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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 012827 | CASPER PHARMA LLC | 1961-08-11 | 3 |
| NDA 017558 | HIKMA | 1975-02-06 | 2 |
| ANDA 089335 | AM REGENT | 1986-07-23 | 5 |
| ANDA 040653 | PH HEALTH | 2006-08-31 | 8 |
| ANDA 040847 | CHARTWELL RX | 2008-03-21 | 2 |
| ANDA 090963 | HIKMA FARMACEUTICA | 2011-09-21 | 15 |
| ANDA 091522 | LGM PHARMA | 2012-03-12 | 3 |
| ANDA 090195 | VELZEN PHARMA PVT | 2012-09-21 | 3 |
| ANDA 202675 | AUROBINDO PHARMA | 2013-04-15 | 8 |
| ANDA 091182 | REGCON HOLDINGS | 2014-02-03 | 6 |
| ANDA 207201 | APPCO | 2017-01-03 | 8 |
| ANDA 208973 | AMNEAL | 2017-06-15 | 7 |
| ANDA 207639 | SOMERSET THERAPS LLC | 2017-06-23 | 7 |
| ANDA 209328 | FRESENIUS KABI USA | 2017-10-27 | 3 |
| NDA 210361 | JOURNEY | 2018-06-28 | 1 |
| NDA 210997 | EXELA PHARMA | 2018-07-11 | 4 |
| ANDA 210842 | PIRAMAL CRITICAL | 2018-10-25 | 13 |
| ANDA 210927 | PRINSTON INC | 2018-10-31 | 6 |
| ANDA 209024 | FRESENIUS KABI USA | 2018-10-31 | 3 |
| ANDA 210244 | EUGIA PHARMA | 2018-11-28 | 4 |
| ANDA 203657 | ALEMBIC | 2018-11-30 | 2 |
| ANDA 211705 | CAPLIN | 2019-03-20 | 12 |
| ANDA 211334 | SANDOZ | 2019-05-14 | 6 |
| ANDA 212612 | GLAND | 2019-09-30 | 14 |
| ANDA 210083 | SAGENT | 2020-02-21 | 2 |
| ANDA 213238 | ACCORD HLTHCARE | 2020-07-08 | 5 |
| ANDA 212227 | XIROMED | 2021-03-04 | 1 |
| ANDA 212802 | MEITHEAL | 2021-07-06 | 4 |
| ANDA 204438 | PH HEALTH | 2021-08-09 | 3 |
| ANDA 212591 | NIVAGEN | 2021-10-13 | 4 |
| NDA 214919 | FRESENIUS KABI USA | 2022-04-21 | 2 |
| ANDA 213698 | ANNORA PHARMA | 2022-07-05 | 3 |
| ANDA 215333 | AMNEAL | 2022-10-21 | 2 |
| ANDA 214635 | ALEMBIC | 2022-10-26 | 4 |
| ANDA 217354 | MANKIND PHARMA | 2023-02-27 | 4 |
| ANDA 212696 | QUAGEN | 2024-07-10 | 5 |
| ANDA 216368 | CHARTWELL RX | 2024-08-28 | 1 |
| ANDA 216297 | SCIEGEN PHARMS | 2024-10-07 | 1 |
| ANDA 216084 | MSN | 2025-04-08 | 1 |
| ANDA 216910 | QUAGEN | 2026-05-18 | 1 |
Showing 40 of 46 applications.
Official labeling on DailyMed
- GLYCOPYRROLATE SOLUTION [QUAGEN PHARMACEUTICALS LLC] · version 2 · 2026-09-11
- GLYCOPYRROLATE INJECTION, SOLUTION [HENRY SCHEIN, INC.] · version 3 · 2026-09-11
- GLYCOPYRROLATE TABLET [BRYANT RANCH PREPACK] · version 107 · 2026-09-11
- GLYCOPYRROLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] · version 12 · 2026-09-07
- GLYCOPYRROLATE INJECTION [AMNEAL PHARMACEUTICALS LLC] · version 11 · 2026-09-02
- GLYCOPYRROLATE TABLET [PAR HEALTH USA, LLC] · version 12 · 2026-08-06
- GLYCOPYRROLATE INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC] · version 11 · 2026-06-25
- GLYCOPYRROLATE INJECTION [MEITHEAL PHARMACEUTICALS INC.] · version 7 · 2026-06-22
- GLYCOPYRROLATE INJECTION [CARDINAL HEALTH 107, LLC] · version 8 · 2026-06-10
- GLYCOPYRROLATE TABLET [REMEDYREPACK INC.] · version 1 · 2026-06-03
- GLYCOPYRROLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 9 · 2026-06-01
- QBREXZA (GLYCOPYRRONIUM) CLOTH [JOURNEY MEDICAL CORPORATION] · version 5 · 2026-05-22
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.