NDC 54868-2470
Nystatin and Triamcinolone 1 mg per 1 g / 100000 [USP'U] per 1 g ointment
On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 51672-1272.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharma Canada Inc. | Brampton, Canada | Makes it | No problems foundMar 27, 2026 · 7 inspections |
Recalls
- Mar 28, 2017 · Class II · Taro Pharmaceuticals U.S.A., Inc.
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Lots: a) 15 g: Lot B505118501, exp. date January 2018; b) 30 g: Lot B504918500, exp. date January 2018; c) 60 g: Lots: I416616979, exp. date August 2017, I416716979, exp. date August 2017 and D504519119, exp. date March 2018
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: every company that makes it
- Form
- ointment
- Strength
- 1 mg per 1 g / 100000 [USP'U] per 1 g
- Approval
- ANDA ANDA063305
- On the market since
- Mar 3, 2005
- Package NDCs
54868-2470-0- Official label
- DailyMed (National Library of Medicine), updated May 10, 2011
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