Nicardipine Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Epic Pharma, Llc (2015-04-23)
Oldest Current Product
1996-07-19
License(s)
ANDA
RxNORM
ORAL CAPSULE\NICARDIPINE
FDAOB
ORAL\CAPSULE\NICARDIPINE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\NICARDIPINE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\NICARDIPINE

product(s) by strength(s)

nicardipine hydrochloride 20 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781020ANDAMylan Pharmaceuticals Inc.1996-07-19NICARDIPINE HYDROCHLORIDEORALCAPSULEANDA074642cdd5fd28-bfeb-4872-b642-95cd82732df3
2428060501ANDAEpic Pharma, Llc2010-05-05NICARDIPINE HYDROCHLORIDEORALCAPSULEANDA074928b8f147b8-955f-4733-9178-2cfa0beb60d6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910640ANDAAvkare, Inc.2010-05-05NICARDIPINE HYDROCHLORIDEORALCAPSULE428060501ANDA074928a91fde4a-fefe-c122-1918-a53b90fbbcb3
2681510092ANDACarilion Materials Management1996-07-19NICARDIPINE HYDROCHLORIDEORALCAPSULE003781020ANDA0746422388174b-8983-4be5-a4b5-f2ec45f3e19c

nicardipine hydrochloride 30 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003781430ANDAMylan Pharmaceuticals Inc.1996-07-19NICARDIPINE HYDROCHLORIDEORALCAPSULEANDA074642cdd5fd28-bfeb-4872-b642-95cd82732df3
2428060502ANDAEpic Pharma, Llc2010-05-05NICARDIPINE HYDROCHLORIDEORALCAPSULEANDA074928b8f147b8-955f-4733-9178-2cfa0beb60d6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910641ANDAAvkare, Inc.2010-05-05NICARDIPINE HYDROCHLORIDEORALCAPSULE428060502ANDA074928a91fde4a-fefe-c122-1918-a53b90fbbcb3
2681510093ANDACarilion Materials Management1996-07-19NICARDIPINE HYDROCHLORIDEORALCAPSULE003781430ANDA0746420555647b-1a62-48b8-8821-ef38b996efb7

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074439NICARDIPINE HYDROCHLORIDEANI PHARMACEUTICALS INC1996-12-10ANDA074439_001, ANDA074439_002
2ANDA074540NICARDIPINE HYDROCHLORIDEANI PHARMACEUTICALS INC1996-10-28ANDA074540_001, ANDA074540_002
3ANDA074642NICARDIPINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC1996-07-18ANDA074642_001, ANDA074642_002
4ANDA074670NICARDIPINE HYDROCHLORIDETrueWATSON LABORATORIES INC1996-10-28ANDA074670_001, ANDA074670_002
5ANDA074928NICARDIPINE HYDROCHLORIDEEPIC PHARMA INC1998-03-19ANDA074928_001, ANDA074928_002
6NDA019488CARDENECHIESI USA INC1988-12-21NDA019488_001, NDA019488_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074439_001RXNICARDIPINE HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB1996-12-10NICARDIPINE HYDROCHLORIDE
2ANDA074439_002RXNICARDIPINE HYDROCHLORIDE (30MG)ORALCAPSULEFalseAB1996-12-10NICARDIPINE HYDROCHLORIDE
3ANDA074540_001RXNICARDIPINE HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB1996-10-28NICARDIPINE HYDROCHLORIDE
4ANDA074540_002RXNICARDIPINE HYDROCHLORIDE (30MG)ORALCAPSULEFalseAB1996-10-28NICARDIPINE HYDROCHLORIDE
5ANDA074642_001RXNICARDIPINE HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB1996-07-18NICARDIPINE HYDROCHLORIDE
6ANDA074642_002RXNICARDIPINE HYDROCHLORIDE (30MG)ORALCAPSULEFalseAB1996-07-18NICARDIPINE HYDROCHLORIDE
7ANDA074670_001discontinuedNICARDIPINE HYDROCHLORIDE (20MG)ORALCAPSULEFalse1996-10-28NICARDIPINE HYDROCHLORIDE
8ANDA074670_002discontinuedNICARDIPINE HYDROCHLORIDE (30MG)ORALCAPSULEFalse1996-10-28NICARDIPINE HYDROCHLORIDE
9ANDA074928_001RXNICARDIPINE HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB1998-03-19NICARDIPINE HYDROCHLORIDE
10ANDA074928_002RXNICARDIPINE HYDROCHLORIDE (30MG)ORALCAPSULEFalseAB1998-03-19NICARDIPINE HYDROCHLORIDE
11NDA019488_001RXNICARDIPINE HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB1988-12-21CARDENE
12NDA019488_002RXNICARDIPINE HYDROCHLORIDE (30MG)ORALCAPSULETrueAB1988-12-21CARDENE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10555647b-1a62-48b8-8821-ef38b996efb7 (view SPL)prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-09-272681510093
22388174b-8983-4be5-a4b5-f2ec45f3e19c (view SPL)prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-09-272681510092
3a91fde4a-fefe-c122-1918-a53b90fbbcb3 (view SPL)NICARDIPINE HYDROCHLORIDE capsuleRx onlyprescriptionHuman PrescriptionAvkare, Inc.2015-05-046422910640, 422910641
4b8f147b8-955f-4733-9178-2cfa0beb60d6 (view SPL)Nicardipine Hydrochloride Capsules 20 mg and 30 mgRx onlyprescriptionHuman PrescriptionEpic Pharma, Llc2015-04-236428060501, 428060502
5cdd5fd28-bfeb-4872-b642-95cd82732df3 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-09-273003781020, 003781430

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