NDC 68258-3013
Prednisone 5 mg tablet
On the label: Dispensing Solutions Inc.. It's repackaged: Dispensing Solutions Inc. rebottles it from Par Health USA, LLC's NDC 0603-5337.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Generics Bidco II LLC d/b/a Prinston Laboratories | Charlotte, NC, United States | Makes it, packages it and labels it | Problems found, fixed voluntarilySep 19, 2025 · 10 inspections, 1 with FDA action |
| Generics Bidco II LLC d/b/a Prinston Laboratories | Charlotte, NC, United States | Makes it and tests it | Problems found, fixed voluntarilySep 19, 2025 · 10 inspections, 1 with FDA action |
| Par Formulations Private Limited | Chennai, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyJun 10, 2026 · 7 inspections |
Recalls
- Mar 4, 2020 · Class III · Par Pharmaceutical Inc.
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Lots: Lot #: 8672518, Exp 12/21
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Prednisone: every company that makes it
- Form
- tablet
- Strength
- 5 mg
- Approval
- ANDA ANDA040256
- On the market since
- May 29, 2008
- Package NDCs
0603-5337-3168258-3013-1- Official label
- DailyMed (National Library of Medicine), updated Jan 28, 2010
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