Active substance
Nisoldipine
- US FDA 5
- US price lines 3
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SULAR | 8.5MG | tablet, extended release · oral | AZURITY | Prescription | 2 Feb 1995 |
| NISOLDIPINE | 8.5MG; 17MG | tablet, extended release · oral | AMTA | Prescription | 10 Apr 2023 |
| SULAR | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 34MG; 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 17MG | tablet, extended release · oral | AZURITY | Discontinued | 2 Feb 1995 |
| NISOLDIPINE | 20MG; 30MG; 40MG | tablet, extended release · oral | MYLAN | Discontinued | 25 Jul 2008 |
| NISOLDIPINE | 8.5MG; 17MG; 25.5MG; 34MG | tablet, extended release · oral | MYLAN | Discontinued | 26 Jan 2011 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | NISOLDIPINE ER 17 MG TABLET | $4.659 | per EA | 19 Nov 2025 |
| US NADAC | NISOLDIPINE ER 34 MG TABLET | $5.23722 | per EA | 17 Jun 2026 |
| US NADAC | NISOLDIPINE ER 8.5 MG TABLET | $3.55988 | per EA | 19 Aug 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 13 Jun 2017 SULAR — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.