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Active ingredient

Cabergoline

12 finished FDA listings contain Cabergoline as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
CABERGOLINE
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
9
Strengths listed
.5 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 47579

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 020664PFIZER1996-12-231
ANDA 076310STRIDES PHARMA INTL2005-12-293
ANDA 077750IVAX SUB TEVA PHARMS2007-03-072
ANDA 204735INGENUS PHARMS LLC2018-08-012
ANDA 218618AMNEAL2024-06-252
ANDA 218109SOMERSET THERAPS LLC2024-09-091
ANDA 220309RENATA2026-06-151

Official labeling on DailyMed

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