NDC 61919-828
Hydrocodone Bitartrate And Acetaminophen 10 mg / 325 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Aurolife Pharma LLC's NDC 13107-021.
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 |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Acetaminophen and Hydrocodone: every company that makes it
- Form
- tablet
- Strength
- 10 mg / 325 mg
- Approval
- ANDA ANDA201013
- On the market since
- Aug 21, 2019
- Package NDCs
61919-828-2661919-828-90- Official label
- DailyMed (National Library of Medicine), updated May 23, 2023
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