Guaifenesin / Hydrocodone / Pseudoephedrine Oral Solution

Brand(s)
Hycofenix
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mission Pharmacal Company (2015-08-18)
Oldest Current Product
2015-08-18
License(s)
NDA
RxNORM
ORAL SOLUTION\GUAIFENESIN:HYDROCODONE:PSEUDOEPHEDRINE
FDAOB
ORAL\SOLUTION\GUAIFENESIN: HYDROCODONE BITARTRATE: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Active
ORAL\LIQUID\GUAIFENESIN: HYDROCODONE BITARTRATE: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Moiety
ORAL\LIQUID\GUAIFENESIN: HYDROCODONE: PSEUDOEPHEDRINE

product(s) by strength(s)

guaifenesin 40 mg/ml / hydrocodone 0.5 mg/ml / pseudoephedrine hydrochloride 6 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001783291HycofenixNDAMission Pharmacal Company2015-08-18GUAIFENESIN, HYDROCODONE BITARTRATE, PSEUDOEPHEDRINE HYDROCHLORIDEORALLIQUIDNDA0222791cfa7c8f-0309-3591-e054-00144ff8d46c

application(s)

#idtitleapplicantapprovedapproved drug
1NDA022279HYCOFENIXMIKART INC2015-05-14NDA022279_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022279_001RXPSEUDOEPHEDRINE HYDROCHLORIDE (30MG/5ML), GUAIFENESIN (200MG/5ML), HYDROCODONE BITARTRATE (2.5MG/5ML)ORALSOLUTIONTrue2015-05-14HYCOFENIX

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
11cfa7c8f-0309-3591-e054-00144ff8d46c (view SPL)These highlights do not include all the information needed to use HYCOFENIXTM safely and effectively. See full prescribing information for HYCOFENIX. HYCOFENIX (hydrocodone bitartrate, pseudoephedrine hydrochloride, and guaifenesin) oral solution, CII Initial U.S. Approval: 2015prescriptionHuman PrescriptionMission Pharmacal Company2015-08-182001783291

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