FDA.reportPublic FDA data

BELBUCA

Product NDC
59385-021
11-digit product format
593850021
Labeler code
59385
Product ID
59385-021_16403e7a-5881-43d2-990c-a7d673971c3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine hydrochloride
Dosage form
FILM, SOLUBLE
Route
BUCCAL
Labeler
BioDelivery Sciences International Inc
Application
NDA207932
Marketing category
NDA
Marketing start
2017-09-01
Substance
BUPRENORPHINE HYDROCHLORIDE
Active strength
75 ug/1
Pharmacologic classes
Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BELBUCA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE75 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii56W8MW3EN1
Rxcui1716057, 1716063, 1716065, 1716067, 1716069, 1716071, 1716073, 1716075, 1716077, 1716079, 1716081, 1716083, 1716086, 1716090

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68654759-f50b-79ef-24c5-544d94fe7d87Product name320251114
08a295bb-88df-4ab0-a120-a75a789a74f1Product name120231013
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
a5920611-4285-f024-69b9-39ff338b81eaProduct name520170609
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59385-021-602021-07-29C16284748780-1c7ccaba7-10fb-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use BELBUCA safely and effectively. See full prescribing information for BELBUCA. BELBUCA ® (buprenorphine buccal film), CIII Initial U.S. Approval: 1981
59385-021-602021-07-23C16284748780-1c7ccaba7-10fb-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use BELBUCA safely and effectively. See full prescribing information for BELBUCA. BELBUCA ® (buprenorphine buccal film), CIII Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59385-021-01BELBUCA1 in 1 POUCHFILM, SOLUBLE118
59385-021-60BELBUCA60 in 1 CARTONFILM, SOLUBLE6018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59385-021-01EA - Each59385-021b8b9a4da-a323-4f8a-b692-f4c63c2d2f1112018-03-08
59385-021-60EA - Each59385-021a260c1b5-0964-4a28-9447-c673d4ab5bf312017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59385-021BELBUCA (BUPRENORPHINE HYDROCHLORIDE) FILM, SOLUBLE [BIODELIVERY SCIENCES INTERNATIONAL INC]17Current NDC, Legacy NDC, 2 package rows20240104_bc2b7a3d-72cf-497c-95b0-ba2b71f63c64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1716063Belbuca 150 MCG Buccal FilmPSNbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716067Belbuca 300 MCG Buccal FilmPSNbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716071Belbuca 450 MCG Buccal FilmPSNbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716075Belbuca 600 MCG Buccal FilmPSNbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716079Belbuca 75 MCG Buccal FilmPSNbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716083Belbuca 750 MCG Buccal FilmPSNbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716090Belbuca 900 MCG Buccal FilmPSNbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716057buprenorphine HCl 150 MCG Buccal FilmPSNbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716065buprenorphine HCl 300 MCG Buccal FilmPSNbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716069buprenorphine HCl 450 MCG Buccal FilmPSNbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716073buprenorphine HCl 600 MCG Buccal FilmPSNbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716077buprenorphine HCl 75 MCG Buccal FilmPSNbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716081buprenorphine HCl 750 MCG Buccal FilmPSNbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716086buprenorphine HCl 900 MCG Buccal FilmPSNbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716079buprenorphine 0.075 MG Buccal Film [Belbuca]SBDbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716063buprenorphine 0.15 MG Buccal Film [Belbuca]SBDbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716067buprenorphine 0.3 MG Buccal Film [Belbuca]SBDbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716071buprenorphine 0.45 MG Buccal Film [Belbuca]SBDbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716075buprenorphine 0.6 MG Buccal Film [Belbuca]SBDbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716083buprenorphine 0.75 MG Buccal Film [Belbuca]SBDbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716090buprenorphine 0.9 MG Buccal Film [Belbuca]SBDbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716077buprenorphine 0.075 MG Buccal FilmSCDbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716057buprenorphine 0.15 MG Buccal FilmSCDbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716065buprenorphine 0.3 MG Buccal FilmSCDbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716069buprenorphine 0.45 MG Buccal FilmSCDbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716073buprenorphine 0.6 MG Buccal FilmSCDbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716081buprenorphine 0.75 MG Buccal FilmSCDbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716086buprenorphine 0.9 MG Buccal FilmSCDbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716079Belbuca 0.075 MG (as buprenorphine HCl) Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716063Belbuca 0.15 MG (as buprenorphine HCl) Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716067Belbuca 0.3 MG (as buprenorphine HCl) Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716071Belbuca 0.45 MG (as buprenorphine HCl) Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716075Belbuca 0.6 MG (as buprenorphine HCl) Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716083Belbuca 0.75 MG (as buprenorphine HCl) Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716090Belbuca 0.9 MG (as buprenorphine HCl) Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716063Belbuca 150 MCG Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716067Belbuca 300 MCG Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716071Belbuca 450 MCG Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716075Belbuca 600 MCG Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716079Belbuca 75 MCG Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716083Belbuca 750 MCG Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716090Belbuca 900 MCG Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716057buprenorphine HCl 150 MCG Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716065buprenorphine HCl 300 MCG Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716069buprenorphine HCl 450 MCG Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716073buprenorphine HCl 600 MCG Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716077buprenorphine HCl 75 MCG Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716081buprenorphine HCl 750 MCG Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418
1716086buprenorphine HCl 900 MCG Buccal FilmSYbc2b7a3d-72cf-497c-95b0-ba2b71f63c6418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59385-021-01593850021011 in 1 POUCHHistorical
59385-021-605938500216060 POUCH in 1 CARTON (59385-021-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-021-01) 60 pouch2017-09-010000-00-00NoNoCurrent