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Active ingredient

Pilocarpine

28 finished FDA listings contain Pilocarpine as their only active ingredient; 1 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
PILOCARPINE, PILOCARPINE HYDROCHLORIDE, PILOCARPINE NITRATE
Dosage forms
Solution, Solution/ Drops, Tablet, Film Coated
Routes
Ophthalmic, Oral
Manufacturers / labelers
13
Strengths listed
10 mg/ml · 12.5 mg/ml · 20 mg/ml · 4 mg/ml · 40 mg/ml · 5 mg/1 · 7.5 mg/1
Brand names in FDA listings
Pilocarpine Hydrochloride, Pilocarpine Hydrochloride Ophthalmic, Qlosi, Salagen, Vuity

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 8328

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 020237ADVANZ PHARMA1994-03-225
ANDA 076963INNOGENIX2004-12-221
ANDA 077220LANNETT CO INC2005-10-146
ANDA 077248IMPAX LABS2006-03-311
NDA 200890SANDOZ2010-06-223
ANDA 212377QUAGEN2019-08-132
ANDA 210384SOMERSET THERAPS LLC2019-11-253
ANDA 214193AMNEAL2020-09-213
NDA 214028ABBVIE2021-10-281
NDA 217836ORASIS PHARMS2023-10-171
ANDA 217733AMNEAL2025-04-282

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.