Diltiazem Hydrochloride 60 mg Capsule, Extended Release, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Calcium Channel Blocker class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Diltiazem is used for a few different heart and blood vessel conditions depending on the form you have. The oral extended-release tablets and capsules treat high blood pressure and...
- It depends on the specific product you have. Extended-release tablets like Matzim LA or Cardizem LA can be taken with or without food — food doesn't meaningfully affect their absor...
- Does it matter what time of day I take diltiazem, or whether I take it with food?
- No — please don't do that with extended-release forms of diltiazem. Crushing, chewing, or opening an extended-release capsule or tablet destroys the time-release mechanism, which m...
Patient education
Supplement & herbal interactions
Diltiazem may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 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.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.427 | $142.66 / 100 capsules |
| Medicaid paysCMS SDUD · 12 mo | $1.66 | $165.68 / 100 capsules |
| Medicare drug plans payPart D · Q2 2026 | $1.41 | $141.40 / 100 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Diltiazem Hydrochloride 60 mg 16714-0553-01 | Northstar | 100 capsules | $1.374 | AB1 | Discontinued | save 4% |
| Diltiazem Hydrochloride 60 mg 00378-6060-01 | Mylan | 100 capsules | $1.427 | AB1 | Availability likely | — |
| Diltiazem Hydrochloride 60 mg 24979-0181-01 | Upsher-Smith | 100 capsules | $1.427 | AB1 | Availability likely | — |
| Diltiazem Hydrochloride 60 mg 50742-0564-01 | Ingenus | 100 capsules | $1.427 | AB1 | Availability likely | — |
| Diltiazem Hydrochloride 60 mg 51079-0924-20 | Mylan | 1 capsule | $1.427 | AB1 | Availability likely | — |
| Diltiazem Hydrochloride 60 mgthis 68462-0850-01 | GLENMARK | 100 capsules | $1.427 | AB1 | Availability likely | — |
| Diltiazem Hydrochloride Extended-Release 60 mg 75907-0044-01 | Dr. | 100 capsules | $1.427 | AB1 | Availability likely | — |
| Diltiazem Hydrochloride 60 mg 48433-0030-20 | Safecor | 1 capsule | — | AB1 | FDA listed | — |
| Diltiazem Hydrochloride Extended-Release 60 mg 73190-0011-01 | AvKARE | 100 capsules | — | AB1 | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68462-0850-01 You're viewing this | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-850-01) | 2021-03-22 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Dosages must be adjusted to each patient’s needs, starting with 60 to 120 mg twice daily. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. Although individual patients may respond to lower doses, the usual optimum dosage range in clinical trials was 240 to 360 mg/day.
Diltiazem Hydrochloride Extended-Release Capsules have an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of Diltiazem Hydrochloride Extended-Release Capsules or the concomitant antihypertensives may need to be adjusted when adding one to the other. See WARNINGS and PRECAUTIONS regarding use with beta-blockers.
⛔ Contraindications ▾
CONTRAINDICATIONS Diltiazem hydrochloride is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by X-ray on admission.
⚠️ Warnings ▾
WARNINGS Cardiac Conduction Diltiazem hydrochloride prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This effect may rarely result in abnormally slow heart rates (particularly in patients with sick sinus syndrome) or second- or third-degree AV block (9 of 2,111 patients or 0.43%). Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction.
A patient with Prinzmetal’s angina developed periods of asystole (2 to 5 seconds) after a single dose of 60 mg of diltiazem (see ADVERSE REACTIONS ). Congestive Heart Failure Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). An acute study of oral diltiazem in patients with impaired ventricular function (ejection fraction 24% ± 6%) showed improvement in indices of ventricular function without significant decrease in contractile function (dp/dt).
Experience with the use of diltiazem hydrochloride in combination with beta- blockers in patients with impaired ventricular function is limited. Caution should be exercised when using this combination. Hypotension Decreases in blood pressure associated with diltiazem hydrochloride therapy may occasionally result in symptomatic hypotension.
Acute Hepatic Injury Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed in clinical studies. Such elevations were usually transient and frequently resolved even with continued diltiazem treatment. 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.
These reactions tended to occur early after therapy initiation (1 to 8 weeks) and have been reversible upon discontinuation of drug therapy. The relationship to diltiazem hydrochloride is uncertain in some cases, but probable in some (see PRECAUTIONS ).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Serious adverse reactions have been rare in studies carried out to date, but it should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies. The adverse events described below represent events observed in clinical studies of hypertensive patients receiving either diltiazem hydrochloride tablets or Diltiazem Hydrochloride Extended-Release Capsules, as well as experiences observed in studies of angina and during marketing.
The most common events in hypertension studies are shown in a table with rates in placebo patients shown for comparison. Less common events are listed by body system; these include any adverse reactions seen in angina studies that were not observed in hypertension studies. In all hypertensive patients studied (over 900), the most common adverse events were edema (9%), headache (8%), dizziness (6%), asthenia (5%), sinus bradycardia (3%), flushing (3%), and first- degree AV block (3%).
Only edema and perhaps bradycardia and dizziness were dose related. The most common events observed in clinical studies (over 2,100 patients) of angina patients and hypertensive patients receiving diltiazem hydrochloride tablets or Diltiazem Hydrochloride Extended-Release Capsules were (i.e., greater than 1%) edema (5.4%), headache (4.5%), dizziness (3.4%), asthenia (2.8%), first-degree AV block (1.8%), flushing (1.7%), nausea (1.6%), bradycardia (1.5%), and rash (1.5%). Double Blind Placebo Controlled Hypertension Trials Adverse Diltiazem N = 315 # pts (%) Placebo N = 211 # pts (%) Headache 38 (12%) 17 (8%) AV block first degree 24 (7.6%) 4 (1.9%) Dizziness 22 (7%) 6 (2.8%) Edema 19 (6%) 2 (0.9%) Bradycardia 19 (6%) 3 (1.4%) ECG abnormality 13 (4.1%) 3 (1.4%) Asthenia 10 (3.2%) 1 (0.5%) Constipation 5 (1.6%) 2 (0.9%) Dyspepsia 4 (1.3%) 1 (0.5%) Nausea 4 (1.3%) 2 (0.9%) Palpitations 4 (1.3%) 2 (0.9%) Polyuria 4 (1.3%) 2 (0.9%) Somnolence 4 (1.3%) — Alk phos increase 3 (1%) 1 (0.5%) Hypotension 3 (1%) 1 (0.5%) Insomnia 3 (1%) 1 (0.5%) Rash 3 (1%) 1 (0.5%) AV block second degree 2 (0.6%) — In addition, the following events were reported infrequently (less than 1%) with Diltiazem Hydrochloride Extended-Release Capsules or diltiazem hydrochloride tablets or have been observed in angina or hypertension trials.
Cardiovascular: Angina, arrhythmia, second- or third-degree AV block (see Conduction Warning), bundle branch block, congestive heart failure, syncope, tachycardia, ventricular extrasystoles. Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, nervousness, paresthesia, personality change, tremor. Gastrointestinal: Anorexia, diarrhea, dry mouth, dysgeusia, mild elevations of SGOT, SGPT, and LDH (see Hepatic Warnings), thirst, vomiting, weight increase.
Dermatological: Petechiae, photosensitivity, pruritus, urticaria. Other : Amblyopia, CPK increase, dyspnea, epistaxis, eye irritation, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, nocturia, osteoarticular pain, sexual difficulties, tinnitus. The following post-marketing events have been reported infrequently in patients receiving diltiazem hydrochloride: acute generalized exanthematous pustulosis, allergic reactions, alopecia, angioedema (including facial or periorbital edema), asystole, erythema multiforme (including Stevens-Johnson Syndrome, toxic epidermal necrolysis), extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, leukopenia, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), purpura, retinopathy, myopathy, and thrombocytopenia.
There have been observed cases of a generalized rash, some characterized as leukocytoclastic vasculitis. In addition, events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease in these patients. A definitive cause and e…
🤰 Pregnancy ▾
Pregnancy Reproduction studies have been conducted in mice, rats, and rabbits. Administration of doses ranging from five to ten times greater (on a mg/kg basis) than the daily recommended therapeutic dose has resulted in embryo and fetal lethality. These doses, in some studies, have been reported to cause skeletal abnormalities.
In the perinatal/postnatal studies, there was some reduction in early individual pup weights and survival rates. There was an increased incidence of stillbirths at doses of 20 times the human dose or greater. There are no well controlled studies in pregnant women; therefore, use diltiazem hydrochloride in pregnant women only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🆘 Overdosage ▾
OVERDOSAGE The oral LD 50’s in mice and rats range from 415 to 740 mg/kg and from 560 to 810 mg/kg, respectively. The intravenous LD 50’s in these species were 60 and 38 mg/kg, respectively. The oral LD 50 in dogs is considered to be in excess of 50 mg/kg, while lethality was seen in monkeys at 360 mg/kg.
The toxic dose in man is not known. Due to extensive metabolism, blood levels after a standard dose of diltiazem can vary over tenfold, limiting the usefulness of blood levels in overdose cases. There have been reports of diltiazem overdose in doses ranging from 1 g to 18 g.
Of cases with known outcome, most patients recovered and in cases with a fatal outcome, the majority involved multiple drug ingestion. Events observed following diltiazem overdose included bradycardia, hypotension, heart block, and cardiac failure. Most reports of overdose described some supportive medical measure and/or drug treatment.
Bradycardia frequently responded favorably to atropine, as did heart block, although cardiac pacing was also frequently utilized to treat heart block. Fluids and vasopressors were used to maintain blood pressure and in cases of cardiac failure inotropic agents were administered. In addition, some patients received treatment with ventilatory support, gastric lavage, activated charcoal, and/or intravenous calcium.
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.
In the event of overdosage or exaggerated response, appropriate supportive measures should be employed in addition to gastrointestinal decontamination. 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.
Based on the known pharmacological effects of diltiazem and/or reported clinical experiences 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 norepinephrine bitartrate).
Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The therapeutic effects of diltiazem hydrochloride are believed to be related to its ability to inhibit the influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle. Mechanism of Action Diltiazem Hydrochloride Extended-Release Capsules produces its antihypertensive effect primarily by relaxation of vascular smooth muscle and the resultant decrease in peripheral vascular resistance. The magnitude of blood pressure reduction is related to the degree of hypertension; thus, hypertensive individuals experience an antihypertensive effect, whereas there is only a modest fall in blood pressure in normotensives.
Hemodynamic and Electrophysiological Effects Like other calcium channel antagonists, diltiazem decreases sinoatrial and atrioventricular conduction in isolated tissues and has a negative inotropic effect in isolated preparations. In the intact animal, prolongation of the AH interval can be seen at higher doses. In man, diltiazem prevents spontaneous and ergonovine-provoked coronary artery spasm.
It causes a decrease in peripheral vascular resistance and a modest fall in blood pressure in normotensive individuals and, in exercise tolerance studies in patients with ischemic heart disease, reduces the heart rate-blood pressure product for any given workload. Studies to date, primarily in patients with good ventricular function, have not revealed evidence of a negative inotropic effect; cardiac output, ejection fraction, and left ventricular end diastolic pressure have not been affected. Increased heart failure has, however, been reported in occasional patients with preexisting impairment of ventricular function.
There are as yet few data on the interaction of diltiazem and beta-blockers in patients with poor ventricular function. Resting heart rate is usually slightly reduced by diltiazem. Diltiazem Hydrochloride Extended-Release Capsules produces antihypertensive effects both in the supine and standing positions.
Postural hypotension is infrequently noted upon suddenly assuming an upright position. No reflex tachycardia is associated with the chronic antihypertensive effects. Diltiazem Hydrochloride Extended-Release Capsules decrease vascular resistance, increase cardiac output (by increasing stroke volume), and produce a slight decrease or no change in heart rate.
During dynamic exercise, increases in diastolic pressure are inhibited, while maximum achievable systolic pressure is usually reduced. Heart rate at maximum exercise does not change or is slightly reduced. Chronic therapy with diltiazem hydrochloride produces no change or an increase in plasma catecholamines.
No increased activity of the renin- angiotensin-aldosterone axis has been observed. Diltiazem Hydrochloride Extended-Release Capsules antagonize the renal and peripheral effects of angiotensin II. Hypertensive animal models respond to diltiazem with reductions in blood pressure and increased urinary output and natriuresis without a change in urinary sodium/potassium ratio.
Intravenous diltiazem hydrochloride in doses of 20 mg prolongs AH conduction time and AV node functional and effective refractory periods by approximately 20%. In a study involving single oral doses of 300 mg of diltiazem hydrochloride in six normal volunteers, the average maximum PR prolongation was 14% with no instances of greater than first-degree AV block. Diltiazem-associated prolongation of the AH interval is not more pronounced in patients with first-degree heart block.
In patients with sick sinus syndrome, diltiazem significantly prolongs sinus cycle length (up to 50% in some cases). Chronic oral administration of diltiazem hydrochloride in doses of up to 360 mg/day has resulted in small increases in PR interval, and on occasion produces abnormal prolongation (see WARNINGS ). Pharmacokinetics and Metabolism Diltiazem is well absorbed from the gastrointestinal tract and is subject to an extensive first-pass effect, giving an absolut…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Diltiazem Hydrochloride Extended-Release Capsules, USP (Twice-a-Day Dosage) are available as following: Diltiazem Hydrochloride Extended-Release Capsules, USP Strength Quantity NDC Number Description 60 mg Bottles of 100 with child-resistant closure 68462-850-01 The 60 mg capsules are hard shell gelatin capsules with a dark pink opaque cap and a white opaque body, imprinted with “Y” on the cap and “689” on the body with black ink, filled with white to off-white pellets. 90 mg Bottles of 100 with child-resistant closure 68462-851-01 The 90 mg capsules are hard shell gelatin capsules with a dark pink opaque cap and a yellow opaque body, imprinted with “Y” on the cap and “688” on the body with black ink, filled with white to off-white pellets.
120 mg Bottles of 100 with child-resistant closure 68462-562-01 The 120 mg capsules are hard shell gelatin capsules with a dark pink opaque cap and a dark pink opaque body, imprinted with “Y” on the cap and “562” on the body with black ink, filled with white to off-white pellets. Store at 20°C to 25°C (68°F to 77 ° F); excursions permitted to 15 ° C to 30 ° C (59°F to 86 ° F) [see USP Controlled Room Temperature]. Avoid excessive humidity.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com July 2025 logo1
📋 Description ▾
DESCRIPTION Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is Molecular formula: C 22 H 26 N 2 O 4 S•HCl Diltiazem hydrochloride, USP is a white crystalline powder or small crystals.
It is freely soluble in chloroform, formic acid, methanol, water, sparingly soluble in dehydrated alcohol and insoluble in ether. It has a molecular weight of 450.98 g/mol. Each Diltiazem Hydrochloride Extended-Release Capsules, USP contains either 60 mg diltiazem hydrochloride (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem).
Also contains: Diethyl phthalate, ethyl cellulose, methacrylic acid and ethyl acrylate copolymer, polysorbate, povidone, sodium lauryl sulfate, sugar spheres (corn starch, hypromellose and sucrose) and talc. The capsule shells contain D&C Yellow No. 10 (90 mg only), FD&C Red No.
3, FD&C Red No.40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. The black printing ink contains black iron oxide, potassium hydroxide and shellac.
For oral administration. FDA approved dissolution test specifications differ from USP. Structure.jpg