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Active ingredient

Pyridostigmine

26 finished FDA listings contain Pyridostigmine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
PYRIDOSTIGMINE BROMIDE
Dosage forms
Injection, Solution, Solution, Tablet, Tablet, Extended Release
Routes
Intravenous, Oral, Parenteral
Manufacturers / labelers
21
Strengths listed
105 mg/1 · 180 mg/1 · 30 mg/1 · 5 mg/ml · 60 mg/1 · 60 mg/5ml
Brand names in FDA listings
Mestinon, Pryidostigmine Bromide, Pyridostigmine, Regonol

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 9000

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 009829BAUSCH1955-04-061
NDA 011665BAUSCH1959-01-122
NDA 015193BAUSCH1965-01-251
NDA 017398SANDOZ1973-08-141
NDA 020414US ARMY2003-02-051
ANDA 040502IMPAX LABS2003-04-243
ANDA 040512ANI PHARMS2003-10-081
ANDA 205650ZYDUS PHARMS2015-06-224
ANDA 204737ALVOGEN2015-06-261
ANDA 205464RISING2017-08-151
ANDA 211181MLV2018-07-202
ANDA 211694NOVITIUM PHARMA2019-03-082
ANDA 208797RISING2020-01-092
ANDA 212702AMNEAL2020-01-101
ANDA 212405MILLA PHARMS2022-04-191
ANDA 216512MSN2023-09-211
NDA 217604AMNEAL2024-10-041

Official labeling on DailyMed

Showing the 12 most recent of 23 labels.

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