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VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Injection, Solution, 4 mL — NDC 51662-1398-1 (Billing 51662-1398-01)

by HF Acquisition Co LLC, DBA HealthFirst · 4 mL in 1 VIAL

This is a package of 4 mL of VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Injection, Solution from HF Acquisition Co LLC, DBA HealthFirst, marketed since Oct 2019 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 51662-1398-01
🏷️ FDA NDC (as labeled) 51662-1398-1 billing pads the package segment with a zero
This package
Contains4 mL Pack sizes2 compare ↓
Main listing for product 51662-1398 · Also comes in: 25 pouches 51662-1398-3
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51662-1398-1
Product NDC 51662-1398
11-digit billing NDC 51662139801
RxCUI 1665061
UNII V3888OEY5R
Application # ANDA070737
SPL Set ID 951c7fd7-10ef-2b07-e053-2995a90aaffd
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 2019-10-17
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance VERAPAMIL HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1665061
Why two NDCs? The FDA registers this code as 51662-1398-1 — 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 → 51662-1398-01. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Verapamil tablets treat angina, certain fast heart rhythms and high blood pressure. Extended-release forms are used for high blood pressure. The injectio...
  • Extended-release tablets are taken with food in the morning. The PM capsules are taken at bedtime. Swallow capsules whole, or sprinkle the entire contents on applesauce. Never crus...
  • How should I take my extended-release verapamil?
  • Constipation is the most common, along with headache, dizziness and ankle swelling. Tell your doctor if they bother you. Call right away for fainting, a very slow heartbeat, shortn...
📖 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.

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

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51662-1398-01 You're viewing this Main listing 4 mL in 1 VIAL 2019-10-17 — Active
51662-1398-03 51662-1398-3 25 POUCH in 1 CASE / 1 mL in 1 POUCH 2021-01-12 — Active

Pack size FAQ

What quantity is in this package?
This package contains 4 mL — 4 ml in 1 vial.
How does this package differ from NDC 51662-1398-03?
Both are VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Injection, Solution — the drug itself is identical. This page's package is the 4 mL one, while NDC 51662-1398-03 is the 25 pouches package.
What NDC number is used to bill for this package of VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Verapamil Hydrochloride 2.5 mg/mL 00404-9967-04 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 23155-0912-41 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 43066-0035-05 Baxter 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mLthis 51662-1398-01 HF 4 ml — AP FDA listed —
Verapamil Hci 2.5 mg/mL 51662-1548-01 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 55150-0343-01 Eugia 1 vial — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 65145-0114-05 Caplin 5 vials — AP FDA listed —
Verapamil hydrochloride 2.5 mg/mL 68083-0448-05 Gland 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70069-0272-05 Somerset 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 70710-1644-05 Zydus 5 vials — AP FDA listed —
verapamil hydrochloride 2.5 mg/mL 70756-0606-05 Lifestar 5 vials — AP FDA listed —
Verapamil Hydrochloride 10 mg/4mL 72485-0109-05 Armas 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 51662-1549-01 HF 2 ml — 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 68083-0447-25 Gland 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 70771-1602-05 Zydus 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 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 70756-0605-25 Lifestar 25 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 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 84549-0605-25 ProPharma 2 ml — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 65145-0113-25 Caplin 25 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70518-4453-00 REMEDYREPACK 25 vials — AP FDA listed —
Verapamil hydrochloride 2.5 mg/mL 23155-0911-41 Heritage 5 vials — AP FDA listed —
verapamil hydrochloride 2.5 mg/mL 71872-7356-01 Medical 1 vial — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70710-1937-07 Zydus 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 51662-1686-03 HF 25 pouches — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 00409-4011-01 Hospira, 5 ampules — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 43066-0031-25 Baxter 25 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70121-1585-05 Amneal 25 vials — — FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 51662-1270-01 HF 1 syringe — — FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 70710-1643-07 Zydus 5 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 00404-9968-04 Henry 1 syringe — — FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 65219-0384-02 FRESENIUS 25 vials — AP FDA listed —
Verapamil Hydrochloride 2.5 mg/mL 00404-9966-02 Henry 1 vial — 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

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 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.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderHOSPIRA INC
FDA applicationANDA070737 (ANDA)
Labeler code51662
First marketedOct 2019
Product typeHuman Prescription Drug
Portfolio333 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~1 min read ▾

INDICATIONS & 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 & 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, 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 189 words ▾

CONTRAINDICATIONS Verapamil hydrochloride injection is contraindicated in: 1. Severe hypotension or cardiogenic shock. 2.

Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker). 3. Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker).

4. Severe congestive heart failure (unless secondary to a supraventricular tachycardia amenable to verapamil therapy). 5.

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. 6.

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. 7.

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. 8.

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: 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 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 c… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 129 words ▾

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. * Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. ADVERSE REACTIONS

🆘 Overdosage 91 words ▾

OVERDOSAGE Treatment of overdosage should be supportive and individualized. Beta-adrenergic stimulation and/or parenteral administration of calcium injections may increase calcium 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 107 words ▾

HOW SUPPLIED VERAPAMIL HYDROCHLORIDE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1398-1 VERAPAMIL HYDROCHLORIDE INJECTION, USP, (2.5 mg/mL 4ML VIAL) NDC 51662-1398-2 Pouch containing a single VERAPAMIL HYDROCHLORIDE INJECTION, USP, (2.5 mg/mL 4ML VIAL) NDC 51662-1398-3 Case of 25 pouches VERAPAMIL HYDROCHLORIDE INJECTION, USP, (2.5 mg/mL 4ML VIAL) HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 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.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-0885-3.0 05/2018 How Supplied logo

📋 Description 201 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 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: C27H38N2O4 • HCl Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs.

The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material.

STRUCTURE

⚠️ Precautions ~3 min read ▾

PRECAUTIONS Drug Interactions: (See WARNINGS: Concomitant Antiarrhythmic Therapy.) Verapamil hydrochloride injection has been used concomitantly with other cardioactive drugs (especially digitalis) without evidence of serious negative drug interactions. In rare instances, including when patients with severe cardiomyopathy, congestive heart failure, or recent myocardial infarction were given intravenous beta-adrenergic blocking agents or disopyramide concomitantly with intravenous verapamil, serious adverse effects have occurred.

Concomitant use of verapamil hydrochloride with β-adrenergic blockers may result in an exaggerated hypotensive response. Such an effect was observed in one study, following the concomitant administration of verapamil and prazosin. It may be necessary to decrease the dose of verapamil and/or dose of the neuromuscular blocking agent when the drugs are used concomitantly.

As verapamil is highly bound to plasma proteins, it should be administered with caution to patients receiving other highly protein-bound drugs. Other Cimetidine: The interaction between cimetidine and chronically administered verapamil has not been studied. In acute studies of healthy volunteers, clearance of verapamil was either reduced or unchanged.

Lithium: Increased sensitivity to the effects of lithium (neurotoxicity) has been reported during concomitant verapamil-lithium therapy with either no change or an increase in serum lithium levels. The addition of verapamil, however, has also resulted in the lowering of serum lithium levels in patients receiving chronic stable oral lithium. Patients receiving both drugs must be monitored carefully.

Carbamazepine: Verapamil therapy may increase carbamazepine concentrations during combined therapy. This may produce carbamazepine side effects such as diplopia, headache, ataxia, or dizziness. Rifampin: Therapy with rifampin may markedly reduce oral verapamil bioavailability.

Phenobarbital: Phenobarbital therapy may increase verapamil clearance. Cyclosporin: Verapamil therapy may increase serum levels of cyclosporin. Inhalation Anesthetics: Animal experiments have shown that inhalation anesthetics depress cardiovascular activity by decreasing the inward movement of calcium ions.

When used concomitantly, inhalation anesthetics and calcium antagonists (such as verapamil) should be titrated carefully to avoid excessive cardiovascular depression. Neuromuscular Blocking Agents: Clinical data and animal studies suggest that verapamil may potentiate the activity of depolarizing and nondepolarizing neuromuscular blocking agents. It may be necessary to decrease the dose of verapamil and/or the dose of the neuromuscular blocking agent when the drugs are used concomitantly.

Dantrolene: Two animal studies suggest concomitant intravenous use of verapamil and dantrolene sodium may result in cardiovascular collapse. There has been one report of hyperkalemia and myocardial depression following the coadministration of oral verapamil and intravenous dantrolene. 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. Labor and Delivery: There have been few controlled studies to determine whether the use of verapamil during labor or delivery has immediate or delayed adverse effects on the fetus, or whether it prolongs the duration of labor… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 50 words ▾

PRINCIPAL DISPLAY PANEL - VIAL LABELING (3 PARTS) VIAL PART 1 VIAL LAELING PART 2 VIAL LABELING PART 3

PRINCIPAL DISPLAY PANEL - SERIALIZED VIAL LABELING RFID Label

Principal Display Panel - 51662-1398-2 - Pouch Labeling Pouch Labeling

Principal Display Panel - 51662-1398-3 - Carton Labeling Case Label Case Label

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

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