NDC 43386-118
Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg / 1.5 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
- Mar 5, 2018 · Class III · Novel Laboratories, Inc.
Failed Impurities/Degradation Specifications
Lots: M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Hydrocodone and Methylhomatropine: every company that makes it
- Form
- tablet, oral
- Strength
- 5 mg / 1.5 mg
- Approval
- ANDA ANDA091528
- On the market since
- Sep 23, 2014
- Package NDCs
43386-118-0143386-118-0343386-118-05- Official label
- DailyMed (National Library of Medicine), updated Sep 12, 2024
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