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Active ingredient

Silodosin

29 finished FDA listings contain Silodosin as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
SILODOSIN
Dosage forms
Capsule
Routes
Oral
Manufacturers / labelers
13
Strengths listed
4 mg/1 · 8 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 720825

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 209745AMNEAL PHARMS CO2018-12-036
ANDA 210687MSN2018-12-033
ANDA 211166MACLEODS PHARMS2018-12-033
ANDA 206541LUPIN2018-12-032
ANDA 211060AJANTA PHARMA LTD2018-12-032
ANDA 210626AUROBINDO PHARMA LTD2018-12-103
ANDA 211731ALEMBIC2019-11-224
ANDA 204793HETERO LABS LTD V2020-02-142
ANDA 213230PHARMAZONE2022-01-034

Official labeling on DailyMed

Showing the 12 most recent of 17 labels.

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