NDC 68180-352

Sertraline Hydrochloride 50 mg tablet, film coated

On the label: Lupin Pharmaceuticals, Inc..

Where it's made

Lupin Limited

Salcette, India · makes it and packages it

Problems found, fixed voluntarily Last FDA inspection Nov 21, 2025. 9 inspections on record, 1 with serious problems.

Lupin Limited

Pithampur, India · makes it and packages it

Serious problems, FDA action Last FDA inspection Jul 17, 2025. 6 inspections on record, 4 with serious problems.

Lupin Limited

Chhatrapati Sambhajinagar, India · makes it and packages it

Problems found, fixed voluntarily Last FDA inspection Mar 15, 2024. 5 inspections on record.

Recalls

• Nov 5, 2025 · Class II · Ongoing
  Defective container - seal not adhering to bottles
  Lots: Lot # QB00865, exp. date Feb 2028

Product details

Generic drug

Sertraline: see every company that makes it

Form

tablet, film coated, oral

Strength

50 mg

Approval

ANDA ANDA077670

On the market since

Feb 6, 2007

Package NDCs

68180-352-01 68180-352-02 68180-352-03 68180-352-05 68180-352-06 68180-352-09 68180-352-11

Official label

DailyMed (National Library of Medicine), updated Oct 14, 2025

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