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Active ingredient

Midodrine

109 finished FDA listings contain Midodrine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
MIDODRINE HYDROCHLORIDE
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
33
Strengths listed
10 mg/1 · 2.5 mg/1 · 5 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6963

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
ANDA 076577MYLAN PHARMS INC2003-09-106
ANDA 076725BEIJING YILING2004-11-037
ANDA 077746APOTEX2006-09-1218
ANDA 207169PH HEALTH2018-10-295
ANDA 207613UNIQUE2018-11-027
ANDA 212543RUBICON RESEARCH2019-08-1913
ANDA 212774AUROBINDO PHARMA LTD2020-08-1010
ANDA 213055ZYDUS LIFESCIENCES2020-09-016
ANDA 207849XIROMED2020-10-0115
ANDA 214734ALEMBIC2021-01-216
ANDA 211973NOVUGEN2023-10-173
ANDA 217271MANKIND PHARMA2023-11-0113

Official labeling on DailyMed

Showing the 12 most recent of 50 labels.

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