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Active ingredient

Bisoprolol

49 finished FDA listings contain Bisoprolol as their only active ingredient; 42 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
BISOPROLOL, BISOPROLOL FUMARATE
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
24
Strengths listed
10 mg/1 · 2.5 mg/1 · 5 mg/1
Brand names in FDA listings
Bisoprolol

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 19484

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 075643RUBICON RESEARCH2000-11-165
ANDA 075474TP ANDA HOLDINGS2002-10-255
ANDA 075831NATCO PHARMA USA2005-12-142
ANDA 077910AUROBINDO PHARMA2006-12-275
ANDA 078635UNICHEM2009-08-187
ANDA 204891ALEMBIC2017-01-114
ANDA 215563NOVITIUM PHARMA2021-10-295
ANDA 215680ZYDUS LIFESCIENCES2022-07-254
ANDA 217368PRINSTON INC2023-07-142
ANDA 217617HARMAN FINOCHEM2024-01-186
ANDA 219044UNIQUE PHARM2025-04-162
ANDA 218303MICRO LABS2026-03-092

Official labeling on DailyMed

Showing the 12 most recent of 31 labels.

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