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VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Injection, Solution — NDC 55150-0342-05 package photo

VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Injection, Solution

by Eugia US LLC · 5 VIAL, SINGLE-DOSE in 1 CARTON (55150-342-05) / 2 mL in 1 VIAL, SINGLE-DOSE
NDC 55150-0342-05
🏷️ FDA NDC (as labeled) 55150-342-05 billing pads the product segment with a zero
This package
Contains2 mL in 1 vial, single-dose Pack sizes3 compare ↓
Also comes in: 2 mL 55150-0342-01 25 vials 55150-0342-25
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 →

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 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) 55150-342-05
Product NDC 55150-342
11-digit billing NDC 55150034205
RxCUI 1665057, 1665061
UNII V3888OEY5R
UPC 0355150342013, 0355150343010, 0355150342051
Application # ANDA212965
SPL Set ID def3b9ba-523d-4b83-a80d-fa6f362e111c
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 2020-07-06
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance VERAPAMIL HYDROCHLORIDE
GPI-14 34000030102005
GPI class Verapamil HCl
GCN Seq No 000563
GCN 01650
HICL code 000180
Ingredient (HICL) Verapamil Hcl
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A9
Therapeutic class — intermediate (HIC2) Calcium Antagonists
HIC3 code A9A
Therapeutic class — specific (HIC3) Calcium Channel Blocking Agents
AHFS code 24:04.04.24
AHFS class Class Iv Antiarrhythmics
FDB label name VERAPAMIL 5 MG/2 ML VIAL
FDB brand name Verapamil Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 55150-342-05 — 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 → 55150-0342-05. 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

LabelerEugia US LLC
Application holderEUGIA PHARMA SPECIALITIES LTD
FDA applicationANDA212965 (ANDA)
Labeler code55150
First marketedJul 2020
Product typeHuman Prescription Drug
Portfolio241 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

Label name VERAPAMIL 5 MG/2 ML VIAL Ingredient Verapamil Hcl
📗 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 Full Verapamil 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.

🧪 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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 8.5 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 2 mL 25 vials
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 2.5 mg/mL 00404-9966-02 Henry 1 vial — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 00409-1144-02 Hospira, 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 00409-4011-01 Hospira, 5 ampules — AP FDA listed —
Verapamil hydrochloride 2.5 mg/mL 23155-0911-41 Heritage 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 25021-0312-02 Sagent 25 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 42571-0313-75 Micro 1 vial — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 43066-0031-25 Baxter 25 vials — AP FDA listed —
Verapamil Hci 2.5 mg/mL 51662-1269-01 HF 2 ml — AP FDA listed —
Verapamil Hci 2.5 mg/mL 51662-1442-01 HF 2 ml — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 51662-1549-01 HF 2 ml — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 51662-1686-03 HF 25 pouches — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 51754-0203-02 EXELA 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 51754-0204-02 EXELA 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mLthis 55150-0342-05 Eugia 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 65145-0113-25 Caplin 25 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 65219-0384-02 FRESENIUS 25 vials — AP FDA listed —
Verapamil hydrochloride 2.5 mg/mL 68083-0447-25 Gland 25 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70069-0271-05 Somerset 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70069-0273-05 Somerset 5 ampules — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70121-1585-05 Amneal 25 vials — — FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70518-4453-00 REMEDYREPACK 25 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70710-1643-07 Zydus 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70710-1937-07 Zydus 5 vials — AP FDA listed —
verapamil hydrochloride 2.5 mg/mL 70756-0605-25 Lifestar 25 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70771-1601-07 Zydus 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 71872-7048-01 Medical 1 vial — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 71872-7183-01 Medical 1 vial — AP FDA listed —
Verapamil Hydrochloride 5 mg/2mL 71872-7203-01 Medical 1 vial — AP FDA listed —
Verapamil Hydrochloride 5 mg/2mL 71872-7210-01 Medical 1 vial — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 71872-7243-01 Medical 1 vial — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 71872-7291-01 Medical 1 vial — AP FDA listed —
verapamil hydrochloride 2.5 mg/mL 71872-7356-01 Medical 1 vial — AP FDA listed —
Verapamil Hydrochloride 5 mg/2mL 72485-0108-05 Armas 5 vials — AP FDA listed —
verapamil hydrochloride 2.5 mg/mL 84549-0605-25 ProPharma 2 ml — AP FDA listed —
Verapamil hydrochloride 2.5 mg/mL 68083-0448-05 Gland 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70771-1602-05 Zydus 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 55150-0343-01 Eugia 1 vial — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70069-0272-05 Somerset 5 vials — AP FDA listed —
verapamil hydrochloride 2.5 mg/mL 70756-0606-05 Lifestar 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 00404-9967-04 Henry 1 vial — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 43066-0035-05 Baxter 5 vials — AP FDA listed —
Verapamil hydrochloride 2.5 mg/mL 23155-0912-41 Heritage 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 65145-0114-05 Caplin 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70121-1586-03 Amneal 5 vials — — FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 51662-1270-01 HF 1 syringe — — FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 00404-9968-04 Henry 1 syringe — — FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 51662-1398-01 HF 4 ml — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 51662-1685-01 HF 4 ml — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70710-1644-05 Zydus 5 vials — AP 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

🏛️
2020
On the market since
Jul 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial55150-0342-01 77 Rx · $464
5 vials this page55150-0342-05 No Medicaid data
25 vials55150-0342-25 No Medicaid data
Drug total (last 4 qtrs): 77 Rx · 67 units · $464 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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
55150-0342-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-342-01) / 2 mL in 1 VIAL, SINGLE-DOSE 2020-07-06 Active
55150-0342-05 You're viewing this 5 VIAL, SINGLE-DOSE in 1 CARTON (55150-342-05) / 2 mL in 1 VIAL, SINGLE-DOSE 2020-07-06 Active
55150-0342-25 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-342-25) / 2 mL in 1 VIAL, SINGLE-DOSE 2020-07-06 Active

Pack size FAQ

What quantity is in NDC 55150-0342-05?
NDC 55150-0342-05 is listed by the FDA — 5 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Injection, Solution?
Bill NDC 55150-0342-05 — the 11-digit billing format is 55150034205. 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 55150-342-05, 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: 55150-0342-05, written without dashes as 55150034205. 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 55150-0342-05, the first segment (55150) is the labeler code FDA assigned to Eugia US LLC; the middle segment (0342) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Eugia US LLC. 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 1 vial (55150-0342-01), 25 vials (55150-0342-25). 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?
Eugia US LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage ~1 min read ▾

INDICATIONS AND USAGE Verapamil hydrochloride injection, USP is indicated for the following: Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong- Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration. Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).

In controlled studies in the United States, about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. Uncontrolled studies reported in the world literature describe a conversion rate of about 80%. About 70% of patients with atrial flutter and/or fibrillation with a faster ventricular rate respond with a decrease in ventricular rate of at least 20%.

Conversion of atrial flutter or fibrillation to sinus rhythm is uncommon (about 10%) after verapamil hydrochloride and may reflect the spontaneous conversion rate, since the conversion rate after placebo was similar. Slowing of the ventricular rate in patients with atrial fibrillation/flutter lasts 30 to 60 minutes after a single injection. Because a small fraction (<1.0%) of patients treated with verapamil hydrochloride respond with life-threatening adverse responses (rapid ventricular rate in atrial flutter/fibrillation and an accessory bypass tract, marked hypotension, or extreme bradycardia/asystole-see CONTRAINDICATIONS and WARNINGS ), the initial use of verapamil hydrochloride injection should, if possible, be in a treatment setting with monitoring and resuscitation facilities, including D.C.-cardioversion capability (see ADVERSE REACTIONS, Suggested Treatment of Acute Cardiovascular Adverse Reactions ).

As familiarity with the patient's response is gained, use in an office setting may be acceptable. Cardioversion has been used safely and effectively after verapamil hydrochloride injection.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION (For Intravenous Use Only). VERAPAMIL HYDROCHLORIDE INJECTION SHOULD BE GIVEN AS A SLOW INTRAVENOUS INJECTION OVER AT LEAST A TWO-MINUTE PERIOD OF TIME UNDER CONTINUOUS ELECTROCARDIOGRAPHIC (ECG) AND BLOOD PRESSURE MONITORING. The recommended intravenous doses of verapamil hydrochloride injection are as follows: Adult: Initial dose - 5 to 10 mg (0.075 to 0.15 mg/kg body weight) given as an intravenous bolus over at least 2 minutes.

Repeat dose - 10 mg (0.15 mg/kg body weight) 30 minutes after the first dose if the initial response is not adequate. An optimal interval for subsequent intravenous doses has not been determined, and should be individualized for each patient. Older patients - The dose should be administered over at least 3 minutes to minimize the risk of untoward drug effects.

Pediatric: Initial dose: 0 to 1 year: 0.1 to 0.2 mg/kg body weight (usual single-dose range: 0.75 to 2 mg) should be administered as an intravenous bolus over at least 2 minutes under continuous ECG monitoring . 1 to 15 years: 0.1 to 0.3 mg/kg body weight (usual single-dose range: 2 to 5 mg) should be administered as an intravenous bolus over at least 2 minutes. Do not exceed 5 mg .

Repeat dose: 0 to 1 year: 0.1 to 0.2 mg/kg body weight (usual single-dose range: 0.75 to 2 mg) 30 minutes after the first dose if the initial response is not adequate ( under continuous ECG monitoring ). An optimal interval for subsequent intravenous doses has not been determined, and should be individualized for each patient. 1 to 15 years: 0.1 to 0.3 mg/kg body weight (usual single-dose range: 2 to 5 mg) 30 minutes after the first dose if the initial response is not adequate.

Do not exceed 10 mg as a single-dose. An optimal interval for subsequent intravenous doses has not been determined, and should be individualized for each patient. Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Use only if solution is clear and vial seal is intact. Unused amount of solution should be discarded immediately following withdrawal of any portion of contents. For stability reasons this product is not recommended for dilution with Sodium Lactate Injection, USP in polyvinyl chloride bags.

Verapamil hydrochloride is physically compatible and chemically stable for at least 24 hours at 25°C protected from light in most common large volume parenteral solutions. Admixing verapamil hydrochloride injection with albumin, amphotericin B, hydralazine hydrochloride and trimethoprim with sulfamethoxazole should be avoided. Verapamil hydrochloride injection will precipitate in any solution with a pH above 6.0.

⛔ Contraindications 184 words ▾

CONTRAINDICATIONS Verapamil hydrochloride injection is contraindicated in: Severe hypotension or cardiogenic shock. Second-or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker). Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker).

Severe congestive heart failure (unless secondary to a supraventricular tachycardia amenable to verapamil hydrochloride therapy). Patients receiving intravenous beta-adrenergic blocking drugs (e.g., propranolol). Intravenous verapamil hydrochloride and intravenous beta-adrenergic blocking drugs should not be administered in close proximity to each other (within a few hours), since both may have a depressant effect on myocardial contractility and AV conduction.

Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff- Parkinson-White, Lown-Ganong-Levine syndromes) are at risk to develop ventricular tachyarrhythmia including ventricular fibrillation if verapamil hydrochloride is administered. Therefore, the use of verapamil hydrochloride in these patients is contraindicated. Ventricular tachycardia: Administration of intravenous verapamil hydrochloride to patients with wide-complex ventricular-tachycardia (QRS ≥ 0.12 sec) can result in marked hemodynamic deterioration and ventricular fibrillation.

Proper pre-therapy diagnosis and differentiation from wide-complex supraventricular tachycardia is imperative in the emergency room setting. Known hypersensitivity to verapamil hydrochloride.

⚠️ Warnings ~3 min read ▾

WARNINGS VERAPAMIL HYDROCHLORIDE SHOULD BE GIVEN AS A SLOW INTRAVENOUS INJECTION OVER AT LEAST A TWO-MINUTE PERIOD OF TIME ( see DOSAGE AND ADMINISTRATION ). Hypotension: Verapamil hydrochloride injection often produces a decrease in blood pressure below baseline levels that is usually transient and asymptomatic but may result in dizziness. Systolic pressure less than 90 mm Hg and/or diastolic pressure less than 60 mm Hg was seen in 5% to 10% of patients in controlled U.S. trials in supraventricular tachycardia and in about 10% of the patients with atrial flutter/fibrillation.

The incidence of symptomatic hypotension observed in studies conducted in the U.S. was approximately 1.5%. Three of the five symptomatic patients required intravenous pharmacologic treatment (norepinephrine bitartrate, metaraminol bitartrate, or 10% calcium gluconate). All recovered without sequelae.

Extreme Bradycardia/Asystole: Verapamil hydrochloride affects the AV and SA nodes and rarely may produce second- or third-degree AV block, bradycardia, and, in extreme cases, asystole. This is more likely to occur in patients with a sick sinus syndrome (SA nodal disease), which is more common in older patients. Bradycardia associated with sick sinus syndrome was reported in 0.3% of the patients treated in controlled double-blind trials in the U.S.

The total incidence of bradycardia (ventricular rate less than 60 beats/min) was 1.2% in these studies. Asystole in patients other than those with sick sinus syndrome is usually of short duration (few seconds or less), with spontaneous return to AV nodal or normal sinus rhythm. If this does not occur promptly, appropriate treatment should be initiated immediately.

(See Adverse Reactions and Suggested Treatment of Acute Cardiovascular Adverse Reactions .) Heart Failure: When heart failure is not severe or rate related, it should be controlled with digitalis glycosides and diuretics, as appropriate, before verapamil hydrochloride is used. In patients with moderately severe to severe cardiac dysfunction (pulmonary wedge pressure above 20 mm Hg, ejection fraction less than 30%), acute worsening of heart failure may be seen. Concomitant Antiarrhythmic Therapy: Digitalis: Verapamil hydrochloride injection has been used concomitantly with digitalis preparations without the occurrence of serious adverse effects.

However, since both drugs slow AV conduction, patients should be monitored for AV block or excessive bradycardia. Procainamide: Verapamil hydrochloride injection has been administered to a small number of patients receiving oral procainamide without the occurrence of serious adverse effects. Quinidine: Verapamil hydrochloride injection has been administered to a small number of patients receiving oral quinidine without the occurrence of serious adverse effects.

However, three patients have been described in whom the combination resulted in an exaggerated hypotensive response presumably from the combined ability of both drugs to antagonize the effects of catecholamines on α-adrenergic receptors. Caution should therefore be used when employing this combination of drugs. Beta-Adrenergic Blocking Drugs: Verapamil hydrochloride injection has been administered to patients receiving oral beta-blockers without the development of serious adverse effects.

However, since both drugs may depress myocardial contractility and AV conduction, the possibility of detrimental interactions should be considered. The concomitant administration of intravenous beta-blockers and intravenous verapamil hydrochloride has resulted in serious adverse reactions (see CONTRAINDICATIONS ), especially in patients with severe cardiomyopathy, congestive heart failure or recent myocardial infarction. Disopyramide: Until data on possible interactions between verapamil hydrochloride and all forms of disopyramide phosphate are obtained, disopyramide should not be administered within 48 hours before or 24 hours after verapamil hydrochloride administration.…

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS The following reactions were reported with verapamil hydrochloride injection used in controlled U.S. clinical trials involving 324 patients: Cardiovascular: Symptomatic hypotension (1.5%); bradycardia (1.2%); severe tachycardia (1.0%). The worldwide experience in open clinical trials in more than 7,900 patients was similar. Central Nervous System Effects: Dizziness (1.2%); headache (1.2%).

Occasional cases of seizures during verapamil hydrochloride injection have been reported. Gastrointestinal: Nausea (0.9%); abdominal discomfort (0.6%). In rare cases of hypersensitive patients, broncho/laryngeal spasm accompanied by itch and urticaria have been reported.

The following reactions have been reported at low frequency: emotional depression, rotary nystagmus, sleepiness, vertigo, muscle fatigue, diaphoresis, and respiratory failure. Suggested Treatment of Acute Cardiovascular Adverse Reactions* The frequency of these adverse reactions was quite low, and experience with their treatment has been limited. * Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. Adverse Reaction Proven Effective Treatment Supportive Treatment 1.

Symptomatic hypotension requiring treatment Calcium chloride (Intravenous) Norepinephrine bitartrate (Intravenous) Metaraminol bitartrate (Intravenous) Isoproterenol HCl (Intravenous) Dopamine (Intravenous) Intravenous fluids Trendelenburg position 2. Bradycardia, AV block, Asystole Isoproterenol HCl (Intravenous) Calcium chloride (Intravenous) Cardiac pacing Norepinephrine bitartrate (Intravenous) Atropine (Intravenous) Intravenous fluids (slow drip) 3. Rapid ventricular rate (due to antegrade conduction in flutter/fibrillation with W-P-W or L-G-L syndromes) DC-cardioversion (high energy may be required) Procainamide (Intravenous) Lidocaine (Intravenous) Intravenous fluids (slow drip) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🆘 Overdosage 94 words ▾

OVERDOSAGE Treatment of overdosage should be supportive and individualized. Beta-adrenergic stimulation and/or parenteral administration of calcium solutions may increase calcium ion flux across the slow channel, and have been effectively used in treatment of deliberate overdosage with oral verapamil hydrochloride. Verapamil hydrochloride 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 isoproterenol hydrochloride, other vasopressor agents, or cardiopulmonary resuscitation (See ADVERSE REACTIONS: Suggested Treatment of Acute Cardiovascular Adverse Reactions . )

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action: Verapamil hydrochloride inhibits the calcium ion (and possibly sodium ion) influx through slow channels into conductile and contractile myocardial cells and vascular smooth muscle cells. The antiarrhythmic effect of verapamil hydrochloride appears to be due to its effect on the slow channel in cells of the cardiac conduction system. The vasodilatory effect of verapamil hydrochloride appears to be due to its effect on blockade of calcium channels as well as α receptors.

In the isolated rabbit heart, concentrations of verapamil hydrochloride that markedly affect SA nodal fibers or fibers in the upper and middle regions of the AV node have very little effect on fibers in the lower AV node (NH region) and no effect on atrial action potentials or His bundle fibers. Electrical activity in the SA and AV nodes depends, to a large degree, upon calcium influx through the slow channel. By inhibiting this influx, verapamil hydrochloride slows AV conduction and prolongs the effective refractory period within the AV node in a rate-related manner.

This effect results in a reduction of the ventricular rate in patients with atrial flutter and/or atrial fibrillation and a rapid ventricular response. By interrupting reentry at the AV node, verapamil hydrochloride can restore normal sinus rhythm in patients with paroxysmal supraventricular tachycardias (PSVT), including PSVT associated with Wolff-Parkinson-White syndrome. Verapamil hydrochloride does not induce peripheral arterial spasm.

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. Verapamil hydrochloride does not alter total serum calcium levels.

Hemodynamics: Verapamil hydrochloride reduces afterload and myocardial contractility. The commonly used intravenous doses of 5 to 10 mg verapamil hydrochloride produce transient, usually asymptomatic, reduction in normal systemic arterial pressure, systemic vascular resistance and contractility; left ventricular filling pressure is slightly increased. In most patients, including those with organic cardiac disease, the negative inotropic action of verapamil hydrochloride is countered by reduction of afterload, and cardiac index is usually not reduced.

However, in patients with moderately severe to severe cardiac dysfunction (pulmonary wedge pressure above 20 mm Hg, ejection fraction less than 30%), acute worsening of heart failure may be seen. Peak therapeutic effects occur within 3 to 5 minutes after a bolus injection. Pharmacokinetics: Intravenously administered verapamil hydrochloride has been shown to be rapidly metabolized.

Following intravenous infusion in man, verapamil hydrochloride is eliminated bi-exponentially, with a rapid early distribution phase (half-life about 4 minutes) and a slower terminal elimination phase (half-life 2 to 5 hours). In healthy men, orally administered verapamil hydrochloride undergoes extensive metabolism in the liver, with 12 metabolites having been identified, most in only trace amounts. The major metabolites have been identified as various N- and O-dealkylated products of verapamil hydrochloride.

Approximately 70% of an administered dose is excreted in the urine and 16% more in the feces within 5 days. About 3 to 4% is excreted as unchanged drug. Aging may affect the pharmacokinetics of verapamil hydrochloride given to hypertensive patients.

Elimination half-life may be prolonged in the elderly.

📦 How Supplied / Storage and Handling 147 words ▾

HOW SUPPLIED Verapamil Hydrochloride Injection, USP is a sterile, clear colorless solution and is supplied in single-dose containers as follows: 5 mg per 2 mL (2.5 mg/mL) 2 mL Single-Dose Vial NDC 55150-342-01 1-unit pack carton 2 mL Single-Dose Vials NDC 55150-342-05 5 pack carton 2 mL Single-Dose Vials 25-unit pack carton NDC 55150-342-25 10 mg per 4 mL (2.5 mg/mL) 4 mL Single-Dose Vial NDC 55150-343-01 1-unit pack carton 4 mL Single-Dose Vials NDC 55150-343-05 5 pack carton 4 mL Single-Dose Vials 25-unit pack carton NDC 55150-343-25 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light by retaining in carton until ready to use. The vial stopper is not made with natural rubber latex. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd.

E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: June 2023

📋 Description 147 words ▾

DESCRIPTION Verapamil hydrochloride is a calcium antagonist or slow channel inhibitor. Verapamil hydrochloride injection, USP is a sterile, clear colorless solution and is available in 5 mg/2 mL and 10 mg/4 mL single-dose vials (for intravenous administration). Each 1 mL of solution contains 2.5 mg verapamil hydrochloride, USP and 8.5 mg sodium chloride in water for injection.

Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of solution is between 4.0 and 6.5. Protect contents from light.

Verapamil hydrochloride injection, USP vials are sterile. The structural formula of verapamil hydrochloride is given below: The chemical name of verapamil hydrochloride is Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride, USP is white or practically white, crystalline powder.

It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol, practically insoluble in ether. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs. Chemical Structure

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