Dicloxacillin Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2015-07-21)
Oldest Current Product
1971-04-01
License(s)
ANDA
RxNORM
ORAL CAPSULE\DICLOXACILLIN
FDAOB
ORAL\CAPSULE\DICLOXACILLIN SODIUM
SPL Active
ORAL\CAPSULE\DICLOXACILLIN SODIUM
SPL Moiety
ORAL\CAPSULE\DICLOXACILLIN

product(s) by strength(s)

dicloxacillin 250 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000933123ANDATeva Pharmaceuticals Usa Inc1990-09-30DICLOXACILLIN SODIUMORALCAPSULEANDA0622868478f242-c715-4984-ac1d-dc79dc28665e
2007812248ANDASandoz Inc1971-04-01DICLOXACILLIN SODIUMORALCAPSULEANDA06145465c3e99b-ec77-416c-ad70-596d6f0a9c31

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1004401380ANDALiberty Pharmaceuticals, Inc.1971-04-01DICLOXACILLIN SODIUMORALCAPSULE007812248ANDA0614544e2a0cc3-009b-40d0-a0e9-43feb7b250a2
2004407380ANDALiberty Pharmaceuticals, Inc.1990-09-30DICLOXACILLIN SODIUMORALCAPSULE000933123ANDA062286939f13c5-c394-49c1-ae57-edc44438a9de
3216950124ANDARebel Distributors Corp1971-04-01DICLOXACILLIN SODIUMORALCAPSULE007812248ANDA06145433434f66-1d36-4506-9b3d-9755c978d9b2
4430630180ANDAPd-Rx Pharmaceuticals, Inc.2011-01-20DICLOXACILLIN SODIUMORALCAPSULE000933123ANDA062286c17cd62d-ff5d-47ba-8673-3346c7f2365f
5500900116ANDAA-S Medication Solutions Llc1990-09-30DICLOXACILLIN SODIUMORALCAPSULE000933123ANDA06228669a08b51-3175-4100-8ca2-5a061d909367
6500900117ANDAA-S Medication Solutions Llc1971-04-01DICLOXACILLIN SODIUMORALCAPSULE007812248ANDA061454a8898bea-70dd-44f3-abb8-45ecfa98141e
7545690384ANDAA-S Medication Solutions Llc1990-09-30DICLOXACILLIN SODIUMORALCAPSULE000933123ANDA062286c5b2fb7f-9145-4df7-9ea6-6c82b27a59f8
8548680937ANDAPhysicians Total Care, Inc.2004-08-17DICLOXACILLIN SODIUMORALCAPSULE007812248ANDA0614545e878949-ae82-41e9-9fc6-3c54fe28c032
9552890592ANDAPd-Rx Pharmaceuticals, Inc.2011-01-20DICLOXACILLIN SODIUMORALCAPSULE000933123ANDA0622869e2bbe03-44cb-45d1-acdb-b61d9016055e

dicloxacillin 500 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000933125ANDATeva Pharmaceuticals Usa Inc1990-09-30DICLOXACILLIN SODIUMORALCAPSULEANDA0622868478f242-c715-4984-ac1d-dc79dc28665e
2007812258ANDASandoz Inc1971-04-01DICLOXACILLIN SODIUMORALCAPSULEANDA06145465c3e99b-ec77-416c-ad70-596d6f0a9c31

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900076ANDAStat Rx Usa Llc2011-01-20DICLOXACILLIN SODIUMORALCAPSULE000933125ANDA062286e12a13dd-b93d-452c-8671-aec751ddaa4d
2430630473ANDAPd-Rx Pharmaceuticals, Inc.1990-09-30DICLOXACILLIN SODIUMORALCAPSULE000933125ANDA06228624e821aa-85b8-4f5a-aa13-83ff132952ca
3499990120ANDALake Erie Medical Dba Quality Care Products Llc2012-03-19DICLOXACILLIN SODIUMORALCAPSULE000933125ANDA062286781fb93d-4827-41e3-8cbb-649c48817cc2
4500900310ANDAA-S Medication Solutions Llc1990-09-30DICLOXACILLIN SODIUMORALCAPSULE000933125ANDA06228669a08b51-3175-4100-8ca2-5a061d909367
5529590049ANDAH.J. Harkins Company, Inc.2011-01-20DICLOXACILLIN SODIUMORALCAPSULE000933125ANDA0622863393668f-ea58-442e-b293-c7107b69d1af
6545691889ANDAA-S Medication Solutions Llc1990-09-30DICLOXACILLIN SODIUMORALCAPSULE000933125ANDA062286c5b2fb7f-9145-4df7-9ea6-6c82b27a59f8
7548681380ANDAPhysicians Total Care, Inc.1992-10-21DICLOXACILLIN SODIUMORALCAPSULE007812258ANDA0614545e878949-ae82-41e9-9fc6-3c54fe28c032
8552890094ANDAPd-Rx Pharmaceuticals, Inc.1971-04-01DICLOXACILLIN SODIUMORALCAPSULE007812258ANDA0614545913023a-e3e4-4961-8adb-a299d9e66a37
9672960122ANDARedpharm Drug Inc.2011-01-20DICLOXACILLIN SODIUMORALCAPSULE000933125ANDA0622862861a407-7898-489d-a43c-1e316341863e

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060254DYCILLTrueGLAXOSMITHKLINEANDA060254_002, ANDA060254_003
2ANDA061454DICLOXACILLIN SODIUMSANDOZ INCANDA061454_001, ANDA061454_002, ANDA061454_003
3ANDA062238DYCILLTrueGLAXOSMITHKLINEANDA062238_001, ANDA062238_002
4ANDA062286DICLOXACILLIN SODIUMTEVA PHARMACEUTICALS USA INC1982-06-03ANDA062286_001, ANDA062286_002
5NDA050011PATHOCILTrueWYETH AYERST LABORATORIESNDA050011_002, NDA050011_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA060254_002discontinuedDICLOXACILLIN SODIUM (EQ 250MG BASE)ORALCAPSULEFalseDYCILL
2ANDA060254_003discontinuedDICLOXACILLIN SODIUM (EQ 500MG BASE)ORALCAPSULEFalseDYCILL
3ANDA061454_001RXDICLOXACILLIN SODIUM (EQ 250MG BASE)ORALCAPSULEFalseABDICLOXACILLIN SODIUM
4ANDA061454_002RXDICLOXACILLIN SODIUM (EQ 125MG BASE)ORALCAPSULEFalseDICLOXACILLIN SODIUM
5ANDA061454_003RXDICLOXACILLIN SODIUM (EQ 500MG BASE)ORALCAPSULETrueABDICLOXACILLIN SODIUM
6ANDA062238_001discontinuedDICLOXACILLIN SODIUM (EQ 250MG BASE)ORALCAPSULEFalseDYCILL
7ANDA062238_002discontinuedDICLOXACILLIN SODIUM (EQ 500MG BASE)ORALCAPSULEFalseDYCILL
8ANDA062286_001RXDICLOXACILLIN SODIUM (EQ 250MG BASE)ORALCAPSULEFalseAB1982-06-03DICLOXACILLIN SODIUM
9ANDA062286_002RXDICLOXACILLIN SODIUM (EQ 500MG BASE)ORALCAPSULEFalseAB1982-06-03DICLOXACILLIN SODIUM
10NDA050011_002discontinuedDICLOXACILLIN SODIUM (EQ 250MG BASE)ORALCAPSULEFalsePATHOCIL
11NDA050011_003discontinuedDICLOXACILLIN SODIUM (EQ 500MG BASE)ORALCAPSULEFalse1983-03-28PATHOCIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
124e821aa-85b8-4f5a-aa13-83ff132952ca (view SPL)DICLOXACILLIN SODIUM CAPSULES USP31233125Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-12-064430630473
22861a407-7898-489d-a43c-1e316341863e (view SPL)DICLOXACILLIN SODIUM CAPSULES USP31233125Rx onlyprescriptionHuman PrescriptionRedpharm Drug Inc.manufacture2011-08-231672960122
333434f66-1d36-4506-9b3d-9755c978d9b2 (view SPL)Dicloxacillin Sodium Capsules, USP250 mgprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-201216950124
43393668f-ea58-442e-b293-c7107b69d1af (view SPL)DICLOXACILLIN SODIUM CAPSULES USP31233125Rx onlyprescriptionHuman PrescriptionH.J. Harkins Company, Inc.MANUFACTURE2011-12-071529590049
54e2a0cc3-009b-40d0-a0e9-43feb7b250a2 (view SPL)Dicloxacillin Sodium Capsules, USP250 mg and 500 mgprescriptionHuman PrescriptionLiberty Pharmaceuticals, Inc.2013-09-231004401380
65913023a-e3e4-4961-8adb-a299d9e66a37 (view SPL)Dicloxacillin Sodium Capsules, USP250 mg and 500 mgprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2007-09-1010552890094
75e878949-ae82-41e9-9fc6-3c54fe28c032 (view SPL)Dicloxacillin Sodium Capsules, USP250 mg and 500 mgprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-01-093548680937, 548681380
865c3e99b-ec77-416c-ad70-596d6f0a9c31 (view SPL)Dicloxacillin Sodium Capsules, USP250 mg and 500 mgprescriptionHuman PrescriptionSandoz IncAPI MANUFACTURE2015-07-2113007812248, 007812258
969a08b51-3175-4100-8ca2-5a061d909367 (view SPL)DICLOXACILLIN SODIUM CAPSULES USP31233125Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-02-151500900116, 500900310
10781fb93d-4827-41e3-8cbb-649c48817cc2 (view SPL)DICLOXACILLIN SODIUM CAPSULES USP31233125Rx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2012-09-133674499990120
118478f242-c715-4984-ac1d-dc79dc28665e (view SPL)DICLOXACILLIN SODIUM CAPSULES USP 31233125 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-08-174000933123, 000933125
12939f13c5-c394-49c1-ae57-edc44438a9de (view SPL)DICLOXACILLIN SODIUM CAPSULES USP31233125Rx onlyprescriptionHuman PrescriptionLiberty Pharmaceuticals, Inc.2013-09-062004407380
139e2bbe03-44cb-45d1-acdb-b61d9016055e (view SPL)DICLOXACILLIN SODIUM CAPSULES USP31233125Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-01-201552890592
14a8898bea-70dd-44f3-abb8-45ecfa98141e (view SPL)Dicloxacillin Sodium Capsules, USP250 mg and 500 mgprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-02-151500900117
15c17cd62d-ff5d-47ba-8673-3346c7f2365f (view SPL)DICLOXACILLIN SODIUM CAPSULES USP31233125Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-01-201430630180
16c5b2fb7f-9145-4df7-9ea6-6c82b27a59f8 (view SPL)DICLOXACILLIN SODIUM CAPSULES USP31233125Rx onlyprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-201545690384, 545691889
17e12a13dd-b93d-452c-8671-aec751ddaa4d (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-02-231165900076

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