Buprenorphine Buccal Film

Brand(s)
Belbuca
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Endo Pharmaceuticals Inc. (2015-10-26)
Oldest Current Product
2015-06-01
License(s)
NDA
RxNORM
BUCCAL FILM\BUPRENORPHINE
FDAOB
BUCCAL\FILM\BUPRENORPHINE HYDROCHLORIDE
SPL Active
BUCCAL\FILM\BUPRENORPHINE HYDROCHLORIDE
SPL Moiety
BUCCAL\FILM\BUPRENORPHINE

product(s) by strength(s)

buprenorphine 0.075 mg buccal film

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634810161BelbucaNDAEndo Pharmaceuticals Inc.2015-06-01BUPRENORPHINE HYDROCHLORIDEBUCCALFILMNDA20793269df676c-0357-4e67-a92d-f6b337b34a2f

buprenorphine 0.15 mg buccal film

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634810207BelbucaNDAEndo Pharmaceuticals Inc.2015-06-01BUPRENORPHINE HYDROCHLORIDEBUCCALFILMNDA20793269df676c-0357-4e67-a92d-f6b337b34a2f

buprenorphine 0.3 mg buccal film

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634810348BelbucaNDAEndo Pharmaceuticals Inc.2015-06-01BUPRENORPHINE HYDROCHLORIDEBUCCALFILMNDA20793269df676c-0357-4e67-a92d-f6b337b34a2f

buprenorphine 0.45 mg buccal film

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634810519BelbucaNDAEndo Pharmaceuticals Inc.2015-06-01BUPRENORPHINE HYDROCHLORIDEBUCCALFILMNDA20793269df676c-0357-4e67-a92d-f6b337b34a2f

buprenorphine 0.6 mg buccal film

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634810685BelbucaNDAEndo Pharmaceuticals Inc.2015-06-01BUPRENORPHINE HYDROCHLORIDEBUCCALFILMNDA20793269df676c-0357-4e67-a92d-f6b337b34a2f

buprenorphine 0.75 mg buccal film

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1634810820BelbucaNDAEndo Pharmaceuticals Inc.2015-06-01BUPRENORPHINE HYDROCHLORIDEBUCCALFILMNDA20793269df676c-0357-4e67-a92d-f6b337b34a2f

application(s)

#idtitleapplicantapprovedexclusivityapproved drugin other drug docs
1NDA207932BELBUCAENDO PHARMACEUTICALS INC2015-10-23NEW PRODUCT [2018-10-23]NDA207932_001, NDA207932_002, NDA207932_003, NDA207932_004, NDA207932_005, NDA207932_006, NDA207932_007Buprenorphine Buccal Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA207932_001RXBUPRENORPHINE HYDROCHLORIDE (75MCG)BUCCALFILMFalse2015-10-23BELBUCA
2NDA207932_002RXBUPRENORPHINE HYDROCHLORIDE (150MCG)BUCCALFILMFalse2015-10-23BELBUCA
3NDA207932_003RXBUPRENORPHINE HYDROCHLORIDE (300MCG)BUCCALFILMFalse2015-10-23BELBUCA
4NDA207932_004RXBUPRENORPHINE HYDROCHLORIDE (450MCG)BUCCALFILMFalse2015-10-23BELBUCA
5NDA207932_005RXBUPRENORPHINE HYDROCHLORIDE (600MCG)BUCCALFILMFalse2015-10-23BELBUCA
6NDA207932_006RXBUPRENORPHINE HYDROCHLORIDE (750MCG)BUCCALFILMFalse2015-10-23BELBUCA
7NDA207932_007RXBUPRENORPHINE HYDROCHLORIDE (900MCG)BUCCALFILMFalse2015-10-23BELBUCA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
169df676c-0357-4e67-a92d-f6b337b34a2f (view SPL)These highlights do not include all the information needed to useBELBUCA safely and effectively. See full prescribing information for BELBUCA. BELBUCATM (buprenorphine) buccal film CIII Initial U.S. Approval: 1981prescriptionHuman PrescriptionEndo Pharmaceuticals Inc.MANUFACTURE2015-10-263634810161, 634810207, 634810348, 634810519, 634810685, 634810820, 634810952Buprenorphine Buccal Tablet

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