NDC 67046-851
Venlafaxine 75 mg tablet
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-021.
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 |
Repackaging site
- Coupler Enterprises, Location not on file · relabels it
Recalls
- Mar 21, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Lots: Lot #: M314265, Exp.: 31 October 2025. - Mar 5, 2013 · Class II · Zydus Pharmaceuticals USA Inc
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Lots: Lot #: MM8490, Exp 09/14
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Venlafaxine: every company that makes it
- Form
- tablet
- Strength
- 75 mg
- Approval
- ANDA ANDA077653
- On the market since
- Sep 21, 2017
- Package NDCs
67046-851-0767046-851-1467046-851-1567046-851-2067046-851-2167046-851-2867046-851-3067046-851-60- Official label
- DailyMed (National Library of Medicine), updated Sep 21, 2017
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