NDC 87063-016
Promethazine Hydrochloride 50 mg tablet
On the label: Asclemed USA, Inc.. It's repackaged: Asclemed USA, Inc. rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-042.
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
- Asclemed USA Inc. dba Enovachem, Torrance, 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
- 50 mg
- Approval
- ANDA ANDA040596
- On the market since
- Dec 14, 2005
- Package NDCs
87063-016-0087063-016-0187063-016-0587063-016-1087063-016-2087063-016-3087063-016-6087063-016-90- Official label
- DailyMed (National Library of Medicine), updated Jul 2, 2026
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