NDC 63629-1591
Promethazine Hydrochloride 12.5 mg tablet
On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-040.
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
- Bryant Ranch Prepack, Burbank, CA, United States · repackages it and relabels 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, oral
- Strength
- 12.5 mg
- Approval
- ANDA ANDA040596
- On the market since
- Dec 14, 2005
- Package NDCs
63629-1591-063629-1591-163629-1591-263629-1591-363629-1591-563629-1591-663629-1591-763629-1591-863629-1591-9- Official label
- DailyMed (National Library of Medicine), updated Apr 2, 2024
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