NDC 21695-207
Fluocinonide 0.5 mg per 1 g cream
On the label: Rebel Distributors Corp... It's repackaged: Rebel Distributors Corp.. rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 51672-1253.
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
- Sep 20, 2017 · Class III · Taro Pharmaceuticals U.S.A., Inc.
Cross contamination with other products: traces of Dapsone were found in the finished product.
Lots: Lot #: A771026850, Exp 6/18 - Mar 17, 2017 · Class III · Taro Pharmaceuticals U.S.A., Inc.
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Lots: Lot #: D301311473, D301411473, Exp 3/2017
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluocinonide: every company that makes it
- Form
- cream
- Strength
- 0.5 mg per 1 g
- Approval
- ANDA ANDA019117
- On the market since
- Jun 26, 1984
- Package NDCs
21695-207-1521695-207-3021695-207-60- Official label
- DailyMed (National Library of Medicine), updated Sep 27, 2010
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