Diltiazem Extended Release Oral Tablet

Brand(s)
Cardizem, Matzim
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Valeant Pharmaceuticals North America Llc (2015-04-15)
Oldest Current Product
2010-03-15
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\DILTIAZEM
FDAOB
ORAL\TABLET, EXTENDED RELEASE\DILTIAZEM HYDROCHLORIDE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\DILTIAZEM HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\DILTIAZEM

product(s) by strength(s)

24 hr diltiazem hydrochloride 120 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001872045CardizemNDAValeant Pharmaceuticals North America Llc2010-12-25DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA0213923e180dc7-c871-4efc-8755-cae882976c8d

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440690MatzimANDAActavis Pharma, Inc.2011-03-28DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA077686e8c8dd18-9d95-4068-9762-bec1eb1bc25c
2620370690ANDAActavis Pharma, Inc.2010-03-15DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA077686813eb1bb-1475-4958-821d-e97c5abb7462

24 hr diltiazem hydrochloride 180 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001872046CardizemNDAValeant Pharmaceuticals North America Llc2010-12-25DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA0213923e180dc7-c871-4efc-8755-cae882976c8d

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440691MatzimANDAActavis Pharma, Inc.2011-03-28DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA077686e8c8dd18-9d95-4068-9762-bec1eb1bc25c
2620370691ANDAActavis Pharma, Inc.2010-03-15DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA077686813eb1bb-1475-4958-821d-e97c5abb7462
3686820705NDA AUTHORIZED GENERICOceanside Pharmaceuticals2014-02-06DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA02139273b3607a-99d0-44d8-92ef-0074684c9d7d

24 hr diltiazem hydrochloride 240 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001872047CardizemNDAValeant Pharmaceuticals North America Llc2010-12-25DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA0213923e180dc7-c871-4efc-8755-cae882976c8d

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440692MatzimANDAActavis Pharma, Inc.2011-03-28DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA077686e8c8dd18-9d95-4068-9762-bec1eb1bc25c
2620370692ANDAActavis Pharma, Inc.2010-03-15DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA077686813eb1bb-1475-4958-821d-e97c5abb7462
3686820706NDA AUTHORIZED GENERICOceanside Pharmaceuticals2014-02-06DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA02139273b3607a-99d0-44d8-92ef-0074684c9d7d

24 hr diltiazem hydrochloride 300 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000743063CardizemNDAAbbvie Inc.2010-12-25DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA021392b4626a8d-a28d-4937-aa61-b9d958ae336c

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440693MatzimANDAActavis Pharma, Inc.2011-03-28DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA077686e8c8dd18-9d95-4068-9762-bec1eb1bc25c
2620370693ANDAActavis Pharma, Inc.2010-03-15DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA077686813eb1bb-1475-4958-821d-e97c5abb7462
3686820707NDA AUTHORIZED GENERICOceanside Pharmaceuticals2014-02-06DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA02139273b3607a-99d0-44d8-92ef-0074684c9d7d

24 hr diltiazem hydrochloride 360 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001872049CardizemNDAValeant Pharmaceuticals North America Llc2010-12-25DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA0213923e180dc7-c871-4efc-8755-cae882976c8d

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440694MatzimANDAActavis Pharma, Inc.2011-03-28DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA077686e8c8dd18-9d95-4068-9762-bec1eb1bc25c
2620370694ANDAActavis Pharma, Inc.2010-03-15DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA077686813eb1bb-1475-4958-821d-e97c5abb7462
3686820708NDA AUTHORIZED GENERICOceanside Pharmaceuticals2014-02-06DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA02139273b3607a-99d0-44d8-92ef-0074684c9d7d

24 hr diltiazem hydrochloride 420 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000743069CardizemNDAAbbvie Inc.2010-12-25DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA021392b4626a8d-a28d-4937-aa61-b9d958ae336c

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440695MatzimANDAActavis Pharma, Inc.2011-03-28DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA077686e8c8dd18-9d95-4068-9762-bec1eb1bc25c
2620370695ANDAActavis Pharma, Inc.2010-03-15DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA077686813eb1bb-1475-4958-821d-e97c5abb7462
3686820709NDA AUTHORIZED GENERICOceanside Pharmaceuticals2014-02-06DILTIAZEM HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA02139273b3607a-99d0-44d8-92ef-0074684c9d7d

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA077686DILTIAZEM HYDROCHLORIDEACTAVIS LABORATORIES FL INC2010-03-15ANDA077686_001, ANDA077686_002, ANDA077686_003, ANDA077686_004, ANDA077686_005, ANDA077686_006
2NDA021392CARDIZEM LAVALEANT INTERNATIONAL BARBADOS SRL2003-02-06p7108866, TREATMENT OF HYPERTENSION AND ANGINA PECTORIS, SUBSTANCE
p6923984, SUBSTANCE
NDA021392_001, NDA021392_002, NDA021392_003, NDA021392_004, NDA021392_005, NDA021392_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077686_001RXDILTIAZEM HYDROCHLORIDE (420MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-03-15DILTIAZEM HYDROCHLORIDE
2ANDA077686_002RXDILTIAZEM HYDROCHLORIDE (360MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-03-15DILTIAZEM HYDROCHLORIDE
3ANDA077686_003RXDILTIAZEM HYDROCHLORIDE (300MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-03-15DILTIAZEM HYDROCHLORIDE
4ANDA077686_004RXDILTIAZEM HYDROCHLORIDE (240MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-03-15DILTIAZEM HYDROCHLORIDE
5ANDA077686_005RXDILTIAZEM HYDROCHLORIDE (180MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-03-15DILTIAZEM HYDROCHLORIDE
6ANDA077686_006RXDILTIAZEM HYDROCHLORIDE (120MG)ORALTABLET, EXTENDED RELEASEFalseAB2010-03-15DILTIAZEM HYDROCHLORIDE
7NDA021392_001RXDILTIAZEM HYDROCHLORIDE (120MG)ORALTABLET, EXTENDED RELEASEFalseAB2003-02-06CARDIZEM LA
8NDA021392_002RXDILTIAZEM HYDROCHLORIDE (180MG)ORALTABLET, EXTENDED RELEASEFalseAB2003-02-06CARDIZEM LA
9NDA021392_003RXDILTIAZEM HYDROCHLORIDE (240MG)ORALTABLET, EXTENDED RELEASEFalseAB2003-02-06CARDIZEM LA
10NDA021392_004RXDILTIAZEM HYDROCHLORIDE (300MG)ORALTABLET, EXTENDED RELEASEFalseAB2003-02-06CARDIZEM LA
11NDA021392_005RXDILTIAZEM HYDROCHLORIDE (360MG)ORALTABLET, EXTENDED RELEASEFalseAB2003-02-06CARDIZEM LA
12NDA021392_006RXDILTIAZEM HYDROCHLORIDE (420MG)ORALTABLET, EXTENDED RELEASETrueAB2003-02-06CARDIZEM LA

patent(s)

#idexpiration dateapplication(s)
1p6923984 (view patent)2021-02-25NDA021392
2p7108866 (view patent)2019-12-17NDA021392

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13e180dc7-c871-4efc-8755-cae882976c8d (view SPL)These highlights do not include all the information needed to use CARDIZEM LA safely and effectively. See full prescribing information for CARDIZEM LA.CARDIZEM LA (diltiazem hydrochloride) extended-release tablets, for oral useInitial U.S. Approval: 1982prescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2015-04-156001872045, 001872046, 001872047, 001872049, 001872048, 001872050
273b3607a-99d0-44d8-92ef-0074684c9d7d (view SPL)Diltiazem Hydrochloride Extended-Release TabletsprescriptionHuman PrescriptionOceanside PharmaceuticalsMANUFACTURE2014-02-061686820705, 686820706, 686820707, 686820708, 686820709
3813eb1bb-1475-4958-821d-e97c5abb7462 (view SPL)DILTIAZEM HYDROCHLORIDE EXTENDED- RELEASE TABLETSprescriptionHuman PrescriptionActavis Pharma, Inc.MANUFACTURE2011-05-2713620370690, 620370691, 620370692, 620370693, 620370694, 620370695
4b4626a8d-a28d-4937-aa61-b9d958ae336c (view SPL)CARDIZEM LA (Diltiazem Hydrochloride) Extended-Release TabletsprescriptionHuman PrescriptionAbbvie Inc.MANUFACTURE2013-05-214000743063, 000743069, 000743045, 000743061, 000743062, 000743064
5e8c8dd18-9d95-4068-9762-bec1eb1bc25c (view SPL)Matzim LA (Diltiazem Hydrochloride) Extended-release TabletsprescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-12-015525440690, 525440691, 525440692, 525440693, 525440694, 525440695

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