Tools / Drug approvals and letters / Drugs Diltiazem Hydrochloride Manages chronic stable angina and angina due to coronary artery spasm. Sold as Cardizem, Cardizem Sr, Cardizem Cd, Dilacor Xr, Tiazac and 4 more. Every FDA application for this active ingredient: 11 branded and 60 generic.
As of Nov 15, 2026, FDA lists 71 applications for Diltiazem Hydrochloride (sold as Cardizem, Cardizem Sr, Cardizem Cd and others), first approved Nov 5, 1982, with 8 new uses approved and 0 published complete response letters.
First approved : Nov 5, 1982 Applications : 71 New uses approved : 8 Complete response letters : 0 Medicare spending, 2025 : $216M
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Diltiazem 24hr ER (Cd) Part D $89.6M -13% 937,873 Diltiazem 12hr ER Part D $33.5M +3% 56,899 Diltiazem 24hr ER Part D $19.2M -3% 177,498 Diltiazem 24hr ER (La) Part D $18.0M +10% 62,365 Diltiazem HCl Part D $14.7M -12% 191,849 Dilt-XR Part D $12.6M -10% 113,590 Diltiazem 24hr ER (XR) Part D $7.9M +2% 80,054 Cartia Xt Part D $6.9M -8% 113,969 Tiadylt ER Part D $6.2M -4% 61,089 Matzim La Part D $4.2M -6% 15,080 Cardizem CD Part D $3.0M -19% 331 Cardizem La Part D $463K -32% 437 Cardizem Part D $109K -25% 26 Tiazac Part D $67K -13% 98 Taztia Xt Part D $0K -100% 0
What Pharmacies Pay Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change DILTIAZEM 120 MG TABLET: $0.091 per unit Generic · -12% in a year DILTIAZEM 12HR ER 120 MG CAP: $1.94 per unit Generic · -12% in a year DILTIAZEM 12HR ER 60 MG CAP: $1.34 per unit Generic · -1% in a year DILTIAZEM 12HR ER 90 MG CAP: $1.75 per unit Generic · 0% in a year DILTIAZEM 24H ER(CD) 120 MG CP: $0.146 per unit Generic · -2% in a year DILTIAZEM 24H ER(CD) 180 MG CP: $0.186 per unit Generic · +4% in a year DILTIAZEM 24H ER(CD) 240 MG CP: $0.205 per unit Generic · -4% in a year DILTIAZEM 24H ER(CD) 300 MG CP: $0.304 per unit Generic · +3% in a year DILTIAZEM 24H ER(CD) 360 MG CP: $0.315 per unit Generic · -4% in a year DILTIAZEM 24H ER(LA) 120 MG TB: $1.01 per unit Generic · -36% in a year DILTIAZEM 24H ER(LA) 180 MG TB: $1.17 per unit Generic · -25% in a year DILTIAZEM 24H ER(LA) 240 MG TB: $1.05 per unit Generic · -25% in a year
Shortages FDA's drug shortage list, as of Nov 13, 2026 Clinical Trials 12 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted A Comparison of Beta-blockers and Calcium Channel Blockers in Atrial Fibrillation Atrial Fibrillation (AF) · University Hospital, Basel, Switzerland Phase 4 Not yet recruiting Oct 29, 2026 Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy Malignant Digestive System Neoplasm · Mayo Clinic Phase 1 / Phase 2 Recruiting Mar 9, 2026 Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes Premature Ventricular Complexes, Premature Ventricular Contraction (PVC) · Western Sydney Local Health District Not applicable Recruiting Mar 3, 2026 Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation Atrial Fibrillation (AF), Coronary Artery Disease · Universitaire Ziekenhuizen KU Leuven Phase 4 Recruiting Feb 12, 2026 Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study Post-stroke Pneumonia · First Teaching Hospital of Tianjin University of Traditional Chinese Medicine — Not yet recruiting Dec 4, 2025 The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction Hypertrophic Cardiomyopathy (HCM) · Second Affiliated Hospital, Zhejiang University, School of Medicine Phase 4 Enrolling by invitation Aug 5, 2025 PERceptions of Diltiazem Versus ADEnosine for Treatment of Supraventricular Tachycardia in the Emergency Department Supraventricular Tachycardia (SVT) · University of Iowa — Recruiting Jul 25, 2025 Adenosine vs Diltiazem for Treatment of SVT in the ED Supraventricular Tachycardia (SVT) · Anne E. Zepeski Phase 4 Recruiting May 28, 2025
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Nov 5, 1982 Cardizem NDA 18602 · New molecular entity 54 Marketed Jan 23, 1989 Cardizem Sr NDA 19471 · New dosage form 27 Discontinued Oct 24, 1991 Cardizem NDA 20027 · New dosage form 20 Discontinued Dec 27, 1991 Cardizem Cd NDA 20062 · New formulation or manufacturer 38 Marketed May 29, 1992 Dilacor Xr NDA 20092 · New formulation or manufacturer 15 Discontinued Nov 5, 1992 Diltiazem Hydrochloride ANDA 74093 14 Discontinued Nov 5, 1992 Diltiazem Hydrochloride ANDA 72838 11 Discontinued Nov 5, 1992 Diltiazem Hydrochloride ANDA 74067 13 Discontinued Mar 31, 1993 Diltiazem Hydrochloride ANDA 74051 9 Discontinued Nov 30, 1993 Diltiazem Hydrochloride ANDA 74079 7 Discontinued Mar 3, 1995 Diltiazem Hydrochloride ANDA 74168 1 Discontinued May 31, 1995 Diltiazem Hydrochloride ANDA 74185 10 Marketed Sep 11, 1995 Tiazac NDA 20401 · New dosage form 28 Marketed Feb 28, 1996 Diltiazem Hydrochloride ANDA 74617 10 Marketed May 2, 1997 Diltiazem Hydrochloride ANDA 74910 4 Marketed Aug 26, 1997 Diltiazem Hydrochloride ANDA 74894 7 Discontinued Sep 5, 1997 Cardizem NDA 20792 · New dosage form 3 Discontinued Oct 10, 1997 Diltiazem Hydrochloride ANDA 74852 9 Discontinued Mar 18, 1998 Diltiazem Hydrochloride ANDA 75124 7 Discontinued Apr 9, 1998 Diltiazem Hydrochloride ANDA 75086 3 Marketed Apr 15, 1998 Diltiazem Hydrochloride ANDA 74941 4 Discontinued Jul 9, 1998 Cartia Xt ANDA 74752 22 Marketed Aug 6, 1998 Diltiazem Hydrochloride ANDA 74943 8 Marketed Apr 29, 1999 Diltiazem Hydrochloride ANDA 75106 0 Discontinued Sep 15, 1999 Diltiazem Hydrochloride ANDA 74845 0 Discontinued Sep 30, 1999 Diltiazem Hydrochloride ANDA 75375 2 Discontinued Dec 20, 1999 Diltiazem Hydrochloride ANDA 74984 15 Marketed Dec 23, 1999 Diltiazem Hydrochloride ANDA 75116 6 Marketed Jan 28, 2000 Diltiazem Hydrochloride NDA 20939 · New formulation or manufacturer 2 Discontinued Feb 16, 2000 Diltiazem Hydrochloride ANDA 75004 1 Discontinued Nov 21, 2001 Diltiazem Hydrochloride ANDA 75749 1 Discontinued Dec 17, 2002 Diltiazem Hydrochloride ANDA 75853 2 Marketed Feb 6, 2003 Cardizem La NDA 21392 · New dosage form 7 Marketed Apr 10, 2003 Taztia Xt ANDA 75401 2 Discontinued May 20, 2004 Dilt-Cd ANDA 76151 4 Discontinued Feb 1, 2006 Diltzac ANDA 76395 4 Discontinued Sep 12, 2006 Diltiazem Hydrochloride ANDA 76563 2 Discontinued Dec 17, 2008 Diltiazem Hydrochloride ANDA 78538 0 Marketed Mar 15, 2010 Diltiazem Hydrochloride ANDA 77686 5 Marketed Nov 15, 2010 Diltiazem Hydrochloride ANDA 90421 4 Discontinued Oct 28, 2011 Diltiazem Hydrochloride ANDA 90492 2 Discontinued Aug 9, 2012 Diltiazem Hydrochloride ANDA 202651 0 Marketed Sep 28, 2012 Diltiazem Hydrochloride ANDA 91022 0 Marketed Dec 7, 2012 Diltiazem Hydrochloride ANDA 202463 3 Marketed Jun 8, 2017 Diltiazem Hydrochloride ANDA 203023 2 Marketed Aug 8, 2017 Diltiazem Hydrochloride ANDA 206534 2 Marketed Aug 11, 2017 Diltiazem Hydrochloride ANDA 206641 1 Marketed May 30, 2018 Diltiazem Hydrochloride ANDA 209766 0 Discontinued Aug 30, 2018 Diltiazem Hydrochloride ANDA 205231 2 Marketed Jun 14, 2019 Diltiazem Hydrochloride ANDA 208783 2 Marketed Nov 18, 2019 Diltiazem Hydrochloride ANDA 211596 1 Discontinued Apr 28, 2020 Diltiazem Hydrochloride ANDA 206997 0 Marketed Mar 22, 2021 Diltiazem Hydrochloride ANDA 212317 0 Marketed Oct 28, 2021 Diltiazem Hydrochloride In Dextrose 5% NDA 215252 · New formulation or manufacturer 0 Discontinued May 5, 2022 Diltiazem Hydrochloride ANDA 215775 0 Marketed Aug 8, 2022 Diltiazem Hydrochloride ANDA 216304 0 Marketed Sep 23, 2022 Diltiazem Hydrochloride ANDA 216521 0 Marketed Mar 1, 2023 Diltiazem Hydrochloride ANDA 217377 0 Marketed Mar 7, 2023 Diltiazem Hydrochloride ANDA 216439 1 Marketed Mar 29, 2023 Diltiazem Hydrochloride ANDA 216552 0 Discontinued Apr 6, 2023 Diltiazem Hydrochloride ANDA 216327 1 Marketed Oct 18, 2024 Diltiazem Hydrochloride ANDA 218587 0 Marketed Nov 8, 2024 Diltiazem Hydrochloride ANDA 216968 1 Marketed Feb 21, 2025 Diltiazem Hydrochloride In 0.72% Sodium Chloride NDA 218038 · New formulation or manufacturer 0 Marketed Mar 24, 2025 Diltiazem Hydrochloride ANDA 219073 0 Marketed Jul 2, 2025 Diltiazem Hydrochloride ANDA 218032 0 Marketed Aug 8, 2025 Diltiazem Hydrochloride ANDA 219253 0 Marketed Nov 14, 2025 Diltiazem Hydrochloride ANDA 217633 0 Marketed Feb 27, 2026 Diltiazem Hydrochloride ANDA 218744 0 Marketed Sep 25, 2026 Diltiazem Hydrochloride ANDA 220590 0 Marketed — Diltiazem Hydrochloride ANDA 74084 0 Discontinued
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
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