Nicardipine Injectable Solution

Brand(s)
Cardene
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Chiesi Usa, Inc. (2015-07-15)
Oldest Current Product
1992-01-30
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\NICARDIPINE
FDAOB
INJECTION\INJECTION\NICARDIPINE HYDROCHLORIDE\rdfq
INTRAVENOUS\INJECTION\NICARDIPINE HYDROCHLORIDE
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\NICARDIPINE HYDROCHLORIDE
INTRAVENOUS\INJECTION\NICARDIPINE HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\NICARDIPINE
INTRAVENOUS\INJECTION\NICARDIPINE

product(s) by strength(s)

nicardipine hydrochloride 0.1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1101220314CardeneNDAChiesi Usa, Inc.1992-01-30NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA0197340d58f812-37bf-439f-b3f2-c31f8eefe22e
2244770312CardeneNDAEkr Therapeutics, Inc.1992-01-30NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA019734b7dfde10-01d4-11de-87af-0800200c9a66

nicardipine hydrochloride 0.2 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1101220325CardeneNDAChiesi Usa, Inc.1992-01-30NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA01973472c19612-6dc6-4413-80a2-3f85953e4763
2101220326CardeneNDAChiesi Usa, Inc.1992-01-30NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA01973472c19612-6dc6-4413-80a2-3f85953e4763

nicardipine hydrochloride 2.5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439542NDAWest-Ward Pharmaceutical Corp2012-03-02NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTIONNDA02227655bd6dcc-1f12-4378-8e9e-1ceed26818f5
2001439689NDAWest-Ward Pharmaceutical Corp2012-03-02NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTIONNDA02227618fb1c2b-0c1e-436c-a5b6-d4840b5da228
3244770030CardeneNDAEkr Therapeutics, Inc.1992-01-30NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTIONNDA01973413b13720-f64d-11df-93a0-0002a5d5c51b

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005170735ANDAAmerican Regent, Inc.2009-11-17NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA09053476fcb7e0-9034-4fcd-be14-ce7e9ccaee2a
2007813204ANDASandoz Inc2009-11-17NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTIONANDA090125c84cda13-e2fb-46d6-a9a2-5a3311387ff8
3007819324ANDASandoz Inc2010-09-27NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTIONANDA090125d2f0b90f-9495-48c5-b21f-86e487a04854
4145930124ANDAEmcure2009-11-17NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTIONANDA09012552e42bf6-34a3-4b95-9907-5e8d19108d47
5400420047ANDAPharmaforce, Inc.2009-11-17NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA090534be9e2dda-80da-4e0d-a3ee-ab2bd9f3f2ee
6556480631ANDAWockhardt Limited2009-11-09NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTIONANDA090671a6512740-17e0-4f22-a233-4ac084277879
7646790631ANDAWockhardt Usa Llc.2009-11-09NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTIONANDA090671e61159ba-ff6b-4696-a642-4f64c79c4708
8674570224ANDAMylan Institutional Llc2011-12-23NICARDIPINE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONANDA0906640a7c6372-a22b-4501-a6c6-539457a6cd9d

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA078714NICARDIPINE HYDROCHLORIDEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2009-12-28ANDA078714_001
2ANDA090125NICARDIPINE HYDROCHLORIDENAVINTA LLC2009-11-17ANDA090125_001
3ANDA090534NICARDIPINE HYDROCHLORIDELUITPOLD PHARMACEUTICALS INC2009-11-17ANDA090534_001
4ANDA090664NICARDIPINE HYDROCHLORIDEMYLAN INSTITUTIONAL LLC2009-11-17ANDA090664_001
5ANDA090671NICARDIPINE HYDROCHLORIDEWOCKHARDT LTD2009-11-17ANDA090671_001
6NDA019734CARDENECHIESI USA INC1992-01-30p7612102, SUBSTANCE
p8455524, METHOD FOR TREATING ACUTE ELEVATIONS OF BLOOD PRESSURE IN HUMAN SUBJECT IN NEED THEREOF
p7659291, METHOD FOR TREATING ACUTE ELEVATIONS OF BLOOD PRESSURE IN HUMAN SUBJECT IN NEED THEREOF
NDA019734_001, NDA019734_002, NDA019734_003, NDA019734_004, NDA019734_005
7NDA022276NICARDIPINE HYDROCHLORIDEEXELA PHARMA SCIENCES2008-07-24NDA022276_001
8NDA078405NICARDIPINE HYDROCHLORIDESUN PHARMA GLOBAL FZE2009-11-17NDA078405_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078714_001RXNICARDIPINE HYDROCHLORIDE (25MG/10ML)INJECTIONFalseAP2009-12-28NICARDIPINE HYDROCHLORIDE
2ANDA090125_001RXNICARDIPINE HYDROCHLORIDE (25MG/10ML)INJECTIONFalseAP2009-11-17NICARDIPINE HYDROCHLORIDE
3ANDA090534_001RXNICARDIPINE HYDROCHLORIDE (25MG/10ML)INJECTIONFalseAP2009-11-17NICARDIPINE HYDROCHLORIDE
4ANDA090664_001RXNICARDIPINE HYDROCHLORIDE (25MG/10ML)INJECTIONFalseAP2009-11-17NICARDIPINE HYDROCHLORIDE
5ANDA090671_001RXNICARDIPINE HYDROCHLORIDE (25MG/10ML)INJECTIONFalseAP2009-11-17NICARDIPINE HYDROCHLORIDE
6NDA019734_001RXNICARDIPINE HYDROCHLORIDE (25MG/10ML)INJECTIONTrueAP1992-01-30CARDENE
7NDA019734_002RXNICARDIPINE HYDROCHLORIDE (20MG/200ML)INTRAVENOUSINJECTIONTrue2008-07-31CARDENE
8NDA019734_003RXNICARDIPINE HYDROCHLORIDE (20MG/200ML)INTRAVENOUSINJECTIONTrue2008-07-31CARDENE
9NDA019734_004RXNICARDIPINE HYDROCHLORIDE (40MG/200ML)INTRAVENOUSINJECTIONTrue2008-11-07CARDENE
10NDA019734_005RXNICARDIPINE HYDROCHLORIDE (40MG/200ML)INTRAVENOUSINJECTIONTrue2008-11-07CARDENE
11NDA022276_001RXNICARDIPINE HYDROCHLORIDE (25MG/10ML)INJECTIONFalseAP2008-07-24NICARDIPINE HYDROCHLORIDE
12NDA078405_001RXNICARDIPINE HYDROCHLORIDE (25MG/10ML)INJECTIONFalseAP2009-11-17NICARDIPINE HYDROCHLORIDE

patent(s)

#idexpiration dateapplication(s)
1p7612102 (view patent)2027-12-26NDA019734
2p7659291 (view patent)2027-04-18NDA019734
3p8455524 (view patent)2027-04-18NDA019734

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10a7c6372-a22b-4501-a6c6-539457a6cd9d (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2011-07-194674570224
20d58f812-37bf-439f-b3f2-c31f8eefe22e (view SPL)These highlights do not include all the information needed to use CARDENE IVsafely and effectively. See full prescribing information for CARDENE IV. CARDENE IV (nicardipine hydrochloride) premixed injection for intravenous useInitial U.S. Approval: 1988prescriptionHuman PrescriptionChiesi Usa, Inc.2015-07-156101220314, 101220313
30eb7d839-63d9-4b51-bf7b-4a8fde6339b5 (view SPL)NICARDIPINE HYDROCHLORIDE INJECTION Rx Only NOVAPLUS These highlights do not include all the information needed to use Nicardipine Hydrochloride Injection safely and effectively. See full prescribing information for Nicardipine Hydrochloride Injection. Nicardipine Hydrochloride Injection Initial U.S. Approval: 1988prescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2015-09-103001439593
413b13720-f64d-11df-93a0-0002a5d5c51b (view SPL)Cardene I.V.(nicardipine hydrochloride)prescriptionHuman PrescriptionEkr Therapeutics, Inc.MANUFACTURE2010-11-221244770030
518fb1c2b-0c1e-436c-a5b6-d4840b5da228 (view SPL)NICARDIPINEHYDROCHLORIDE INJECTION Rx Only These highlights do not include all the information needed to use Nicardipine Hydrochloride Injection safely and effectively. See full prescribing information for Nicardipine Hydrochloride Injection. Nicardipine Hydrochloride Injection Initial U.S. Approval: 1988prescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2015-09-106001439689
652e42bf6-34a3-4b95-9907-5e8d19108d47 (view SPL)Rx onlyprescriptionHuman PrescriptionEmcureANALYSIS, MANUFACTURE2009-12-043145930124
755bd6dcc-1f12-4378-8e9e-1ceed26818f5 (view SPL)NICARDIPINEHYDROCHLORIDE INJECTION Rx OnlyPREMIERProRx These highlights do not include all the information needed to use Nicardipine Hydrochloride Injection safely and effectively. See full prescribing information for Nicardipine Hydrochloride Injection.Nicardipine Hydrochloride InjectionInitial U.S. Approval: 1988prescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2015-09-102001439542
872c19612-6dc6-4413-80a2-3f85953e4763 (view SPL)These highlights do not include all the information needed to use CARDENE IV safely and effectively. See full prescribing information for CARDENE IV. CARDENE IV (nicardipine hydrochloride) premixed injection for intravenous useInitial U.S. Approval: 1988prescriptionHuman PrescriptionChiesi Usa, Inc.2015-07-154101220325, 101220326
976fcb7e0-9034-4fcd-be14-ce7e9ccaee2a (view SPL)These highlights do not include all the information needed to use nicardipine hydrochloride safely and effectively. See full prescribing information for nicardipine hydrochloride. Nicardipine hydrochloride injection for intravenous useInitial U.S. Approval: 1988prescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, MANUFACTURE2015-05-043005170735
108b54643f-55b2-404a-b282-39fc6b2d8121 (view SPL)NICARdipine Hydrochloride InjectionprescriptionHuman PrescriptionSun Pharma Global Inc.analysis, manufacture2009-11-192416160882
11a6512740-17e0-4f22-a233-4ac084277879 (view SPL)Nicardipine Hydrochloride Injection Rx onlyprescriptionHuman PrescriptionWockhardt LimitedANALYSIS, LABEL, MANUFACTURE, PACK2012-10-113556480631
12b7dfde10-01d4-11de-87af-0800200c9a66 (view SPL)These highlights do not include all the information needed to use Cardene I.V. (nicardipine hydrochloride) Premixed Injection safely and effectively. See full prescribing information for Cardene I.V. Premixed Injection (0.1 mg/mL) in either 4.8% Dextrose or 0.86% Sodium Chloride. Cardene I.V. Premixed Injection Initial U.S. Approval: 1988prescriptionHuman PrescriptionEkr Therapeutics, Inc.MANUFACTURE2010-10-275244770312
13be9e2dda-80da-4e0d-a3ee-ab2bd9f3f2ee (view SPL)Nicardipine Hydrochloride InjectionprescriptionHuman PrescriptionPharmaforce, Inc.2009-11-171400420047
14c84cda13-e2fb-46d6-a9a2-5a3311387ff8 (view SPL)Rx onlyprescriptionHuman PrescriptionSandoz IncANALYSIS, MANUFACTURE2011-07-134007813204
15d2f0b90f-9495-48c5-b21f-86e487a04854 (view SPL)Rx onlyprescriptionHuman PrescriptionSandoz Inc2011-05-172007819324
16e61159ba-ff6b-4696-a642-4f64c79c4708 (view SPL)Nicardipine Hydrochloride Injection Rx onlyprescriptionHuman PrescriptionWockhardt Usa Llc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-10-113646790631
17f8ef8420-01d2-11de-a455-0002a5d5c51b (view SPL)These highlights do not include all the information needed to use Cardene I.V. (nicardipine hydrochloride) Premixed Injection safely and effectively. See full prescribing information for Cardene I.V. Premixed Injection (0.2 mg/mL) in either 5% Dextrose or 0.83% Sodium Chloride. Cardene I.V. Premixed Injection Initial U.S. Approval: 1988prescriptionHuman PrescriptionEkr Therapeutics, Inc.MANUFACTURE2010-10-276244770324

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII