Guaifenesin / Pseudoephedrine Extended Release Oral Tablet

Brand(s)
Mucinex D
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Reckitt Benckiser Llc (2012-08-10)
Oldest Current Product
2008-01-07
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\GUAIFENESIN:PSEUDOEPHEDRINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\GUAIFENESIN: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\GUAIFENESIN: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\GUAIFENESIN: PSEUDOEPHEDRINE

product(s) by strength(s)

12 hr guaifenesin 1200 mg / pseudoephedrine hydrochloride 120 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1638240041Mucinex DNDAReckitt Benckiser Llc2012-06-26GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA021585d9264518-2f2c-498f-b733-6f3397336a01

12 hr guaifenesin 600 mg / pseudoephedrine hydrochloride 60 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1638240057Mucinex DNDAReckitt Benckiser Llc2012-06-26GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA021585d5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685849Mucinex DNDAPhysicians Total Care, Inc.2008-01-07GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, EXTENDED RELEASE638240057NDA0215859ae3a598-a423-4007-9ca6-95c687cb56d5
2682583035Mucinex DNDADispensing Solutions, Inc.2008-02-08GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEORALTABLET, EXTENDED RELEASE63824005718NDA02158598149172-3ec7-4212-9a37-5501bbfb5829

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA091071GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEACTAVIS LABORATORIES FL INC2015-05-27ANDA091071_001, ANDA091071_002
2NDA021585MUCINEX DRECKITT BENCKISER LLC2004-06-22p6372252, SUBSTANCE
p6955821, EXPECTORANT AND NASAL DECONGESTANT, SUBSTANCE
p7838032, SUBSTANCE
NDA021585_001, NDA021585_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA091071_001OTCPSEUDOEPHEDRINE HYDROCHLORIDE (60MG), GUAIFENESIN (600MG)ORALTABLET, EXTENDED RELEASEFalse2015-05-27GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
2ANDA091071_002OTCGUAIFENESIN (1.2GM), PSEUDOEPHEDRINE HYDROCHLORIDE (120MG)ORALTABLET, EXTENDED RELEASEFalse2015-05-27GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
3NDA021585_001OTCPSEUDOEPHEDRINE HYDROCHLORIDE (60MG), GUAIFENESIN (600MG)ORALTABLET, EXTENDED RELEASEFalse2004-06-22MUCINEX D
4NDA021585_002OTCPSEUDOEPHEDRINE HYDROCHLORIDE (120MG), GUAIFENESIN (1.2GM)ORALTABLET, EXTENDED RELEASETrue2004-06-22MUCINEX D

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6372252 (view patent)2020-04-28NDA021585, NDA021282, NDA021620Dextromethorphan / Guaifenesin Extended Release Oral Tablet
Guaifenesin Extended Release Oral Tablet
2p6955821 (view patent)2020-04-28NDA021585, NDA021282, NDA021620Dextromethorphan / Guaifenesin Extended Release Oral Tablet
Guaifenesin Extended Release Oral Tablet
3p7838032 (view patent)2020-04-28NDA021585, NDA021282, NDA021620Dextromethorphan / Guaifenesin Extended Release Oral Tablet
Guaifenesin Extended Release Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
198149172-3ec7-4212-9a37-5501bbfb5829 (view SPL)MucinexDprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2010-03-021682583035
29ae3a598-a423-4007-9ca6-95c687cb56d5 (view SPL)MucinexDotcHuman OTCPhysicians Total Care, Inc.relabel2009-12-231548685849
3d5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f (view SPL)MucinexDotcHuman OTCReckitt Benckiser Llc2012-07-254638240057
4d9264518-2f2c-498f-b733-6f3397336a01 (view SPL)MucinexDotcHuman OTCReckitt Benckiser Llc2012-08-106638240041

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