapamil is known to decrease gastrointestinal transit time.

Treatment of overdosage should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium solutions may increase calcium ion flux across the slow channel and have been used effectively in treatment of deliberate overdosage with verapamil. In a few reported cases, overdose with calcium channel blockers has been associated with hypotension and bradycardia, initially refractory to atropine but becoming more responsive to this treatment when the patients received large doses (close to 1 gram/ hour for more than 24 hours) of calcium chloride.

Verapamil cannot be removed by hemodialysis. Clinically significant hypotensive reactions or high degree AV block should be treated with vasopressor agents or cardiac pacing, respectively. Asystole should be handled by the usual measures including cardiopulmonary resuscitation.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Verapamil hydrochloride is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) that exerts its pharmacologic effects by modulating the influx of ionic calcium across the cell membrane of the arterial smooth muscle as well as in conductile and contractile myocardial cells. Mechanism of Action Angina: The precise mechanism of action of verapamil hydrochloride as an antianginal agent remains to be fully determined, but includes the following two mechanisms: Relaxation and prevention of coronary artery spasm: Verapamil hydrochloride dilates the main coronary arteries and coronary arterioles, both in normal and ischemic regions, and is a potent inhibitor of coronary artery spasm, whether spontaneous or ergonovine-induced.

This property increases myocardial oxygen delivery in patients with coronary artery spasm and is responsible for the effectiveness of verapamil hydrochloride in vasospastic (Prinzmetal's or variant) as well as unstable angina at rest. Whether this effect plays any role in classical effort angina is not clear, but studies of exercise tolerance have not shown an increase in the maximum exercise rate-pressure product, a widely accepted measure of oxygen utilization. This suggests that, in general, relief of spasm or dilation of coronary arteries is not an important factor in classical angina.

Reduction of oxygen utilization: Verapamil hydrochloride regularly reduces the total peripheral resistance (afterload) against which the heart works both at rest and at a given level of exercise by dilating peripheral arterioles. This unloading of the heart reduces myocardial energy consumption and oxygen requirements and probably accounts for the effectiveness of verapamil hydrochloride in chronic stable effort angina. Arrhythmia: Electrical activity through the AV node depends, to a significant degree, upon calcium influx through the slow channel.

By decreasing the influx of calcium, verapamil hydrochloride prolongs the effective refractory period within the AV node and slows AV conduction in a rate-related manner. This property accounts for the ability of verapamil hydrochloride to slow the ventricular rate in patients with chronic atrial flutter or atrial fibrillation. Normal sinus rhythm is usually not affected, but in patients with sick sinus syndrome, verapamil hydrochloride may interfere with sinus-node impulse generation and may induce sinus arrest or sinoatrial block.

Atrioventricular block can occur in patients without preexisting conduction defects ( see WARNINGS ). Verapamil hydrochloride decreases the frequency of episodes of paroxysmal supraventricular tachycardia. Verapamil hydrochloride does not alter the normal atrial action potential or intraventricular conduction time, but in depressed atrial fibers it decreases amplitude, velocity of depolarization, and conduction velocity.

Verapamil hydrochloride may shorten the antegrade effective refractory period of the accessory bypass tract. Acceleration of ventricular rate and/or ventricular fibrillation has been reported in patients with atrial flutter or atrial fibrillation and a coexisting accessory AV pathway following administration of verapamil ( see WARNINGS ). Verapamil hydrochloride has a local anesthetic action that is 1.6 times that of procaine on an equimolar basis.

It is not known whether this action is important at the doses used in man. Essential hypertension : Verapamil hydrochloride exerts antihypertensive effects by decreasing systemic vascular resistance, usually without orthostatic decreases in blood pressure or reflex tachycardia; bradycardia (rate less than 50 beats/min) is uncommon (1.4%). During isometric or dynamic exercise, verapamil hydrochloride does not alter systolic cardiac function in patients with normal ventricular function.

Verapamil hydrochloride does not alter total serum calcium levels. However, one report suggested that calcium levels above the normal range may alter the therapeut…

🧬 Mechanism of Action ~3 min read

Mechanism of Action Angina: The precise mechanism of action of verapamil hydrochloride as an antianginal agent remains to be fully determined, but includes the following two mechanisms: Relaxation and prevention of coronary artery spasm: Verapamil hydrochloride dilates the main coronary arteries and coronary arterioles, both in normal and ischemic regions, and is a potent inhibitor of coronary artery spasm, whether spontaneous or ergonovine-induced. This property increases myocardial oxygen delivery in patients with coronary artery spasm and is responsible for the effectiveness of verapamil hydrochloride in vasospastic (Prinzmetal's or variant) as well as unstable angina at rest.

Whether this effect plays any role in classical effort angina is not clear, but studies of exercise tolerance have not shown an increase in the maximum exercise rate-pressure product, a widely accepted measure of oxygen utilization. This suggests that, in general, relief of spasm or dilation of coronary arteries is not an important factor in classical angina. Reduction of oxygen utilization: Verapamil hydrochloride regularly reduces the total peripheral resistance (afterload) against which the heart works both at rest and at a given level of exercise by dilating peripheral arterioles.

This unloading of the heart reduces myocardial energy consumption and oxygen requirements and probably accounts for the effectiveness of verapamil hydrochloride in chronic stable effort angina. Arrhythmia: Electrical activity through the AV node depends, to a significant degree, upon calcium influx through the slow channel. By decreasing the influx of calcium, verapamil hydrochloride prolongs the effective refractory period within the AV node and slows AV conduction in a rate-related manner.

This property accounts for the ability of verapamil hydrochloride to slow the ventricular rate in patients with chronic atrial flutter or atrial fibrillation. Normal sinus rhythm is usually not affected, but in patients with sick sinus syndrome, verapamil hydrochloride may interfere with sinus-node impulse generation and may induce sinus arrest or sinoatrial block. Atrioventricular block can occur in patients without preexisting conduction defects ( see WARNINGS ).

Verapamil hydrochloride decreases the frequency of episodes of paroxysmal supraventricular tachycardia. Verapamil hydrochloride does not alter the normal atrial action potential or intraventricular conduction time, but in depressed atrial fibers it decreases amplitude, velocity of depolarization, and conduction velocity. Verapamil hydrochloride may shorten the antegrade effective refractory period of the accessory bypass tract.

Acceleration of ventricular rate and/or ventricular fibrillation has been reported in patients with atrial flutter or atrial fibrillation and a coexisting accessory AV pathway following administration of verapamil ( see WARNINGS ). Verapamil hydrochloride has a local anesthetic action that is 1.6 times that of procaine on an equimolar basis. It is not known whether this action is important at the doses used in man.

Essential hypertension : Verapamil hydrochloride exerts antihypertensive effects by decreasing systemic vascular resistance, usually without orthostatic decreases in blood pressure or reflex tachycardia; bradycardia (rate less than 50 beats/min) is uncommon (1.4%). During isometric or dynamic exercise, verapamil hydrochloride does not alter systolic cardiac function in patients with normal ventricular function. Verapamil hydrochloride does not alter total serum calcium levels.

However, one report suggested that calcium levels above the normal range may alter the therapeutic effect of Verapamil hydrochloride. Pharmacokinetics and metabolism: More than 90% of the orally administered dose of Verapamil hydrochloride is absorbed. Because of rapid biotransformation of verapamil during its first pass through the portal circulation, bioavailability ranges from 20% to 35%.

Peak plasma concentratio…

📦 How Supplied / Storage and Handling 90 words

HOW SUPPLIED Verapamil Hydrochloride Tablets, USP 120 mg tablets are round, standard concave, white film-coated, scored, debossed "HP" above and "27" below on one side and plain on the reverse side, supplied as: NDC: 71335-1004-1: 30 Tablets in a BOTTLE NDC: 71335-1004-2: 90 Tablets in a BOTTLE NDC: 71335-1004-3: 100 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature] and protect from light. Dispense in a tight, light-resistant container using a child-resistant closure. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc.

Burbank, CA 91504

📋 Description 122 words

DESCRIPTION Verapamil hydrochloride (verapamil HCl) tablets, USP is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) available for oral administration in film-coated tablets containing 40 mg, 80 mg or 120 mg of verapamil hydrochloride. The structural formula of verapamil HCl is: C 27 H 38 N 2 O 4 • HCl M.W. = 491.08 Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste.

It is soluble in water, chloroform, and methanol. Verapamil HCl is not chemically related to other cardioactive drugs. Inactive ingredients include colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, light mineral oil, sodium lauryl sulfate, titanium dioxide and hypromellose.

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