Diltiazem Hydrochloride 360 mg Capsule, Extended Release, 30-count
Other active recalls for Diltiazem Hydrochloride (different manufacturers) — 6 · tap to view
🆔 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 to treat high blood pressure and to control angina (chest pain). Diltiazem is in a class of medications called calcium-channel blockers. It works by relaxing the blood vessels so the heart does not have to pump as hard. It also increases the supply of blood and oxygen to the heart. High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys, and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In...
Read the full MedlinePlus article ↗- 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 0ZBX0N59RZ
A plasticizer derived from citric acid that is added to tablet coatings and film formulations. It increases flexibility and durability of the coating layer, helping the tablet withstand handling and moisture without cracking.
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Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
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FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
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Shellac is a natural resin secreted by lac beetles, purified and processed into a coating material. It seals and protects tablets and capsules, controls how quickly the medicine dissolves, and gives pills their glossy finish.
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UNII 274KW0O50M
Sucrose stearate is a compound made from sugar and stearic acid (a fatty substance). It works as an emulsifier and surfactant to help mix oils and water-based ingredients together in the medicine.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
12 inactive ingredients listed in the exact product block matched to this NDC.
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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
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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 each | Per 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 · Q2 2026 | $0.3502 | $10.51 / 30 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Diltiazem Hydrochloride 360 mg 00228-2918-09 | Actavis | 90 capsules | $0.353 | AB3 | Availability likely | — |
| Diltiazem Hydrochloride 360 mg 24979-0030-07 | Upsher-Smith | 90 capsules | $0.353 | AB3 | Availability likely | — |
| Diltiazem Hydrochloride 360 mg 47335-0673-13 | Sun | 500 capsules | $0.609 | — | FDA listed | — |
| Diltiazem Hydrochloride EXTENDED RELEASE 360 mg 68682-0371-90 | Oceanside | 90 capsules | $0.609 | AB4 | FDA listed | — |
| Cardizem CD 360 mg 00187-0799-42 | Bausch | 90 capsules | — | AB3 | FDA listed | — |
| Tiazac Extended Release 360 mg 00187-2616-30 | Bausch | 30 capsules | — | AB4 | FDA listed | — |
| Diltiazem Hydrochloride 360 mg 33342-0525-02 | Macleods | 6 capsules | — | AB3 | FDA listed | — |
| Diltiazem Hydrochloride 360 mgthis 46708-0729-30 | Alembic | 30 capsules | — | AB3 | FDA listed | — |
| Diltiazem Hydrochloride 360 mg 47335-0679-13 | Sun | 500 capsules | — | — | FDA listed | — |
| diltiazem hydrochloride 360 mg 50742-0252-05 | Ingenus | 500 capsules | — | AB3 | FDA listed | — |
| Diltiazem Hydrochloride 360 mg 62332-0729-30 | Alembic | 30 capsules | — | AB3 | FDA listed | — |
| Diltiazem hydrochloride 360 mg 63304-0722-05 | Sun | 500 capsules | — | — | FDA listed | — |
| Diltiazem Hydrochloride EXTENDED RELEASE 360 mg 63629-7981-01 | Bryant | 30 capsules | — | AB4 | FDA listed | — |
| diltiazem hydrochloride 360 mg 68382-0599-01 | Zydus | 100 capsules | — | AB3 | FDA listed | — |
| Tiadylt Er 360 mg 68382-0749-01 | Zydus | 100 capsules | — | AB4 | FDA listed | — |
| diltiazem hydrochloride 360 mg 70771-1034-01 | Zydus | 100 capsules | — | AB3 | FDA listed | — |
| Tiadylt Er 360 mg 70771-1039-00 | Zydus | 1000 capsules | — | AB4 | FDA listed | — |
| diltiazem hydrochloride 360 mg 71335-1897-01 | Bryant | 30 capsules | — | AB3 | FDA listed | — |
| diltiazem hydrochloride 360 mg 84677-0043-90 | Golden | 90 capsules | — | AB3 | 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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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 46708-0729-30 You're viewing this | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-729-30) | 2024-11-14 | Active |
| 46708-0729-90 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-729-90) | 2024-11-14 | Active |
| 46708-0729-91 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-729-91) | 2024-11-14 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 46708-0729-30?
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Patients controlled on diltiazem alone or in combination with other medications may be switched to diltiazem hydrochloride extended-release capsules at the nearest equivalent total daily dose. Higher doses of diltiazem hydrochloride extended-release capsules may be needed in some patients. Monitor patients closely.
Subsequent titration to higher or lower doses may be necessary. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.
Hypertension: Adjust dosage to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, schedule dosage adjustments accordingly.
The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. Angina: Dosages for the treatment of angina should be adjusted to each patient’s needs, starting with a dose of 120 or 180 mg once daily.
Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7-to 14-day period. Concomitant Use with Other Cardiovascular Agents: Sublingual NTG: May be taken as required to abort acute anginal attacks during diltiazem hydrochloride therapy.
Prophylactic Nitrate Therapy: Diltiazem hydrochloride may be safely coadministered with short-and long-acting nitrates. Beta-blockers: (See WARNINGS and PRECAUTIONS .) Antihypertensives: Diltiazem hydrochloride has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride or the concomitant antihypertensives may need to be adjusted when adding one to the other.
⛔ 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 (13 of 3290 patients or 0.4%). 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).
Worsening of congestive heart failure has been reported in patients with preexisting impairment of ventricular function. 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 following table presents the most common adverse reactions reported in placebo-controlled angina and hypertension trials in patients receiving diltiazem hydrochloride extended-release capsules up to 360 mg with rates in placebo patients shown for comparison. Diltiazem Hydrochloride Extended-Release Capsule Placebo-Controlled Angina and Hypertension Trials Combined Adverse Reactions Diltiazem Hydrochloride Extended-Release Capsule (n=607) Placebo (n=301) Headache 5.4% 5% Dizziness 3% 3% Bradycardia 3.3% 1.3% AV Block First Degree 3.3% 0% Edema 2.6% 1.3% Asthenia 1.8% 1.7% In addition, the following events were reported infrequently (less than 1%) in angina or hypertension trials: Cardiovascular: Congestive heart failure, palpitations, syncope, ventricular extrasystoles.
Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tinnitus, tremor. Gastrointestinal: Anorexia, constipation, diarrhea, dry mouth, dysgeusia, dyspepsia, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase (see WARNINGS, Acute Hepatic Injury ), 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, polyuria, sexual difficulties. The following postmarketing 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), exfoliative dermatitis, 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.
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 number of well-documented cases of generalized rash, some characterized as leukocytoclastic vasculitis, have been reported. However, a definitive cause and effect relationship between these events and diltiazem hydrochloride therapy is yet to be established.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🆘 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. Because of its 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 amounts 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.
In the event of overdose 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).
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 are believed to be related to its ability to inhibit the cellular influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle. Mechanisms of Action Hypertension: Diltiazem 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.
Angina: Diltiazem has been shown to produce increases in exercise tolerance, probably due to its ability to reduce myocardial oxygen demand. This is accomplished via reductions in heart rate and systemic blood pressure at submaximal and maximal workloads. Diltiazem has been shown to be a potent dilator of coronary arteries, both epicardial and subendocardial.
Spontaneous and ergonovine-induced coronary artery spasms are inhibited by diltiazem. In animal models, diltiazem interferes with the slow inward (depolarizing) current in excitable tissue. It causes excitation-contraction uncoupling in various myocardial tissues without changes in the configuration of the action potential.
Diltiazem produces relaxation of coronary vascular smooth muscle and dilation of both large and small coronary arteries at drug levels that cause little or no negative inotropic effect. The resultant increases in coronary blood flow (epicardial and subendocardial) occur in ischemic and nonischemic models and are accompanied by dose-dependent decreases in systemic blood pressure and decreases in peripheral resistance. Hemodynamic and Electrophysiologic 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, 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. Such data have no predictive value with respect to effects in patients with poor ventricular function, and increased heart failure has been reported in patients with preexisting impairment of ventricular function. There are 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. In hypertensive patients, diltiazem hydrochloride extended-release capsules produces antihypertensive effects both in the supine and standing positions. In a double-blind, parallel, dose-response study utilizing doses ranging from 90 to 540 mg once daily, diltiazem hydrochloride extended-release capsules lowered supine diastolic blood pressure in an apparent linear manner over the entire dose range studied.
The changes in diastolic blood pressure, measured at trough, for placebo, 90 mg, 180 mg, 360 mg, and 540 mg were –2.9, –4.5, –6.1, –9.5, and –10.5 mm Hg, respectively. 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 decreases vascular resistance, increases cardiac output (by increasing stroke volume), and produces a slight decrease or no change in heart rate. During dynamic exercise, increases in…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Diltiazem Hydrochloride Extended-Release Capsules, USP are: 120 mg, light blue opaque/light blue opaque, size 2, hard gelatin capsules, imprinted with “A227” on cap in blue ink, filled with white to off-white pellets. Bottle of 30 capsules with child resistant closure, NDC 46708-725-30 Bottle of 90 capsules with child resistant closure, NDC 46708-725-90 Bottle of 1000 capsules, NDC 46708-725-91 180 mg, blue opaque/light blue opaque, size 0, hard gelatin capsules, imprinted with “A228” on cap in white ink, filled with white to off-white pellets.
Bottle of 30 capsules with child resistant closure, NDC 46708-726-30 Bottle of 90 capsules with child resistant closure, NDC 46708-726-90 Bottle of 1000 capsules, NDC 46708-726-91 240 mg, blue opaque/blue opaque, size 0EL, hard gelatin capsules, imprinted with “A229” on cap in white ink, filled with white to off-white pellets. Bottle of 30 capsules with child resistant closure, NDC 46708-727-30 Bottle of 90 capsules with child resistant closure, NDC 46708-727-90 Bottle of 1000 capsules, NDC 46708-727-91 300 mg, blue opaque/light grey opaque, size 00, hard gelatin capsules, imprinted with “A230” on cap in white ink, filled with white to off-white pellets.
Bottle of 30 capsules with child resistant closure, NDC 46708-728-30 Bottle of 90 capsules with child resistant closure, NDC 46708-728-90 Bottle of 1000 capsules, NDC 46708-728-91 360 mg, blue opaque/white opaque, size 00, hard gelatin capsules, imprinted with “A231” on cap in white ink, filled with white to off-white pellets. Bottle of 30 capsules with child resistant closure, NDC 46708-729-30 Bottle of 90 capsules with child resistant closure, NDC 46708-729-90 Bottle of 1000 capsules, NDC 46708-729-91 Storage Conditions: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Avoid excessive humidity. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Village Panelav, P. O.
Tajpura, Near Baska, Taluka-Halol, Panchmahal, Gujarat, India. Revised: 10/2022
📋 Description ▾
DESCRIPTION Diltiazem hydrochloride, USP 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: Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste.
It is freely soluble in chloroform, in formic acid, in methanol and in water, sparingly soluble in dehydrated ethanol, insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP are formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem).
The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules contain microcrystalline cellulose, sucrose stearate, povidone K-30, ethylcellulose, hypromellose, talc, acetyl tributyl citrate. The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsule shells contain FD&C Blue 1, titanium dioxide and gelatin. The 300 mg capsule shell also contain iron oxide black.
The 120 mg capsule shells are imprinted with edible blue ink containing shellac and FD&C Blue # 2 Aluminum Lake. The 180 mg, 240 mg, 300 mg and 360 mg capsule shells are imprinted with edible white ink containing shellac, potassium hydroxide and titanium dioxide. For oral administration.
FDA approved dissolution test specifications differ from USP. diltiazem-str.jpg