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Diltiazem Hydrochloride 120 mg Capsule, Extended Release — NDC 48433-0032-20 package photo

Diltiazem Hydrochloride 120 mg Capsule, Extended Release

by Safecor Health LLC · 100 BLISTER PACK in 1 CARTON (48433-032-20) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (48433-032-01)
NDC 48433-0032-20
🏷️ FDA NDC (as labeled) 48433-032-20 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Diltiazem Hydrochloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0342-2025
Class II · Nov 1, 2024 — cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0095-2025
Class II · Nov 1, 2024 — cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0093-2025
Class II · Nov 1, 2024 — cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0094-2025
Class II · Apr 17, 2024 — Failed Dissolution Specifications (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0472-2024
Class II · Mar 26, 2024 — Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0430-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 48433-032-20
Product NDC 48433-032
11-digit billing NDC 48433003220
RxCUI 830865, 830869, 830872
UNII OLH94387TE
Application # ANDA074910
SPL Set ID fc02db0f-5311-4b61-896e-bfe340832735
Established class (EPC) Calcium Channel Blocker
Mechanism of action Calcium Channel Antagonists; Cytochrome P450 3A4 Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-02
Route ORAL
Dosage form CAPSULE, EXTENDED RELEASE
Substance DILTIAZEM HYDROCHLORIDE
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 48433-032-20 — a 5-3-2 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 product segment → 48433-0032-20. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Calcium Channel Blocker class.

Pharmacologic class Calcium Channel Blocker
Drug family (ATC) Muscle relaxants, Benzothiazepine derivatives
How it works Calcium Channel Antagonists, Cytochrome P450 3A4 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSafecor Health LLC
Application holderMYLAN PHARMACEUTICALS INC
FDA applicationANDA074910 (ANDA)
Labeler code48433
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio48 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Diltiazem guide →

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.

🧪 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.

💊 What it looks like

Color pink / white
ShapeCapsule
ImprintMYLAN;6120
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII UF064M00AF
    Diethyl phthalate is a clear, colorless liquid made from phthalic acid. It's used in medicines as a plasticizer to make tablet coatings flexible and as a solvent to help dissolve and distribute active ingredients evenly throughout the product.
  • 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.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 5KY68S2577
    A synthetic plastic polymer made from two chemical compounds combined in a specific ratio. It forms a coating on tablets and capsules to control how and where the medication dissolves in the digestive tract.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1.41 $141.40 / 100 capsule
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diltiazem Hydrochloride Extended-Release 120 mg 10370-0829-05 Endo 500 capsules $0.146 AB3 Discontinued —
Cartia XT 120 mg 62037-0597-05 Actavis 500 capsules $0.146 AB3 Availability likely —
Diltiazem Hydrochloride 120 mg 24979-0026-02 Upsher-Smith 500 capsules $0.146 AB3 Availability likely —
Diltiazem Hydrochloride 120 mg 00904-7217-61 Major 1 capsule $0.146 AB3 Availability likely —
Diltiazem Hydrochloride Extended-Release 120 mg 60687-0195-01 American 1 capsule $0.146 AB3 Availability likely —
Diltiazem hydrochloride 120 mg 63304-0718-05 Sun 500 capsules $0.149 — FDA listed —
Diltiazem Hydrochloride 120 mg 68682-0993-98 OCEANSIDE 90 capsules $0.172 AB3 FDA listed —
Diltiazem Hydrochloride 120 mg 47335-0669-13 Sun 500 capsules $0.218 — FDA listed —
Diltiazem Hydrochloride EXTENDED RELEASE 120 mg 68682-0367-90 Oceanside 90 capsules $0.218 AB4 FDA listed —
Diltiazem Hydrochloride 120 mg 16729-0303-01 Accord 100 capsules $0.308 AB2 Availability likely —
Diltiazem Hydrochloride 120 mg 60505-0014-06 Apotex 100 capsules $0.320 AB2 Availability likely —
Diltiazem Hydrochloride 120 mg 62332-0815-31 Alembic 100 capsules $0.320 AB2 Availability likely —
Diltiazem Hydrochloride 120 mg 16714-0523-01 NORTHSTAR 100 capsules $0.320 AB2 Availability likely —
Diltiazem Hydrochloride 120 mg 70436-0191-01 Slate 100 capsules $0.320 AB2 Availability likely —
Diltiazem Hydrochloride 120 mg 00378-6120-01 Mylan 100 capsules $1.979 AB1 Availability likely —
Diltiazem Hydrochloride 120 mg 24979-0183-01 Upsher-Smith 100 capsules $1.979 AB1 Availability likely —
Diltiazem Hydrochloride 120 mg 50742-0566-01 Ingenus 100 capsules $1.979 AB1 Availability likely —
Diltiazem Hydrochloride 120 mg 51079-0926-20 Mylan 1 capsule $1.979 AB1 Availability likely —
Diltiazem Hydrochloride 120 mg 68462-0562-01 GLENMARK 100 capsules $1.979 AB1 Availability likely —
Diltiazem Hydrochloride Extended-Release 120 mg 75907-0046-01 Dr. 100 capsules $1.979 AB1 Availability likely —
Diltiazem Hydrochloride 120 mg 16714-0555-01 Northstar 100 capsules $2.156 AB1 Discontinued —
Diltiazem Hydrochloride 120 mgthis 48433-0032-20 Safecor 1 capsule — AB1 FDA listed —
Diltiazem Hydrochloride 120 mg 67046-1481-03 Coupler 30 capsules — AB1 FDA listed —
Diltiazem Hydrochloride Extended-Release 120 mg 73190-0013-01 AvKARE 100 capsules — AB1 FDA listed —
Diltiazem Hydrochloride 120 mg 47335-0675-13 Sun 500 capsules — — FDA listed —
Diltiazem hydrochloride 120 mg 50090-6328-00 A-S 30 capsules — — FDA listed —
Diltiazem Hydrochloride Extended-Release 120 mg 63629-2154-01 Bryant 30 capsules — AB3 FDA listed —
Diltiazem Hydrochloride Extended-Release 120 mg 71335-0745-01 Bryant 30 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 120 mg 68071-4664-03 NuCare 30 capsules — AB3 FDA listed —
diltiazem hydrochloride 120 mg 70518-3484-00 REMEDYREPACK 30 capsules — AB3 FDA listed —
diltiazem hydrochloride 120 mg 70771-1030-01 Zydus 100 capsules — AB3 FDA listed —
Tiazac Extended Release 120 mg 00187-2612-30 Bausch 30 capsules — AB4 FDA listed —
Diltiazem Hydrochloride 120 mg 50090-5416-00 A-S 30 capsules — AB3 FDA listed —
diltiazem hydrochloride 120 mg 68788-7870-01 Preferred 100 capsules — AB3 FDA listed —
Diltiazem Hydrochloride Extended-Release 120 mg 71335-1223-01 Bryant 30 capsules — AB3 FDA listed —
diltiazem hydrochloride 120 mg 71335-2089-01 Bryant 30 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 120 mg 46708-0725-30 Alembic 30 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 120 mg 62332-0725-30 Alembic 30 capsules — AB3 FDA listed —
diltiazem hydrochloride 120 mg 50742-0248-05 Ingenus 500 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 120 mg 33342-0521-02 Macleods 6 capsules — AB3 FDA listed —
Tiadylt Er 120 mg 70771-1035-00 Zydus 1000 capsules — AB4 FDA listed —
diltiazem hydrochloride 120 mg 00615-8379-39 NCS 30 capsules — AB3 FDA listed —
Cardizem CD 120 mg 00187-0795-30 Bausch 30 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 120 mg 51407-0473-90 Golden 90 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 120 mg 55154-4317-00 Cardinal 1 capsule — AB3 FDA listed —
Tiadylt Er 120 mg 68382-0745-01 Zydus 100 capsules — AB4 FDA listed —
Diltiazem Hydrochloride 120 mg 71335-2129-01 Bryant 30 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 120 mg 46708-0815-31 Alembic 100 capsules — AB2 FDA listed —
Cartia XT 120 mg 63629-7896-01 Bryant 30 capsules — AB3 FDA listed —
Diltiazem Hydrochloride 120 mg 71335-1389-01 Bryant 30 capsules — AB3 FDA listed —
Tiadylt Er 120 mg 71335-9719-01 Bryant 30 capsules — AB4 FDA listed —
diltiazem hydrochloride 120 mg 68382-0595-01 Zydus 100 capsules — AB3 FDA listed —
Diltiazem Hydrochloride Extended-Release 120 mg 71335-1611-01 Bryant 30 capsules — AB3 FDA listed —
diltiazem hydrochloride 120 mg 84677-0039-90 Golden 90 capsules — AB3 FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
48433-0032-20 You're viewing this 100 BLISTER PACK in 1 CARTON (48433-032-20) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (48433-032-01) 2026-02-02 Active

🧭 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
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.
“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 FDA registers it as 48433-032-20, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 48433-0032-20, written without dashes as 48433003220. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 48433-0032-20, the first segment (48433) is the labeler code FDA assigned to Safecor Health LLC; the middle segment (0032) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Safecor Health LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Safecor Health 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.

📄 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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 31 words ▾

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 105 words ▾

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 72 words ▾

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 ~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 (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 ~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 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 No. pts (%) Placebo N = 211 No. 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 a…

🔄 Drug Interactions ~3 min read ▾

Drug Interactions Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem hydrochloride concomitantly with any 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 diltiazem hydrochloride (see WARNINGS ). As with all drugs, care should be exercised when treating patients with multiple medications.

Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.

Anesthetics The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. When used concomitantly, anesthetics and calcium blockers should be titrated carefully. Benzodiazepines Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3- 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. Patients receiving these drugs concurrently should be monitored for a potential drug interaction.

Cimetidine A study in six healthy volunteers has shown a significant increase in peak diltiazem plasma levels (58%) and area-under-the-curve (53%) after a 1-week course of cimetidine at 1,200 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 P-450, 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 th…

🤰 Pregnancy 111 words ▾

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 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 82 words ▾

Geriatric Use Clinical studies of diltiazem did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 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. 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 10-20 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 ~3 min read ▾

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 produce their 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 produce 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 absolute…

🧬 Mechanism of Action 58 words ▾

Mechanism of Action Diltiazem hydrochloride extended-release capsules produce their 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.

📦 How Supplied / Storage and Handling ~1 min read ▾

HOW SUPPLIED: Diltiazem Hydrochloride Extended-Release Capsules, USP (Twice-a-Day Dosage) are available containing either 60 mg diltiazem hydrochloride, USP (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride, USP (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem). The 60 mg capsules are hard-shell gelatin capsules with a coral opaque cap and white opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over 6060 in black ink on the cap and body.

They are available as follows: NDC 48433-030-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). The 90 mg capsules are hard-shell gelatin capsules with a coral opaque cap and ivory opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over 6090 in black ink on the cap and body.

They are available as follows: NDC 48433-031-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). The 120 mg capsules are hard-shell gelatin capsules with a coral opaque cap and coral opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over 6120 in black ink on the cap and body.

They are available as follows: NDC 48433-032-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Avoid excessive humidity. Manufactured for: Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India Distributed by: Safecor Health LLC Rockford, IL 61103 U.S.A. 75106328 Revised: 9/2024 MX:DILER:R3

📋 Description 198 words ▾

DESCRIPTION Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is (+)-5-[2-(Dimethylamino)ethyl]- cis -2,3-dihydro-3-hydroxy-2-( p -methoxyphenyl) -1,5-benzothiazepin-4(5 H )-one acetate (ester) monohydrochloride. The chemical structure is Diltiazem hydrochloride, USP 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. Each diltiazem hydrochloride extended-release capsule, USP contains either 60 mg diltiazem hydrochloride, USP (equivalent to 55.1 mg diltiazem), 90 mg diltiazem hydrochloride, USP (equivalent to 82.7 mg diltiazem), or 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem).

Inactive ingredients: diethyl phthalate, FD&C Red No. 40, gelatin, hypromellose, maltodextrin, methacrylic acid copolymer Type B, polyethylene glycol, povidone, silicon dioxide, sodium lauryl sulfate, sugar spheres (corn starch and sucrose) and titanium dioxide. The 90 mg capsules also contain D&C Yellow No.

10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No.

1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.

Meets USP Dissolution Test 4 . For oral administration. Diltiazem Hydrochloride Structural Formula

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 48433-0031-20 · Safecor 48433-0033-08 · Safecor →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.