Quick answers
- What is Diltiazem used for?
- The FDA-approved label (Cardizem, Bausch Health US LLC, April 30, 2025) says: “CARDIZEM is indicated for the management of chronic stable angina and angina due to coronary artery spasm.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Diltiazem have a boxed warning?
- No. None of the 112 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Diltiazem?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated January 5, 2026). Ask your pharmacist about alternatives.
- Has Diltiazem been recalled?
- FDA enforcement reports list 14 recalls of products of this medicine; the newest started March 13, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Diltiazem?
- 50 companies list prescription products of Diltiazem in the FDA NDC Directory, including Bryant Ranch Prepack, Bausch Health US, LLC and Oceanside Pharmaceuticals.
What Diltiazem is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CARDIZEM is indicated for the management of chronic stable angina and angina due to coronary artery spasm.
— FDA label: Cardizem, Bausch Health US LLC, effective April 30, 2025. Read the full label on DailyMed →
The FDA has 112 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 112 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, extended release · Tablet, extended release · Tablet · Tablet, film coated · Capsule, coated, extended release · Injection, solution · Injection · Tablet, coated · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 299 in the FDA NDC Directory |
| Brand names | Tiadylt ER, Cartia Xt, Tiazac Extended Release, Cardizem La, Cardizem Cd, Matzim La, Cardizem |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| diltiazem hydrochloride 120 mg capsule, coated, extended release | Generic | $0.1458 per capsule |
| diltiazem hydrochloride 120 mg capsule, extended release | Generic | $0.1046–$1.94 per capsule 20 packages, lowest to highest |
| diltiazem hydrochloride 120 mg tablet | Generic | $0.0914 per tablet |
| diltiazem hydrochloride 120 mg tablet, extended release | Generic | $1.01 per tablet |
| diltiazem hydrochloride 120 mg tablet, film coated | Generic | $0.0914 per tablet |
| diltiazem hydrochloride 180 mg capsule, coated, extended release | Generic | $0.1860 per capsule |
| diltiazem hydrochloride 180 mg capsule, extended release | Generic | $0.1607–$0.3728 per capsule 14 packages, lowest to highest |
| diltiazem hydrochloride 180 mg tablet, extended release | Generic | $1.17 per tablet |
| diltiazem hydrochloride 240 mg capsule, coated, extended release | Generic | $0.2048 per capsule |
| diltiazem hydrochloride 240 mg capsule, extended release | Generic | $0.1469–$0.5048 per capsule 14 packages, lowest to highest |
| diltiazem hydrochloride 240 mg tablet, extended release | Generic | $1.05 per tablet |
| diltiazem hydrochloride 30 mg tablet | Generic | $0.0508 per tablet |
| diltiazem hydrochloride 30 mg tablet, film coated | Generic | $0.0508 per tablet |
| diltiazem hydrochloride 300 mg capsule, coated, extended release | Generic | $0.3041 per capsule |
| diltiazem hydrochloride 300 mg capsule, extended release | Generic | $0.2737–$0.3041 per capsule 8 packages, lowest to highest |
| diltiazem hydrochloride 300 mg tablet, extended release | Generic | $1.93 per tablet |
| diltiazem hydrochloride 360 mg capsule, extended release | Generic | $0.3150–$0.3480 per capsule 5 packages, lowest to highest |
| diltiazem hydrochloride 360 mg tablet, extended release | Generic | $1.75 per tablet |
| diltiazem hydrochloride 420 mg capsule, extended release | Generic | $0.9976 per capsule |
| diltiazem hydrochloride 420 mg tablet, extended release | Generic | $2.66 per tablet |
| diltiazem hydrochloride 60 mg capsule, extended release | Generic | $1.34 per capsule |
| diltiazem hydrochloride 60 mg tablet | Generic | $0.0722 per tablet |
| diltiazem hydrochloride 60 mg tablet, film coated | Generic | $0.0722 per tablet |
| diltiazem hydrochloride 90 mg capsule, extended release | Generic | $1.75 per capsule |
| diltiazem hydrochloride 90 mg tablet | Generic | $0.0704 per tablet |
| diltiazem hydrochloride 90 mg tablet, film coated | Generic | $0.0704 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack31 products
- Bausch Health US, LLC20 products
- Oceanside Pharmaceuticals20 products
- Zydus Lifesciences Limited15 products
- Alembic Pharmaceuticals Limited12 products
- Alembic Pharmaceuticals Inc.12 products
- Sun Pharmaceutical Industries, Inc.11 products
- Zydus Pharmaceuticals USA Inc.11 products
- Actavis Pharma, Inc.10 products
- ScieGen Pharmaceuticals, Inc.10 products
- Golden State Medical Supply, Inc.9 products
- Slate Run Pharmaceuticals, LLC9 products
- Ingenus Pharmaceuticals, LLC8 products
- Upsher-Smith Laboratories, LLC8 products
- A-S Medication Solutions7 products
- Hikma Pharmaceuticals USA Inc.6 products
- American Health Packaging6 products
- Cipla USA Inc.6 products
- Macleods Pharmaceuticals Limited5 products
- NCS HealthCare of KY, LLC dba Vangard Labs5 products
- Viona Pharmaceuticals Inc4 products
- Major Pharmaceuticals4 products
- Teva Pharmaceuticals USA, Inc.4 products
- Chartwell RX, LLC4 products
- Eugia US LLC3 products
- Apotex Corp.3 products
- AvKARE3 products
- Dr. Reddy's Labratories Inc.3 products
- Safecor Health LLC3 products
- Mylan Institutional Inc.3 products
- HF Acquisition Co LLC, DBA HealthFirst3 products
- Cardinal Health 107, LLC3 products
- Coupler LLC3 products
- Glenmark Pharmaceuticals Inc., USA3 products
- NorthStar Rx LLC3 products
- Accord Healthcare Inc.3 products
- NuCare Pharmaceuticals, Inc.3 products
- Mylan Pharmaceuticals Inc.3 products
- Northwind Health Company, LLC3 products
- Cranbury Pharmaceuticals, LLC3 products
- Direct_Rx2 products
- Remedyrepack Inc.2 products
- WG Critical Care, LLC2 products
- Medical Purchasing Solutions, LLC2 products
- Sagent Pharmaceuticals1 product
- DirectRx1 product
- ProPharma Distribution1 product
- Preferred Pharmaceuticals Inc.1 product
- Hospira, Inc.1 product
- Proficient Rx LP1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018602 CARDIZEM | Bausch | November 5, 1982 | 54, latest April 16, 2025 2025: Labeling · 2020: Manufacturing (CMC) · 2016: Labeling |
| NDA020062 CARDIZEM CD | Bausch | December 27, 1991 | 38, latest April 16, 2025 2025: Labeling · 2020: Labeling · 2017: Manufacturing (CMC) |
| NDA020401 TIAZAC | Bausch | September 11, 1995 | 28, latest April 16, 2025 2025: Labeling · 2016: Labeling · 2015: Manufacturing (CMC) |
| NDA021392 CARDIZEM LA | Bausch | February 6, 2003 | 7, latest April 16, 2025 2025: Labeling · 2025: Labeling · 2016: Labeling |
| NDA218038 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE | Hq Spclt Pharma | February 21, 2025 | — |
Generic approvals (35)
- ANDA074093Chartwell Molecules · November 5, 1992
- ANDA074185Teva · May 31, 1995
- ANDA074617Sagent · February 28, 1996
- ANDA074910Mylan · May 2, 1997
- ANDA074752Actavis Labs Fl Inc · July 9, 1998
- ANDA074943Apotex · August 6, 1998
- ANDA074984Ph Health · December 20, 1999
- ANDA075116Valeant Pharms North · December 23, 1999
- ANDA075853Hospira · December 17, 2002
- ANDA078538Hikma · December 17, 2008
- ANDA077686Actavis Labs Fl Inc · March 15, 2010
- ANDA090421Sun Pharm · November 15, 2010
- ANDA090492Sun Pharm · October 28, 2011
- ANDA202463Actavis Elizabeth · December 7, 2012
- ANDA203023Sun Pharm · June 8, 2017
- ANDA206534Zydus Pharms · August 8, 2017
- ANDA206641Zydus Pharms · August 11, 2017
- ANDA205231Twi Pharms · August 30, 2018
- ANDA208783Novast Labs · June 14, 2019
- ANDA206997Accord Hlthcare · April 28, 2020
- ANDA212317Glenmark Pharms Ltd · March 22, 2021
- ANDA215775DR Reddys Labs SA · May 5, 2022
- ANDA216304Utopic Pharms · August 8, 2022
- ANDA216521Sciegen Pharms · September 23, 2022
- ANDA217377Twi Pharms · March 1, 2023
- ANDA216439Amta · March 7, 2023
- ANDA216552Eugia Pharma · March 29, 2023
- ANDA216327Sciegen Pharms · April 6, 2023
- ANDA218587Alembic · October 18, 2024
- ANDA216968Alembic · November 8, 2024
- ANDA219073Utopic Pharms · March 24, 2025
- ANDA218032Novast Labs · July 2, 2025
- ANDA219253Zydus Lifesciences · August 8, 2025
- ANDA217633Alembic · November 14, 2025
- ANDA218744Macleods Pharms · February 27, 2026
Shortage status
To be discontinued · updated January 5, 2026 · first posted January 5, 2026
| Product | Diltiazem Hydrochloride, Injection, 100 mg Single Dose ADD-Vantage® Glass Vial (NDC 0409-4350-03) |
|---|---|
| Company | Hospira, Inc., a Pfizer Company |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 13, 2025 · Class II · Ongoing · D-0342-2025
CGMP Deviations
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuti — Glenmark Pharmaceuticals Inc., USA
-
November 1, 2024 · Class II · Ongoing · D-0093-2025
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-0 — Glenmark Pharmaceuticals Inc., USA
-
November 1, 2024 · Class II · Ongoing · D-0094-2025
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01. — Glenmark Pharmaceuticals Inc., USA
-
November 1, 2024 · Class II · Ongoing · D-0095-2025
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01. — Glenmark Pharmaceuticals Inc., USA
-
April 17, 2024 · Class II · Ongoing · D-0472-2024
Failed Dissolution Specifications
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562 — Glenmark Pharmaceuticals Inc., USA
-
March 26, 2024 · Class II · Ongoing · D-0430-2024
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562 — Glenmark Pharmaceuticals Inc., USA
-
January 13, 2023 · Class II · Terminated · D-0262-2023
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India; Distributed by: Sun Pharm — SUN PHARMACEUTICAL INDUSTRIES INC
-
July 21, 2022 · Class II · Terminated · D-1302-2022
Failed Dissolution Specifications: below specification limits for dissolution.
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsip — Teva Pharmaceuticals USA Inc
-
October 27, 2021 · Class II · Terminated · D-0232-2022
Labelling: Incorrect Exp. Date
Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054; (b) Manufactured By: Actavis Laborat — Teva Pharmaceuticals USA
-
September 6, 2019 · Class III · Terminated · D-0131-2020
GMP Deviation: lot not intended for commercial distribution.
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ ND — Teva Pharmaceuticals USA
-
January 30, 2019 · Class III · Terminated · D-0488-2019
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewa — Valeant Pharmaceuticals North America LLC
-
January 30, 2019 · Class III · Terminated · D-0487-2019
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewa — Valeant Pharmaceuticals North America LLC
-
January 30, 2019 · Class III · Terminated · D-0489-2019
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottles (NDC 0187-0797-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewa — Valeant Pharmaceuticals North America LLC
-
January 30, 2019 · Class III · Terminated · D-0490-2019
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30); and b) 90-count bottles (NDC 0187-0798-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewa — Valeant Pharmaceuticals North America LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 830795, 830798, 830801, 830803, 830837, 830839, 830845, 830847, 830861, 830863 … (+10) |
|---|---|
| SPL set ID of the quoted label | f3e7ecef-f360-4987-a4f5-933214130ab2 |
| FDA labels (SPL) | 112 |
| FDA applications | NDA018602, NDA020062, NDA020401, NDA021392, NDA218038, 35 ANDA |
| Active ingredients (FDA) | DILTIAZEM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cardizem, Bausch Health US LLC, effective April 30, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →