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Active ingredient

Isosorbide

59 finished FDA listings contain Isosorbide as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ISOSORBIDE MONONITRATE
Dosage forms
Tablet, Tablet, Extended Release
Routes
Oral
Manufacturers / labelers
24
Strengths listed
10 mg/1 · 120 mg/1 · 20 mg/1 · 30 mg/1 · 60 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6057

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 020215OMNIVIUM PHARMS1993-06-307
ANDA 075037GENUS1998-10-304
ANDA 075147ANI PHARMS1998-11-273
ANDA 075522DEXCEL LTD2000-04-177
ANDA 200270TORRENT PHARMS2011-06-036
ANDA 200495TORRENT PHARMS2011-06-036
ANDA 210822DEXCEL LTD2018-08-292
ANDA 210918RICONPHARMA LLC2018-11-0514
ANDA 214115SHANDONG2022-04-293
ANDA 216557AUROBINDO PHARMA2022-11-077

Official labeling on DailyMed

Showing the 12 most recent of 37 labels.

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