NDC 68180-751

Amlodipine Besylate 5 mg tablet

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

Chhatrapati Sambhajinagar, India · makes it and packages it

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

Recalls

• Jun 27, 2023 · Class III · Terminated
  Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
  Lots: Lot #: A102887, Exp. 6/2023
• Feb 19, 2016 · Class III · Terminated
  CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
  Lots: Lot #: G304799, Exp. 4/2016
• Feb 19, 2016 · Class III · Terminated
  CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
  Lots: Lot #: G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, Exp. 4/2016

Product details

Generic drug

Amlodipine: see every company that makes it

Form

tablet

Strength

5 mg

Approval

ANDA ANDA078043

On the market since

Aug 3, 2007

Package NDCs

68180-751-03 68180-751-09 68180-751-17

Official label

DailyMed (National Library of Medicine), updated Apr 20, 2026

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