FDA — authorised 30 January 1992
- Application: NDA019734
- Marketing authorisation holder: CHIESI
- Local brand name: CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 nicardipine intravenous in United States
FDA authorised nicardipine intravenous on 30 January 1992 · 10 US adverse-event reports
Marketing authorisations
FDA — authorised 21 February 1992
- Application: NDA020005
- Marketing authorisation holder: CHIESI
- Local brand name: CARDENE SR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 July 1996
- Application: ANDA074642
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 October 1996
- Application: ANDA074540
- Marketing authorisation holder: ANI PHARMS
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 October 1996
- Application: ANDA074670
- Marketing authorisation holder: ANI PHARMS
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 December 1996
- Application: ANDA074439
- Marketing authorisation holder: ANI PHARMS
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 March 1998
- Application: ANDA074928
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 July 2008
- Application: NDA022276
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 17 November 2009
- Application: ANDA090671
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 November 2009
- Application: ANDA090125
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 November 2009
- Application: ANDA090534
- Marketing authorisation holder: AM REGENT
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 November 2009
- Application: NDA078405
- Marketing authorisation holder: SUN PHARM
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 November 2009
- Application: ANDA090664
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 December 2009
- Application: ANDA078714
- Marketing authorisation holder: HIKMA
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 April 2021
- Application: ANDA211121
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 May 2023
- Application: ANDA217555
- Marketing authorisation holder: BIONPHARMA
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 July 2023
- Application: ANDA216420
- Marketing authorisation holder: MICRO LABS
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 July 2023
- Application: ANDA215377
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 April 2024
- Application: ANDA218202
- Marketing authorisation holder: AMNEAL
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 April 2024
- Application: ANDA203978
- Marketing authorisation holder: INFORLIFE
- Local brand name: NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 6 September 2024
- Application: ANDA217548
- Marketing authorisation holder: CHENGDU SHUODE
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 September 2024
- Application: ANDA215592
- Marketing authorisation holder: CIPLA
- Local brand name: NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 31 October 2024
- Application: ANDA215406
- Marketing authorisation holder: AMNEAL
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 June 2025
- Application: ANDA218638
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 October 2025
- Application: ANDA220243
- Marketing authorisation holder: CAPLIN
- Local brand name: NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 28 October 2025
- Application: ANDA219608
- Marketing authorisation holder: QILU PHARM HAINAN
- Local brand name: NICARDIPINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 10
Most-reported reactions
- Blood Glucose Decreased — 1 report (10%)
- Drug Administration Error — 1 report (10%)
- Hypotension — 1 report (10%)
- Malnutrition — 1 report (10%)
- Overdose — 1 report (10%)
- Oxygen Saturation Decreased — 1 report (10%)
- Poor Peripheral Circulation — 1 report (10%)
- Respiratory Arrest — 1 report (10%)
- Resuscitation — 1 report (10%)
- Sudden Death — 1 report (10%)
Other Cardiovascular approved in United States
Frequently asked questions
Is nicardipine intravenous approved in United States?
Yes. FDA authorised it on 30 January 1992; FDA authorised it on 21 February 1992; FDA authorised it on 18 July 1996.
Who is the marketing authorisation holder for nicardipine intravenous in United States?
CHIESI holds the US marketing authorisation.