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Active ingredient

Brimonidine

35 finished FDA listings contain Brimonidine as their only active ingredient; 23 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
BRIMONIDINE TARTRATE
Dosage forms
Gel, Solution, Solution/ Drops
Routes
Ophthalmic, Topical
Manufacturers / labelers
17
Strengths listed
.25 mg/ml · 1 mg/ml · 1.5 mg/ml · 2 mg/mg · 2 mg/ml · 5 mg/g
Brand names in FDA listings
Alphagan P, Brimonidine, Lumify Preservative Free Eye Drops, Lumify Redness Reliever Eye Drops, Mirvaso

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 134615

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 021262ABBVIE2001-03-162
ANDA 076260BAUSCH AND LOMB INC2003-05-281
ANDA 076254SANDOZ2003-09-161
NDA 021770ABBVIE2005-08-192
NDA 021764SANDOZ2006-05-221
NDA 204708GALDERMA LABS LP2013-08-231
ANDA 091691REGCON HOLDINGS2014-11-182
NDA 208144BAUSCH AND LOMB INC2017-12-221
ANDA 208992SOMERSET THERAPS LLC2019-03-113
ANDA 209158PADAGIS ISRAEL2021-09-232
ANDA 078479APOTEX2022-01-311
ANDA 078480APOTEX2022-12-211
ANDA 215225ALEMBIC2023-03-292
ANDA 216909ALEMBIC2023-08-012
ANDA 217846MICRO LABS2023-11-221
ANDA 203172SANDOZ2024-03-041
NDA 218424BAUSCH AND LOMB INC2024-04-191
ANDA 216772UPSHER SMITH LABS2024-06-121
ANDA 216906SOMERSET THERAPS LLC2024-08-093
ANDA 217599UPSHER SMITH LABS2025-07-301
ANDA 219219GLAND2026-03-111
ANDA 220398MANKIND PHARMA2026-04-163
ANDA 218558MICRO LABS2026-05-071

Official labeling on DailyMed

Showing the 12 most recent of 25 labels.

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