NDC 16729-004

simvastatin 10 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) R2100818, Exp. Date 6/30/2023; R2100964, Exp. Date 6/30/2023; R2100824, Exp. Date 6/30/2023; R2100820, Exp. Date 6/30/2023; R2100822, Exp. Date 6/30/2023; R2101201, Exp. Date 9/30/2023; R2101198, Exp. Date 9/30/2023; R2101199, Exp. Date 9/30/2023; R2101200, Exp. Date 9/30/2023; R2101355…
• Feb 7, 2023 · Class II · Terminated
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) P2106923, Exp. Date 9/30/2023; R2101544, Exp. Date 10/31/2023; R2200732, Exp. Date 5/31/2025; b) P2101634, Exp. Date 2/28/2023; P2102370, Exp. Date 3/31/2023; P2102321, Exp. Date 3/31/2023; P2102411, Exp. Date 3/31/2023; P2102454, Exp. Date 3/31/2023; P2103991, Exp. Date 5/31/2023; …
• Feb 7, 2023 · Class II · Terminated
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) P2102261, P2102284, P2102319, Exp. Date 3/31/2023, P2103536, Exp. Date 5/31/2023, P2104344, P2104342, P2104355, P2104356, P2104296, P2104380, Exp. Date 6/30/2023, R2200238, R2200239, Exp. Date 1/31/2024, R2200383, Exp. Date 2/28/2025; b) R2000554, R2000553, Exp. Date 9/30/2023; P21005…
• Feb 7, 2023 · Class II · Terminated
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) P2103713, P2103692, Exp. Date 5/31/2023, P2104950, P2104984, P2104969, P2104996, P2105274, P2105314, P2105316, Exp. Date 7/31/2023, R2101074, R2101077, R2101078, R2101079, R2101083, R2101084, R2101117, Exp. Date 8/31/2023, R2101330, R2101331, R2101335, R2101336, R2101334, R2101337, R210…
• Feb 7, 2023 · Class II · Terminated
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) R2100387, R2100393, Exp. Date 2/28/2023, P2102556, P2102558, P2102636, Exp. Date 4/30/2023, P2103981, P2103877, P2103958, Exp. Date 5/31/2023, R2101393, R2101395, R2101394, Exp. Date 10/31/2023, P2202681, P2202653, Exp. Date 4/30/2025; b)R2000555, R2000587, R2000599, R2000604, Exp. D…

Product details

Generic drug

Simvastatin: see every company that makes it

Form

tablet, film coated, oral

Strength

10 mg

Approval

ANDA ANDA078155

On the market since

Feb 26, 2008

Package NDCs

16729-004-10 16729-004-12 16729-004-15 16729-004-17

Official label

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

Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?