The short version
11 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.
Ezetimibe and Simvastatin
Ezetimibe and Simvastatin · EZETIMIBE 10 mg/1; SIMVASTATIN 80 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC 51407-0193-05 · 500 TABLET in 1 BOTTLE · ANDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 16714-0781-01) — 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ⓘ
$0.5700per unit
middle half $0.2411–$1.12 · 5,191 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $0.5700
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
94%of plans cover it
tier 1 · prior auth 0% · step therapy 0% · qty limit 78%
*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 2 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)
0.1%chance of a new FDA shortage posting for ezetimibe and simvastatin (oral solid) in the next 90 days
OAI inspection at a producing facility (24 months) · sole-source market
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
- Golden State Medical Supply Inc.United Statesrelabel · repack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA200909
- TE code
- AB
- Approval date
- Apr 26, 2017
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class II · TerminatedOct 14, 2021Golden State Medical Supply Inc. — Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
- Class II · TerminatedOct 14, 2021Golden State Medical Supply Inc. — Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Manufacturers of Ezetimibe and Simvastatin (Tablet)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| A-S Medication Solutions | EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Amneal Pharmaceuticals NY LLC | EZETIMIBE 10 mg/1; SIMVASTATIN 80 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | EZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | EZETIMIBE 10 mg/1; SIMVASTATIN 80 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | EZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | EZETIMIBE 10 mg/1; SIMVASTATIN 80 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | EZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr.Reddys Laboratories Inc | EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr.Reddys Laboratories Inc | EZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr.Reddys Laboratories Inc | EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Dr.Reddys Laboratories Inc | EZETIMIBE 10 mg/1; SIMVASTATIN 80 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Glenmark Pharmaceuticals Inc., USA | EZETIMIBE 10 mg/1; SIMVASTATIN 80 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Glenmark Pharmaceuticals Inc., USA | EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Glenmark Pharmaceuticals Inc., USA | EZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Glenmark Pharmaceuticals Inc., USA | EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Golden State Medical Supply, Inc. | EZETIMIBE 10 mg/1; SIMVASTATIN 80 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Golden State Medical Supply, Inc. | EZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Golden State Medical Supply, Inc. | EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Golden State Medical Supply, Inc. | EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| MSD International GmbH (Singapore Branch) | EZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| MSD International GmbH (Singapore Branch) | EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| MSD International GmbH (Singapore Branch) | EZETIMIBE 10 mg/1; SIMVASTATIN 80 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| MSD International GmbH (Singapore Branch) | EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Northstar Rx Llc | EZETIMIBE 10 mg/1; SIMVASTATIN 80 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Northstar Rx Llc | EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon LLC | EZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon LLC | EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon LLC | EZETIMIBE 10 mg/1; SIMVASTATIN 80 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon LLC | EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon Pharma (Uk) Limited | EZETIMIBE 10 mg/1; SIMVASTATIN 80 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon Pharma (Uk) Limited | EZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon Pharma (Uk) Limited | EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Organon Pharma (Uk) Limited | EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Northstar Rx Llc | EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1 | Jul 15, 2026 | Aug 19, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Ezetimibe and Simvastatin — NDC 51407-0193-05," retrieved September 3, 2026, https://drugdashboards.com/drug/51407019305.
Free to cite with attribution — see how the data is put together.