NDC 52959-558
Nystatin and Triamcinolone Acetonide 1 mg per 1 g / 100000 [USP'U] per 1 g cream
On the label: H.J. Harkins Co., Inc.. It's repackaged: H.J. Harkins Co., Inc. rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 51672-1263.
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 |
| Taro Pharmaceutical Industries Ltd. | Haifa Bay, Israel | Makes it | No problems foundDec 8, 2022 · 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
- cream
- Strength
- 1 mg per 1 g / 100000 [USP'U] per 1 g
- Approval
- ANDA ANDA062364
- On the market since
- Dec 22, 1987
- Package NDCs
52959-558-0152959-558-03- Official label
- DailyMed (National Library of Medicine), updated Apr 19, 2012
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