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DILTIAZEM HCI 5 mg/mL Injection, 5 mL — NDC 51662-1335-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

DILTIAZEM HCI 5 mg/mL Injection, 5 mL — NDC 51662-1335-1 (Billing 51662-1335-01)

by HF Acquisition Co LLC, DBA HealthFirst · 5 mL in 1 VIAL

This is a package of 5 mL of DILTIAZEM HCI 5 mg/mL Injection from HF Acquisition Co LLC, DBA HealthFirst, marketed since Dec 2018 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 51662-1335-01
🏷️ FDA NDC (as labeled) 51662-1335-1 billing pads the package segment with a zero
This package
Contains5 mL Pack sizes2 compare ↓
Main listing for product 51662-1335 · Also comes in: 5 mL 51662-1335-2
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51662-1335-1
Product NDC 51662-1335
11-digit billing NDC 51662133501
RxCUI 1791229
UNII OLH94387TE
Application # ANDA078538
SPL Set ID 7d8e8b1e-f67b-57d2-e053-2991aa0a8d12
Established class (EPC) Calcium Channel Blocker
Mechanism of action Calcium Channel Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-12-21
Route INTRAVENOUS
Dosage form INJECTION
Substance DILTIAZEM HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1791229
Why two NDCs? The FDA registers this code as 51662-1335-1 — 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 → 51662-1335-01. 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) Muscle relaxants, Benzothiazepine derivatives
How it works Calcium Channel Antagonists, Cytochrome P450 3A4 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
  • The pills and capsules you take by mouth are used for high blood pressure and for chronic stable angina, which is chest pain from the heart's workload. Some capsule brands, such as...
  • Usually it's taken once a day, and you should swallow it whole. Don't open, chew or crush the capsules. Some products, like DILT-XR, are best taken in the morning on an empty stoma...
  • How should I take my extended-release capsule or tablet?
  • The most common ones are a stuffy or runny nose, headache, sore throat, constipation, cough, and swelling in the legs or ankles. Most are mild. Call your doctor if you faint, feel...
📖 Read our full Diltiazem guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1163 $0.028 / J1163 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)51662-1335-1
11-digit billing NDC51662-1335-01
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ1163
Descriptor0.5 MG
Billing units / pkg50 units
How the units are derivedThis package is 5; the HCPCS unit is 0.5 MG, so one package = 50 billing units.
Medicare Part B spend (2026 (Q1))$166 · 97 claims · $1.72 per claim (all NDCs under J1163)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51662-1335-01 You're viewing this Main listing 5 mL in 1 VIAL 2018-12-21 — Active
51662-1335-02 51662-1335-2 1 VIAL in 1 POUCH / 5 mL in 1 VIAL 2023-01-19 — Active

Pack size FAQ

What quantity is in this package?
This package contains 5 mL — 5 ml in 1 vial.
What NDC number is used to bill for this package of DILTIAZEM HCI 5 mg/mL Injection?
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
Diltiazem Hydrochloride 5 mg/mL 00641-6013-10 Hikma 10 vials — AP FDA listed —
Diltiazem Hydrochloride 5 mg/mL 00641-9217-10 Hikma 10 vials — AP FDA listed —
Diltiazem Hydrochloride 5 mg/mL 25021-0319-05 Sagent 10 vials — AP FDA listed —
Diltiazem Hci 5 mg/mLthis 51662-1335-01 HF 5 ml — AP FDA listed —
Diltiazem Hydrochloride 5 mg/mL 55150-0425-10 Eugia 10 vials — — FDA listed —
Diltiazem Hydrochloride 5 mg/mL 71872-7063-01 Medical 1 vial — AP FDA listed —
Diltiazem Hydrochloride 5 mg/mL 71872-7345-01 Medical 1 vial — AP FDA listed —
Diltiazem Hydrochloride 5 mg/mL 84549-0319-05 ProPharma 5 ml — 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
Dec 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.

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.

  • 0.75 mg / 1 mL UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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.
  • 0.65 mg / 1 mL UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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.
  • 50 mg / 1 mL UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA078538 (ANDA)
Labeler code51662
First marketedDec 2018
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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

INDICATIONS & USAGE Diltiazem Hydrochloride Injection is indicated for the following: Atrial Fibrillation or Atrial Flutter Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome. Paroxysmal Supraventricular Tachycardia Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm.

This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. The use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium.

For either indication and particularly when employing continuous intravenous infusion, the setting should include continuous monitoring of the ECG and frequent measurement of blood pressure. A defibrillator and emergency equipment should be readily available. In domestic controlled trials in patients with atrial fibrillation or atrial flutter, bolus administration of diltiazem hydrochloride injection was effective in reducing heart rate by at least 20% in 95% of patients.

Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. Following administration of one or two intravenous bolus doses of diltiazem injection, response usually occurs within 3 minutes and maximal heart rate reduction generally occurs in 2 to 7 minutes. Heart rate reduction may last from 1 to 3 hours.

If hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours. A 24-hour continuous infusion of diltiazem injection in the treatment of atrial fibrillation or atrial flutter maintained at least a 20% heart rate reduction during the infusion in 83% of patients. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours).

Hypotension, if it occurs, may be similarly persistent. In the controlled clinical trials, 3.2% of patients required some form of intervention (typically, use of intravenous fluids or the Trendelenburg position) for blood pressure support following diltiazem hydrochloride injection. In domestic controlled trials, bolus administration of diltiazem hydrochloride injection was effective in converting PSVT to normal sinus rhythm in 88% of patients within 3 minutes of the first or second bolus dose.

Symptoms associated with the arrhythmia were improved in conjunction with decreased heart rate or conversion to normal sinus rhythm following administration of diltiazem hydrochloride injection.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE & ADMINISTRATION Direct Intravenous Single Injections (Bolus) The initial dose of diltiazem hydrochloride injection should be 0.25 mg/kg actual body weight as a bolus administered over 2 minutes (20 mg is a reasonable dose for the average patient). If response is inadequate, a second dose may be administered after 15 minutes. The second bolus dose of diltiazem hydrochloride injection should be 0.35 mg/kg actual body weight administered over 2 minutes (25 mg is a reasonable dose for the average patient).

Subsequent intravenous bolus doses should be individualized for each patient. Patients with low body weights should be dosed on a mg/kg basis. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter.

Experience with this dose is limited. Continuous Intravenous Infusion For continued reduction of the heart rate (up to 24 hours) in patients with atrial fibrillation or atrial flutter, an intravenous infusion of diltiazem hydrochloride injection may be administered. Immediately following bolus administration of 20 mg (0.25 mg/kg) or 25 mg (0.35 mg/kg) diltiazem hydrochloride injection and reduction of heart rate, begin an intravenous infusion of diltiazem hydrochloride.

The recommended initial infusion rate of diltiazem hydrochloride is 10 mg/h. Some patients may maintain response to an initial rate of 5 mg/h. The infusion rate may be increased in 5 mg/h increments up to 15 mg/h as needed, if further reduction in heart rate is required.

The infusion may be maintained for up to 24 hours. Diltiazem shows dose-dependent, non-linear pharmacokinetics. Duration of infusion longer than 24 hours and infusion rates greater than 15 mg/h have not been studied.

Therefore, infusion duration exceeding 24 hours and infusion rates exceeding 15 mg/h are not recommended. DILUTION To prepare diltiazem hydrochloride injection for continuous intravenous infusion, aseptically transfer the appropriate quantity (see chart) of diltiazem hydrochloride injection to the desired volume of either Normal Saline, D5W, or D5W/0.45% NaCl. Mix thoroughly.

Use within 24 hours. Keep refrigerated until use. * 5 mg/h may be appropriate for some patients Compatibility Diltiazem hydrochloride injection was tested for compatibility with three commonly used intravenous fluids at a maximal concentration of 1 mg diltiazem hydrochloride per milliliter. Diltiazem hydrochloride injection was found to be physically compatible and chemically stable in the following parenteral solutions for at least 24 hours when stored in glass or polyvinylchloride (PVC) bags at controlled room temperature 15º-30°C (59°-86°F) or under refrigeration 2°-8°C (36°-46°F). dextrose (5%) injection sodium chloride (0.9%) injection dextrose (5%) and sodium chloride (0.45%) injection Physical Incompatibilities Because of potential physical incompatibilities, it is recommended that diltiazem hydrochloride not be mixed with any other drugs in the same container.

If possible, it is recommended that diltiazem hydrochloride not be co-infused in the same intravenous line. Physical incompatibilities (precipitate formation or cloudiness) were observed when diltiazem hydrochloride injection was infused in the same intravenous line with the following drugs: acetazolamide, acyclovir, aminophylline, ampicillin, ampicillin sodium/sulbactam sodium, cefamandole, cefoperazone, diazepam, furosemide, hydrocortisone sodium succinate, insulin (regular: 100 units/mL), methylprednisolone sodium succinate, mezlocillin, nafcillin, phenytoin, rifampin, and sodium bicarbonate.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Transition to Further Antiarrhythmic Therapy Transition to other antiarrhythmic agents following administration of diltiazem hydrochloride injection is generally safe. However, reference should be made to the respective agent manufacturer’s package i… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications ~1 min read ▾

CONTRAINDICATIONS Diltiazem hydrochloride injection is contraindicated in: Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. Patients with severe hypotension or cardiogenic shock.

Patients who have demonstrated hypersensitivity to the drug. Intravenous diltiazem and intravenous beta-blockers should not be administered together or in close proximity (within a few hours). Patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in WPW syndrome or short PR syndrome.

As with other agents which slow AV nodal conduction and do not prolong the refractoriness of the accessory pathway (e.g., verapamil, digoxin), in rare instances patients in atrial fibrillation or atrial flutter associated with an accessory bypass tract may experience a potentially life-threatening increase in heart rate accompanied by hypotension when treated with diltiazem hydrochloride injection. As such, the initial use of diltiazem hydrochloride injection should be, if possible, in a setting where monitoring and resuscitation capabilities, including DC cardioversion/defibrillation, are present (see OVERDOSAGE).

Once familiarity of the patient’s response is established, use in an office setting may be acceptable. Patients with ventricular tachycardia. Administration of other calcium channel blockers to patients with wide complex tachycardia (QRS ≥0.12 seconds) has resulted in hemodynamic deterioration and ventricular fibrillation.

It is important that an accurate pretreatment diagnosis distinguish wide complex QRS tachycardia of superventricular origin from that of ventricular origin prior to administration of diltiazem hydrochloride injection.

⚠️ Warnings ~2 min read ▾

WARNINGS Cardiac Conduction Diltiazem prolongs AV nodal conduction and refractoriness that may rarely result in second- or third-degree AV block in sinus rhythm. Concomitant use of diltiazem with agents known to affect cardiac conduction may result in additive effects (see PRECAUTIONS , Drug Interactions). If high-degree AV block occurs in sinus rhythm, intravenous diltiazem should be discontinued and appropriate supportive measures instituted (see OVERDOSAGE ).

Congestive Heart Failure Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function and in patients with a compromised myocardium, such as severe CHF, acute MI, and hypertrophic cardiomyopathy, have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). Administration of oral diltiazem in patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission is contraindicated.

Experience with the use of diltiazem hydrochloride injection in patients with impaired ventricular function is limited. Caution should be exercised when using the drug in such patients. Hypotension Decreases in blood pressure associated with diltiazem hydrochloride injection therapy may occasionally result in symptomatic hypotension (3.2%).

The use of intravenous diltiazem for control of ventricular response in patients with supraventricular arrhythmias should be undertaken with caution when the patient is compromised hemodynamically. In addition, caution should be used in patients taking other drugs that decrease peripheral resistance, intravascular volume, myocardial contractility or conduction. Acute Hepatic Injury In rare instances, significant elevations in enzymes such as alkaline phosphatase, LDH, SGOT, SGPT, and other phenomena consistent with acute hepatic injury have been noted following oral diltiazem.

Therefore, the potential for acute hepatic injury exists following administration of intravenous diltiazem. Ventricular Premature Beats (VPBs) VPBs may be present on conversion of PSVT to sinus rhythm with diltiazem hydrochloride injection. These VPBs are transient, are typically considered to be benign, and appear to have no clinical significance.

Similar ventricular complexes have been noted during cardioversion, other pharmacologic therapy, and during spontaneous conversion of PSVT to sinus rhythm.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The following adverse reaction rates are based on the use of diltiazem hydrochloride injection in over 400 domestic clinical trial patients with atrial fibrillation/flutter or PSVT under double-blind or open-label conditions. Worldwide experience in over 1300 patients was similar. Adverse events reported in controlled and uncontrolled clinical trials were generally mild and transient.

Hypotension was the most commonly reported adverse event during clinical trials. Asymptomatic hypotension occurred in 4.3% of patients. Symptomatic hypotension occurred in 3.2% of patients.

When treatment for hypotension was required, it generally consisted of administration of saline or placing the patient in the Trendelenburg position. Other events reported in at least 1% of the diltiazem-treated patients were injection site reactions (e.g., itching, burning) - 3.9%, vasodilation (flushing) - 1.7%, and arrhythmia (junctional rhythm or isorhythmic dissociation) - 1%. In addition, the following events were reported infrequently (less than 1%): Cardiovascular Asystole, atrial flutter, AV block first degree, AV block second degree, bradycardia, chest pain, congestive heart failure, sinus pause, sinus node dysfunction, syncope, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia.

Dermatologic Pruritus, sweating. Gastrointestinal Constipation, elevated SGOT or alkaline phosphatase, nausea, vomiting. Nervous System Dizziness, paresthesia.

Other Amblyopia, asthenia, dry mouth, dyspnea, edema, headache, hyperuricemia. Although not observed in clinical trials with diltiazem hydrochloride injection, the following events associated with oral diltiazem may occur. CARDIOVASCULAR AV block (third degree), bundle branch block, ECG abnormality, palpitations, syncope, tachycardia, ventricular extrasystoles.

DERMATOLOGIC Alopecia, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, leukocytoclastic vasculitis, petechiae, photosensitivity, purpura, rash, urticaria. GASTROINTESTINAL Anorexia, diarrhea, dysgeusia, dyspepsia, mild elevations of SGPT and LDH, thirst, weight increase. NERVOUS SYSTEM Abnormal dreams, amnesia, depression, extrapyramidal symptoms, gait abnormality, hallucinations, insomnia, nervousness, personality change, somnolence, tremor.

OTHER Allergic reactions, angioedema (including facial or periorbital edema), CPK elevation, epistaxis, eye irritation, gingival hyperplasia, hemolytic anemia, hyperglycemia, impotence, increased bleeding time, leukopenia, muscle cramps, myopathy, nasal congestion, nocturia, osteoarticular pain, polyuria, retinopathy, sexual difficulties, thrombocytopenia, tinnitus. Events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease for the patient.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Overdosage experience is limited. In the event of overdosage or an exaggerated response, appropriate supportive measures should be employed. The following measures may be considered: Bradycardia Administer atropine (0.6 to 1 mg).

If there is no response to vagal blockade administer isoproterenol cautiously. High-Degree AV Block Treat as for bradycardia above. Fixed high-degree AV block should be treated with cardiac pacing.

Cardiac Failure Administer inotropic agents (isoproterenol, dopamine, or dobutamine) and diuretics. Hypotension Vasopressors (e.g., dopamine or levarterenol bitartrate). The effectiveness of intravenous calcium administration to reverse the pharmacological effects of diltiazem overdose has been inconsistent.

In a few reported cases, overdose with calcium channel blockers associated with hypotension and bradycardia that was initially refractory to atropine became more responsive to atropine after the patients received intravenous calcium. In some cases intravenous calcium has been administered (1 g calcium chloride or 3 g calcium gluconate) over 5 minutes, and repeated every 10 to 20 minutes as necessary. Calcium gluconate has also been administered as a continuous infusion at a rate of 2 g per hour for 10 hours.

Infusions of calcium for 24 hours or more may be required. Patients should be monitored for signs of hypercalcemia. Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician.

Diltiazem does not appear to be removed by peritoneal or hemodialysis. Limited data suggest that plasmapheresis or charcoal hemoperfusion may hasten diltiazem elimination following overdose. The intravenous LD 50s in mice and rats were 60 and 38 mg/kg, respectively.

The toxic dose in man is not known.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanisms of Action Diltiazem inhibits the influx of calcium (Ca 2+) ions during membrane depolarization of cardiac and vascular smooth muscle. The therapeutic benefits of diltiazem in supraventricular tachycardias are related to its ability to slow AV nodal conduction time and prolong AV nodal refractoriness. Diltiazem exhibits frequency (use) dependent effects on AV nodal conduction such that it may selectively reduce the heart rate during tachycardias involving the AV node with little or no effect on normal AV nodal conduction at normal heart rates.

Diltiazem slows the ventricular rate in patients with a rapid ventricular response during atrial fibrillation or atrial flutter. Diltiazem converts paroxysmal supraventricular tachycardia (PSVT) to normal sinus rhythm by interrupting the reentry circuit in AV nodal reentrant tachycardias and reciprocating tachycardias, e.g., Wolff-Parkinson-White syndrome (WPW). Diltiazem prolongs the sinus cycle length.

It has no effect on the sinus node recovery time or on the sinoatrial conduction time in patients without SA nodal dysfunction. Diltiazem has no significant electrophysiologic effects on tissues in the heart that are fast sodium channel dependent, e.g., His-Purkinje tissue, atrial and ventricular muscle, and extranodal accessory pathways. Like other calcium channel antagonists, because of its effect on vascular smooth muscle, diltiazem decreases total peripheral resistance resulting in a decrease in both systolic and diastolic blood pressure.

Hemodynamics In patients with cardiovascular disease, diltiazem hydrochloride administered intravenously in single bolus doses, followed in some cases by a continuous infusion, reduced blood pressure, systemic vascular resistance, the rate-pressure product, and coronary vascular resistance and increased coronary blood flow. In a limited number of studies of patients with compromised myocardium (severe congestive heart failure, acute myocardial infarction, hypertrophic cardiomyopathy), administration of intravenous diltiazem produced no significant effect on contractility, left ventricular end diastolic pressure, or pulmonary capillary wedge pressure.

The mean ejection fraction and cardiac output/index remained unchanged or increased. Maximal hemodynamic effects usually occurred within 2 to 5 minutes of an injection. However, in rare instances, worsening of congestive heart failure has been reported in patients with preexisting impaired ventricular function.

Pharmacodynamics The prolongation of PR interval correlated significantly with plasma diltiazem concentration in normal volunteers using the Sigmoidal Emax model. Changes in heart rate, systolic blood pressure, and diastolic blood pressure did not correlate with diltiazem plasma concentrations in normal volunteers. Reduction in mean arterial pressure correlated linearly with diltiazem plasma concentration in a group of hypertensive patients.

In patients with atrial fibrillation and atrial flutter, a significant correlation was observed between the percent reduction in HR and plasma diltiazem concentration using the Sigmoidal Emax model. Based on this relationship, the mean plasma diltiazem concentration required to produce a 20% decrease in heart rate was determined to be 80 ng/mL. Mean plasma diltiazem concentrations of 130 ng/mL and 300 ng/mL were determined to produce reductions in heart rate of 30% and 40%.

Pharmacokinetics and Metabolism Following a single intravenous injection in healthy male volunteers, diltiazem hydrochloride appears to obey linear pharmacokinetics over a dose range of 10.5 to 21 mg. The plasma elimination half-life is approximately 3.4 hours. The apparent volume of distribution of diltiazem is approximately 305 L.

Diltiazem is extensively metabolized in the liver with a systemic clearance of approximately 65 L/h. After constant rate intravenous infusion to healthy male volunteers, diltiazem exhibits nonlinear pharmacokinetics over an infus… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 88 words ▾

HOW SUPPLIED DILTIAZEM HCI INJECTION is supplied in the following dosage forms. NDC 51662-1335-1 DILTIAZEM HCI INJECTION 25mg/5mL (5 mg/mL) 5mL VIAL NDC 51662-1335-2 DILTIAZEM HCI INJECTION 25mg/5mL (5 mg/mL) 5mL VIAL IN A POUCH HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 SINGLE-DOSE VIALS. DISCARD UNUSED PORTION.

This product, including the packaging components, is free of latex. Store diltiazem hydrochloride injection under refrigeration 2º-8ºC (36º-46ºF). DO NOT FREEZE.

May be stored at room temperature for up to 1 month. Destroy after 1 month at room temperature.

📋 Description 125 words ▾

DESCRIPTION Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium channel antagonist). Chemically, diltiazem hydrochloride is (+)-5-[2-(Dimethylamino)ethyl]-cis-2,3-dihydro-3-hydroxy-2-(p-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one acetate(ester) monohydrochloride. The structural formula is: C22H26N2O4S• HCl MW: 450.98 Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste.

It is soluble in water, methanol, and chloroform. Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. It has a pH range of 3.7 to 4.1.

Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. Each mL contains: 5 mg Diltiazem Hydrochloride, USP, 0.75 mg Citric Acid Anhydrous, USP, 0.65 mg Sodium Citrate Dihydrate USP, 50 mg Sorbitol NF, and Water for Injection, USP q.s. Sodium Hydroxide or Hydrochloric Acid is used to adjust pH.

STRUCTURE

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. The drug should be used with caution in patients with impaired renal or hepatic function (see WARNINGS ). High intravenous dosages (4.5 mg/kg tid) administered to dogs resulted in significant bradycardia and alterations in AV conduction.

In subacute and chronic dog and rat studies designed to produce toxicity, high oral doses of diltiazem were associated with hepatic damage. In special subacute hepatic studies, oral doses of 125 mg/kg and higher in rats were associated with histological changes in the liver, which were reversible when the drug was discontinued. In dogs, oral doses of 20 mg/kg were also associated with hepatic changes; however, these changes were reversible with continued dosing.

Dermatologic events progressing to erythema multiforme and/or exfoliative dermatitis have been infrequently reported following oral diltiazem. Therefore, the potential for these dermatologic reactions exists following exposure to intravenous diltiazem. Should a dermatologic reaction persist, the drug should be discontinued.

Drug Interactions As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem.

Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels. ANESTHETICS The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. When used concomitantly, anesthetics and calcium blockers should be titrated carefully.

BENZODIAZEPINES Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3-4 fold and Cmaxby 2-fold, compared to placebo. The elimination half-life of midazolam and triazolam also increased (1.5 to 2.5 fold) during coadministration with diltiazem. These pharmacokinectic effects seen during diltiazem coadministration can result in increased clinical effects (e.g. prolonged sedation) of both midazolam and triazolam.

BETA-BLOCKERS Intravenous diltiazem has been administered to patients on chronic oral beta-blocker therapy. The combination of the two drugs was generally well tolerated without serious adverse effects. If intravenous diltiazem is administered to patients receiving chronic oral beta-blocker therapy, the possibility for bradycardia, AV block, and/or depression of contractility should be considered (see CONTRAINDICATIONS ).

Oral administration of diltiazem with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and bioavailability of propranolol was increased approximately 50%. In vitro, propranolol appears to be displaced from its binding sites by diltiazem. BUSPIRONE In nine healthy subjects, diltiazem significantly increased the mean buspirone AUC 5.5 fold and Cmax 4.1 fold compared to placebo.

The T1/2 and Tmax of buspirone were not significantly affected by diltiazem. Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with diltiazem. Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment.

CARBAMAZEPINE Concomitant administration of oral diltiazem with carbamazepine has been reported to result in elevated plasma levels of carbamazepine (by 40 to 72%), resulting in toxicity in some cases. Patients receiving these drugs concurrently should be monitored for a potential drug interaction. CIMETIDINE A study i… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 43 words ▾

PRINCIPAL DISPLAY PANEL-VIAL LABEL VIAL LABEL

PRINCIPAL DISPLAY PANEL-LABEL ON VIAL LABEL ON VIAL

PRINCIPAL DISPLAY PANEL-SERIALIZED LABELING SERIALIZED LABELING

PRINCIPAL DISPLAY PANEL, NDC 51662-1335-2 POUCH LABELING NDC 51662-1335-2 POUCH LABELING POUCH RFID LABELING VIAL LABELING POUCH LABELING SERIALIZED RFID LABELING VIAL 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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Finished prescription product
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NDC identity (package / product / labeler codes) ✓ Available
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Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
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Inactive ingredients (structured) ✓ Available
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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.
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Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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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 HF Acquisition Co LLC, DBA HealthFirst. 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 1 vial (51662-1335-02). 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?
HF Acquisition Co LLC, DBA HealthFirst 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1163 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
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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.
← 51662-1334-01 · HF 51662-1336-01 · HF →
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