NDC 68180-545
Nystatin and Triamcinolone Acetonide 1 mg per 1 g / 100000 [USP'U] per 1 g cream
On the label: Lupin Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Pithampur, India | Makes it and packages it | Problems found, fixed voluntarilyJul 17, 2025 · 3 inspections |
Recalls
- Jul 17, 2019 · Class III · Lupin Pharmaceuticals Inc.
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Lots: Lot #: K800245, Exp. Dec 2019; K900036 Exp. Sep 20; K900153, Exp. 09/2020
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 and Triamcinolone Acetonide: every company that makes it
- Form
- cream, topical
- Strength
- 1 mg per 1 g / 100000 [USP'U] per 1 g
- Approval
- ANDA ANDA208205
- On the market since
- Nov 29, 2018
- Package NDCs
68180-545-0168180-545-0268180-545-03- Official label
- DailyMed (National Library of Medicine), updated Nov 28, 2025
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