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Simvastatin

NDC 65862-054 · Aurobindo Pharma Limited

Generic nameSimvastatin

Dosage formTABLET, FILM COATED

RouteORAL

Active ingredient(s)SIMVASTATIN

Strength80 mg/1

Pharmacologic classHMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

Marketing categoryANDA

Packages

65862-054-00 — 100 TABLET, FILM COATED in 1 BOTTLE (65862-054-00)

65862-054-30 — 30 TABLET, FILM COATED in 1 BOTTLE (65862-054-30)

65862-054-39 — 3000 TABLET, FILM COATED in 1 BOTTLE (65862-054-39)

65862-054-45 — 45 TABLET, FILM COATED in 1 BOTTLE (65862-054-45)

65862-054-90 — 90 TABLET, FILM COATED in 1 BOTTLE (65862-054-90)

65862-054-99 — 1000 TABLET, FILM COATED in 1 BOTTLE (65862-054-99)

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

63187-449 — simvastatin, 63629-3385 — simvastatin, 63629-3392 — simvastatin, 63629-3393 — simvastatin, 63629-3408 — simvastatin, 63629-7421 — simvastatin, 65862-050 — Simvastatin, 65862-051 — Simvastatin, 65862-052 — Simvastatin, 65862-053 — Simvastatin, 67046-0542 — SIMVASTATIN, 67046-0626 — SIMVASTATIN, 67046-0628 — SIMVASTATIN, 67877-507 — Ezetimibe and Simvastatin, 67877-508 — Ezetimibe and Simvastatin, 67877-509 — Ezetimibe and Simvastatin, 67877-510 — Ezetimibe and Simvastatin, 68071-1646 — simvastatin, 68071-1711 — simvastatin, 68071-2559 — Simvastatin, +172 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q3 (July 2026 release). All data sources · How to read the labels