Niacin Extended Release Oral Tablet

Brand(s)
Niaspan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Zydus Pharmaceuticals (Usa) Inc. (2015-05-15)
Oldest Current Product
1997-07-28
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\NIACIN
FDAOB
ORAL\TABLET, EXTENDED RELEASE\NIACIN
SPL Active
ORAL\TABLET, EXTENDED RELEASE\NIACIN
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\NIACIN
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\NIACIN
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\NIACIN

product(s) by strength(s)

24 hr niacin 1000 mg extended release oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1683820203NDAZydus Pharmaceuticals (Usa) Inc.2014-06-30NIACINORALTABLET, FILM COATED, EXTENDED RELEASENDA02038162efc71c-9746-d603-3e9d-a8786f7d4de8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937394ANDATeva Pharmaceuticals Usa Inc2013-09-20NIACINORALTABLET, EXTENDED RELEASEANDA076250068b9b2e-0ec1-4635-8257-62bb852f0d71
2473350613ANDASun Pharma Global Fze2014-06-27NIACINORALTABLET, FILM COATED, EXTENDED RELEASEANDA2004848e290f96-e8c6-47fd-863f-1c9480f28d9b
3651620323ANDAAmneal Pharmaceuticals2015-07-27NIACINORALTABLET, EXTENDED RELEASEANDA2035786e604319-e164-4056-ab80-b78b98c519c7

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950865NiaspanNDARebel Distributors Corp1997-07-28NIACINORALTABLET, FILM COATED, EXTENDED RELEASE000743080NDA020381ccc64ee7-f581-493b-b8c2-6147a0db197e
2353560302NiaspanNDALake Erie Medical Dba Quality Care Products Llc2012-04-03NIACINORALTABLET, FILM COATED, EXTENDED RELEASE000743080NDA0203810f049ee9-ab85-401c-b1d7-06c98d559055
3548680017NiaspanNDAPhysicians Total Care, Inc.2009-05-12NIACINORALTABLET, FILM COATED, EXTENDED RELEASE000743080NDA020381f9b97613-c62e-40b0-a2aa-a7fde6bd5bc7
4551540626NiaspanNDACardinal Health2010-06-29NIACINORALTABLET, FILM COATED, EXTENDED RELEASE000743080NDA020381eac1abb4-58bf-4cd0-aa66-a93e116f516c
5680840773ANDAAmerican Health Packaging2014-10-20NIACINORALTABLET, EXTENDED RELEASE681800223ANDA09044609bccfc6-71eb-420f-92d3-cd21789a0dbc
6682586037NiaspanNDADispensing Solutions, Inc.1997-07-28NIACINORALTABLET, FILM COATED, EXTENDED RELEASE000743080NDA020381414b3d30-cc7f-4f91-b21e-5090b7f5b529

24 hr niacin 500 mg extended release oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1683820201NDAZydus Pharmaceuticals (Usa) Inc.2014-06-30NIACINORALTABLET, FILM COATED, EXTENDED RELEASENDA02038162efc71c-9746-d603-3e9d-a8786f7d4de8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937392ANDATeva Pharmaceuticals Usa Inc2013-09-20NIACINORALTABLET, EXTENDED RELEASEANDA076378068b9b2e-0ec1-4635-8257-62bb852f0d71
2473350539ANDASun Pharma Global Fze2014-06-27NIACINORALTABLET, FILM COATED, EXTENDED RELEASEANDA2004848e290f96-e8c6-47fd-863f-1c9480f28d9b
3651620321ANDAAmneal Pharmaceuticals2015-07-27NIACINORALTABLET, EXTENDED RELEASEANDA2035786e604319-e164-4056-ab80-b78b98c519c7
4681800221ANDALupin Pharmaceuticals, Inc.2014-03-20NIACINORALTABLET, EXTENDED RELEASEANDA09086092b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950852NiaspanNDARebel Distributors Corp2010-03-10NIACINORALTABLET, FILM COATED, EXTENDED RELEASE000743074NDA020381ccc64ee7-f581-493b-b8c2-6147a0db197e
2499990475NiaspanNDALake Erie Medical Dba Quality Care Products Llc2011-02-07NIACINORALTABLET, FILM COATED, EXTENDED RELEASE000743074NDA0203810dfe662a-f2ac-4f10-9a08-54cbd0c6dec6
3548684899NiaspanNDAPhysicians Total Care, Inc.2009-07-27NIACINORALTABLET, FILM COATED, EXTENDED RELEASE000743074NDA020381f9b97613-c62e-40b0-a2aa-a7fde6bd5bc7
4551540625NiaspanNDACardinal Health2010-06-29NIACINORALTABLET, FILM COATED, EXTENDED RELEASE000743074NDA020381eac1abb4-58bf-4cd0-aa66-a93e116f516c
5680840756ANDAAmerican Health Packaging2014-10-20NIACINORALTABLET, EXTENDED RELEASE681800221ANDA09086009bccfc6-71eb-420f-92d3-cd21789a0dbc
6681514068NiaspanNDACarilion Materials Management2010-06-29NIACINORALTABLET, FILM COATED, EXTENDED RELEASE000743074NDA0203810dd18020-c211-423d-b3d8-a926ae626e14
7682586032NiaspanNDADispensing Solutions, Inc.2010-06-29NIACINORALTABLET, FILM COATED, EXTENDED RELEASE000743074NDA020381c64d7717-8e8e-4e17-8f00-2b18f496b321

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1680840957ANDAAmerican Health Packaging2015-03-31NIACINORALTABLET, EXTENDED RELEASE681800222ANDA09089209bccfc6-71eb-420f-92d3-cd21789a0dbc

24 hr niacin 750 mg extended release oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1683820202NDAZydus Pharmaceuticals (Usa) Inc.2014-06-30NIACINORALTABLET, FILM COATED, EXTENDED RELEASENDA02038162efc71c-9746-d603-3e9d-a8786f7d4de8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937393ANDATeva Pharmaceuticals Usa Inc2013-09-20NIACINORALTABLET, EXTENDED RELEASEANDA076378068b9b2e-0ec1-4635-8257-62bb852f0d71
2473350614ANDASun Pharma Global Fze2014-06-27NIACINORALTABLET, FILM COATED, EXTENDED RELEASEANDA2012738e290f96-e8c6-47fd-863f-1c9480f28d9b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560301NiaspanNDALake Erie Medical Dba Quality Care Products Llc2012-04-03NIACINORALTABLET, FILM COATED, EXTENDED RELEASE000743079NDA0203810f049ee9-ab85-401c-b1d7-06c98d559055
2548684867NiaspanNDAPhysicians Total Care, Inc.2005-03-29NIACINORALTABLET, FILM COATED, EXTENDED RELEASE000743079NDA020381f9b97613-c62e-40b0-a2aa-a7fde6bd5bc7
3681514069NiaspanNDACarilion Materials Management1997-07-28NIACINORALTABLET, FILM COATED, EXTENDED RELEASE000743079NDA020381fc312806-1441-478d-95a2-68ce9a7a796d

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA076250NIACINBARR LABORATORIES INC2005-04-14ANDA076250_001
2ANDA076378NIACINBARR LABORATORIES INC2005-04-26ANDA076378_001, ANDA076378_002
3ANDA090446NIACINLUPIN LTD2014-03-20ANDA090446_001
4ANDA090860NIACINLUPIN LTD2014-03-20ANDA090860_001
5ANDA090892NIACINLUPIN LTD2014-03-20ANDA090892_001
6ANDA200484NIACINSUN PHARMA GLOBAL FZE2014-04-23ANDA200484_001, ANDA200484_002
7ANDA201273NIACINSUN PHARMA GLOBAL FZE2014-04-23ANDA201273_001
8ANDA203578NIACINAMNEAL PHARMACEUTICALS2015-07-24ANDA203578_001, ANDA203578_002
9NDA020381NIASPANABBVIE INC1997-07-28p6080428, METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT/ REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT/ TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT/ REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT/ REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
p6469035, REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT/ TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT/ REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT/ REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER DAY IN THE EVENING OR A T NIGHT/ A METHOD OF REDUCING THE CAPACITY OF EXTENDED RELEASE NICOTINIC ACID TO PROVOKE A FLUSHING REACTION BY PRETREATING AN INDIVIDUAL WITH A FLUSH INHIBITING AGENT PRIOR TO THE ADMINISTRATION OF THE EXTENDED RELEASE NICOTINIC ACID
NDA020381_001, NDA020381_002, NDA020381_003, NDA020381_004, NDA020381_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076250_001RXNIACIN (1GM)ORALTABLET, EXTENDED RELEASEFalseAB2005-04-14NIACIN
2ANDA076378_001RXNIACIN (500MG)ORALTABLET, EXTENDED RELEASEFalseAB2005-04-26NIACIN
3ANDA076378_002RXNIACIN (750MG)ORALTABLET, EXTENDED RELEASEFalseAB2005-04-26NIACIN
4ANDA090446_001RXNIACIN (1GM)ORALTABLET, EXTENDED RELEASEFalseAB2014-03-20NIACIN
5ANDA090860_001RXNIACIN (500MG)ORALTABLET, EXTENDED RELEASEFalseAB2014-03-20NIACIN
6ANDA090892_001RXNIACIN (750MG)ORALTABLET, EXTENDED RELEASEFalseAB2014-03-20NIACIN
7ANDA200484_001RXNIACIN (500MG)ORALTABLET, EXTENDED RELEASEFalseAB2014-04-23NIACIN
8ANDA200484_002RXNIACIN (1GM)ORALTABLET, EXTENDED RELEASEFalseAB2014-04-23NIACIN
9ANDA201273_001RXNIACIN (750MG)ORALTABLET, EXTENDED RELEASEFalseAB2014-04-23NIACIN
10ANDA203578_001RXNIACIN (500MG)ORALTABLET, EXTENDED RELEASEFalseAB2015-07-24NIACIN
11ANDA203578_002RXNIACIN (1GM)ORALTABLET, EXTENDED RELEASEFalseAB2015-07-24NIACIN
12NDA020381_001discontinuedNIACIN (375MG)ORALTABLET, EXTENDED RELEASEFalse1997-07-28NIASPAN
13NDA020381_002RXNIACIN (500MG)ORALTABLET, EXTENDED RELEASEFalseAB1997-07-28NIASPAN
14NDA020381_003RXNIACIN (750MG)ORALTABLET, EXTENDED RELEASETrueAB1997-07-28NIASPAN
15NDA020381_004RXNIACIN (1GM)ORALTABLET, EXTENDED RELEASETrueAB1997-07-28NIASPAN
16NDA020381_005discontinuedFalse1997-07-28NIASPAN

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6080428 (view patent)2017-05-27NDA020381, NDA021249, NDA022078Lovastatin / Niacin Extended Release Oral Tablet
Niacin / Simvastatin Extended Release Oral Tablet
2p6469035 (view patent)2018-03-15NDA020381, NDA021249, NDA022078Lovastatin / Niacin Extended Release Oral Tablet
Niacin / Simvastatin Extended Release Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1068b9b2e-0ec1-4635-8257-62bb852f0d71 (view SPL)These highlights do not include all the information needed to use Niacin Extended-Release Tablets, USP safely and effectively. See full prescribing information for Niacin Extended-Release Tablets, USP. NIACIN extended-release tablets, for oral use.Initial U.S. Approval: 1997prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-09-113000937392, 000937393, 000937394
209bccfc6-71eb-420f-92d3-cd21789a0dbc (view SPL)These highlights do not include all the information needed to use Niacin Extended-release Tablets USP safely and effectively. See full prescribing information for Niacin Extended-release Tablets USP. NIACIN extended-release tablets USP, film-coated, for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-07-204680840756, 680840773, 680840957
30dd18020-c211-423d-b3d8-a926ae626e14 (view SPL)These highlights do not include all the information needed to use NIASPAN safely and effectively. See full prescribing information for NIASPAN. NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997 prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-08-202681514068
40dfe662a-f2ac-4f10-9a08-54cbd0c6dec6 (view SPL)These highlights do not include all the information needed to use NIASPAN safely and effectively. See full prescribing information for NIASPAN. NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, relabel2011-02-042144499990475
50f049ee9-ab85-401c-b1d7-06c98d559055 (view SPL)These highlights do not include all the information needed to use NIASPAN safely and effectively. See full prescribing information for NIASPAN. NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-04-033741353560301, 353560302
635433c7b-556c-49a0-bfb5-0d498359925b (view SPL)These highlights do not include all the information needed to use NIASPAN safely and effectively. See full prescribing information for NIASPAN. NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997prescriptionHuman PrescriptionAbbvie Inc.2015-04-271470000743074, 000743079, 000743080
7414b3d30-cc7f-4f91-b21e-5090b7f5b529 (view SPL)These highlights do not include all the information needed to use NIASPAN safely and effectively. See full prescribing information for NIASPAN. NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2012-10-102682586037
862efc71c-9746-d603-3e9d-a8786f7d4de8 (view SPL)These highlights do not include all the information needed to use niacin extended-release tablets safely and effectively. See full prescribing information for niacin extended-release tablets. Niacin extended-release tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997prescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.2015-05-1524683820201, 683820202, 683820203
96e604319-e164-4056-ab80-b78b98c519c7 (view SPL)These highlights do not include all the information needed to use niacin extended-release tablets safely and effectively. See full prescribing information for niacin extended-release tablets. NIACIN extended-release tablets, film-coated, for oral use. Initial U.S. Approval: 1997prescriptionHuman PrescriptionAmneal Pharmaceuticals2015-06-302651620321, 651620323
108e290f96-e8c6-47fd-863f-1c9480f28d9b (view SPL)These highlights do not include all the information needed to use NIACIN EXTENDED-RELEASE TABLETS, USP safely and effectively. See full prescribing information for NIACIN EXTENDED-RELEASE TABLETS, USPNIACIN EXTENDED-RELEASE tablets, film-coated, for oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2015-07-2011473350539, 473350613, 473350614
1192b3ec1d-0dc7-4bde-9817-57b1bdf7f0b9 (view SPL)These highlights do not include all the information needed to use NIACIN EXTENDED-RELEASE TABLETS USP safely and effectively. See full prescribing information for NIACIN EXTENDED-RELEASE TABLETS USP. NIACIN EXTENDED-RELEASE tablets, film-coated, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2015-09-028681800221
12c64d7717-8e8e-4e17-8f00-2b18f496b321 (view SPL)These highlights do not include all the information needed to use NIASPAN safely and effectively. See full prescribing information for NIASPAN. NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2012-02-171682586032
13ccc64ee7-f581-493b-b8c2-6147a0db197e (view SPL)These highlights do not include all the information needed to use NIASPAN safely and effectively. See full prescribing information for NIASPAN. NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-011216950852, 216950865
14eac1abb4-58bf-4cd0-aa66-a93e116f516c (view SPL)These highlights do not include all the information needed to use NIASPAN safely and effectively. See full prescribing information for NIASPAN. NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997prescriptionHuman PrescriptionCardinal HealthREPACK2014-08-044551540625, 551540626
15f9b97613-c62e-40b0-a2aa-a7fde6bd5bc7 (view SPL)These highlights do not include all the information needed to use NIASPAN safely and effectively. See full prescribing information for NIASPAN. NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-09-185548680017, 548684867, 548684899
16fc312806-1441-478d-95a2-68ce9a7a796d (view SPL)These highlights do not include all the information needed to use NIASPAN safely and effectively. See full prescribing information for NIASPAN. NIASPAN (niacin extended-release) tablet, film coated, extended release for oral use. Initial U.S. Approval: 1997 prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-08-202681514069

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