NDC 67046-1069
Promethazine Hydrochloride 25 mg tablet
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-041.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
| Zydus Lifesciences Limited | Solan, India | Makes it and tests it | No problems foundMar 9, 2020 · 6 inspections |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- May 8, 2014 · Class II · Zydus Pharmaceuticals USA Inc
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Lots: Lot #: MN9081, Expiry: 09/2015
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Promethazine: every company that makes it
- Form
- tablet
- Strength
- 25 mg
- Approval
- ANDA ANDA040596
- On the market since
- Nov 12, 2024
- Package NDCs
67046-1069-3- Official label
- DailyMed (National Library of Medicine), updated Nov 12, 2024
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?