Bupivacaine liposome Injectable Suspension

Brand(s)
Exparel
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pacira Pharmaceuticals Inc. (2015-04-22)
Oldest Current Product
2012-01-01
License(s)
NDA
RxNORM
INJECTABLE SUSPENSION\BUPIVACAINE LIPOSOME
FDAOB
INJECTION\INJECTABLE, LIPOSOMAL\BUPIVACAINE\rdfq
SPL Active
INFILTRATION\INJECTION, SUSPENSION, LIPOSOMAL\BUPIVACAINE
SPL Moiety
INFILTRATION\INJECTION, SUSPENSION, LIPOSOMAL\BUPIVACAINE

product(s) by strength(s)

bupivacaine liposome 13.3 mg/ml injectable suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1652500266ExparelNDAPacira Pharmaceuticals Inc.2012-01-01BUPIVACAINEINFILTRATIONINJECTION, SUSPENSION, LIPOSOMALNDA022496bb5a9e59-0f51-11df-8a39-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022496EXPARELPACIRA PHARMACEUTICALS INC2011-10-28p8182835, SINGLE DOSE ADMINISTRATION INTO THE SURGICAL SITE TO PRODUCE POSTSURGICAL ANALGESIA, SUBSTANCE
p8834921, SINGLE-DOSE INFILTRATION INTO THE SURGICAL SITE TO PRODUCE POSTSURGICAL ANALGESIA., SUBSTANCE
NEW PRODUCT [2014-10-28]NDA022496_001, NDA022496_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA022496_001discontinuedBUPIVACAINE (133MG/10ML)INJECTABLE, LIPOSOMALFalse2011-10-28EXPAREL
2NDA022496_002RXBUPIVACAINE (266MG/20ML)INJECTABLE, LIPOSOMALTrue2011-10-28EXPAREL

patent(s)

#idexpiration dateapplication(s)
1p8182835 (view patent)2018-09-18NDA022496
2p8834921 (view patent)2018-09-18NDA022496

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1bb5a9e59-0f51-11df-8a39-0800200c9a66 (view SPL)These highlights do not include all the information needed to use EXPAREL safely and effectively. See full prescribing information for EXPAREL. EXPAREL (bupivacaine liposome injectable suspension) Initial U.S. Approval: 1972prescriptionHuman PrescriptionPacira Pharmaceuticals Inc.MANUFACTURE, REPACK2015-04-226652500266

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