Cetirizine Disintegrating Oral Tablet

Brand(s)
Zyrtec
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division (2013-12-02)
Oldest Current Product
2014-01-20
License(s)
NDA
RxNORM
DISINTEGRATING ORAL TABLET\CETIRIZINE
FDAOB
ORAL\TABLET, ORALLY DISINTEGRATING\CETIRIZINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, ORALLY DISINTEGRATING\CETIRIZINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, ORALLY DISINTEGRATING\CETIRIZINE

product(s) by strength(s)

cetirizine hydrochloride 10 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1505800778ZyrtecNDAJohnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division2014-01-20CETIRIZINE HYDROCHLORIDEORALTABLET, ORALLY DISINTEGRATINGNDA0225786a962a1c-c197-492b-bfa6-e0c28eda1533

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA205490CETIRIZINE HYDROCHLORIDE ALLERGYPAR PHARMACEUTICAL INC2015-09-02ANDA205490_001
2NDA022578ZYRTEC ALLERGYJOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISION2010-09-03NDA022578_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA205490_001OTCCETIRIZINE HYDROCHLORIDE (10MG)ORALTABLET, ORALLY DISINTEGRATINGFalse2015-09-02CETIRIZINE HYDROCHLORIDE ALLERGY
2NDA022578_001OTCCETIRIZINE HYDROCHLORIDE (10MG)ORALTABLET, ORALLY DISINTEGRATINGTrue2010-09-03ZYRTEC ALLERGY

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
16a962a1c-c197-492b-bfa6-e0c28eda1533 (view SPL)ZYRTECotcHuman OTCJohnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division2013-12-027505800778
2a1edc2e6-3661-4d7a-884c-709d73cb89e0 (view SPL)Children's ZYRTEC ALLERGYotcHuman OTCJohnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division2015-10-153505800782

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