NDC 0121-0868
Nystatin 100000 [USP'U] per 1 mL suspension
On the label: Pharmaceutical Associates, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma | Greenville, SC, United States | Makes it, tests it, packages it and labels it | No problems foundAug 1, 2025 · 18 inspections, 1 with FDA action |
Recalls
- Jul 29, 2021 · Class II · PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Lots: Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Nystatin: every company that makes it
- Form
- suspension, oral
- Strength
- 100000 [USP'U] per 1 mL
- Approval
- ANDA ANDA203621
- On the market since
- Jul 17, 2020
- Package NDCs
0121-0868-000121-0868-020121-0868-050121-0868-160121-0868-400121-0868-50- Official label
- DailyMed (National Library of Medicine), updated Jul 21, 2026
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