Apl Healthcare Limited
Tirupati, India · makes it and tests it
Problems found, fixed voluntarily Last FDA inspection Dec 17, 2025. 5 inspections on record.
NDC 67046-554
Sertraline Hydrochloride 100 mg tablet, film coated
On the label: Coupler Enterprises Inc..
It's a repackaged product: Coupler Enterprises Inc. rebottles it from Aurobindo Pharma Limited's NDC 65862-013.
Where the pills inside were made
Aurobindo Pharma Limited
Medchal, India · makes it and tests it
Problems found, fixed voluntarily Last FDA inspection Jul 21, 2023. 13 inspections on record, 1 with serious problems.
Aurobindo Pharma Limited
Mahabubnagar, India · makes it and tests it
Problems found, fixed voluntarily Last FDA inspection May 10, 2022. 7 inspections on record, 1 with serious problems.
Repackaging site
- Coupler Enterprises, · repackages it
Product details
- Generic drug
- Sertraline: see every company that makes it
- Form
- tablet, film coated
- Strength
- 100 mg
- Approval
- ANDA ANDA077206
- On the market since
- Sep 9, 2020
- Package NDCs
67046-554-30- Official label
- DailyMed (National Library of Medicine), updated Mar 7, 2021
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