NDC 67046-1071
Valacyclovir 500 mg tablet, film coated
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Camber Pharmaceuticals Inc.'s NDC 31722-704.
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 |
| Hetero Labs Limited | Hobli Vemagal Kolar, India | Makes it | No problems foundJan 31, 2025 · 1 inspection |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- Feb 13, 2018 · Class II · Hetero Labs Limited Unit V
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Lots: Lot # VLC17027 Exp 07-2019
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, film coated, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA203047
- On the market since
- Apr 23, 2026
- Package NDCs
67046-1071-3- Official label
- DailyMed (National Library of Medicine), updated Apr 23, 2026
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