Methadone Oral Tablet

Brand(s)
Dolophine, Methadose
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2015-04-24)
Oldest Current Product
1947-08-13
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\METHADONE
FDAOB
ORAL\SYRUP\METHADONE HYDROCHLORIDE
ORAL\TABLET\METHADONE HYDROCHLORIDE
SPL Active
ORAL\TABLET\METHADONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\METHADONE

product(s) by strength(s)

methadone hydrochloride 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000544219DolophineNDARoxane Laboratories, Inc1947-08-13METHADONE HYDROCHLORIDEORALTABLETNDA0061347a4840d6-98e3-4523-81a0-ef0b3a47d0c2
2000544571NDARoxane Laboratories, Inc1947-08-13METHADONE HYDROCHLORIDEORALTABLETNDA006134802ab399-479b-4271-a2a7-07aadde91cff

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004065771ANDAMallinckrodt, Inc.2009-05-19METHADONE HYDROCHLORIDEORALTABLETANDA040517eddf7077-02fb-4771-9823-31984f4ff2bb
2131070089ANDAAurolife Pharma Llc2015-09-15METHADONE HYDROCHLORIDEORALTABLETANDA2035026984eb5a-57a3-4686-bc67-91bc3e7a531e
3666890810ANDAVistapharm Inc.1998-05-29METHADONE HYDROCHLORIDEORALTABLETANDA040241d3b7a707-78af-4fd5-9b66-b63050bbd6f6
4678770116ANDAAscend Laboratories, Llc2012-01-16METHADONE HYDROCHLORIDEORALTABLETANDA090635aa8e14c1-fbfd-4e4d-b59e-2d4ae1ca815f

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560834NDALake Erie Medical Dba Quality Care Products Llc1947-08-13METHADONE HYDROCHLORIDEORALTABLET000544571NDA006134db37a292-5685-4f10-92fc-57631e1a25f9
2425490578ANDAStat Rx Usa Llc2009-05-19METHADONE HYDROCHLORIDEORALTABLET004065771ANDA040517a36705c4-867f-41f1-94c9-78b8b31836ce
3499990839ANDALake Erie Medical Dba Quality Care Products Llc2010-10-11, 2012-02-06METHADONE HYDROCHLORIDEORALTABLET004065771ANDA04051704d04496-36bb-46df-a6e9-5c8aa8578222, 1deb3865-48b5-4860-880f-625f912d7ed4
4529590386ANDAH.J. Harkins Company, Inc.2009-05-19METHADONE HYDROCHLORIDEORALTABLET004065755ANDA0405173c926b78-999e-4d26-9498-7f1bcaf0b992
5548684948ANDAPhysicians Total Care, Inc.2004-01-07METHADONE HYDROCHLORIDEORALTABLET004065771ANDA040517cf10ec82-1f41-45c0-b438-5ade38b5625a
6552890814DolophineNDAPd-Rx Pharmaceuticals, Inc.2010-01-01METHADONE HYDROCHLORIDEORALTABLET000544571NDA0061344a3b2bc3-d837-4ca9-aee1-452633b6a06b
7619190670NDADirect Rx2014-01-01METHADONE HYDROCHLORIDEORALTABLET000544571NDA006134af2fa7bc-5d43-47d8-835e-b9adc565600a
8636293771ANDABryant Ranch Prepack2009-05-19METHADONE HYDROCHLORIDEORALTABLET004065771ANDA04051720127592-3a20-e280-2c70-f3d4e1ce009f
9680840738ANDAAmerican Health Packaging2014-10-02METHADONE HYDROCHLORIDEORALTABLET678770116ANDA0906355e23b861-c635-4749-9c2a-be9d4a501823

methadone hydrochloride 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000544218DolophineNDARoxane Laboratories, Inc1947-08-13METHADONE HYDROCHLORIDEORALTABLETNDA0061347a4840d6-98e3-4523-81a0-ef0b3a47d0c2
2000544570NDARoxane Laboratories, Inc1947-08-13METHADONE HYDROCHLORIDEORALTABLETNDA006134802ab399-479b-4271-a2a7-07aadde91cff

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1004065755ANDAMallinckrodt, Inc.2009-05-19METHADONE HYDROCHLORIDEORALTABLETANDA040517eddf7077-02fb-4771-9823-31984f4ff2bb
2004066974MethadoseANDAMallinckrodt, Inc.2010-02-232017-01-31METHADONE HYDROCHLORIDEORALTABLETANDA0400506059a68d-5434-4a0e-9f53-b793c3dc8630
3131070088ANDAAurolife Pharma Llc2015-09-15METHADONE HYDROCHLORIDEORALTABLETANDA2035026984eb5a-57a3-4686-bc67-91bc3e7a531e

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900689NDAStat Rx Usa Llc1947-08-13METHADONE HYDROCHLORIDEORALTABLET000544570NDA006134ec41ab86-a948-44e4-b21c-c65a22cdf294
2353560835NDALake Erie Medical Dba Quality Care Products Llc1947-08-13METHADONE HYDROCHLORIDEORALTABLET000544570NDA006134db37a292-5685-4f10-92fc-57631e1a25f9
3425490577ANDAStat Rx Usa Llc2009-05-19METHADONE HYDROCHLORIDEORALTABLET004065755ANDA040517a36705c4-867f-41f1-94c9-78b8b31836ce
4430630222DolophineNDAPd-Rx Pharmaceuticals, Inc.2010-01-01METHADONE HYDROCHLORIDEORALTABLET000544570NDA006134f2057290-4286-4581-9711-50a0a834e228
5499990963ANDALake Erie Medical Dba Quality Care Products Llc2010-09-15, 2010-10-04METHADONE HYDROCHLORIDEORALTABLET004065755ANDA040517052cc172-e3f8-436a-ad92-234c3b7b4e38, cf106b94-9c17-4a22-a1ba-ad45d32b41ce
6529590435ANDAH.J. Harkins Company, Inc.2009-05-19METHADONE HYDROCHLORIDEORALTABLET004065771ANDA0405173c926b78-999e-4d26-9498-7f1bcaf0b992
7548685701ANDAPhysicians Total Care, Inc.2007-03-12METHADONE HYDROCHLORIDEORALTABLET004065755ANDA040517cf10ec82-1f41-45c0-b438-5ade38b5625a
8636293788ANDABryant Ranch Prepack2009-05-19METHADONE HYDROCHLORIDEORALTABLET004065755ANDA0405170b72a120-ca4e-4b90-7d89-52967a39adb3

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040050METHADOSEMALLINCKRODT CHEMICAL INC1993-04-15ANDA040050_001, ANDA040050_002
2ANDA040241METHADONE HYDROCHLORIDESANDOZ INC1998-05-29ANDA040241_001, ANDA040241_002
3ANDA040517METHADONE HYDROCHLORIDEMALLINCKRODT INC2004-04-27ANDA040517_001, ANDA040517_002
4ANDA074081METHADONE HYDROCHLORIDETrueROXANE LABORATORIES INC1995-04-28ANDA074081_001
5ANDA088108METHADONE HYDROCHLORIDETrueROXANE LABORATORIES INC1983-03-08ANDA088108_001
6ANDA088109METHADONE HYDROCHLORIDETrueROXANE LABORATORIES INC1983-03-08ANDA088109_001
7ANDA090065METHADONE HYDROCHLORIDECOREPHARMA LLC2015-08-18ANDA090065_001, ANDA090065_002
8ANDA090635METHADONE HYDROCHLORIDETHE PHARMANETWORK LLC2009-11-25ANDA090635_001
9ANDA203502METHADONE HYDROCHLORIDEAUROLIFE PHARMA LLC2015-08-31ANDA203502_001, ANDA203502_002
10NDA006134DOLOPHINE HYDROCHLORIDEROXANE LABORATORIES INCNDA006134_002, NDA006134_004, NDA006134_010

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040050_001RXMETHADONE HYDROCHLORIDE (5MG)ORALTABLETFalseAA1993-04-15METHADOSE
2ANDA040050_002RXMETHADONE HYDROCHLORIDE (10MG)ORALTABLETFalseAA1993-04-15METHADOSE
3ANDA040241_001discontinuedMETHADONE HYDROCHLORIDE (5MG)ORALTABLETFalse1998-05-29METHADONE HYDROCHLORIDE
4ANDA040241_002RXMETHADONE HYDROCHLORIDE (10MG)ORALTABLETFalseAA1998-05-29METHADONE HYDROCHLORIDE
5ANDA040517_001RXMETHADONE HYDROCHLORIDE (5MG)ORALTABLETFalseAA2004-04-27METHADONE HYDROCHLORIDE
6ANDA040517_002RXMETHADONE HYDROCHLORIDE (10MG)ORALTABLETFalseAA2004-04-27METHADONE HYDROCHLORIDE
7ANDA074081_001discontinuedMETHADONE HYDROCHLORIDE (40MG)ORALTABLETFalse1995-04-28METHADONE HYDROCHLORIDE
8ANDA088108_001discontinuedMETHADONE HYDROCHLORIDE (5MG)ORALTABLETFalse1983-03-08METHADONE HYDROCHLORIDE
9ANDA088109_001discontinuedMETHADONE HYDROCHLORIDE (10MG)ORALTABLETFalse1983-03-08METHADONE HYDROCHLORIDE
10ANDA090065_001RXMETHADONE HYDROCHLORIDE (5MG)ORALTABLETFalseAA2015-08-18METHADONE HYDROCHLORIDE
11ANDA090065_002RXMETHADONE HYDROCHLORIDE (10MG)ORALTABLETFalseAA2015-08-18METHADONE HYDROCHLORIDE
12ANDA090635_001RXMETHADONE HYDROCHLORIDE (10MG)ORALTABLETFalseAA2009-11-25METHADONE HYDROCHLORIDE
13ANDA203502_001RXMETHADONE HYDROCHLORIDE (5MG)ORALTABLETFalseAA2015-08-31METHADONE HYDROCHLORIDE
14ANDA203502_002RXMETHADONE HYDROCHLORIDE (10MG)ORALTABLETFalseAA2015-08-31METHADONE HYDROCHLORIDE
15NDA006134_002RXMETHADONE HYDROCHLORIDE (5MG)ORALTABLETTrueAADOLOPHINE HYDROCHLORIDE
16NDA006134_004discontinuedMETHADONE HYDROCHLORIDE (10MG/30ML)ORALSYRUPFalseDOLOPHINE HYDROCHLORIDE
17NDA006134_010RXMETHADONE HYDROCHLORIDE (10MG)ORALTABLETTrueAADOLOPHINE HYDROCHLORIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
104d04496-36bb-46df-a6e9-5c8aa8578222 (view SPL)Methadone Hydochloride 10mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-10-28426499990839
2052cc172-e3f8-436a-ad92-234c3b7b4e38 (view SPL)Methadone Hydrochloride 5 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, repack2010-09-15387499990963
30b72a120-ca4e-4b90-7d89-52967a39adb3 (view SPL)METHADONE HYDROCHLORIDE TABLETS USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-173636293788
41deb3865-48b5-4860-880f-625f912d7ed4 (view SPL)Methadone Hydochloride 10mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-10-103540499990839
520127592-3a20-e280-2c70-f3d4e1ce009f (view SPL)OXYCODONE AND ACETAMINOPHENprescriptionHuman PrescriptionBryant Ranch PrepackANALYSIS, MANUFACTURE, RELABEL, REPACK2012-10-125636293771
63c926b78-999e-4d26-9498-7f1bcaf0b992 (view SPL)METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mgCIIRx onlyprescriptionHuman PrescriptionH.J. Harkins Company, Inc.analysis, manufacture2011-12-083529590386, 529590435
74a3b2bc3-d837-4ca9-aee1-452633b6a06b (view SPL)DOLOPHINE HYDROCHLORIDE CII(Methadone Hydrochloride Tablets, USP)5 mg, 10 mgprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-09-2910552890814
85e23b861-c635-4749-9c2a-be9d4a501823 (view SPL)These highlights do not include all the information needed to use methadone hydrochloride tablets safely and effectively. See full prescribing information for methadone hydrochloride tablets. Methadone Hydrochloride Tablets, for oral use, CII.Initial U.S. Approval: 1947prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-02-132680840738
96059a68d-5434-4a0e-9f53-b793c3dc8630 (view SPL)These highlights do not include all the information needed to use Methadose Oral Tablets (methadone hydrochloride tablets USP) safely and effectively. See full prescribing information for Methadose Oral Tablets (methadone hydrochloride tablets USP). Methadose Oral Tablets (methadone hydrochloride tablets USP), for oral use, CII Initial U.S. Approval: 1947prescriptionHuman PrescriptionMallinckrodt, Inc.ANALYSIS, MANUFACTURE2014-04-3015004066974
106984eb5a-57a3-4686-bc67-91bc3e7a531e (view SPL)These highlights do not include all the information needed to use methadone hydrochloride tablets safely and effectively. See full prescribing information for methadone hydrochloride tablets. METHADONE Hydrochloride Tablets USP, for oral use, CII Initial U.S. Approval: 1947prescriptionHuman PrescriptionAurolife Pharma LlcMANUFACTURE2015-07-153131070088, 131070089
117a4840d6-98e3-4523-81a0-ef0b3a47d0c2 (view SPL)These highlights do not include all the information needed to use DOLOPHINE safely and effectively. See full prescribing information for DOLOPHINE.DOLOPHINE (methadone hydrochloride) tablets, for oral use, CIIInitial U.S. Approval: 1947prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-04-0310000544218, 000544219
12802ab399-479b-4271-a2a7-07aadde91cff (view SPL)These highlights do not include all the information needed to use Methadone Hydrochloride Tablets USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets USP.Methadone Hydrochloride Tablets USP, for oral use, CIIInitial U.S. Approval: 1947prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-04-245000544570, 000544571, 000548553, 000548554
13a36705c4-867f-41f1-94c9-78b8b31836ce (view SPL)METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mgCIIRx onlyprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-04-201425490577, 425490578
14aa8e14c1-fbfd-4e4d-b59e-2d4ae1ca815f (view SPL)These highlights do not include all the information needed to use methadone hydrochloride tablets safely and effectively. See full prescribing information for methadone hydrochloride tablets. METHADONE Hydrochloride Tablets, for oral use, CIIInitial U.S. Approval: 1947prescriptionHuman PrescriptionAscend Laboratories, Llcmanufacture2015-07-015678770116
15af2fa7bc-5d43-47d8-835e-b9adc565600a (view SPL)METHADONE HYDROCHLORIDEprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-04-071619190670
16cf106b94-9c17-4a22-a1ba-ad45d32b41ce (view SPL)Methadone Hydrochloride 5 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, repack2010-10-04409499990963
17cf10ec82-1f41-45c0-b438-5ade38b5625a (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-06-141548684948, 548685701
18d3b7a707-78af-4fd5-9b66-b63050bbd6f6 (view SPL)These highlights do not include all the information needed to use methadone hydrochloride tablets, USP safely and effectively. See full prescribing information for methadone hydrochloride tablets, USP. METHADONE hydrochloride tablets, USP for oral use, CIIInitial U.S. Approval: 1947prescriptionHuman PrescriptionVistapharm Inc.2015-06-0915666890810
19db37a292-5685-4f10-92fc-57631e1a25f9 (view SPL)These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP.Initial U.S. Approval: 1947prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-03-201353560834, 353560835
20ec41ab86-a948-44e4-b21c-c65a22cdf294 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-11-051165900689
21eddf7077-02fb-4771-9823-31984f4ff2bb (view SPL)These highlights do not include all the information needed to use Methadone Hydrochloride Tablets USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets USP. METHADONE Hydrochloride Tablets USP, for oral use, CII Initial U.S. Approval: 1947prescriptionHuman PrescriptionMallinckrodt, Inc.ANALYSIS, MANUFACTURE2015-04-1920004065755, 004065771
22f2057290-4286-4581-9711-50a0a834e228 (view SPL)DOLOPHINE HYDROCHLORIDE CII(Methadone Hydrochloride Tablets, USP)5 mg, 10 mgprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-09-297430630222

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