HomeNDC LookupIngredientsVerapamil Hydrochloride › 70069-0271-25
Verapamil Hydrochloride 2.5 mg/mL Injection, Solution — NDC 70069-0271-25 package photo

Verapamil Hydrochloride 2.5 mg/mL Injection, Solution

by Somerset Therapeutics, LLC · 25 VIAL in 1 CARTON (70069-271-25) / 2 mL in 1 VIAL
NDC 70069-0271-25
🏷️ FDA NDC (as labeled) 70069-271-25 billing pads the product segment with a zero
This package
Contains2 mL in 1 vial Medicaid pays$6.50 / unit · 12 mo Per package$324.93 / 50 ml · Medicaid Pack sizes2 compare ↓
Also comes in: 5 vials 70069-0271-05
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) 70069-271-25
Product NDC 70069-271
11-digit billing NDC 70069027125
NCPDP billing unit ML — per mL (volume)
RxCUI 1665057, 1665061
UNII V3888OEY5R
UPC 0370069271254, 0370069272251, 0370069272015, 0370069271018 +4 more
Application # ANDA211015
SPL Set ID 50131bbc-ad43-4708-946f-e4000828137c
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 2018-06-18
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance VERAPAMIL HYDROCHLORIDE
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 70069-271-25 — 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 → 70069-0271-25. 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

LabelerSomerset Therapeutics, LLC
Application holderSOMERSET THERAPEUTICS LLC
FDA applicationANDA211015 (ANDA)
Labeler code70069
First marketedJun 2018
Product typeHuman Prescription Drug
Portfolio182 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 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 →
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
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 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 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $6.50 $324.93 / 50 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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/mL 55150-0342-01 Eugia 1 vial 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/mLthis 70069-0271-25 Somerset 25 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

🏛️
2018
On the market since
Jun 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70069-0271-25, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
175
Units reimbursed last 4 qtrs
151
Gross reimbursed last 4 qtrs
$981.29
Avg / prescription
$5.61
Avg / unit
$6.4986
Latest quarter Q4 2025
19Rx
Fee-for-service vs managed care
100% MCO
Fee-for-service · 0 Rx Managed care · 175 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 151 units · 3.3 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.33.3
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 3.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 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.
Drug total (last 4 qtrs): 216 Rx · 229 units · $1,134 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
70069-0271-05 5 VIAL in 1 CARTON (70069-271-05) / 2 mL in 1 VIAL (70069-271-01) 2018-06-18 Active
70069-0271-25 You're viewing this 25 VIAL in 1 CARTON (70069-271-25) / 2 mL in 1 VIAL 2018-06-18 Active

In Medicaid, this is the most-dispensed pack of this product — about 81% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 70069-0271-25?
NDC 70069-0271-25 is listed by the FDA — 25 vial in 1 carton / 2 ml in 1 vial.
What NDC number is used to bill for this package of Verapamil Hydrochloride 2.5 mg/mL Injection, Solution?
Bill NDC 70069-0271-25 — the 11-digit billing format is 70069027125. 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) ✓ Available
“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 70069-271-25, 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: 70069-0271-25, written without dashes as 70069027125. 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 70069-0271-25, the first segment (70069) is the labeler code FDA assigned to Somerset Therapeutics, LLC; the middle segment (0271) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (25) 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 Somerset Therapeutics, 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 1 other package presentation of this same product, including 5 vials (70069-0271-05). 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?
Somerset Therapeutics, 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 ~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%) 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 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, amphoteric in 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 181 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 therapy). Patients receiving intravenous beta-adrenergic blocking drugs (e.g., propranolol). Intravenous verapamil 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 is administered. Therefore, the use of verapamil in these patients is contraindicated. Ventricular tachycardia: Administration of intravenous verapamil to patients with wide-complex ventricular tachycardia (QRS ≥ 0.12 sec) can result in marked hemodynamic deterioration and ventricular fibrillation.

Proper pretherapy 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 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: Intravenous verapamil has been administered to a small number of patients receiving oral procainamide without the occurrence of serious adverse effects. Quinidine: Intravenous verapamil 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 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 and all forms of disopyramide phosphate are obtained, disopyramide should not be administered within 48 hours before or 24 hours after verapamil administration.

Flecainide: A study in healthy volunteers showed that the concomitant administr…

🤒 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 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 has 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. Adverse Reaction Proven Effective Treatment Supportive Treatment 1.

Symptomatic hypotension requiring treatment Dopamine intravenous Calcium chloride intravenous Norepinephrine bitartrate intravenous Metaraminol bitartrate intravenous Isoproterenol HCl intravenous Intravenous fluids Trendelenburg position 2. Bradycardia, AV block, Asystole Isoproterenol HCl intravenous Calcium chloride intravenous Norepinephrine bitartrate intravenous Atropine intravenous Cardiac pacing 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) *Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician.

🤰 Pregnancy 115 words

Pregnancy: Teratogenic Effects: Reproduction studies have been performed in rabbits and rats at oral verapamil doses up to 1.5 (15 mg/kg/day) and 6 (60 mg/kg/day) times the human oral daily dose, respectively, and have revealed no evidence of teratogenicity. In the rat, this multiple of the human dose was embryocidal and retarded fetal growth and development, probably because of adverse maternal effects reflected in reduced weight gains of the dams. This oral dose has also been shown to cause hypotension in rats.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 161 words

Pediatric Use: Controlled studies with verapamil have not been conducted in pediatric patients, but uncontrolled experience with intravenous administration in more than 250 patients, about half under 12 months of age and about 25% newborn, indicates that results of treatment are similar to those in adults. In rare instances, however, severe hemodynamic side effects - some of them fatal - have occurred following the intravenous administration of verapamil to neonates and infants. Caution should therefore be used when administering verapamil to this group of pediatric patients.

The most commonly used single doses in patients up to 12 months of age have ranged from 0.1 to 0.2 mg/kg of body weight, while in patients aged 1 to 15 years, the most commonly used single doses ranged from 0.1 to 0.3 mg/kg of body weight. Most of the patients received the lower dose of 0.1 mg/kg once, but in some cases, the dose was repeated once or twice every 10 to 30 minutes.

🆘 Overdosage 92 words

OVERDOSAGE Treatment of overdosage should be supportive and individualized. Beta-adrenergic stimulation and/or parenteral administration of calcium solutions may increase calcium injections ion flux across the slow channel, and have been effectively used in treatment of deliberate overdosage with oral verapamil hydrochloride. 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 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 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 appears to be due to its effect on the slow channel in cells of the cardiac conduction system. The vasodilatory effect of verapamil 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 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 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 can restore normal sinus rhythm in patients with paroxysmal supraventricular tachycardias (PSVT), including PSVT associated with Wolff-Parkinson-White syndrome. Verapamil does not induce peripheral arterial spasm.

Verapamil 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 does not alter total serum calcium levels.

Hemodynamics: Verapamil 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 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 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.

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 given to hypertensive patients.

Elimination half-life may be prolonged in the elderly.

📦 How Supplied / Storage and Handling 128 words

HOW SUPPLIED Verapamil Hydrochloride Injection, USP 2.5 mg/mL is supplied in single-dose containers as follows: NDC No. Container Volume Total Content/container 70069- 272 -05 Single-dose Vial 4 mL (5 pack carton) 10 mg 70069- 272 -25 Single-dose Vial 4 mL (25 pack carton) 10 mg 70069- 271 -25 Single-dose Vial 2 mL (25 pack carton) 5 mg 70069- 271 -05 Single-dose Vial 2 mL (5 pack carton) 5 mg 70069- 273 -05 Ampule 2 mL (5 pack tray) 5 mg Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light by retaining in package until ready to use.

For Product Inquiry call +1-800-417-9175 Manufactured for: Somerset Therapeutics, LLC Somerset, NJ 08873 Made in India Code No.: KR/DRUGS/KTK/28/289/97 1201382 ST-VRP/P/03 Revised: November, 2025

📋 Description 144 words

DESCRIPTION Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil Hydrochloride Injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride 2.5 mg/mL and sodium chloride 8.5 mg/mL in water for injection. The solution contains no bacteriostat or antimicrobial agent and is intended for single-dose intravenous administration.

May contain hydrochloric acid and/or sodium hydroxide for pH adjustment; pH is 4.0 to 6.5. The chemical name of Verapamil Hydrochloride, USP is benzeneacetonitrile, α-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is a white or practically white crystalline powder.

It is practically odorless and has a bitter taste. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether. It has the following structural formula: Molecular weight: 491.07 Molecular formula: C 27 H 38 N 2 O 4 • HCl Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs.

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