NDC 21695-333
Clotrimazole and Betamethasone Dipropionate 10 mg per 1 g / 0.64 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 51672-4048.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Taro Pharmaceutical Industries Ltd. | Haifa Bay, Israel | Makes it | No problems foundDec 8, 2022 · 7 inspections |
Recalls
- Feb 25, 2022 · Class III · Taro Pharmaceuticals U.S.A., Inc.
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Lots: Lot #: AC33883, Exp. Date June 2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Betamethasone and Clotrimazole: every company that makes it
- Form
- cream
- Strength
- 10 mg per 1 g / 0.64 mg per 1 g
- Approval
- ANDA ANDA075673
- On the market since
- May 29, 2001
- Package NDCs
21695-333-1521695-333-45- Official label
- DailyMed (National Library of Medicine), updated Sep 24, 2010
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