Chlorzoxazone Oral Tablet

Brand(s)
Lorzone, Parafon Forte DSC
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Pharmaceuticals, Inc. (2012-04-04)
Oldest Current Product
1987-06-15
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\CHLORZOXAZONE
FDAOB
ORAL\TABLET\CHLORZOXAZONE
SPL Active
ORAL\TABLET\CHLORZOXAZONE
SPL Moiety
ORAL\TABLET\CHLORZOXAZONE

product(s) by strength(s)

chlorzoxazone 375 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1466720118ANDAMikart, Inc.2010-06-01CHLORZOXAZONEORALTABLETANDA0408614499f9ad-433b-485d-b523-c2f3bc441ebb
2680250046LorzoneANDAVertical Pharmaceuticals, Llc2011-10-01CHLORZOXAZONEORALTABLETANDA040861bdd61b83-5bcd-4d23-8ef5-aeb9ca2f7c14

chlorzoxazone 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580625Parafon Forte DSCNDAJanssen Pharmaceuticals, Inc.1987-06-15CHLORZOXAZONEORALTABLETNDA0115295fbdbe83-3e24-4fb2-a67d-499ed3523363

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005912520ANDAWatson Laboratories, Inc.2011-08-22CHLORZOXAZONEORALTABLETANDA0898592f05e8e2-616f-475b-ac9f-c42e1a5dbe81
2683870375ANDAKeltman Pharmaceuticals Inc.2004-06-20CHLORZOXAZONEORALTABLETANDA0898955af155d7-3780-435b-9a87-0ce01f1ed6ec

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900478ANDAStat Rx Usa Llc2008-12-23CHLORZOXAZONEORALTABLET005913968ANDA089859ddd41f29-8c98-4fae-94e3-104a8e9365fc
2216950569ANDARebel Distributors Corp1988-05-04CHLORZOXAZONEORALTABLET000930542ANDA089895e1e1c8de-5658-4f94-bf20-f42b59b993c5
3332610021ANDAAidarex Pharmaceuticals Llc2011-08-22CHLORZOXAZONEORALTABLET005912520ANDA08985963f43b2a-dd5b-482c-a00c-7643d91c2292
4422540076ANDARebel Distributors Corp2011-08-22CHLORZOXAZONEORALTABLET005912520ANDA0898599437b8ac-4f0e-4e5d-b699-23c492bf28ab
5493490766Parafon Forte DSCNDARemedyrepack Inc.2012-11-28, 2015-05-19CHLORZOXAZONEORALTABLET504580625NDA011529262297fa-891c-4696-923b-b961b57a06fd, a8d84a0a-aa31-4ebe-bdf8-5b09b2df69a9
6499990044ANDALake Erie Medical Dba Quality Care Products Llc2011-04-12CHLORZOXAZONEORALTABLET005913968ANDA089859fd11228a-0be9-4328-9527-ea41b2e1a22a
7504363444ANDAUnit Dose Services2011-08-22CHLORZOXAZONEORALTABLET005912520ANDA0898596d07e505-f5c6-412c-add5-5b5a7bab31e9
8545691970ANDAA-S Medication Solutions Llc2011-08-22CHLORZOXAZONEORALTABLET005912520ANDA089859527ec3d3-4e48-403b-b1b2-cf33d343ccbb
9548680735ANDAPhysicians Total Care, Inc.1995-04-24CHLORZOXAZONEORALTABLET005913968ANDA089859650657fc-5655-41a4-974a-bc0e3a8317ab
10550451594ANDADispensing Solutions, Inc.2011-01-16CHLORZOXAZONEORALTABLET005550585ANDA0898953b91e3ba-1eb6-4297-9d1b-28d87b36a5b3
11552890633ANDAPd-Rx Pharmaceuticals, Inc.2008-12-23CHLORZOXAZONEORALTABLET005912520ANDA0898598650d342-92df-48d7-9f3d-cdd6f6f4c0e7
12581182520ANDAClinical Solutions Wholesale2011-08-22CHLORZOXAZONEORALTABLET005912520ANDA0898593412520b-fa8a-4d3e-a999-75fe39294119
13617860458ANDARemedyrepack Inc.2015-11-17CHLORZOXAZONEORALTABLET005912520ANDA089859721b1bd4-a9f1-4836-8ec5-915de1fc9ad9, 742e80a9-ea9f-4331-8823-00a643d49c6c, cfa713b6-75e5-4eab-abc6-61a7b8b4ad66
14619190478ANDADirect Rx2014-01-01CHLORZOXAZONEORALTABLET005912520ANDA0898590ed64990-f2f2-40e9-be91-874f0a862f83
15631870317ANDAProficient Rx Lp2011-08-22CHLORZOXAZONEORALTABLET005912520ANDA08985963338935-f3dd-4ef1-bb66-856a83c95f41
16636291586ANDABryant Ranch Prepack2008-12-23CHLORZOXAZONEORALTABLET005913968ANDA0898595e6889c9-a091-4622-0a00-ad0fc1830f78

chlorzoxazone 750 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1466720117ANDAMikart, Inc.2010-06-01CHLORZOXAZONEORALTABLETANDA0408614499f9ad-433b-485d-b523-c2f3bc441ebb
2680250047LorzoneANDAVertical Pharmaceuticals, Llc2011-10-01CHLORZOXAZONEORALTABLETANDA040861bdd61b83-5bcd-4d23-8ef5-aeb9ca2f7c14

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040113CHLORZOXAZONETrueACTAVIS ELIZABETH LLC1995-09-29ANDA040113_001
2ANDA040137CHLORZOXAZONETrueWATSON LABORATORIES INC1996-08-09ANDA040137_001
3ANDA040861CHLORZOXAZONEMIKART INC2010-06-01ANDA040861_001, ANDA040861_002
4ANDA081008STRIFON FORTE DSCTrueFERNDALE LABORATORIES INC1988-12-23ANDA081008_001
5ANDA081019CHLORZOXAZONETrueWATSON LABORATORIES INC1991-07-29ANDA081019_001
6ANDA081040CHLORZOXAZONETrueWATSON LABORATORIES INC1989-08-22ANDA081040_001
7ANDA081298CHLORZOXAZONETrueOHM LABORATORIES INC.1993-12-29ANDA081298_001
8ANDA081299CHLORZOXAZONETrueOHM LABORATORIES INC.1993-12-29ANDA081299_001
9ANDA086901CHLORZOXAZONETrueWATSON LABORATORIES INCANDA086901_001
10ANDA086948CHLORZOXAZONETrueWATSON LABORATORIES INC1982-08-09ANDA086948_001
11ANDA087981CHLORZOXAZONETruePAR PHARMACEUTICAL INC1983-09-20ANDA087981_001
12ANDA088928CHLORZOXAZONETrueACTAVIS ELIZABETH LLC1987-05-08ANDA088928_001
13ANDA089592CHLORZOXAZONETruePIONEER PHARMACEUTICALS INC1989-01-06ANDA089592_001
14ANDA089852CHLORZOXAZONETrueSANDOZ INC1988-05-04ANDA089852_001
15ANDA089853CHLORZOXAZONETrueSANDOZ INC1988-05-04ANDA089853_001
16ANDA089859CHLORZOXAZONEWATSON LABORATORIES INC1988-05-04ANDA089859_001
17ANDA089895CHLORZOXAZONEBARR LABORATORIES INC1988-05-04ANDA089895_001
18ANDA089948CHLORZOXAZONETruePIONEER PHARMACEUTICALS INC1989-01-06ANDA089948_001
19ANDA089970CHLORZOXAZONETrueMUTUAL PHARMACEUTICAL CO INC1990-09-27ANDA089970_001
20NDA011300PARAFLEXTrueORTHO MCNEIL PHARMACEUTICAL INCNDA011300_003
21NDA011529PARAFON FORTE DSCJANSSEN RESEARCH AND DEVELOPMENT LLC1987-06-15NDA011529_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040113_001discontinuedCHLORZOXAZONE (500MG)ORALTABLETFalse1995-09-29CHLORZOXAZONE
2ANDA040137_001discontinuedCHLORZOXAZONE (500MG)ORALTABLETFalse1996-08-09CHLORZOXAZONE
3ANDA040861_001RXCHLORZOXAZONE (375MG)ORALTABLETFalse2010-06-01CHLORZOXAZONE
4ANDA040861_002RXCHLORZOXAZONE (750MG)ORALTABLETFalse2010-06-01CHLORZOXAZONE
5ANDA081008_001discontinuedCHLORZOXAZONE (500MG)ORALTABLETFalse1988-12-23STRIFON FORTE DSC
6ANDA081019_001discontinuedCHLORZOXAZONE (500MG)ORALTABLETFalse1991-07-29CHLORZOXAZONE
7ANDA081040_001discontinuedCHLORZOXAZONE (500MG)ORALTABLETFalse1989-08-22CHLORZOXAZONE
8ANDA081298_001discontinuedCHLORZOXAZONE (250MG)ORALTABLETFalse1993-12-29CHLORZOXAZONE
9ANDA081299_001discontinuedCHLORZOXAZONE (500MG)ORALTABLETFalse1993-12-29CHLORZOXAZONE
10ANDA086901_001discontinuedCHLORZOXAZONE (250MG)ORALTABLETFalseCHLORZOXAZONE
11ANDA086948_001discontinuedCHLORZOXAZONE (250MG)ORALTABLETFalse1982-08-09CHLORZOXAZONE
12ANDA087981_001discontinuedCHLORZOXAZONE (250MG)ORALTABLETFalse1983-09-20CHLORZOXAZONE
13ANDA088928_001discontinuedCHLORZOXAZONE (250MG)ORALTABLETFalse1987-05-08CHLORZOXAZONE
14ANDA089592_001discontinuedCHLORZOXAZONE (250MG)ORALTABLETFalse1989-01-06CHLORZOXAZONE
15ANDA089852_001discontinuedCHLORZOXAZONE (250MG)ORALTABLETFalse1988-05-04CHLORZOXAZONE
16ANDA089853_001discontinuedCHLORZOXAZONE (500MG)ORALTABLETFalse1988-05-04CHLORZOXAZONE
17ANDA089859_001RXCHLORZOXAZONE (500MG)ORALTABLETFalseAA1988-05-04CHLORZOXAZONE
18ANDA089895_001RXCHLORZOXAZONE (500MG)ORALTABLETFalseAA1988-05-04CHLORZOXAZONE
19ANDA089948_001discontinuedCHLORZOXAZONE (500MG)ORALTABLETFalse1989-01-06CHLORZOXAZONE
20ANDA089970_001discontinuedCHLORZOXAZONE (500MG)ORALTABLETFalse1990-09-27CHLORZOXAZONE
21NDA011300_003discontinuedCHLORZOXAZONE (250MG)ORALTABLETFalsePARAFLEX
22NDA011529_002RXCHLORZOXAZONE (500MG)ORALTABLETTrueAA1987-06-15PARAFON FORTE DSC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10ed64990-f2f2-40e9-be91-874f0a862f83 (view SPL)CHLORZOXAZONEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-11-092619190478
2262297fa-891c-4696-923b-b961b57a06fd (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-11-281493490766
32f05e8e2-616f-475b-ac9f-c42e1a5dbe81 (view SPL)ChlorzoxazoneTablets,USP 500 mg Revised:March 2015 Rx only 195609-1prescriptionHuman PrescriptionWatson Laboratories, Inc.2015-03-017005912520
43412520b-fa8a-4d3e-a999-75fe39294119 (view SPL)prescriptionHuman PrescriptionClinical Solutions Wholesalerelabel, repack2013-07-032581182520
53b91e3ba-1eb6-4297-9d1b-28d87b36a5b3 (view SPL)CHLORZOXAZONE TABLETS, USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-09-071550451594
64499f9ad-433b-485d-b523-c2f3bc441ebb (view SPL)prescriptionHuman PrescriptionMikart, Inc.2014-07-172466720117, 466720118
7527ec3d3-4e48-403b-b1b2-cf33d343ccbb (view SPL)CHLORZOXAZONE TABLETS, USP 500 mg Revised:November 2010 Rx only 195609prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-10-061545691970
85af155d7-3780-435b-9a87-0ce01f1ed6ec (view SPL)Parafon DSC (chlorzoxazone)prescriptionHuman PrescriptionKeltman Pharmaceuticals Inc.MANUFACTURE2010-02-091683870375
95e6889c9-a091-4622-0a00-ad0fc1830f78 (view SPL)CHLORZOXAZONE TABLETS, USP 500 mgprescriptionHuman PrescriptionBryant Ranch PrepackMANUFACTURE, RELABEL, REPACK2008-12-232636291586
105fbdbe83-3e24-4fb2-a67d-499ed3523363 (view SPL)PARAFON FORTE DSC (chlorzoxazone) Caplets 500 mgprescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.API MANUFACTURE, MANUFACTURE2012-04-042504580625
1163338935-f3dd-4ef1-bb66-856a83c95f41 (view SPL)CHLORZOXAZONE TABLETS, USP 500 mg Revised:November 2010 Rx only 195609prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870317
1263f43b2a-dd5b-482c-a00c-7643d91c2292 (view SPL)CHLORZOXAZONE TABLETS, USP 500 mg Revised:November 2010 Rx only 195609prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2012-09-142332610021
13650657fc-5655-41a4-974a-bc0e3a8317ab (view SPL)CHLORZOXAZONE TABLETS, USP 500 mg0542 Rx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-09-161548680735
146d07e505-f5c6-412c-add5-5b5a7bab31e9 (view SPL)Revised:November 2010 195609 CHLORZOXAZONE TABLETS, USP 500 mg Rx onlyprescriptionHuman PrescriptionUnit Dose ServicesREPACK2011-09-212504363444
15721b1bd4-a9f1-4836-8ec5-915de1fc9ad9 (view SPL)ChlorzoxazoneTablets,USP 500 mgRevised:March 2015Rx only195609-1prescriptionHuman PrescriptionRemedyrepack Inc.2015-11-171617860458
16742e80a9-ea9f-4331-8823-00a643d49c6c (view SPL)ChlorzoxazoneTablets,USP 500 mgRevised:March 2015Rx only195609-1prescriptionHuman PrescriptionRemedyrepack Inc.2015-11-171617860458
178650d342-92df-48d7-9f3d-cdd6f6f4c0e7 (view SPL)CHLORZOXAZONE TABLETS, USP 500 mg Revised:November 2010 Rx only 195609prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-06-0315552890633
189437b8ac-4f0e-4e5d-b699-23c492bf28ab (view SPL)CHLORZOXAZONE TABLETS, USP 500 mg Revised:November 2010 Rx only 195609prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-01-243422540076
19a8d84a0a-aa31-4ebe-bdf8-5b09b2df69a9 (view SPL)PARAFON FORTE DSC (chlorzoxazone) Caplets 500 mgprescriptionHuman PrescriptionRemedyrepack Inc.2015-05-191493490766
20bdd61b83-5bcd-4d23-8ef5-aeb9ca2f7c14 (view SPL)prescriptionHuman PrescriptionVertical Pharmaceuticals, Llc2015-06-222680250046, 680250047
21cfa713b6-75e5-4eab-abc6-61a7b8b4ad66 (view SPL)ChlorzoxazoneTablets,USP 500 mgRevised:March 2015Rx only195609-1prescriptionHuman PrescriptionRemedyrepack Inc.2015-11-171617860458
22ddd41f29-8c98-4fae-94e3-104a8e9365fc (view SPL)CHLORZOXAZONE TABLETS, USP 500 mg Revised:November 2010 Rx only 195609prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-09-231165900478
23e1e1c8de-5658-4f94-bf20-f42b59b993c5 (view SPL)CHLORZOXAZONE TABLETS, USP 500 mg0542prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-232216950569
24fd11228a-0be9-4328-9527-ea41b2e1a22a (view SPL)CHLORZOXAZONE TABLETS, USP 500 mg Revised:November 2010 Rx only 195609prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcMANUFACTURE, repack2011-11-103135499990044

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