metaxalone Oral Tablet

Brand(s)
Metaxall, Skelaxin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Corepharma, Llc (2012-02-16)
Oldest Current Product
1962-08-13
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\METAXALONE
FDAOB
ORAL\TABLET\METAXALONE
SPL Active
ORAL\TABLET\METAXALONE
SPL Moiety
ORAL\TABLET\METAXALONE

product(s) by strength(s)

metaxalone 400 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647200126ANDACorepharma, Llc2015-03-31METAXALONEORALTABLETANDA040486e3fc5cd2-7625-4e14-bc63-13d0825960f6

metaxalone 800 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647200321NDACorepharma, Llc2007-11-01METAXALONEORALTABLETNDA013217da237968-1c52-47c3-986b-4f878bd6b173

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850448ANDAEon Labs, Inc.2010-03-31METAXALONEORALTABLETANDA0404450aff6dda-b9fd-4f01-85b2-eb3097b760b0
2510210333MetaxallANDASircle Laboratories, Llc2015-09-25METAXALONEORALTABLETANDA20339922a8cbe9-3914-2881-e054-00144ff8d46c
3537460553ANDAAmneal Pharmaceuticals, Llc2013-05-31METAXALONEORALTABLETANDA203399f06f2b96-3684-483c-89f7-6c9201fd4664
4651620553ANDAAmneal Pharmaceuticals2013-05-31METAXALONEORALTABLETANDA2033993aa9dba9-29b0-4520-a0f7-66d19d52c6bc
5680010004ANDABluepoint Laboratories2014-04-22METAXALONEORALTABLETANDA20339952eb8992-136a-4338-8207-209038601d94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440002NDABlenheim Pharmacal, Inc.2010-05-20METAXALONEORALTABLET647200321NDA013217f001063b-6577-4b48-899c-b05684b5e2b1
2105440144ANDABlenheim Pharmacal, Inc.2013-09-11METAXALONEORALTABLET651620553ANDA203399117c6190-77a2-2036-e054-00144ff8d46c
3105440524SkelaxinNDABlenheim Pharmacal, Inc.2010-03-15METAXALONEORALTABLET607930136NDA01321711a55d5f-72b9-0b65-e054-00144ff88e88
4165900207SkelaxinNDAStat Rx Usa Llc2002-08-30METAXALONEORALTABLET607930136NDA0132175e1ec092-4748-47c6-9b72-1b826da0ce02
5165900346NDAStat Rx Usa Llc2007-11-01METAXALONEORALTABLET647200321NDA013217b2f5989a-deb8-4437-93a5-9277c00a3183
6216950123SkelaxinNDARebel Distributors Corp1962-08-13METAXALONEORALTABLET607930136NDA013217cb47d76e-a7e3-4bac-8074-8d7e95c6a6eb
7216950585ANDARebel Distributors Corp2010-03-31METAXALONEORALTABLET001850448ANDA04044521618014-77c1-4a35-acca-cd5678d7bb89
8332610724ANDAAidarex Pharmaceuticals Llc2013-05-31METAXALONEORALTABLET651620553ANDA2033995311bdb3-37a7-48d8-a5bb-5765b3d43fbc
9353560570NDALake Erie Medical Dba Quality Care Products Llc2011-12-06METAXALONEORALTABLET647200321NDA013217ac32ec3b-29f3-4008-8995-9c468bbd4318
10422540040NDARebel Distributors Corp2007-11-01METAXALONEORALTABLET647200321NDA013217b28a2d3c-69ca-4c97-915b-41135b9b5bc0
11422910587ANDAAvkare, Inc.2015-05-22METAXALONEORALTABLET537460553ANDA203399b0f165ff-027e-8a66-6083-6e808b838554
12425490650NDAStat Rx Usa Llc2007-11-01METAXALONEORALTABLET647200321NDA013217bcf9b39a-aa68-4f07-accb-9e9287c63068
13430630239NDAPd-Rx Pharmaceuticals, Inc.2007-11-01METAXALONEORALTABLET647200321NDA0132178e1493da-6e00-441b-a785-416c123e3c1a
14430630581NDAPd-Rx Pharmaceuticals, Inc.2007-11-01METAXALONEORALTABLET647200321NDA01321736827d11-e2cb-487a-a722-0a832bec70fa
15493490945NDARemedyrepack Inc.2012-03-29METAXALONEORALTABLET647200321NDA01321717bd31b6-887d-46ce-8c4b-1ceeffa0a258
16499990363SkelaxinNDALake Erie Medical Dba Quality Care Products Llc2011-12-14METAXALONEORALTABLET607930136NDA0132170485d087-a215-4f61-8687-4161b9a55f06
17502680530ANDAAvpak2015-03-13METAXALONEORALTABLET651620553ANDA2033999b21a974-6a5a-9efb-e9de-470363217126
18504363024NDAUnit Dose Services2007-11-01METAXALONEORALTABLET647200321NDA0132178605de17-f114-4d53-8192-744f0161e9ab
19516550162ANDANorthwind Pharmaceuticals, Llc2014-02-12METAXALONEORALTABLET651620553ANDA2033995a0f574e-df84-4682-83eb-87272a7f5294
20516550163NDANorthwind Pharmaceuticals, Llc2014-04-01METAXALONEORALTABLET647200321NDA0132174e5283d0-a1fb-467d-8832-4d833a1d43e4
21529590596NDAH.J. Harkins Company, Inc.2007-11-01METAXALONEORALTABLET647200321NDA0132171c410d74-2c12-4a6b-854e-8a03b5bf2fbf
22548684733SkelaxinNDAPhysicians Total Care, Inc.2003-01-30METAXALONEORALTABLET607930136NDA013217cb28abf4-608f-4dcb-b179-9dcf71274dbb
23548686102ANDAPhysicians Total Care, Inc.2010-04-07METAXALONEORALTABLET001850448ANDA040445c3ad15a2-c518-45f3-a322-9ddcfe4bae77
24551543650SkelaxinNDACardinal Health2002-08-30METAXALONEORALTABLET607930136NDA01321724da58e8-86e8-4206-9ad3-4ebb27522cc8
25552890736SkelaxinNDAPd-Rx Pharmaceuticals, Inc.2002-08-30METAXALONEORALTABLET607930136NDA013217eca7792e-c07b-4a42-9b2b-48a4366b77a6
26581180553ANDAClinical Solutions Wholesale2013-05-31METAXALONEORALTABLET651620553ANDA2033993877b27f-43c4-4258-a6a5-8edcc10219c3
27607600054NDASt Marys Medical Park Pharmacy2011-01-30METAXALONEORALTABLET64720032110NDA0132177c577c9e-45cf-4e23-8db6-ea87d248f647
28619190262ANDADirect Rx2015-01-01METAXALONEORALTABLET651620553ANDA203399e8643c67-c531-4a4f-931d-0e3c91cfc0c8
29619190346NDADirect Rx2014-01-01METAXALONEORALTABLET647200321NDA01321761fc1a6a-ecfd-4467-b172-a11bebbc32d3
30631870490ANDAProficient Rx Lp2013-05-31METAXALONEORALTABLET651620553ANDA203399fba1601d-3ac4-41cf-9548-35ec4994a95e
31636292768NDABryant Ranch Prepack2007-11-01METAXALONEORALTABLET647200321NDA013217edc1656d-26f0-95c2-ee8f-50518fd5affd
32636294205NDABryant Ranch Prepack2007-11-01METAXALONEORALTABLET647200321NDA01321743671e90-7df9-8e45-f741-35ca6a8f3b65
33680840135ANDAAmerican Health Packaging2013-12-18METAXALONEORALTABLET680010004ANDA2033996aeb78ea-1d73-4d27-bedc-9a19f3bcccb2
34681514668NDACarilion Materials Management2007-11-01METAXALONEORALTABLET647200321NDA0132179b22176d-95af-46d6-b02b-6a45ccb115ec
35682587100NDADispensing Solutions, Inc.2007-11-01METAXALONEORALTABLET647200321NDA0132170755d115-dbf4-44ac-a02f-4d8a013902e3
36683870108ANDAKeltman Pharmaceuticals Inc.2008-06-25METAXALONEORALTABLET647200321ANDA04048683cfbe48-4b69-445a-9c13-742ea345830e
37687880881SkelaxinNDAPreferred Pharmaceuticals, Inc.2003-01-30METAXALONEORALTABLET647200321NDA013217d8684144-6c2d-4664-943a-2d3d2b46b1fc
38687889277ANDAPreferred Pharmaceuticals, Inc.2015-01-06METAXALONEORALTABLET651620553ANDA203399ae9d3f6f-8967-4e72-b1d0-e19afd1d1da5
39687889896NDAPreferred Pharmaceuticals, Inc.2014-02-14METAXALONEORALTABLET647200321NDA0132175c489585-7839-4701-8b26-bb84f0e970c1

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA040445METAXALONESANDOZ INC2010-03-31ANDA040445_001
2ANDA040486METAXALONECOREPHARMA LLC2015-02-27ANDA040486_001
3ANDA203399METAXALONEAMNEAL PHARMACEUTICALS2013-06-21ANDA203399_001
4NDA013217SKELAXINKING PHARMACEUTICALS INCp7714006, USE OF METAXALONE FOR TREATMENT OF MUSCULSKELETAL CONDITIONS
p7122566, TREATMENT OF MUSCULOSKELETAL CONDITIONS
NDA013217_001, NDA013217_003
5NDA022503METAXALONECOREPHARMA LLC2015-06-01NDA022503_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040445_001RXMETAXALONE (800MG)ORALTABLETFalseAB2010-03-31METAXALONE
2ANDA040486_001RXMETAXALONE (400MG)ORALTABLETFalse2015-02-27METAXALONE
3ANDA203399_001RXMETAXALONE (800MG)ORALTABLETFalseAB2013-06-21METAXALONE
4NDA013217_001discontinuedMETAXALONE (400MG)ORALTABLETFalseSKELAXIN
5NDA013217_003RXMETAXALONE (800MG)ORALTABLETTrueAB2002-08-30SKELAXIN
6NDA022503_001RXMETAXALONE (640MG)ORALTABLETFalse2015-06-01METAXALONE

patent(s)

#idexpiration dateapplication(s)
1p7122566 (view patent)2026-02-06NDA013217
2p7714006 (view patent)2021-12-03NDA013217

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10485d087-a215-4f61-8687-4161b9a55f06 (view SPL)SKELAXIN (Metaxalone) TabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2011-12-143382499990363
20755d115-dbf4-44ac-a02f-4d8a013902e3 (view SPL)METAXALONE TABLETS 800 mgprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2011-09-221682587100
30aff6dda-b9fd-4f01-85b2-eb3097b760b0 (view SPL)Metaxalone Tablets, 800 mgprescriptionHuman PrescriptionEon Labs, Inc.2011-09-2312001850448
4117c6190-77a2-2036-e054-00144ff8d46c (view SPL)Metaxalone TabletsprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-09-023105440144
511a55d5f-72b9-0b65-e054-00144ff88e88 (view SPL)SKELAXIN (Metaxalone) TabletsprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-03-191105440524
617bd31b6-887d-46ce-8c4b-1ceeffa0a258 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-03-291493490945
71c410d74-2c12-4a6b-854e-8a03b5bf2fbf (view SPL)METAXALONE TABLETS 800 mgprescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-08-151529590596
821618014-77c1-4a35-acca-cd5678d7bb89 (view SPL)Metaxalone Tablets, 800 mgprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-10-041216950585
922a8cbe9-3914-2881-e054-00144ff8d46c (view SPL)prescriptionHuman PrescriptionSircle Laboratories, Llc2015-10-211510210333
1024da58e8-86e8-4206-9ad3-4ebb27522cc8 (view SPL)SKELAXIN (Metaxalone) TabletsprescriptionHuman PrescriptionCardinal HealthREPACK2011-08-042551543650
1136827d11-e2cb-487a-a722-0a832bec70fa (view SPL)Metaxalone Tablets800 mgprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-02-166430630581
123877b27f-43c4-4258-a6a5-8edcc10219c3 (view SPL)Metaxalone TabletsprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2013-10-181581180553
133aa9dba9-29b0-4520-a0f7-66d19d52c6bc (view SPL)Metaxalone TabletsprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2013-04-192651620553
1443671e90-7df9-8e45-f741-35ca6a8f3b65 (view SPL)METAXALONE TABLETSprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-143636294205
154e5283d0-a1fb-467d-8832-4d833a1d43e4 (view SPL)prescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-06-031516550163
1652eb8992-136a-4338-8207-209038601d94 (view SPL)Metaxalone TabletsprescriptionHuman PrescriptionBluepoint LaboratoriesANALYSIS, LABEL, MANUFACTURE, PACK2015-06-124680010004
175311bdb3-37a7-48d8-a5bb-5765b3d43fbc (view SPL)Metaxalone TabletsprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-131332610724
185a0f574e-df84-4682-83eb-87272a7f5294 (view SPL)prescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-06-031516550162
195c489585-7839-4701-8b26-bb84f0e970c1 (view SPL)Metaxalone Tablets800 mgprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-02-102687889896
205e1ec092-4748-47c6-9b72-1b826da0ce02 (view SPL)SKELAXIN (Metaxalone) TabletsprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-08-151165900207
2161fc1a6a-ecfd-4467-b172-a11bebbc32d3 (view SPL)METAXALONEprescriptionHuman PrescriptionDirect Rxrelabel, repack2014-11-141619190346
226aeb78ea-1d73-4d27-bedc-9a19f3bcccb2 (view SPL)Metaxalone TabletsprescriptionHuman PrescriptionAmerican Health PackagingREPACK2013-12-181680840135
237a4163f2-c553-4d14-7e98-d14c5c7f772a (view SPL)SKELAXIN (Metaxalone) TabletsprescriptionHuman PrescriptionPfizer Laboratories Div Pfizer IncANALYSIS, LABEL, MANUFACTURE, PACK2015-11-047607930136
247c577c9e-45cf-4e23-8db6-ea87d248f647 (view SPL)MetaxaloneprescriptionHuman PrescriptionSt Marys Medical Park Pharmacy2011-01-301607600054
2583cfbe48-4b69-445a-9c13-742ea345830e (view SPL)Metaxalone Tablets, 800 mgprescriptionHuman PrescriptionKeltman Pharmaceuticals Inc.repack2010-09-271683870108
268605de17-f114-4d53-8192-744f0161e9ab (view SPL)METAXALONE TABLETS 800 mgprescriptionHuman PrescriptionUnit Dose ServicesREPACK2011-01-142504363024
278e1493da-6e00-441b-a785-416c123e3c1a (view SPL)Metaxalone Tablets800 mgprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-02-168430630239
289b21a974-6a5a-9efb-e9de-470363217126 (view SPL)Metaxalone TabletsprescriptionHuman PrescriptionAvpak2015-03-241502680530
299b22176d-95af-46d6-b02b-6a45ccb115ec (view SPL)Metaxalone Tablets800 mgprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-02-162681514668
30ac32ec3b-29f3-4008-8995-9c468bbd4318 (view SPL)METAXALONE TABLETS 800 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2011-12-053319353560570
31ae9d3f6f-8967-4e72-b1d0-e19afd1d1da5 (view SPL)Metaxalone TabletsprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-02-101687889277
32b0f165ff-027e-8a66-6083-6e808b838554 (view SPL)Metaxalone TabletsprescriptionHuman PrescriptionAvkare, Inc.2015-05-221422910587
33b28a2d3c-69ca-4c97-915b-41135b9b5bc0 (view SPL)METAXALONE TABLETS 800 mgprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-12-131422540040
34b2f5989a-deb8-4437-93a5-9277c00a3183 (view SPL)Metaxalone Tablets800 mgprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-09-282165900346
35bcf9b39a-aa68-4f07-accb-9e9287c63068 (view SPL)METAXALONE TABLETS 800 mgprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-02-271425490650
36c3ad15a2-c518-45f3-a322-9ddcfe4bae77 (view SPL)Metaxalone Tablets, 800 mgprescriptionHuman PrescriptionPhysicians Total Care, Inc.RELABEL, REPACK2010-03-314548686102
37cb28abf4-608f-4dcb-b179-9dcf71274dbb (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-07-211548684733
38cb47d76e-a7e3-4bac-8074-8d7e95c6a6eb (view SPL)SKELAXIN (Metaxalone) TabletsprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-041216950123
39d8684144-6c2d-4664-943a-2d3d2b46b1fc (view SPL)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.relabel, repack2011-05-035687880881
40da237968-1c52-47c3-986b-4f878bd6b173 (view SPL)Metaxalone Tablets800 mgprescriptionHuman PrescriptionCorepharma, LlcANALYSIS, LABEL, MANUFACTURE, PACK2012-02-165647200321
41e3fc5cd2-7625-4e14-bc63-13d0825960f6 (view SPL)Metaxalone Tablets400 mgRx OnlyprescriptionHuman PrescriptionCorepharma, LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-02-063647200126
42e8643c67-c531-4a4f-931d-0e3c91cfc0c8 (view SPL)METAXALONE- metaxalone tabletprescriptionHuman PrescriptionDirect Rxrepack2015-06-231619190262
43eca7792e-c07b-4a42-9b2b-48a4366b77a6 (view SPL)SKELAXIN (Metaxalone) TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-09-066552890736
44edc1656d-26f0-95c2-ee8f-50518fd5affd (view SPL)METAXALONE TABLETSprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-124636292768
45f001063b-6577-4b48-899c-b05684b5e2b1 (view SPL)METAXALONE TABLETS 800 mgprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2011-06-062105440002
46f06f2b96-3684-483c-89f7-6c9201fd4664 (view SPL)Metaxalone TabletsprescriptionHuman PrescriptionAmneal Pharmaceuticals, LlcANALYSIS, LABEL, MANUFACTURE, PACK2014-08-292537460553
47fba1601d-3ac4-41cf-9548-35ec4994a95e (view SPL)Metaxalone TabletsprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870490

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