Methadone Oral Solution

Brand(s)
Methadose
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mallinckrodt, Inc. (2014-10-01)
Oldest Current Product
1981-05-22
License(s)
NDA, ANDA
RxNORM
ORAL SOLUTION\METHADONE
FDAOB
ORAL\CONCENTRATE\METHADONE HYDROCHLORIDE
ORAL\SOLUTION\METHADONE HYDROCHLORIDE
SPL Active
ORAL\CONCENTRATE\METHADONE HYDROCHLORIDE
ORAL\SOLUTION\METHADONE HYDROCHLORIDE
SPL Moiety
ORAL\CONCENTRATE\METHADONE
ORAL\SOLUTION\METHADONE

product(s) by strength(s)

methadone hydrochloride 0.333 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004068725MethadoseNDAMallinckrodt, Inc.2010-03-10METHADONE HYDROCHLORIDEORALCONCENTRATENDA017116808a9d0b-720b-4034-a862-5122ff514608

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540391ANDARoxane Laboratories, Inc1988-04-30METHADONE HYDROCHLORIDEORALCONCENTRATEANDA089897e72841bf-364b-49b1-8e69-7e26ddcd2657
2000540392ANDARoxane Laboratories, Inc1988-04-30METHADONE HYDROCHLORIDEORALCONCENTRATEANDA040180e72841bf-364b-49b1-8e69-7e26ddcd2657
3000543553ANDARoxane Laboratories, Inc1988-09-06METHADONE HYDROCHLORIDEORALCONCENTRATEANDA089897d0e6a966-179a-45e0-8444-4c1b8523f8d2
4666890694ANDAVistapharm Inc.2009-10-30METHADONE HYDROCHLORIDEORALCONCENTRATEANDA040088d5bd3e97-b3f6-4bc2-9fb7-02921be35cdb
5666890695ANDAVistapharm Inc.2011-12-01METHADONE HYDROCHLORIDEORALCONCENTRATEANDA040088d5bd3e97-b3f6-4bc2-9fb7-02921be35cdb

methadone hydrochloride 1 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543555ANDARoxane Laboratories, Inc1981-05-22METHADONE HYDROCHLORIDEORALSOLUTIONANDA0873938c363f90-c378-48ae-abbc-aeb25c9bf5cb
2666890711ANDAVistapharm Inc.2010-08-01METHADONE HYDROCHLORIDEORALSOLUTIONANDA0907077ff89589-149c-4007-8144-5f60131b8c33

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1178563555ANDAAtlantic Biologicals Corps1981-05-22METHADONE HYDROCHLORIDEORALSOLUTION000543555ANDA087393c3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb

methadone hydrochloride 2 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543556ANDARoxane Laboratories, Inc1982-08-30METHADONE HYDROCHLORIDEORALSOLUTIONANDA0879978c363f90-c378-48ae-abbc-aeb25c9bf5cb
2666890712ANDAVistapharm Inc.2010-08-01METHADONE HYDROCHLORIDEORALSOLUTIONANDA0907077ff89589-149c-4007-8144-5f60131b8c33

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA040088METHADONE HYDROCHLORIDEVISTAPHARM INC1994-11-30ANDA040088_001
2ANDA040180METHADONE HYDROCHLORIDEROXANE LABORATORIES INC1998-04-30ANDA040180_001
3ANDA087393METHADONE HYDROCHLORIDEROXANE LABORATORIES INCANDA087393_001
4ANDA087997METHADONE HYDROCHLORIDEROXANE LABORATORIES INC1982-08-30ANDA087997_001
5ANDA089897METHADONE HYDROCHLORIDE INTENSOLROXANE LABORATORIES INC1988-09-06ANDA089897_001
6ANDA090707METHADONE HYDROCHLORIDEVISTAPHARM INC2010-06-30ANDA090707_001, ANDA090707_002
7NDA017116METHADOSEMALLINCKRODT CHEMICAL INCNDA017116_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040088_001RXMETHADONE HYDROCHLORIDE (10MG/ML)ORALCONCENTRATEFalseAA1994-11-30METHADONE HYDROCHLORIDE
2ANDA040180_001RXMETHADONE HYDROCHLORIDE (10MG/ML)ORALCONCENTRATEFalseAA1998-04-30METHADONE HYDROCHLORIDE
3ANDA087393_001RXMETHADONE HYDROCHLORIDE (5MG/5ML)ORALSOLUTIONTrueAAMETHADONE HYDROCHLORIDE
4ANDA087997_001RXMETHADONE HYDROCHLORIDE (10MG/5ML)ORALSOLUTIONTrueAA1982-08-30METHADONE HYDROCHLORIDE
5ANDA089897_001RXMETHADONE HYDROCHLORIDE (10MG/ML)ORALCONCENTRATEFalseAA1988-09-06METHADONE HYDROCHLORIDE INTENSOL
6ANDA090707_001RXMETHADONE HYDROCHLORIDE (5MG/5ML)ORALSOLUTIONFalseAA2010-06-30METHADONE HYDROCHLORIDE
7ANDA090707_002RXMETHADONE HYDROCHLORIDE (10MG/5ML)ORALSOLUTIONFalseAA2010-06-30METHADONE HYDROCHLORIDE
8NDA017116_002RXMETHADONE HYDROCHLORIDE (10MG/ML)ORALCONCENTRATETrueAAMETHADOSE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
17ff89589-149c-4007-8144-5f60131b8c33 (view SPL)These highlights do not include all the information needed to use Methadone Hydrochloride Oral Solution safely and effectively. See full prescribing information for Methadone Hydrochloride Oral Solution METHADONE hydrochloride oral solution, USP CII.Initial U.S. Approval: 1947prescriptionHuman PrescriptionVistapharm Inc.ANALYSIS, MANUFACTURE2014-09-225666890711, 666890712
2808a9d0b-720b-4034-a862-5122ff514608 (view SPL)Methadose Oral Concentrate(methadone hydrochloride oral concentrate USP) and Methadose Sugar-Free Oral Concentrate(methadone hydrochloride oral concentrate USP)dye-free, sugar-free, unflavored CII Rx only FOR ORAL USE ONLYprescriptionHuman PrescriptionMallinckrodt, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-10-0111004068725, 004060527
38c363f90-c378-48ae-abbc-aeb25c9bf5cb (view SPL)These highlights do not include all the information needed to use METHADONE Hydrochloride Oral Solution USP safely and effectively. See full prescribing information for METHADONE Hydrochloride Oral Solution USP. METHADONE Hydrochloride Oral Solution USP, for oral use, CII Initial U.S. Approval: 1947prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-04-305000543555, 000543556
4c3c1b3f7-3bb1-4864-b634-8fc9dbaac9bb (view SPL)These highlights do not include all the information needed to use Methadone Hydrochloride Oral Solution USP safely and effectively. See full prescribing information for Methadone Hydrochloride Oral Solution USP. METHADONE Hydrochloride Oral Solution USP, for oral use, CII Initial U.S. Approval: 1947prescriptionHuman PrescriptionAtlantic Biologicals Corpsrelabel, repack2015-04-233178563555
5d0e6a966-179a-45e0-8444-4c1b8523f8d2 (view SPL)These highlights do not include all the information needed to use METHADONE hydrochloride Intensol TM (oral concentrate USP) safely and effectively. See full prescribing information for METHADONE hydrochloride Intensol TM (oral concentrate USP) METHADONE hydrochloride Intensol TM (oral concentrate USP), for oral use, CIIInitial U.S. Approval: 1947prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-04-174000543553
6d5bd3e97-b3f6-4bc2-9fb7-02921be35cdb (view SPL)Methadone Hydrochloride Oral Concentrate, USPandMethadone Hydrochloride Oral Concentrate, USP (Dye-Free, Sugar-Free, Unflavored)10 mg/mLCIIprescriptionHuman PrescriptionVistapharm Inc.ANALYSIS, MANUFACTURE, REPACK2011-11-293666890694, 666890695
7e72841bf-364b-49b1-8e69-7e26ddcd2657 (view SPL)Methadone Hydrochloride Oral Concentrate USP, 10 mg per mL(Dye-Free, Sugar-Free, Unflavored) andMethadone Hydrochloride Oral Concentrate USP, 10 mg per mL(Cherry)prescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-08-217000540391, 000540392

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