EZETIMIBE; SIMVASTATIN | N021687 | ORGANON LLC A SUB OF ORGANON AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps, & McNamara P.C. FDA-2026-P-5995 · 7 docket documents The law firm Hyman, Phelps & McNamara P.C., on behalf of an unnamed client, submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Ezetimibe and Simvastatin Tablets in 10 mg/15 mg and 10 mg/30 mg strengths suitable for s | Suitability | 2026-05-28 | Open | Hyman, Phelps, & McNamara P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$13.89
per ea
Lowest NADAC/Unit
$13.76
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 78206017501VYTORIN 10-20 MG TABLET | $13.89 | EA | Brand | $0.3013 | 2026-01-01 |
| 78206017502VYTORIN 10-20 MG TABLET | $13.89 | EA | Brand | $0.3013 | 2026-01-01 |
| 78206017601VYTORIN 10-40 MG TABLET | $13.76 | EA | Brand | $0.3719 | 2026-06-17 |
| 78206017602VYTORIN 10-40 MG TABLET | $13.76 | EA | Brand | $0.3719 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.