Nimodipine Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Heritage Pharmaceuticals Inc. (2014-02-28)
Oldest Current Product
2007-06-28
License(s)
ANDA
RxNORM
ORAL CAPSULE\NIMODIPINE
FDAOB
ORAL\CAPSULE\NIMODIPINE
SPL Active
ORAL\CAPSULE, LIQUID FILLED\NIMODIPINE
ORAL\CAPSULE\NIMODIPINE
SPL Moiety
ORAL\CAPSULE, LIQUID FILLED\NIMODIPINE
ORAL\CAPSULE\NIMODIPINE

product(s) by strength(s)

nimodipine 30 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550108ANDAHeritage Pharmaceuticals Inc.2008-03-21NIMODIPINEORALCAPSULE, LIQUID FILLEDANDA076740a0a13a26-b9dc-4ed1-b2c4-46e14fb60bfc
2576640135ANDACaraco Pharmaceutical Laboratories, Ltd.2007-06-28NIMODIPINEORALCAPSULEANDA077067d6a161d9-7e7a-4711-ba0e-c9040c42268d
3625590210ANDAAnip Acquisition Company2015-11-01NIMODIPINEORALCAPSULEANDA20183283e0df20-c3b1-4139-9679-f7c7661f5caa
4678770297ANDAAscend Laboratories, Llc2015-01-01NIMODIPINEORALCAPSULE, LIQUID FILLEDANDA0901032f4813da-931d-448d-bbe1-f0b90724af22

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551544560ANDACardinal Health2007-06-28NIMODIPINEORALCAPSULE576640135ANDA07706726730ffb-7c80-4c54-bded-8e519bffe12f
2604290146ANDAGolden State Medical Supply, Inc.2008-03-21NIMODIPINEORALCAPSULE, LIQUID FILLED231550108ANDA076740d1035cf9-d687-48df-ac03-aa00ef06618c
3680840912ANDAAmerican Health Packaging2015-02-15NIMODIPINEORALCAPSULE, LIQUID FILLED678770297ANDA0901035a2bedd7-3d9a-4f42-800b-14c814628089

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076740NIMODIPINEBANNER LIFE SCIENCES LLC2008-01-17ANDA076740_001
2ANDA077067NIMODIPINESUN PHARMACEUTICAL INDUSTRIES INC2007-04-17ANDA077067_001
3ANDA077811NIMODIPINEBARR LABORATORIES INC2007-05-02ANDA077811_001
4ANDA090103NIMODIPINETHEPHARMANETWORK LLC2014-04-07ANDA090103_001
5ANDA201832NIMODIPINESOFGEN PHARMACEUTICALS2015-07-24ANDA201832_001
6NDA018869NIMOTOPTrueBAYER PHARMACEUTICALS CORP1988-12-28NDA018869_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076740_001RXNIMODIPINE (30MG)ORALCAPSULETrueAB2008-01-17NIMODIPINE
2ANDA077067_001RXNIMODIPINE (30MG)ORALCAPSULEFalseAB2007-04-17NIMODIPINE
3ANDA077811_001RXNIMODIPINE (30MG)ORALCAPSULEFalseAB2007-05-02NIMODIPINE
4ANDA090103_001RXNIMODIPINE (30MG)ORALCAPSULEFalseAB2014-04-07NIMODIPINE
5ANDA201832_001RXNIMODIPINE (30MG)ORALCAPSULEFalseAB2015-07-24NIMODIPINE
6NDA018869_001discontinuedNIMODIPINE (30MG)ORALCAPSULEFalse1988-12-28NIMOTOP

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
126730ffb-7c80-4c54-bded-8e519bffe12f (view SPL)prescriptionHuman PrescriptionCardinal HealthREPACK2012-08-023551544560
22f4813da-931d-448d-bbe1-f0b90724af22 (view SPL)Nimodipine CapsulesFor Oral UseprescriptionHuman PrescriptionAscend Laboratories, Llcmanufacture2015-04-213678770297
35a2bedd7-3d9a-4f42-800b-14c814628089 (view SPL)Nimodipine CapsulesFor Oral UseprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-162680840912
483e0df20-c3b1-4139-9679-f7c7661f5caa (view SPL)Nimodipine Capsules For Oral Use Rx OnlyprescriptionHuman PrescriptionAnip Acquisition Company2015-08-071625590210
5a0a13a26-b9dc-4ed1-b2c4-46e14fb60bfc (view SPL)Nimodipine Capsules For Oral Use Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2014-02-2812231550108
6d1035cf9-d687-48df-ac03-aa00ef06618c (view SPL)Nimodipine CapsulesFor Oral Use OnlyRx onlyprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290146
7d6a161d9-7e7a-4711-ba0e-c9040c42268d (view SPL)prescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.MANUFACTURE2012-08-135576640135

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