Skip to content

Active ingredient

Glycopyrronium

194 finished FDA listings contain Glycopyrronium as their only active ingredient; 4 combination products also contain it.

FDA NDC Directory

Ingredient names as written by FDA
GLYCOPYRROLATE, GLYCOPYRRONIUM, GLYCOPYRRONIUM TOSYLATE
Dosage forms
Cloth, Injection, Injection, Solution, Liquid, Solution, Tablet
Routes
Intramuscular, Intravenous, Oral, Topical
Manufacturers / labelers
63
Strengths listed
.2 mg/ml · .4 mg/2ml · 1 mg/1 · 1 mg/5ml · 1.5 mg/1 · 2 mg/1 · 2.4 g/100g · 4 mg/20ml
Brand names in FDA listings
Cuvposa, Glycate, Glycopyrrolate 1ml, Glycopyrrolate Oral Solution, Glyrx-Pf, Qbrexza

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1546438

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 012827CASPER PHARMA LLC1961-08-113
NDA 017558HIKMA1975-02-062
ANDA 089335AM REGENT1986-07-235
ANDA 040653PH HEALTH2006-08-318
ANDA 040847CHARTWELL RX2008-03-212
ANDA 090963HIKMA FARMACEUTICA2011-09-2115
ANDA 091522LGM PHARMA2012-03-123
ANDA 090195VELZEN PHARMA PVT2012-09-213
ANDA 202675AUROBINDO PHARMA2013-04-158
ANDA 091182REGCON HOLDINGS2014-02-036
ANDA 207201APPCO2017-01-038
ANDA 208973AMNEAL2017-06-157
ANDA 207639SOMERSET THERAPS LLC2017-06-237
ANDA 209328FRESENIUS KABI USA2017-10-273
NDA 210361JOURNEY2018-06-281
NDA 210997EXELA PHARMA2018-07-114
ANDA 210842PIRAMAL CRITICAL2018-10-2513
ANDA 210927PRINSTON INC2018-10-316
ANDA 209024FRESENIUS KABI USA2018-10-313
ANDA 210244EUGIA PHARMA2018-11-284
ANDA 203657ALEMBIC2018-11-302
ANDA 211705CAPLIN2019-03-2012
ANDA 211334SANDOZ2019-05-146
ANDA 212612GLAND2019-09-3014
ANDA 210083SAGENT2020-02-212
ANDA 213238ACCORD HLTHCARE2020-07-085
ANDA 212227XIROMED2021-03-041
ANDA 212802MEITHEAL2021-07-064
ANDA 204438PH HEALTH2021-08-093
ANDA 212591NIVAGEN2021-10-134
NDA 214919FRESENIUS KABI USA2022-04-212
ANDA 213698ANNORA PHARMA2022-07-053
ANDA 215333AMNEAL2022-10-212
ANDA 214635ALEMBIC2022-10-264
ANDA 217354MANKIND PHARMA2023-02-274
ANDA 212696QUAGEN2024-07-105
ANDA 216368CHARTWELL RX2024-08-281
ANDA 216297SCIEGEN PHARMS2024-10-071
ANDA 216084MSN2025-04-081
ANDA 216910QUAGEN2026-05-181

Showing 40 of 46 applications.

Official labeling on DailyMed

Showing the 12 most recent of 117 labels.

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