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Active ingredient

Carvedilol

206 finished FDA listings contain Carvedilol as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
CARVEDILOL, CARVEDILOL PHOSPHATE
Dosage forms
Capsule, Extended Release, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
42
Strengths listed
10 mg/1 · 12.5 mg/1 · 20 mg/1 · 25 mg/1 · 3.125 mg/1 · 40 mg/1 · 6.25 mg/1 · 80 mg/1
Brand names in FDA listings
Coreg, Coreg Cr

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 20352

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 020297WAYLIS THERAP1995-09-144
NDA 022012WAYLIS THERAP2006-10-204
ANDA 078384REGCON HOLDINGS2007-09-0522
ANDA 078332AUROBINDO PHARMA2007-09-0517
ANDA 078165RUBICON RESEARCH2007-09-0516
ANDA 076373TEVA2007-09-0514
ANDA 078227SANDOZ2007-09-051
ANDA 078251GLENMARK PHARMS LTD2007-09-0525
ANDA 076649RISING2007-09-054
ANDA 077614ZYDUS PHARMS USA INC2007-09-0562
ANDA 078786MLV2009-12-228
ANDA 090132SUN PHARM INDUSTRIES2017-10-2517
ANDA 204717IMPAX LABS INC2018-05-0712

Official labeling on DailyMed

Showing the 12 most recent of 121 labels.

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