Diclofenac / Misoprostol Oral Tablet

Brand(s)
Arthrotec
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
G.D. Searle Llc Division Of Pfizer Inc (2015-08-11)
Oldest Current Product
1997-12-24
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\DICLOFENAC:MISOPROSTOL
FDAOB
ORAL\TABLET, DELAYED RELEASE\DICLOFENAC SODIUM: MISOPROSTOL
SPL Active
ORAL\TABLET, DELAYED RELEASE\DICLOFENAC SODIUM: MISOPROSTOL
ORAL\TABLET, FILM COATED\DICLOFENAC SODIUM: MISOPROSTOL
SPL Moiety
ORAL\TABLET, DELAYED RELEASE\DICLOFENAC: MISOPROSTOL
ORAL\TABLET, FILM COATED\DICLOFENAC: MISOPROSTOL

product(s) by strength(s)

diclofenac sodium 50 mg / misoprostol 0.2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000251411ArthrotecNDAG.D. Searle Llc Division Of Pfizer Inc1997-12-24DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, FILM COATEDNDA020607600fe842-45d9-4d68-9ef2-456dbbebaa11

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005910397ANDAWatson Laboratories, Inc.2012-11-01DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, DELAYED RELEASEANDA201089df8b8660-0c24-4848-8bea-c1b935090c66
2423670110ANDAEagle Pharmaceuticals, Inc.2014-07-15DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, DELAYED RELEASEANDA2005404616cae3-c91b-477c-94b0-d3f4468a59d9
3597620028NDA AUTHORIZED GENERICGreenstone Llc2012-11-01DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, FILM COATEDNDA020607a7701e8c-4e16-4165-8b83-de2c08d5ded3
4680010231ANDABluepoint Laboratories2014-02-26DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, DELAYED RELEASEANDA2010899a22cb4b-e49a-4bd7-b235-47405c302658

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910232ANDAAvkare, Inc.2012-12-14DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, DELAYED RELEASE005910397ANDA2010893643ab1b-9f8f-b2f4-e02d-950d0a02e587
2548684164ArthrotecNDAPhysicians Total Care, Inc.2009-10-07DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, FILM COATED000251411NDA0206074f0a7109-2915-4daa-a752-8f78cf040b37
3552890406ArthrotecNDAPd-Rx Pharmaceuticals, Inc.1997-12-24DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, FILM COATED000251411NDA020607a388be87-4a3e-4501-8895-46101fdda1f3

diclofenac sodium 75 mg / misoprostol 0.2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000251421ArthrotecNDAG.D. Searle Llc Division Of Pfizer Inc1997-12-24DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, FILM COATEDNDA020607600fe842-45d9-4d68-9ef2-456dbbebaa11

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005910398ANDAWatson Laboratories, Inc.2012-11-01DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, DELAYED RELEASEANDA201089df8b8660-0c24-4848-8bea-c1b935090c66
2423670111ANDAEagle Pharmaceuticals, Inc.2014-07-15DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, DELAYED RELEASEANDA2005404616cae3-c91b-477c-94b0-d3f4468a59d9
3597620029NDA AUTHORIZED GENERICGreenstone Llc2012-11-01DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, FILM COATEDNDA020607a7701e8c-4e16-4165-8b83-de2c08d5ded3
4680010232ANDABluepoint Laboratories2014-02-26DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, DELAYED RELEASEANDA2010899a22cb4b-e49a-4bd7-b235-47405c302658

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440949ANDABlenheim Pharmacal, Inc.2015-10-07DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, DELAYED RELEASE005910398ANDA201089219caa9b-96f2-643e-e054-00144ff88e88
2165900024ArthrotecNDAStat Rx Usa Llc1997-12-24DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, FILM COATED000251421NDA020607bdf17a90-9444-4dba-aff6-df27e07f23d5
3216950425ArthrotecNDARebel Distributors Corp1997-12-24DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, FILM COATED000251421NDA0206071cdede45-4e2b-490a-bd22-eca5315af316
4422910233ANDAAvkare, Inc.2012-12-14DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, DELAYED RELEASE005910398ANDA2010893643ab1b-9f8f-b2f4-e02d-950d0a02e587
5499990987ArthrotecNDALake Erie Medical Dba Quality Care Products Llc2012-02-23DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, FILM COATED000251421NDA020607758c886c-decb-41a3-a147-b6565014eaa5
6548684165ArthrotecNDAPhysicians Total Care, Inc.2004-12-28DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, FILM COATED000251421NDA0206074f0a7109-2915-4daa-a752-8f78cf040b37
7619190094NDADirect Rx2014-01-01DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, FILM COATED597620029NDA020607253ee985-e0a0-4674-a114-cfea96304c79
8636293359ArthrotecNDABryant Ranch Prepack1997-12-24DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, FILM COATED000251421NDA020607b5e8af50-ddf8-826e-f167-34026fd35d59
9636294970ANDABryant Ranch Prepack2012-11-01DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, DELAYED RELEASE005910398ANDA2010898c7a84ca-915f-4e71-9bb0-3ca70a5ae517
10680840978ANDAAmerican Health Packaging2015-03-31DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, DELAYED RELEASE680010232ANDA20108927ccf64c-fc2b-44d3-bf57-397417b406f8
11687889290ANDAPreferred Pharmaceuticals, Inc.2015-02-03DICLOFENAC SODIUM, MISOPROSTOLORALTABLET, DELAYED RELEASE005910398ANDA201089ab5dc1b9-dc3f-4c06-9839-46515a9a05f5

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA200158DICLOFENAC SODIUM AND MISOPROSTOLSANDOZ INC2013-05-09ANDA200158_001, ANDA200158_002
2ANDA200540DICLOFENAC SODIUM AND MISOPROSTOLEAGLE PHARMACEUTICALS INC2014-03-14ANDA200540_001, ANDA200540_002
3ANDA201089DICLOFENAC SODIUM AND MISOPROSTOLACTAVIS LABORATORIES FL INC2012-07-09ANDA201089_001, ANDA201089_002
4NDA020607ARTHROTECGD SEARLE LLC1997-12-24NDA020607_001, NDA020607_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA200158_001RXMISOPROSTOL (0.2MG), DICLOFENAC SODIUM (50MG)ORALTABLET, DELAYED RELEASEFalseAB2013-05-09DICLOFENAC SODIUM AND MISOPROSTOL
2ANDA200158_002RXDICLOFENAC SODIUM (75MG), MISOPROSTOL (0.2MG)ORALTABLET, DELAYED RELEASEFalseAB2013-05-09DICLOFENAC SODIUM AND MISOPROSTOL
3ANDA200540_001RXMISOPROSTOL (0.2MG), DICLOFENAC SODIUM (50MG)ORALTABLET, DELAYED RELEASEFalseAB2014-03-14DICLOFENAC SODIUM AND MISOPROSTOL
4ANDA200540_002RXDICLOFENAC SODIUM (75MG), MISOPROSTOL (0.2MG)ORALTABLET, DELAYED RELEASEFalseAB2014-03-14DICLOFENAC SODIUM AND MISOPROSTOL
5ANDA201089_001RXDICLOFENAC SODIUM (50MG), MISOPROSTOL (0.2MG)ORALTABLET, DELAYED RELEASEFalseAB2012-07-09DICLOFENAC SODIUM AND MISOPROSTOL
6ANDA201089_002RXMISOPROSTOL (0.2MG), DICLOFENAC SODIUM (75MG)ORALTABLET, DELAYED RELEASEFalseAB2012-07-09DICLOFENAC SODIUM AND MISOPROSTOL
7NDA020607_001RXDICLOFENAC SODIUM (50MG), MISOPROSTOL (0.2MG)ORALTABLET, DELAYED RELEASEFalseAB1997-12-24ARTHROTEC
8NDA020607_002RXDICLOFENAC SODIUM (75MG), MISOPROSTOL (0.2MG)ORALTABLET, DELAYED RELEASETrueAB1997-12-24ARTHROTEC

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11cdede45-4e2b-490a-bd22-eca5315af316 (view SPL)ARTHROTEC (diclofenac sodium/misoprostol) TabletsprescriptionHuman PrescriptionRebel Distributors CorpREPACK, relabel2009-11-101216950425
2219caa9b-96f2-643e-e054-00144ff88e88 (view SPL)Diclofenac Sodium and Misoprostol Delayed-Release TabletsprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.relabel2015-10-081105440949
3253ee985-e0a0-4674-a114-cfea96304c79 (view SPL)DICLOFENAC SODIUM AND MISOPROSTOLprescriptionHuman PrescriptionDirect Rxrelabel, repack2014-11-171619190094
427ccf64c-fc2b-44d3-bf57-397417b406f8 (view SPL)Diclofenac Sodium and Misoprostol Delayed-Release TabletsprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-03-101680840978
53643ab1b-9f8f-b2f4-e02d-950d0a02e587 (view SPL)Diclofenac Sodium and Misoprostol Delayed-Release TabletsRx onlyprescriptionHuman PrescriptionAvkare, Inc.2015-08-042422910232, 422910233
64616cae3-c91b-477c-94b0-d3f4468a59d9 (view SPL)Diclofenac sodium and misoprostol delayed-release tabletsprescriptionHuman PrescriptionEagle Pharmaceuticals, Inc.MANUFACTURE2014-07-183423670110, 423670111
74f0a7109-2915-4daa-a752-8f78cf040b37 (view SPL)ARTHROTEC (diclofenac sodium/misoprostol) TabletsprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-01-175548684164, 548684165
8600fe842-45d9-4d68-9ef2-456dbbebaa11 (view SPL)ARTHROTEC (diclofenac sodium/misoprostol) TabletsprescriptionHuman PrescriptionG.D. Searle Llc Division Of Pfizer IncAPI MANUFACTURE, MANUFACTURE2015-08-1121000251411, 000251421
9758c886c-decb-41a3-a147-b6565014eaa5 (view SPL)ARTHROTEC (diclofenac sodium/misoprostol) TabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-02-233585499990987
108c7a84ca-915f-4e71-9bb0-3ca70a5ae517 (view SPL)Diclofenac Sodium and Misoprostol Delayed-Release TabletsRevised:May 2013204843-5 Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-231001636294970
119a22cb4b-e49a-4bd7-b235-47405c302658 (view SPL)Diclofenac Sodium and Misoprostol Delayed-Release Tablets Rx onlyprescriptionHuman PrescriptionBluepoint LaboratoriesANALYSIS, LABEL, MANUFACTURE, PACK2015-05-143680010231, 680010232
12a388be87-4a3e-4501-8895-46101fdda1f3 (view SPL)ARTHROTEC (diclofenac sodium/misoprostol) TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-07-2810552890406
13a7701e8c-4e16-4165-8b83-de2c08d5ded3 (view SPL)Diclofenac Sodium/Misoprostol TabletsprescriptionHuman PrescriptionGreenstone LlcAPI MANUFACTURE, MANUFACTURE, PACK2014-11-147597620028, 597620029
14ab5dc1b9-dc3f-4c06-9839-46515a9a05f5 (view SPL)Diclofenac Sodium and Misoprostol Delayed-Release TabletsprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2015-02-041687889290
15b5e8af50-ddf8-826e-f167-34026fd35d59 (view SPL)ARTHROTECprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-284636293359
16bdf17a90-9444-4dba-aff6-df27e07f23d5 (view SPL)ARTHROTEC (diclofenac sodium/misoprostol) TabletsprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-06-131165900024
17df8b8660-0c24-4848-8bea-c1b935090c66 (view SPL)Diclofenac Sodium and Misoprostol Delayed-Release TabletsprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-07-0122005910397, 005910398

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