NDC 64850-633
Hydrocodone Bitartrate and Acetaminophen 10 mg / 325 mg tablet
On the label: Elite Laboratories, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Elite Laboratories, Inc. | Northvale, NJ, United States | Makes it and labels it | Problems found, fixed voluntarilyAug 1, 2025 · 12 inspections, 1 with FDA action |
Product details
- Generic drug
- Acetaminophen and Hydrocodone: every company that makes it
- Form
- tablet, oral
- Strength
- 10 mg / 325 mg
- Approval
- ANDA ANDA209924
- On the market since
- Nov 16, 2018
- Package NDCs
64850-633-01- Official label
- DailyMed (National Library of Medicine), updated Oct 23, 2025
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