NDC 67046-335
Acyclovir 400 mg tablet
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from Camber Pharmaceuticals Inc.'s NDC 31722-777.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hetero Labs Limited | Mahabubnagar, India | Makes it | Problems found, fixed voluntarilyAug 12, 2022 · 5 inspections, 1 with FDA action |
Repackaging site
- Coupler Enterprises, Location not on file · repackages it
Recalls
- Apr 27, 2017 · Class III · Hetero USA Inc
Presence of Foreign Substance: human hair melded into tablet.
Lots: Lot # ACY16075 Exp. 09/2018
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Acyclovir: every company that makes it
- Form
- tablet
- Strength
- 400 mg
- Approval
- ANDA ANDA203834
- On the market since
- Jun 15, 2020
- Package NDCs
67046-335-30- Official label
- DailyMed (National Library of Medicine), updated Jun 1, 2020
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