NDC 16729-047

Atorvastatin Calcium 80 mg tablet, film coated

On the label: Accord Healthcare Inc..

Where it's made

Intas Pharmaceuticals Limited

Ahmedabad, India · makes it and tests it

No problems found Last FDA inspection Jul 12, 2024. 10 inspections on record.

Intas Pharmaceuticals Limited

Ahmedabad, India · makes it and tests it

Serious problems, FDA action Last FDA inspection Dec 2, 2022. 7 inspections on record, 1 with serious problems.

Recalls

• Feb 7, 2023 · Class II · Terminated
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a)R2100455, Exp. Date 3/31/2023; R2200274, Exp. Date 1/31/2024; R2200700, Exp. Date 5/31/2024; b) R2101342, R2101343, R2101476, Exp. Date 9/30/2023; R2101364, R2101365, R2101366, R2101367, Exp. Date 10/31/2023; R2101612, R2101613, R2101614, Exp. Date 11/30/2023; R2200222, R2200221, R22002…
• Feb 7, 2023 · Class II · Terminated
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a)R2100305, Exp. Date 2/28/2023; R2200227, Exp. Date 1/31/2024; R2200797, Exp. Date 6/30/2024; b) R2101423, R2101438, R2101447, R2101446, Exp. Date 10/31/2023; R2200040, R2200041, R2200052, R2200043, R2200044, R2200051, R2200060, R2200061, R2200062, R2200077, R2200078, Exp. Date 12/31/202…
• Feb 7, 2023 · Class II · Terminated
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a)R2100552, R2100553, Exp. Date 4/30/2023; R2200253, Exp. Date 2/29/2024; R2200627, Exp. Date 4/30/2024; R2201113, Exp. Date 6/30/2024; R2201184, Exp. Date 8/31/2024; R2201366, Exp. Date 9/30/2024; b) R2200280, Exp. Date 2/29/2024; R2200385, R2200386, R2200491, R2200490, R2200494, R220049…
• Feb 7, 2023 · Class II · Terminated
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a)R2100283, R2100288, R2100289, Exp. Date 2/28/2023; R2200235, Exp. Date 1/31/2024; R2201037, R2200952, Exp. Date 6/30/2024; b) R2100291, R2100281, R2100282, R2100292, R2100293, R2100294, R2100290, R2100306, R2100348, R2100349, R2100347, R2100350, R2100356, R2100355, Exp. Date 2/28/2023; R…

Product details

Generic drug

Atorvastatin: see every company that makes it

Form

tablet, film coated, oral

Strength

80 mg

Approval

ANDA ANDA207687

On the market since

Aug 6, 2018

Package NDCs

16729-047-01 16729-047-10 16729-047-15 16729-047-16 16729-047-17

Official label

DailyMed (National Library of Medicine), updated Oct 6, 2025

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