Active substance
Nicardipine
- US FDA 36
- US price lines 1
- Safety 7
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CARDENE | 25MG/10ML (2.5MG/ML) | injectable · injection | CHIESI | Prescription | 30 Jan 1992 |
| CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | injectable · intravenous | CHIESI | Prescription | 30 Jan 1992 |
| CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER | 20MG/200ML (0.1MG/ML) | injectable · intravenous | CHIESI | Prescription | 30 Jan 1992 |
| CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER | 40MG/200ML (0.2MG/ML) | injectable · intravenous | CHIESI | Prescription | 30 Jan 1992 |
| NICARDIPINE HYDROCHLORIDE | 20MG; 30MG | capsule · oral | ANI PHARMS | Prescription | 28 Oct 1996 |
| NICARDIPINE HYDROCHLORIDE | 20MG; 30MG | capsule · oral | EPIC PHARMA LLC | Prescription | 19 Mar 1998 |
| NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | injectable · injection | HIKMA INTL PHARMS | Prescription | 24 Jul 2008 |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML); 40MG/200ML (0.2MG/ML) | injectable · intravenous | HIKMA INTL PHARMS | Prescription | 24 Jul 2008 |
| NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | injectable · injection | AM REGENT | Prescription | 17 Nov 2009 |
| NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | injectable · injection | SOMERSET THERAPS LLC | Prescription | 17 Nov 2009 |
| NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | injectable · injection | MANKIND PHARMA | Prescription | 17 Nov 2009 |
| NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | injectable · injection | EUGIA PHARMA | Prescription | 8 Apr 2021 |
| NICARDIPINE HYDROCHLORIDE | 20MG; 30MG | capsule · oral | GLENMARK PHARMS LTD | Prescription | 16 Dec 2022 |
| NICARDIPINE HYDROCHLORIDE | 20MG; 30MG | capsule · oral | BIONPHARMA | Prescription | 3 May 2023 |
| NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | injectable · injection | MICRO LABS | Prescription | 7 Jul 2023 |
| NICARDIPINE HYDROCHLORIDE | 20MG; 30MG | capsule · oral | SENORES PHARMS | Prescription | 17 Jul 2023 |
| NICARDIPINE HYDROCHLORIDE | 20MG; 30MG | capsule · oral | AMNEAL | Prescription | 10 Apr 2024 |
| NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML) | injectable · intravenous | INFORLIFE | Prescription | 17 Apr 2024 |
| NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE | 40MG/200ML (0.2MG/ML) | injectable · intravenous | INFORLIFE | Prescription | 17 Apr 2024 |
| NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | injectable · injection | CHENGDU SHUODE | Prescription | 6 Sep 2024 |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML); 40MG/200ML (0.2MG/ML) | injectable · intravenous | CIPLA | Prescription | 24 Sep 2024 |
| NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | injectable · injection | NANJING KING FRIEND | Prescription | 20 Aug 2025 |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML); 40MG/200ML (0.2MG/ML) | injectable · intravenous | CAPLIN | Prescription | 22 Oct 2025 |
| NICARDIPINE HYDROCHLORIDE | 25MG/10ML (2.5MG/ML) | injectable · injection | QILU PHARM HAINAN | Prescription | 28 Oct 2025 |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | 20MG/200ML (0.1MG/ML); 40MG/200ML (0.2MG/ML) | injectable · intravenous | FRESENIUS KABI USA | Prescription | 4 Aug 2026 |
11 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | NICARDIPINE 20 MG CAPSULE | $1.12012 | per EA | 23 Sep 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 27 Mar 2026 CARDENE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions - US FDA 23 Sep 2016 NICARDIPINE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Drug Interactions - US FDA 26 Aug 2016 CARDENE — safety-related labeling change
Labeling sections changed: Drug Interactions - US FDA 26 Aug 2016 CARDENE SR — safety-related labeling change
Labeling sections changed: Drug Interactions - EMA PRAC 5 Sep 2013 PRAC signal: Acute pulmonary oedema in off-label use during pregnancy
Action for MAH: update of the product information: Yes - EMA PRAC 16 May 2013 PRAC signal: Acute pulmonary oedema in off-label use during pregnancy
Action for MAH: update of the product information: No - EMA PRAC 29 Nov 2012 PRAC signal: Thrombocytopenia
Action for MAH: update of the product information: Yes
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.