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Active ingredient

Rasagiline

31 finished FDA listings contain Rasagiline as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
RASAGILINE, RASAGILINE MESYLATE
Dosage forms
Tablet
Routes
Oral
Manufacturers / labelers
16
Strengths listed
.5 mg/1 · 1 mg/1
Brand names in FDA listings
Azilect, Rasagiline

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 134748

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 021641TEVA2006-05-164
ANDA 201970ORBION PHARMS2016-03-152
ANDA 201889ALKEM LABS LTD2017-10-306
ANDA 201892CHARTWELL RX2018-07-272
ANDA 207004MICRO LABS2019-03-293
ANDA 206153REGCON HOLDINGS2019-10-042
ANDA 201942CARNEGIE2021-11-184
ANDA 218163RISING2024-04-094
ANDA 208866MACLEODS PHARMS2024-06-282
ANDA 210150TORRENT2025-05-052

Official labeling on DailyMed

Showing the 12 most recent of 17 labels.

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