NDC 50268-363
Glycopyrrolate 1 mg tablet
On the label: AvPAK. It's repackaged: AvPAK rebottles it from Aurolife Pharma LLC's NDC 13107-014.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Tirupati, India | Makes it and tests it | Problems found, fixed voluntarilyDec 17, 2025 · 5 inspections |
Recalls
- May 18, 2023 · Class III · Aurolife Pharma, LLC
Failed Impurities/Degradation Specifications
Lots: Lot #: 01421038A1, Exp. Date 05/2023 - Dec 22, 2022 · Class II · Avkare Llc
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Lots: Lot#: 43313, 43342, Exp 12/2023 - Dec 16, 2022 · Class II · Aurolife Pharma, LLC
Failed Impurities/Degradation Specifications
Lots: Lots: 01422002A1, Expiry: 12/2023; 01421078A3, Expiry: 09/2023 - Mar 17, 2022 · Class II · Aurolife Pharma, LLC
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Lots: Lot: 01421008A1, Exp 03/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Glycopyrronium: every company that makes it
- Form
- tablet, oral
- Strength
- 1 mg
- Approval
- ANDA ANDA202675
- On the market since
- Mar 4, 2025
- Package NDCs
50268-363-1150268-363-15- Official label
- DailyMed (National Library of Medicine), updated Mar 4, 2025
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