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Active ingredient

Nebivolol

98 finished FDA listings contain Nebivolol as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
NEBIVOLOL, NEBIVOLOL HYDROCHLORIDE
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
24
Strengths listed
10 mg/1 · 2.5 mg/1 · 20 mg/1 · 5 mg/1
Brand names in FDA listings
Bystolic, Nebivolol

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 31555

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 021742ALLERGAN2007-12-174
ANDA 203659ANI PHARMS2015-04-168
ANDA 203828INDCHEMIE HEALTH2015-07-2910
ANDA 203821GLENMARK PHARMS LTD2017-05-258
ANDA 203825HETERO LABS LTD III2020-11-037
ANDA 208717CADILA PHARMS LTD2021-12-1712
ANDA 211053AUROBINDO PHARMA LTD2021-12-176
ANDA 213830UNICHEM2022-03-154
ANDA 212682PRINSTON INC2022-04-0715
ANDA 216172MANKIND PHARMA2022-11-144
ANDA 216568REGCON HOLDINGS2023-03-304
ANDA 217397MSN2024-10-018
ANDA 212661MACLEODS PHARMS2025-01-288

Official labeling on DailyMed

Showing the 12 most recent of 43 labels.

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