NDC 53217-265
Hydrocodone Bitartrate and Acetaminophen 5 mg / 325 mg tablet
On the label: Aidarex Pharmaceuticals LLC. It's repackaged: Aidarex Pharmaceuticals LLC rebottles it from Aurolife Pharma LLC's NDC 13107-019.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurolife Pharma LLC | Dayton, NJ, United States | Makes it, tests it, packages it and labels it | Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action |
Product details
- Generic drug
- Acetaminophen and Hydrocodone: every company that makes it
- Form
- tablet
- Strength
- 5 mg / 325 mg
- Approval
- ANDA ANDA201013
- On the market since
- Nov 30, 2016
- Package NDCs
53217-265-1253217-265-1553217-265-2053217-265-2453217-265-3053217-265-6053217-265-90- Official label
- DailyMed (National Library of Medicine), updated Apr 7, 2017
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