Nizatidine Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2006-12-19)
Oldest Current Product
2002-07-05
License(s)
ANDA
RxNORM
ORAL CAPSULE\NIZATIDINE
FDAOB
ORAL\CAPSULE\NIZATIDINE
SPL Active
ORAL\CAPSULE\NIZATIDINE
SPL Moiety
ORAL\CAPSULE\NIZATIDINE

product(s) by strength(s)

nizatidine 150 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850150ANDAEon Labs, Inc.2002-07-05NIZATIDINEORALCAPSULEANDA076178c79fd930-cabe-4fef-893c-009172133293
2003785150ANDAMylan Pharmaceuticals Inc.2011-05-04NIZATIDINEORALCAPSULEANDA075806db844934-9c1d-4576-a1b5-ef9b9c66a940
3005913137ANDAWatson Laboratories, Inc.2002-07-09NIZATIDINEORALCAPSULEANDA075616367a1004-59c1-4474-a4f6-ce8bf5a1b043
4551110310ANDADr. Reddy'S Laboratories Ltd2005-09-15NIZATIDINEORALCAPSULEANDA077314faaa7cc4-fda9-d5b8-de2a-71c8744ccb76
5684620425ANDAGlenmark Generics Inc., Usa2011-07-15NIZATIDINEORALCAPSULEANDA0906184e7e5162-a1e7-4fbe-895e-e598f5dc2bd3

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900741ANDAStat Rx Usa Llc2010-01-14NIZATIDINEORALCAPSULE001850150ANDA076178e133d726-2a1f-4f9a-96b3-320f5cd9f7b0
2216950375ANDARebel Distributors Corp2002-07-05NIZATIDINEORALCAPSULE001850150ANDA0761780131d303-52c4-4ea7-a560-b529bb2c1616
3422540093ANDARebel Distributors Corp2002-07-09NIZATIDINEORALCAPSULE005913137ANDA075616565fcd92-6f4a-4060-be06-3001159264d9
4458650374ANDAMedsource Pharmaceuticals2011-07-15NIZATIDINEORALCAPSULE684620425ANDA0906181d6161e3-2ddb-5446-e054-00144ff8d46c
5529590824ANDAH.J. Harkins Company, Inc.2002-07-09NIZATIDINEORALCAPSULE005913137ANDA07561633cf4324-44cb-44df-b459-7319a335b253
6557000091ANDALake Erie Medical Dba Quality Care Products Llc2002-07-09NIZATIDINEORALCAPSULE005913137ANDA07561661e38e9e-af3d-42f2-9e36-59eed1032f82
7631870249ANDAProficient Rx Lp2011-07-15NIZATIDINEORALCAPSULE684620425ANDA0906181a528236-6375-4630-b4e1-8db250a4cbef
8636293639ANDABryant Ranch Prepack2005-09-15NIZATIDINEORALCAPSULE551110310ANDA077314020561cb-ab21-e028-926e-c05621b0c9e3
9681510017ANDACarilion Materials Management2002-07-09NIZATIDINEORALCAPSULE005913137ANDA075616005909e4-77d2-440f-a10b-30fab27ffbc3
10687888913ANDAPreferred Pharmaceuticals, Inc.2015-08-28NIZATIDINEORALCAPSULE684620425ANDA090618d2d06182-2653-47ea-b96a-08f5700a8970
11687889838ANDAPreferred Pharmaceuticals, Inc.2012-03-29NIZATIDINEORALCAPSULE684620425ANDA090618b616ab13-ff66-420a-8ee2-3a6351b51d06

nizatidine 300 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850300ANDAEon Labs, Inc.2002-07-05NIZATIDINEORALCAPSULEANDA076178c79fd930-cabe-4fef-893c-009172133293
2003785300ANDAMylan Pharmaceuticals Inc.2011-05-06NIZATIDINEORALCAPSULEANDA075806db844934-9c1d-4576-a1b5-ef9b9c66a940
3005913138ANDAWatson Laboratories, Inc.2002-07-09NIZATIDINEORALCAPSULEANDA075616367a1004-59c1-4474-a4f6-ce8bf5a1b043
4551110311ANDADr. Reddy'S Laboratories Ltd2005-09-15NIZATIDINEORALCAPSULEANDA077314faaa7cc4-fda9-d5b8-de2a-71c8744ccb76
5684620426ANDAGlenmark Generics Inc., Usa2011-07-15NIZATIDINEORALCAPSULEANDA0906184e7e5162-a1e7-4fbe-895e-e598f5dc2bd3

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950043ANDARebel Distributors Corp2002-07-09NIZATIDINEORALCAPSULE005913138ANDA075616487b4138-f7db-480f-96d2-8010fd5c0c06
2636292769ANDABryant Ranch Prepack2005-09-15NIZATIDINEORALCAPSULE551110311ANDA077314cbfb5d8a-a136-4d78-befa-d2cea6661030
3682583006ANDADispensing Solutions, Inc.2009-01-22NIZATIDINEORALCAPSULE00591313830ANDA0756163666b5f5-cdcf-42be-a67d-226603435d08

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075461NIZATIDINETrueANI PHARMACEUTICALS INC2002-07-08ANDA075461_001, ANDA075461_002
2ANDA075616NIZATIDINEWATSON LABORATORIES INC2002-07-09ANDA075616_001, ANDA075616_002
3ANDA075668NIZATIDINEANI PHARMACEUTICALS INC2002-09-12ANDA075668_001, ANDA075668_002
4ANDA075806NIZATIDINEMYLAN PHARMACEUTICALS INC.2002-07-05ANDA075806_001, ANDA075806_002
5ANDA075934NIZATIDINETrueMYLAN PHARMACEUTICALS INC.2002-07-09ANDA075934_001, ANDA075934_002
6ANDA076178NIZATIDINESANDOZ INC2002-07-05ANDA076178_001, ANDA076178_002
7ANDA076383NIZATIDINETrueAPOTEX INC2003-01-23ANDA076383_001, ANDA076383_002
8ANDA077314NIZATIDINEDR REDDYS LABORATORIES LTD2005-09-15ANDA077314_001, ANDA077314_002
9ANDA090618NIZATIDINEGLENMARK GENERICS INC USA2011-07-15ANDA090618_001, ANDA090618_002
10NDA019508AXIDTrueSMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE1988-04-12NDA019508_001, NDA019508_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075461_001discontinuedNIZATIDINE (150MG)ORALCAPSULEFalse2002-07-08NIZATIDINE
2ANDA075461_002discontinuedNIZATIDINE (300MG)ORALCAPSULEFalse2002-07-08NIZATIDINE
3ANDA075616_001RXNIZATIDINE (150MG)ORALCAPSULEFalseAB2002-07-09NIZATIDINE
4ANDA075616_002RXNIZATIDINE (300MG)ORALCAPSULEFalseAB2002-07-09NIZATIDINE
5ANDA075668_001RXNIZATIDINE (150MG)ORALCAPSULEFalseAB2002-09-12NIZATIDINE
6ANDA075668_002RXNIZATIDINE (300MG)ORALCAPSULEFalseAB2002-09-12NIZATIDINE
7ANDA075806_001RXNIZATIDINE (150MG)ORALCAPSULEFalseAB2002-07-05NIZATIDINE
8ANDA075806_002RXNIZATIDINE (300MG)ORALCAPSULETrueAB2002-07-05NIZATIDINE
9ANDA075934_001discontinuedNIZATIDINE (150MG)ORALCAPSULEFalse2002-07-09NIZATIDINE
10ANDA075934_002discontinuedNIZATIDINE (300MG)ORALCAPSULEFalse2002-07-09NIZATIDINE
11ANDA076178_001RXNIZATIDINE (150MG)ORALCAPSULEFalseAB2002-07-05NIZATIDINE
12ANDA076178_002RXNIZATIDINE (300MG)ORALCAPSULEFalseAB2002-07-05NIZATIDINE
13ANDA076383_001discontinuedNIZATIDINE (150MG)ORALCAPSULEFalse2003-01-23NIZATIDINE
14ANDA076383_002discontinuedNIZATIDINE (300MG)ORALCAPSULEFalse2003-01-23NIZATIDINE
15ANDA077314_001RXNIZATIDINE (150MG)ORALCAPSULEFalseAB2005-09-15NIZATIDINE
16ANDA077314_002RXNIZATIDINE (300MG)ORALCAPSULEFalseAB2005-09-15NIZATIDINE
17ANDA090618_001RXNIZATIDINE (150MG)ORALCAPSULEFalseAB2011-07-15NIZATIDINE
18ANDA090618_002RXNIZATIDINE (300MG)ORALCAPSULEFalseAB2011-07-15NIZATIDINE
19NDA019508_001discontinuedNIZATIDINE (150MG)ORALCAPSULEFalse1988-04-12AXID
20NDA019508_002discontinuedNIZATIDINE (300MG)ORALCAPSULEFalse1988-04-12AXID

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1005909e4-77d2-440f-a10b-30fab27ffbc3 (view SPL)Nizatidine Capsules 150 mg and 300 mgprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2011-09-092681510017
20131d303-52c4-4ea7-a560-b529bb2c1616 (view SPL)Nizatidine Capsules USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-171216950375
3020561cb-ab21-e028-926e-c05621b0c9e3 (view SPL)NIZATIDINE CAPSULESprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2005-09-152636293639
41a528236-6375-4630-b4e1-8db250a4cbef (view SPL)Nizatidine Capsules USPprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-09-011631870249
51d6161e3-2ddb-5446-e054-00144ff8d46c (view SPL)Nizatidine Capsules USPprescriptionHuman PrescriptionMedsource Pharmaceuticalsrepack2015-08-151458650374
633cf4324-44cb-44df-b459-7319a335b253 (view SPL)Nizatidine Capsules 150 mg and 300 mgprescriptionHuman PrescriptionH.J. Harkins Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-10-121529590824
73666b5f5-cdcf-42be-a67d-226603435d08 (view SPL)Nizatidine Capsules USP Rx onlyprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2010-03-031682583006
8367a1004-59c1-4474-a4f6-ce8bf5a1b043 (view SPL)Nizatidine Capsules 150 mg and 300 mgprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-09-092005913137, 005913138
9487b4138-f7db-480f-96d2-8010fd5c0c06 (view SPL)Nizatidine Capsules 300 mgprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-02-091216950043
104e7e5162-a1e7-4fbe-895e-e598f5dc2bd3 (view SPL)Nizatidine Capsules USPprescriptionHuman PrescriptionGlenmark Generics Inc., UsaANALYSIS, API MANUFACTURE, MANUFACTURE2011-09-206684620425, 684620426
11565fcd92-6f4a-4060-be06-3001159264d9 (view SPL)Nizatidine Capsules 150 mg and 300 mgprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-02-091422540093
1261e38e9e-af3d-42f2-9e36-59eed1032f82 (view SPL)Nizatidine Capsules 150 mg and 300 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2015-03-271557000091
13b616ab13-ff66-420a-8ee2-3a6351b51d06 (view SPL)Nizatidine Capsules USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2012-03-291687889838
14c79fd930-cabe-4fef-893c-009172133293 (view SPL)Nizatidine Capsules USPprescriptionHuman PrescriptionEon Labs, Inc.2011-10-2017001850150, 001850300
15cbfb5d8a-a136-4d78-befa-d2cea6661030 (view SPL)NIZATIDINE CAPSULESprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636292769
16d2d06182-2653-47ea-b96a-08f5700a8970 (view SPL)Nizatidine Capsules USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-08-281687888913
17db844934-9c1d-4576-a1b5-ef9b9c66a940 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2006-12-195003785150, 003785300
18e133d726-2a1f-4f9a-96b3-320f5cd9f7b0 (view SPL)Nizatidine Insert & LabelprescriptionHuman PrescriptionStat Rx Usa Llc2010-01-141165900741
19faaa7cc4-fda9-d5b8-de2a-71c8744ccb76 (view SPL)NIZATIDINE CAPSULESprescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2009-09-011551110310, 551110311

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