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Active ingredient

Nicardipine

52 finished FDA listings contain Nicardipine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
NICARDIPINE, NICARDIPINE HYDROCHLORIDE
Dosage forms
Capsule, Injection, Injection, Solution
Routes
Intravenous, Oral
Manufacturers / labelers
29
Strengths listed
.1 mg/ml · .2 mg/ml · 2.5 mg/10ml · 2.5 mg/ml · 20 mg/1 · 25 mg/10ml · 30 mg/1
Brand names in FDA listings
Cardene Iv, Nicardipine Hydrochloride, Nicardipine Hydrochloride In Sodium Chloride

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 7396

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 019734CHIESI1992-01-307
ANDA 074670ANI PHARMS1996-10-282
ANDA 074928EPIC PHARMA LLC1998-03-194
NDA 022276HIKMA INTL PHARMS2008-07-246
ANDA 090664SOMERSET THERAPS LLC2009-11-171
ANDA 090534AM REGENT2009-11-172
ANDA 090671MANKIND PHARMA2009-11-171
ANDA 211121EUGIA PHARMA2021-04-082
ANDA 216357GLENMARK PHARMS LTD2022-12-162
ANDA 217555BIONPHARMA2023-05-032
ANDA 216420MICRO LABS2023-07-072
ANDA 215377SENORES PHARMS2023-07-176
ANDA 218202AMNEAL2024-04-102
ANDA 203978INFORLIFE2024-04-172
ANDA 217548CHENGDU SHUODE2024-09-062
ANDA 215592CIPLA2024-09-242
ANDA 216819NANJING KING FRIEND2025-08-201
ANDA 220243CAPLIN2025-10-224
ANDA 219608QILU PHARM HAINAN2025-10-282

Official labeling on DailyMed

Showing the 12 most recent of 34 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.