Home NDC 59385-024 BELBUCA
Product NDC 59385-024
11-digit product format 593850024
Labeler code 59385
Product ID 59385-024_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 2017-08-21
Substance BUPRENORPHINE HYDROCHLORIDE
Active strength 450 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207932-001 BELBUCA BUPRENORPHINE HYDROCHLORIDE EQ 0.075MG BASE FILM / BUCCAL RLD 2015-10-23 N207932-002 BELBUCA BUPRENORPHINE HYDROCHLORIDE EQ 0.15MG BASE FILM / BUCCAL RLD 2015-10-23 N207932-003 BELBUCA BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE FILM / BUCCAL RLD 2015-10-23 N207932-004 BELBUCA BUPRENORPHINE HYDROCHLORIDE EQ 0.45MG BASE FILM / BUCCAL RLD 2015-10-23 N207932-005 BELBUCA BUPRENORPHINE HYDROCHLORIDE EQ 0.6MG BASE FILM / BUCCAL RLD 2015-10-23 N207932-006 BELBUCA BUPRENORPHINE HYDROCHLORIDE EQ 0.75MG BASE FILM / BUCCAL RLD 2015-10-23 N207932-007 BELBUCA BUPRENORPHINE HYDROCHLORIDE EQ 0.9MG BASE FILM / BUCCAL RLD, RS 2015-10-23
Orange Book patents# Current patent rows page 1 of 1 · 21 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207932-001 8147866 2027-07-23 U-1769 Drug product 2015-11-20 N207932-001 9655843 2027-07-23 U-1556 Drug product 2017-06-13 N207932-001 9901539 2032-12-21 U-1556 2018-03-28 N207932-002 8147866 2027-07-23 U-1769 Drug product 2015-11-20 N207932-002 9655843 2027-07-23 U-1556 Drug product 2017-06-13 N207932-002 9901539 2032-12-21 U-1556 2018-03-28 N207932-003 8147866 2027-07-23 U-1769 Drug product 2015-11-20 N207932-003 9655843 2027-07-23 U-1556 Drug product 2017-06-13 N207932-003 9901539 2032-12-21 U-1556 2018-03-28 N207932-004 8147866 2027-07-23 U-1769 Drug product 2015-11-20 N207932-004 9655843 2027-07-23 U-1556 Drug product 2017-06-13 N207932-004 9901539 2032-12-21 U-1556 2018-03-28 N207932-005 8147866 2027-07-23 U-1769 Drug product 2015-11-20 N207932-005 9655843 2027-07-23 U-1556 Drug product 2017-06-13 N207932-005 9901539 2032-12-21 U-1556 2018-03-28 N207932-006 8147866 2027-07-23 U-1769 Drug product 2015-11-20 N207932-006 9655843 2027-07-23 U-1556 Drug product 2017-06-13 N207932-006 9901539 2032-12-21 U-1556 2018-03-28 N207932-007 8147866 2027-07-23 U-1769 Drug product 2015-11-20 N207932-007 9655843 2027-07-23 U-1556 Drug product 2017-06-13 N207932-007 9901539 2032-12-21 U-1556 2018-03-28
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 8 · 287 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N207932-001 BELBUCA EQ 0.075MG BASE FILM / BUCCAL RLD 2015-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-002 BELBUCA EQ 0.15MG BASE FILM / BUCCAL RLD 2015-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-003 BELBUCA EQ 0.3MG BASE FILM / BUCCAL RLD 2015-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-004 BELBUCA EQ 0.45MG BASE FILM / BUCCAL RLD 2015-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-005 BELBUCA EQ 0.6MG BASE FILM / BUCCAL RLD 2015-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-006 BELBUCA EQ 0.75MG BASE FILM / BUCCAL RLD 2015-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-007 BELBUCA EQ 0.9MG BASE FILM / BUCCAL RLD, RS 2015-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-001 BELBUCA EQ 0.075MG BASE FILM / BUCCAL RLD 2015-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-002 BELBUCA EQ 0.15MG BASE FILM / BUCCAL RLD 2015-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-003 BELBUCA EQ 0.3MG BASE FILM / BUCCAL RLD 2015-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-004 BELBUCA EQ 0.45MG BASE FILM / BUCCAL RLD 2015-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-005 BELBUCA EQ 0.6MG BASE FILM / BUCCAL RLD 2015-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-006 BELBUCA EQ 0.75MG BASE FILM / BUCCAL RLD 2015-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-007 BELBUCA EQ 0.9MG BASE FILM / BUCCAL RLD, RS 2015-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207932-001 BELBUCA EQ 0.075MG BASE FILM / BUCCAL RLD 2015-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207932-002 BELBUCA EQ 0.15MG BASE FILM / BUCCAL RLD 2015-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207932-003 BELBUCA EQ 0.3MG BASE FILM / BUCCAL RLD 2015-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207932-004 BELBUCA EQ 0.45MG BASE FILM / BUCCAL RLD 2015-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207932-005 BELBUCA EQ 0.6MG BASE FILM / BUCCAL RLD 2015-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207932-006 BELBUCA EQ 0.75MG BASE FILM / BUCCAL RLD 2015-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207932-007 BELBUCA EQ 0.9MG BASE FILM / BUCCAL RLD, RS 2015-10-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207932-001 BELBUCA EQ 0.075MG BASE FILM / BUCCAL RLD 2015-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207932-002 BELBUCA EQ 0.15MG BASE FILM / BUCCAL RLD 2015-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207932-003 BELBUCA EQ 0.3MG BASE FILM / BUCCAL RLD 2015-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207932-004 BELBUCA EQ 0.45MG BASE FILM / BUCCAL RLD 2015-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207932-005 BELBUCA EQ 0.6MG BASE FILM / BUCCAL RLD 2015-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207932-006 BELBUCA EQ 0.75MG BASE FILM / BUCCAL RLD 2015-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207932-007 BELBUCA EQ 0.9MG BASE FILM / BUCCAL RLD, RS 2015-10-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207932-001 BELBUCA EQ 0.075MG BASE FILM / BUCCAL RLD 2015-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207932-002 BELBUCA EQ 0.15MG BASE FILM / BUCCAL RLD 2015-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207932-003 BELBUCA EQ 0.3MG BASE FILM / BUCCAL RLD 2015-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207932-004 BELBUCA EQ 0.45MG BASE FILM / BUCCAL RLD 2015-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207932-005 BELBUCA EQ 0.6MG BASE FILM / BUCCAL RLD 2015-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207932-006 BELBUCA EQ 0.75MG BASE FILM / BUCCAL RLD 2015-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207932-007 BELBUCA EQ 0.9MG BASE FILM / BUCCAL RLD, RS 2015-10-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207932-001 BELBUCA EQ 0.075MG BASE FILM / BUCCAL RLD 2015-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207932-002 BELBUCA EQ 0.15MG BASE FILM / BUCCAL RLD 2015-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207932-003 BELBUCA EQ 0.3MG BASE FILM / BUCCAL RLD 2015-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207932-004 BELBUCA EQ 0.45MG BASE FILM / BUCCAL RLD 2015-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207932-005 BELBUCA EQ 0.6MG BASE FILM / BUCCAL RLD 2015-10-23 03ed91905a0d…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 23 · 903 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N207932-001 8147866 2027-07-23 U-1769 Drug product 2015-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-001 9655843 2027-07-23 U-1556 Drug product 2017-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-001 9901539 2032-12-21 U-1556 2018-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-002 8147866 2027-07-23 U-1769 Drug product 2015-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-002 9655843 2027-07-23 U-1556 Drug product 2017-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-002 9901539 2032-12-21 U-1556 2018-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-003 8147866 2027-07-23 U-1769 Drug product 2015-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-003 9655843 2027-07-23 U-1556 Drug product 2017-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-003 9901539 2032-12-21 U-1556 2018-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-004 8147866 2027-07-23 U-1769 Drug product 2015-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-004 9655843 2027-07-23 U-1556 Drug product 2017-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-004 9901539 2032-12-21 U-1556 2018-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-005 8147866 2027-07-23 U-1769 Drug product 2015-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-005 9655843 2027-07-23 U-1556 Drug product 2017-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-005 9901539 2032-12-21 U-1556 2018-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-006 8147866 2027-07-23 U-1769 Drug product 2015-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-006 9655843 2027-07-23 U-1556 Drug product 2017-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-006 9901539 2032-12-21 U-1556 2018-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-007 8147866 2027-07-23 U-1769 Drug product 2015-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-007 9655843 2027-07-23 U-1556 Drug product 2017-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207932-007 9901539 2032-12-21 U-1556 2018-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-001 8147866 2027-07-23 U-1769 Drug product 2015-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-001 9655843 2027-07-23 U-1556 Drug product 2017-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-001 9901539 2032-12-21 U-1556 2018-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-002 8147866 2027-07-23 U-1769 Drug product 2015-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-002 9655843 2027-07-23 U-1556 Drug product 2017-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-002 9901539 2032-12-21 U-1556 2018-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-003 8147866 2027-07-23 U-1769 Drug product 2015-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-003 9655843 2027-07-23 U-1556 Drug product 2017-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-003 9901539 2032-12-21 U-1556 2018-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-004 8147866 2027-07-23 U-1769 Drug product 2015-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-004 9655843 2027-07-23 U-1556 Drug product 2017-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-004 9901539 2032-12-21 U-1556 2018-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-005 8147866 2027-07-23 U-1769 Drug product 2015-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-005 9655843 2027-07-23 U-1556 Drug product 2017-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-005 9901539 2032-12-21 U-1556 2018-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-006 8147866 2027-07-23 U-1769 Drug product 2015-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-006 9655843 2027-07-23 U-1556 Drug product 2017-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-006 9901539 2032-12-21 U-1556 2018-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207932-007 8147866 2027-07-23 U-1769 Drug product 2015-11-20 31067a03dcf5…
Additional Listing Data#
Finished product Yes
Brand name base BELBUCA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPRENORPHINE HYDROCHLORIDE 450 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 56W8MW3EN1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 14 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59385-024-01 BELBUCA 1 in 1 POUCH FILM, SOLUBLE 1 18 59385-024-60 BELBUCA 60 in 1 CARTON FILM, SOLUBLE 60 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59385-024 BELBUCA (BUPRENORPHINE HYDROCHLORIDE) FILM, SOLUBLE [BIODELIVERY SCIENCES INTERNATIONAL INC] 17 Current NDC, Legacy NDC, 2 package rows 20240104_bc2b7a3d-72cf-497c-95b0-ba2b71f63c64.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BELBUCA BUPRENORPHINE HYDROCHLORIDE BioDelivery Sciences International Inc bc2b7a3d-72cf-497c-95b0-ba2b71f63c64 2026-01-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 207932 application number: NDA207932 ndc (product): 59385-024
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59385-024-01 59385002401 1 in 1 POUCH Historical 59385-024-60 59385002460 60 POUCH in 1 CARTON (59385-024-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-024-01) 60 pouch 2017-08-21 0000-00-00 No No Current