NDC 43386-358
Hydrocodone Bitartrate and Acetaminophen 10 mg / 325 mg tablet
On the label: Lupin Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Novel Laboratories, Inc. | Somerset, NJ, United States | Makes it, tests it and packages it | Problems found, fixed voluntarilyApr 17, 2026 · 15 inspections, 1 with FDA action |
Recalls
- May 24, 2018 · Class III · Lupin Somerset
Labeling: Missing Label
Lots: Lot # S800257; Exp. 01/20
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Acetaminophen and Hydrocodone: every company that makes it
- Form
- tablet, oral
- Strength
- 10 mg / 325 mg
- Approval
- ANDA ANDA206245
- On the market since
- Dec 1, 2016
- Package NDCs
43386-358-0143386-358-0343386-358-0543386-358-10- Official label
- DailyMed (National Library of Medicine), updated Feb 2, 2024
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