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Active ingredient

Buspirone

276 finished FDA listings contain Buspirone as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
BUSPIRONE, BUSPIRONE HYDROCHLORIDE
Dosage forms
Capsule, Tablet
Routes
Oral
Manufacturers / labelers
49
Strengths listed
10 mg/1 · 12.5 mg/1 · 15 mg/1 · 2.5 mg/1 · 30 mg/1 · 5 mg/1 · 7.5 mg/1
Brand names in FDA listings
Bucapsol, Buspirone Hcl, Buspirone Hydrochloride

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1827

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 076008MYLAN2001-06-2816
ANDA 075022TEVA2002-02-2825
ANDA 075413RISING2002-03-195
ANDA 075521RUBICON RESEARCH2002-04-057
ANDA 075388OXFORD PHARMS2002-05-0932
ANDA 078302OXFORD PHARMS2007-12-178
ANDA 078246AUROBINDO PHARMA LTD2009-02-2713
ANDA 078888ZYDUS PHARMS2014-02-0726
ANDA 202330STRIDES PHARMA2014-08-2531
ANDA 202557ACCORD HLTHCARE2014-12-3014
ANDA 204582HERITAGE PHARMA2015-09-1813
ANDA 202087AIPING PHARM INC2015-12-1618
ANDA 209696ADAPTIS2018-05-038
ANDA 208972EPIC PHARMA LLC2019-04-168
ANDA 210907UNICHEM2019-11-1445
ANDA 218628EPIC PHARMA LLC2025-03-137

Official labeling on DailyMed

Showing the 12 most recent of 169 labels.

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