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Active ingredient

Isosorbide Dinitrate

55 finished FDA listings contain Isosorbide Dinitrate as their only active ingredient; 6 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
ISOSORBIDE DINITRATE
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
18
Strengths listed
10 mg/1 · 20 mg/1 · 30 mg/1 · 40 mg/1 · 5 mg/1
Brand names in FDA listings
Isosorbide

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6058

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 012093BAUSCH1959-11-092
ANDA 087946PH HEALTH1987-03-121
ANDA 086925PH HEALTH1987-03-123
ANDA 086923PH HEALTH1987-03-122
ANDA 087537PH HEALTH1987-10-023
ANDA 088088HIKMA INTL PHARMS1987-11-0211
ANDA 086223SANDOZ1988-01-071
ANDA 086221SANDOZ1988-01-071
ANDA 089367SANDOZ1988-04-071
ANDA 213057ZYDUS LIFESCIENCES2019-11-2015
ANDA 211290PH HEALTH2021-11-232
ANDA 215723RUBICON RESEARCH2022-07-0811

Official labeling on DailyMed

Showing the 12 most recent of 21 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.