NDC 0187-0799-42 (billing 00187-0799-42) — Cardizem CD diltiazem 360 mg

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0187-0799-42

Product NDC 0187-0799

11-digit billing NDC 00187079942

NCPDP billing unit EA — each (per item)

RxCUI 830795, 830798, 830801, 830803, 830837, 830839, 830845, 830847,

UNII OLH94387TE

UPC 0301870796421

Application # NDA020062

SPL Set ID 1042fa13-e6af-46b9-8008-6c941f0978b1

Established class (EPC) Calcium Channel Blocker

Mechanism of action Calcium Channel Antagonists; Cytochrome P450 3A4 Inhibitors

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2001-04-11

Route ORAL

Dosage form CAPSULE, COATED, EXTENDED RELEASE

Substance DILTIAZEM HYDROCHLORIDE

TE code (Orange Book) AB3 · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 34000010127060

GPI class Cardizem CD

GCN Seq No 032600

GCN 07460

HICL code 000182

Ingredient (HICL) Diltiazem Hcl

HIC1 code A

Therapeutic class — broad (HIC1) Cardiovascular System

HIC2 code A9

Therapeutic class — intermediate (HIC2) Calcium Antagonists

HIC3 code A9A

Therapeutic class — specific (HIC3) Calcium Channel Blocking Agents

AHFS code 24:04.04.24

AHFS class Class Iv Antiarrhythmics

FDB label name CARDIZEM CD 360 MG CAPSULE

FDB brand name Cardizem Cd

Legend status F — Federal legend — prescription drug or device

Quick answers

GSN (GCN sequence number): 032600
GCN: 07460
GPI-14 (Medi-Span): 34000010127060
HICL (First Databank): 000182
AHFS class code: 24:04.04.24
RxCUI (RxNorm): 830795

Why two NDCs? The FDA registers this code as 0187-0799-42 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00187-0799-42. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

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.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

Label name CARDIZEM CD 360 MG CAPSULE Ingredient Diltiazem Hcl

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

2

Nutrient depletion considerations

Diltiazem may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

COENZYME Q10 Insufficient Evidence VITAMIN C Insufficient Evidence

🧪 Full Diltiazem nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026

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	$92.91	$8,361.93 / 90 capsules

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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
00187-0799-42 You're viewing this Main listing	90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC	2001-04-11	—	Active

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Diltiazem Hydrochloride 360 mg 00228-2918-09	Actavis	90 capsules	$0.333	AB3	Availability likely	—
Diltiazem Hydrochloride 360 mg 24979-0030-07	Upsher-Smith	90 capsules	$0.333	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 mgthis 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 mg 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	—

About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.

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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Sep 3, 2026
CMS NADAC weekly file

Availability & generic status

🏛️

2001

On the market since

Apr 2001

📍

2026

Currently FDA-listed

25 years listed

🔓

·

Generic versions listed

see equivalents

✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

FDA Orange Book · refreshed Sep 3, 2026

Inactive Ingredients / Excipients

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

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII P2OM2Q86BI
A synthetic polymer made from two types of plastic-like chemicals bonded together. It forms a protective coating on tablets or capsules to control how quickly the medicine dissolves and releases in your digestive system.
UNII H3R47K3TBD
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.
300 mg UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
UNII 2G86QN327L
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.
UNII 3NXW29V3WO
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.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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.
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
UNII U725QWY32X
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.
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.
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.
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.

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.

FDA label on DailyMed · label index refreshed Oct 1, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

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

LabelerBausch Health US LLC

Application holderBAUSCH HEALTH US LLC

FDA applicationNDA020062 (NDA)

Labeler code00187

First marketedApr 2001

Product typeHuman Prescription Drug

Portfolio41 products on file

🔎 All NDCs from Bausch Health US LLC

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.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description

🎯 Indications and Usage 42 words ▾

INDICATIONS AND USAGE CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. CARDIZEM CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Patients controlled on diltiazem alone or in combination with other medications may be switched to CARDIZEM CD capsules at the nearest equivalent total daily dose. Higher doses of CARDIZEM CD 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 72 words ▾

CONTRAINDICATIONS CARDIZEM CD 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 ~1 min read ▾

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 0.40%). 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 ~2 min read ▾

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 CARDIZEM CD up to 360 mg with rates in placebo patients shown for comparison. CARDIZEM CD Capsule Placebo-Controlled Angina and Hypertension Trials Combined Adverse Reactions CARDIZEM CD (n=607) Placebo (n=301) Headache 5.4% 5.0% Dizziness 3.0% 3.0% Bradycardia 3.3% 1.3% AV Block First Degree 3.3% 0.0% 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 Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions ~3 min read ▾

Drug Interactions Because of the potential for additive effects, slow titration is warranted in patients receiving diltiazem hydrochloride concomitantly with other agents known to affect cardiac contractility and/or conduction (see WARNINGS ). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with CARDIZEM CD (see WARNINGS ). Diltiazem is both a substrate and an inhibitor of the Pg-p and cytochrome P450 3A4 enzyme system which may affect exposure to diltiazem and concomitant drugs metabolized by those pathways.

Patients with renal and/or hepatic impairment may be particularly at risk of exposure changes. 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, titrate anesthetics and calcium blockers slowly.

Benzodiazepines: Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3- to 4-fold and the C max by 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 pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g., prolonged sedation) of both midazolam and triazolam.

Beta-blockers: Controlled and uncontrolled domestic studies suggest that concomitant use of diltiazem hydrochloride and beta-blockers is usually well tolerated, but available data are not sufficient to predict the effects of concomitant treatment in patients with left ventricular dysfunction or cardiac conduction abnormalities. Administration of diltiazem hydrochloride concomitantly 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. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted (see WARNINGS ). Buspirone: In nine healthy subjects, diltiazem significantly increased the mean buspirone AUC 5.5-fold and C max 4.1-fold compared to placebo.

The T 1/2 and T max 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 diltiazem with carbamazepine has been reported to result in elevated serum levels of carbamazepine (40% to 72% increase), resulting in toxicity in some cases. Cimetidine: A study in six healthy volunteers has shown a significant increase in peak diltiazem plasma levels (58%) and AUC (53%) after a 1-week course of cimetidine at 1200 mg per day and a single dose of diltiazem 60 mg. Ranitidine produced smaller, nonsignificant increases.

The effect may be mediated by cimetidine’s known inhibition of hepatic cytochrome P450, the enzyme system responsible for the first-pass metabolism of diltiazem. Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with cimetidine. An adjustment in the diltiazem dose may be warranted.

Clonidine: Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with diltiazem. Monitor heart rate in patients receiving concomitant diltiazem and clonidine. Cyclosporine: A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients.

In renal and cardiac transplant recipients,…

🆘 Overdosage ~2 min read ▾

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 (0.60 to 1.0 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 ~3 min read ▾

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, CARDIZEM CD 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, CARDIZEM CD 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.

CARDIZEM CD 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 diastolic pressure are inhibited, while maximum achievable systolic pressure is usually reduced. Chronic therapy w…

📦 How Supplied / Storage and Handling 182 words ▾

HOW SUPPLIED CARDIZEM® CD (diltiazem hydrochloride) Extended-Release Capsules Strength Quantity NDC Number Description 120 mg 30 count 90 count 0187-0795-30 0187-0795-42 Light turquoise blue/light turquoise blue capsule imprinted with “cardizem CD 120 mg” on body. 180 mg 30 count 90 count 0187-0796-30 0187-0796-42 Light blue/light turquoise blue capsule imprinted with “cardizem CD 180 mg” on body. 240 mg 30 count 90 count 0187-0797-30 0187-0797-42 Light blue/light blue capsule imprinted with “cardizem CD 240 mg” on body.

300 mg 30 count 90 count 0187-0798-30 0187-0798-42 Light blue/light gray capsule imprinted with “cardizem CD 300 mg” on body. 360 mg 90 count 0187-0799-42 Light blue/white capsule imprinted with “cardizem CD 360 mg” on body. 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. Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Steinbach, MB R5G 1Z7, Canada CARDIZEM is a registered trademark of Bausch Health Companies Inc. or its affiliates. © 2025 Bausch Health Companies Inc. or its affiliates Rev.

04/2025 9474004 20005830

📋 Description 159 words ▾

DESCRIPTION CARDIZEM ® CD (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)- cis -. The chemical structure is: Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste.

It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. CARDIZEM CD is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem).

Capsules also contain: black iron oxide (300 mg), FD&C Blue #1, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate, povidone, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. For oral administration. chem structure

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

alopecia: Loss of hair from the scalp or body.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

asthenia: Unusual weakness or lack of physical strength and energy.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

AV block: A slowing or blocking of the electrical signals traveling between the heart's upper and lower chambers, which can slow the heartbeat.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

depression: A lasting low mood with loss of interest that affects everyday life.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose-response: The relationship between the size of a dose and the strength of the body's reaction to it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dysgeusia: A changed or unpleasant sense of taste, such as a metallic taste.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

ejection fraction: The share of blood in the heart's main pumping chamber that gets pushed out with each beat, given as a percentage.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

epistaxis: A nosebleed.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

exfoliative dermatitis: Widespread redness with heavy scaling or peeling of the skin over most of the body.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

extrapyramidal symptoms: Movement problems caused by certain medicines, such as stiffness, tremor, restlessness, or unusually slow movements.

first-pass metabolism: The breakdown of a swallowed medicine by the liver before it reaches the rest of the body.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hyperuricemia: A higher-than-normal level of uric acid in the blood, which can lead to gout.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

monotherapy: Treatment using a single medicine by itself.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

myopathy: A disease of the muscles that can make them weak, painful, or tender.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

petechiae: Tiny flat red or purple spots on the skin caused by small amounts of bleeding underneath.

pharmacokinetic interaction: When one medicine changes how the body absorbs, spreads, breaks down, or removes another, altering its level in the blood.

photosensitivity: An unusually strong skin reaction, such as burning or rash, after being in sunlight or other ultraviolet light.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

pruritus: Itching of the skin.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

refractory: Describing a disease that does not respond to, or improve with, treatment.

retinopathy: Damage to the retina, the light-sensing layer at the back of the eye, which can affect vision.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

sublingual: A tablet or spray placed under the tongue, where it dissolves and is absorbed.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

transaminases: Liver enzymes measured in a blood test; higher-than-normal levels can be a sign that the liver is irritated or damaged.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trough: The lowest level a medicine reaches in the blood, just before the next dose is due.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Cardizem CD — the program that covers self-administered drugs. 1 manufacturer.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cardizem CD. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$61.8K

Claims incl. refills

37

Beneficiaries

30

Spend / beneficiary

$2,061.13

Spend / claim

$1,671.19

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
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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.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The 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.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bausch Health US LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Bausch Health US LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

Related NDC lookups

🧪 All Diltiazem Hydrochloride NDCsSame ingredient 🏭 All Bausch labeler NDCsLabeler code 00187 📚 All Calcium Channel Blocker NDCsDrug class

Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Calcium Channel Blocking Agents.

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Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

First Databank (licensed) · refreshed Oct 1, 2026

Cardizem CD diltiazem hydrochloride 360 mg Capsule, Coated, Extended Release, 90-count — NDC 0187-0799-42 (Billing 00187-0799-42)

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

RxNorm drug class

Clinical

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Supplement & herbal interactions

Pricing

Packaging — all sizes for this product

Therapeutic equivalents

Availability & generic status

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

Full prescribing information FDA SPL

Medicare Part D spend CMS · PART D · 2026 (Q1)

About this NDC listing & data coverage

Questions about this listing

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Related drugs in this class