Isosorbide dinitrate

Generic Name: Isosorbide dinitrate

Brand Names: Bidil, Dilatrate, Isordil

Drug Type: Small Molecule

Chemical Formula: C_₆H_₈N_₂O_₈

CAS Number: 87-33-2

Unique Ingredient Identifier: IA7306519N

Overview

A vasodilator used in the treatment of angina pectoris. Its actions are similar to nitroglycerin but with a slower onset of action.

Indication

For the prevention of angina pectoris due to coronary artery disease.

Associated Conditions

Angina Pectoris
Heart Failure

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Hypertensive Heart Failure Treatment in SSA	2024/05/06	NCT06400784	Phase 4	Completed	University of Abuja
Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts	2024/01/23	NCT06218199	Phase 4	Recruiting	Heart Center Research, LLC
Optimized Treatment of Pulmonary Edema or Congestion	2022/03/11	NCT05276219	Phase 4	Recruiting	Johannes Grand
Nitrate Effect on Exercise Capacitance	2020/03/05	NCT04297241	Phase 2	Completed	Children's Hospital Medical Center, Cincinnati
Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers	2016/06/02	NCT02789033	Phase 3	Completed	University of Guadalajara
Adequate Hydration Therapy Combined With Intravenous Infusion of Isosorbide Dinitrate Prevention for CIN	2016/03/24	NCT02718521	Not Applicable	UNKNOWN	Chinese PLA General Hospital
Short-term Efficacy of Furosemide, Isosorbide Dinitrate and Their Combination in ADHF	2016/01/08	NCT02649998	Not Applicable	Withdrawn	Chinese University of Hong Kong
Medical Management of Late Intrauterine Death.	2015/07/02	NCT02488642	Phase 4	Completed	National Institute of Perinatology
Non-inferiority of Pharmacological Prevention Alone Versus Pancreatic Stents to Prevent Post-ERCP Pancreatitis	2015/02/23	NCT02368795	Not Applicable	UNKNOWN	Tehran University of Medical Sciences
Nitrates In Combination With Hydralazine in cardiorEnal Syndrome (NICHE) Study	2015/01/22	NCT02343393	Phase 3	UNKNOWN	National University Hospital, Singapore

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Isordil Titradose	Bausch Health US LLC	0187-0152	ORAL	5 mg in 1 1	8/8/2019
ISOSORBIDE DINITRATE	Advagen Pharma Ltd	72888-081	ORAL	5 mg in 1 1	7/13/2022
Isosorbide dinitrate	Zydus Lifesciences Limited	70771-1504	ORAL	30 mg in 1 1	11/7/2023
Isosorbide dinitrate	Zydus Lifesciences Limited	70771-1502	ORAL	10 mg in 1 1	11/7/2023
Isosorbide dinitrate	REMEDYREPACK INC.	70518-3444	ORAL	10 mg in 1 1	1/11/2024
isosorbide dinitrate and hydralazine hydrochloride	Wilshire Pharmaceuticals	52536-006	ORAL	20 mg in 1 1	6/30/2020
Isosorbide	State of Florida DOH Central Pharmacy	53808-0274	ORAL	10 mg in 1 1	6/3/2010
Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	70710-1148	ORAL	5 mg in 1 1	11/7/2023
Isosorbide Dinitrate	Par Pharmaceutical, Inc.	49884-556	ORAL	40 mg in 1 1	12/21/2021
Isosorbide Dinitrate	Carilion Materials Management	68151-2476	ORAL	30 mg in 1 1	1/30/2017

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
APO-ISDN TABLET 5 mg	APOTEX INC	SIN01139P	TABLET	5 mg	5/13/1988
AA PHARMA ISDN TABLET 10 mg	APOTEX INC	SIN00055P	TABLET	10 mg	2/24/1988

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
APT-ISOSORBIDE DINITRATE TABLETS 10MG	N/A	APT PHARMA LIMITED	N/A	N/A	3/27/2025

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ISORDIL 10mg tablet bottle	40258	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/22/1992
ISORDIL 10mg tablet blister pack	40257	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/22/1992
ISORDIL 40mg tablet bottle	40250	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/28/1992
ISORDIL 40mg tablet blister pack	40251	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/22/1992
ISORDIL 30mg tablet blister pack	40248	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/22/1992
ISORDIL 5mg tablet	12957	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/19/1991
ISORDIL 30mg tablet bottle	40249	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/22/1992

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NOVO-SORBIDE TAB 30MG	novopharm limited	00458694	Tablet - Oral	30 MG	12/31/1983
CEDOCARD-SR SRT 20MG	paladin pharma inc.	00740721	Tablet (Extended-Release) - Oral	20 MG	12/31/1987
ISORDIL 30 TITRADOSE TAB 30MG	wyeth ltd.	00279536	Tablet - Oral	30 MG	12/31/1974
CORADUR TAB 20MG	glaxo canada inc	00786683	Tablet (Extended-Release) - Oral	20 MG	12/31/1987
PMS-ISOSORBIDE TAB 10MG	Pharmascience Inc	00786667	Tablet - Oral	10 MG	12/31/1990
ISOSORBIDE 30 TAB 30MG	PRO DOC LIMITEE	00584258	Tablet - Oral	30 MG	12/31/1983
ISDN	aa pharma inc	00441686	Tablet - Oral	10 MG	12/31/1982
ISORDIL 30 TITRADOSE TABLETS 30MG	wyeth-ayerst canada inc.	02042614	Tablet - Oral	30 MG	12/31/1994
NU-ISDN TABLETS	nu-pharm inc	02239221	Tablet - Sublingual	5 MG	N/A
ISORDIL 10 TITRADOSE TAB 10MG	wyeth ltd.	00208973	Tablet - Oral	10 MG	12/31/1960

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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