NDC 54868-5248
Fluconazole 10 mg per 1 mL powder, for suspension
On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Mylan Pharmaceuticals Inc.'s NDC 59762-5029.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Pfizer Ireland Pharmaceuticals Unlimited Company | Ringaskiddy, Ireland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyOct 25, 2024 · 6 inspections |
Repackaging site
- Physicians Total Care, Inc., Tulsa, Oklahoma, United States · relabels it
Recalls
- Jan 29, 2014 · Class II · Pfizer Inc.
Defective Container: Tamper evident ring failures discovered on some bottles.
Lots: Lot # A358502; Exp 01/15
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Fluconazole: every company that makes it
- Form
- powder, for suspension
- Strength
- 10 mg per 1 mL
- Approval
- NDA AUTHORIZED GENERIC NDA020090
- On the market since
- Mar 11, 2005
- Package NDCs
54868-5248-0- Official label
- DailyMed (National Library of Medicine), updated Nov 27, 2013
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