Ezetimibe and simvastatin tablets
Reason category: Impurities (e.g. nitrosamines)
FDA recall number D-0462-2025
Cholesterol (statin)
Simvastatin 20 mg tablet
Public data on simvastatin from CMS and FDA: what pharmacies have paid for it, how many generic applications FDA has approved, and whether it appears in FDA's shortage or recall records.
$0.0324
NADAC per ea (2026-11)
approximate acquisition cost, not a retail price
+19%
change over five years
peak $0.0408 in 2024-01
16
approved generic applications (ANDAs) on record for Simvastatin
10 with a product still marketed · first 2006
Not listed
in FDA's current shortage list
no matching FDA shortage entries
NADAC per unit, monthly
SIMVASTATIN 20 MG TABLETShow as table
| Month | NADAC per unit ($) |
|---|---|
| 2013-11 | 0.02688 |
| 2014-02 | 0.03900 |
| 2014-05 | 0.03167 |
| 2014-08 | 0.03227 |
| 2014-11 | 0.02680 |
| 2015-02 | 0.02880 |
| 2015-05 | 0.02869 |
| 2015-08 | 0.02800 |
| 2015-11 | 0.02686 |
| 2016-02 | 0.02471 |
| 2016-05 | 0.02450 |
| 2016-08 | 0.02827 |
| 2016-11 | 0.02638 |
| 2017-02 | 0.02371 |
| 2017-05 | 0.02365 |
| 2017-08 | 0.02312 |
| 2017-11 | 0.02362 |
| 2018-02 | 0.02436 |
| 2018-05 | 0.02665 |
| 2018-08 | 0.02631 |
| 2018-11 | 0.02657 |
| 2019-02 | 0.02762 |
| 2019-05 | 0.03089 |
| 2019-08 | 0.02683 |
| 2019-11 | 0.02933 |
| 2020-02 | 0.02889 |
| 2020-05 | 0.03036 |
| 2020-08 | 0.02601 |
| 2020-11 | 0.02713 |
| 2021-02 | 0.02772 |
| 2021-05 | 0.02760 |
| 2021-08 | 0.02797 |
| 2021-11 | 0.02729 |
| 2022-02 | 0.02801 |
| 2022-05 | 0.02638 |
| 2022-08 | 0.02612 |
| 2022-11 | 0.02705 |
| 2023-02 | 0.02614 |
| 2023-05 | 0.03064 |
| 2023-08 | 0.03076 |
| 2023-11 | 0.03831 |
| 2024-02 | 0.04042 |
| 2024-05 | 0.03286 |
| 2024-08 | 0.03313 |
| 2024-11 | 0.02964 |
| 2025-02 | 0.02937 |
| 2025-05 | 0.03073 |
| 2025-08 | 0.03098 |
| 2025-11 | 0.03092 |
| 2026-02 | 0.03125 |
| 2026-05 | 0.02993 |
| 2026-08 | 0.03024 |
| 2026-11 | 0.03245 |
Source: CMS NADAC weekly files, generic rows, monthly median of weekly averages · data as of 2026-11. Figures can change and may contain errors in the source data. Check the original source before relying on them.
Recall records mentioning simvastatin
openFDA enforcement records, by year reported.
| 2025 | 1 |
| 2023 | 18 |
| 2021 | 8 |
| 2020 | 1 |
| 2019 | 2 |
| 2018 | 1 |
| 2016 | 1 |
| 2015 | 5 |
| 2014 | 4 |
41 records since 2012. A record is one product or lot, not one recall event. Combination products that contain simvastatin are included.
What these numbers mean
NADAC is what retail pharmacies pay on average to buy the drug, published by CMS. It does not include rebates and is not what you pay at the counter. ANDA counts include all strengths and forms and applications whose products are now discontinued.
Most recent recall records
Simvastatin usp
Reason category: cGMP deviations
FDA recall number D-0560-2023
Simvastatin usp
Reason category: cGMP deviations
FDA recall number D-0561-2023
Simvastatin usp
Reason category: cGMP deviations
FDA recall number D-0558-2023
Simvastatin product
Reason category: cGMP deviations
FDA recall number D-0503-2023
Not health advice. GxRadar is for general information only. Nothing here is medical, pharmacy, legal or financial advice. Do not start, stop or change any medicine based on this site. Talk to your pharmacist or prescriber about your own situation.
Articles that mention simvastatin
7 GxRadar articles cite or discuss this drug.
Price histories · Data story · 6 min
What pharmacies paid for simvastatin, 2013 to 2026
Federal survey data put a generic 20 mg simvastatin tablet at 2.7 cents in November 2013 and 3.2 cents in October 2026. The year-by-year record, the 2023 jump and the approvals behind the market.
Price histories · Data story · 5 min
What pharmacies paid for atorvastatin, 2013 to 2026
Federal survey data show the pharmacy cost of a generic 20 mg atorvastatin tablet fell from 18.3 cents in November 2013 to 2.8 cents in October 2026. The year-by-year record, and the FDA approvals behind it.
Generic or brand · Explainer · 5 min
State generic substitution laws
Whether a pharmacist must, may or may not swap in a generic is set by state law. How mandatory and permissive states differ, what consent and notice rules require, and where the Orange Book fits.
Price histories · Data story · 6 min
The generics that cost pharmacies more than they did in 2014
Most generics in GxRadar's 47-drug basket got cheaper. Seven cost pharmacies more than in January 2014, led by furosemide at 2.8 times its 2014 price. What federal cost and shortage data show, drug by drug.
The approval pathway · Explainer · 6 min
Reference listed drug, reference standard and basis of submission, explained
Every generic copies one approved product and is tested against another, and they are often not the same pill. How FDA defines the RLD and the reference standard, and what the Orange Book shows for common generics.
The approval pathway · Explainer · 5 min
Pediatric exclusivity and the six months it adds before generics
A brand company that studies its drug in children at FDA's written request can win six more months of protection from generics. How the 1997 incentive works, what it attaches to, and what FDA's own lists show.