NDC 54868-6394
rizatriptan benzoate 10 mg tablet
On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-466.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Goa, India | Makes it and tests it | Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action |
Repackaging site
- Physicians Total Care, Inc., Tulsa, Oklahoma, United States · relabels it
Recalls
- May 10, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Lots: Lot#: 19224217; Exp. 9/2024 Lot#: 19233789; Exp. 9/2025 Lot#: 19224444; Exp. 9/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Rizatriptan: every company that makes it
- Form
- tablet
- Strength
- 10 mg
- Approval
- ANDA ANDA201967
- On the market since
- Jan 23, 2013
- Package NDCs
54868-6394-054868-6394-1- Official label
- DailyMed (National Library of Medicine), updated Feb 6, 2013
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