DrugDashboards

Simvastatin

Simvastatin · SIMVASTATIN 5 mg/1 · Tablet, Film Coated · Oral · Aurobindo Pharma Limited

NDC 65862-0050-00 · 100 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 65862-0050-90) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$0.1110per unit
middle half $0.0814$0.1559 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $0.1110
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 1 · prior auth 0% · step therapy 0% · qty limit 68%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 5 quarters since 2024.

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.2%chance of a new FDA shortage posting for simvastatin (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market · price up 1% YoY

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA077691
TE code
AB
Approval date
Dec 20, 2006
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedMar 18, 2020
    Aurobindo Pharma USA Inc.CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
  • Class III · TerminatedJul 29, 2019
    Aurobindo Pharma USA Inc.Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B

Manufacturers of Simvastatin (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsSIMVASTATIN 40 mg/1Jul 15, 2026Sep 3, 2026
A-S Medication SolutionsSIMVASTATIN 5 mg/1Jul 15, 2026Sep 3, 2026
A-S Medication SolutionsSIMVASTATIN 10 mg/1Jul 15, 2026Sep 3, 2026
A-S Medication SolutionsSIMVASTATIN 80 mg/1Jul 15, 2026Sep 3, 2026
A-S Medication SolutionsSIMVASTATIN 20 mg/1Jul 15, 2026Sep 3, 2026
Aphena Pharma Solutions - Tennessee, LLCSIMVASTATIN 80 mg/1Jul 15, 2026Sep 3, 2026
Aphena Pharma Solutions - Tennessee, LLCSIMVASTATIN 20 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedSIMVASTATIN 5 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedSIMVASTATIN 40 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedSIMVASTATIN 10 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedSIMVASTATIN 20 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackSIMVASTATIN 10 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackSIMVASTATIN 80 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackSIMVASTATIN 5 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackSIMVASTATIN 40 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackSIMVASTATIN 20 mg/1Jul 15, 2026Sep 3, 2026
Northwind Health Company, LLCSIMVASTATIN 20 mg/1Jul 15, 2026Sep 3, 2026
Northwind Health Company, LLCSIMVASTATIN 40 mg/1Jul 15, 2026Sep 3, 2026
NuCare Pharmaceuticals,Inc.SIMVASTATIN 20 mg/1Jul 15, 2026Sep 3, 2026
NuCare Pharmaceuticals,Inc.SIMVASTATIN 10 mg/1Jul 15, 2026Sep 3, 2026
NuCare Pharmaceuticals,Inc.SIMVASTATIN 40 mg/1Jul 15, 2026Sep 3, 2026
PD-Rx Pharmaceuticals, Inc.SIMVASTATIN 40 mg/1Jul 15, 2026Sep 3, 2026
Proficient Rx LPSIMVASTATIN 40 mg/1Jul 15, 2026Sep 3, 2026
Proficient Rx LPSIMVASTATIN 10 mg/1Jul 15, 2026Sep 3, 2026
Proficient Rx LPSIMVASTATIN 20 mg/1Jul 15, 2026Sep 3, 2026
Accord Healthcare, Inc.SIMVASTATIN 5 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare, Inc.SIMVASTATIN 80 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare, Inc.SIMVASTATIN 10 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare, Inc.SIMVASTATIN 20 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare, Inc.SIMVASTATIN 40 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingSIMVASTATIN 40 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingSIMVASTATIN 10 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingSIMVASTATIN 20 mg/1Jul 15, 2026Sep 2, 2026
Biocon Pharma Inc,SIMVASTATIN 80 mg/1Jul 15, 2026Sep 2, 2026
Biocon Pharma Inc,SIMVASTATIN 10 mg/1Jul 15, 2026Sep 2, 2026
Biocon Pharma Inc,SIMVASTATIN 5 mg/1Jul 15, 2026Sep 2, 2026
Biocon Pharma Inc,SIMVASTATIN 40 mg/1Jul 15, 2026Sep 2, 2026
Biocon Pharma Inc,SIMVASTATIN 20 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.SIMVASTATIN 10 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.SIMVASTATIN 40 mg/1Jul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Simvastatin — NDC 65862-0050-00," retrieved September 3, 2026, https://drugdashboards.com/drug/65862005000.

Free to cite with attribution — see how the data is put together.