Home NDC 59385-012 BUNAVAIL
Product NDC 59385-012
11-digit product format 593850012
Labeler code 59385
Product ID 59385-012_d1c1f84c-1c2c-4ece-9137-60a5eb582427
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name buprenorphine and naloxone
Dosage form FILM
Route BUCCAL
Labeler BioDelivery Sciences International, Inc.
Application NDA205637
Marketing category NDA
Marketing start 2014-09-30
Marketing end 2021-02-28
Substance BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active strength 2 mg/1; mg/1
Pharmacologic classes Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
DEA schedule CIII
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 59385-012-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 59385-012-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 59385-012-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 59385-012-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 59385-012-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 59385-012-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 59385-012-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59385-012-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59385-012-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 59385-012-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 59385-012-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 59385-012-30 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205637-001 BUNAVAIL BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 N205637-002 BUNAVAIL BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 4.2MG BASE;EQ 0.7MG BASE FILM / BUCCAL RLD 2014-06-06 N205637-003 BUNAVAIL BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE EQ 6.3MG BASE;EQ 1MG BASE FILM / BUCCAL RLD 2014-06-06
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205637-001 8147866 2027-07-23 U-1521 Drug product 2014-06-20 N205637-001 9655843 2027-07-23 U-2017 Drug product 2017-06-13 N205637-001 8703177 2032-08-20 Drug product 2014-06-20 N205637-001 9522188 2035-04-24 Drug product 2016-12-20 N205637-002 8147866 2027-07-23 U-1521 Drug product 2014-06-20 N205637-002 9655843 2027-07-23 U-2017 Drug product 2017-06-13 N205637-002 8703177 2032-08-20 Drug product 2014-06-20 N205637-002 9522188 2035-04-24 Drug product 2016-12-20 N205637-003 8147866 2027-07-23 U-1521 Drug product 2014-06-20 N205637-003 9655843 2027-07-23 U-2017 Drug product 2017-06-13 N205637-003 8703177 2032-08-20 Drug product 2014-06-20 N205637-003 9522188 2035-04-24 Drug product 2016-12-20
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 4 · 123 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 N205637-001 BUNAVAIL EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205637-002 BUNAVAIL EQ 4.2MG BASE;EQ 0.7MG BASE FILM / BUCCAL RLD 2014-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205637-003 BUNAVAIL EQ 6.3MG BASE;EQ 1MG BASE FILM / BUCCAL RLD 2014-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-001 BUNAVAIL EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-002 BUNAVAIL EQ 4.2MG BASE;EQ 0.7MG BASE FILM / BUCCAL RLD 2014-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-003 BUNAVAIL EQ 6.3MG BASE;EQ 1MG BASE FILM / BUCCAL RLD 2014-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205637-001 BUNAVAIL EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205637-002 BUNAVAIL EQ 4.2MG BASE;EQ 0.7MG BASE FILM / BUCCAL RLD 2014-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205637-003 BUNAVAIL EQ 6.3MG BASE;EQ 1MG BASE FILM / BUCCAL RLD 2014-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205637-001 BUNAVAIL EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205637-002 BUNAVAIL EQ 4.2MG BASE;EQ 0.7MG BASE FILM / BUCCAL RLD 2014-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205637-003 BUNAVAIL EQ 6.3MG BASE;EQ 1MG BASE FILM / BUCCAL RLD 2014-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205637-001 BUNAVAIL EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205637-002 BUNAVAIL EQ 4.2MG BASE;EQ 0.7MG BASE FILM / BUCCAL RLD 2014-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205637-003 BUNAVAIL EQ 6.3MG BASE;EQ 1MG BASE FILM / BUCCAL RLD 2014-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205637-001 BUNAVAIL EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205637-002 BUNAVAIL EQ 4.2MG BASE;EQ 0.7MG BASE FILM / BUCCAL RLD 2014-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205637-003 BUNAVAIL EQ 6.3MG BASE;EQ 1MG BASE FILM / BUCCAL RLD 2014-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205637-001 BUNAVAIL EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205637-002 BUNAVAIL EQ 4.2MG BASE;EQ 0.7MG BASE FILM / BUCCAL RLD 2014-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205637-003 BUNAVAIL EQ 6.3MG BASE;EQ 1MG BASE FILM / BUCCAL RLD 2014-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205637-001 BUNAVAIL EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205637-002 BUNAVAIL EQ 4.2MG BASE;EQ 0.7MG BASE FILM / BUCCAL RLD 2014-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205637-003 BUNAVAIL EQ 6.3MG BASE;EQ 1MG BASE FILM / BUCCAL RLD 2014-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205637-001 BUNAVAIL EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205637-002 BUNAVAIL EQ 4.2MG BASE;EQ 0.7MG BASE FILM / BUCCAL RLD 2014-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205637-003 BUNAVAIL EQ 6.3MG BASE;EQ 1MG BASE FILM / BUCCAL RLD 2014-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205637-001 BUNAVAIL EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205637-002 BUNAVAIL EQ 4.2MG BASE;EQ 0.7MG BASE FILM / BUCCAL RLD 2014-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205637-003 BUNAVAIL EQ 6.3MG BASE;EQ 1MG BASE FILM / BUCCAL RLD 2014-06-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205637-001 BUNAVAIL EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205637-002 BUNAVAIL EQ 4.2MG BASE;EQ 0.7MG BASE FILM / BUCCAL RLD 2014-06-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205637-003 BUNAVAIL EQ 6.3MG BASE;EQ 1MG BASE FILM / BUCCAL RLD 2014-06-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205637-001 BUNAVAIL EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205637-002 BUNAVAIL EQ 4.2MG BASE;EQ 0.7MG BASE FILM / BUCCAL RLD 2014-06-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205637-003 BUNAVAIL EQ 6.3MG BASE;EQ 1MG BASE FILM / BUCCAL RLD 2014-06-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205637-001 BUNAVAIL EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205637-002 BUNAVAIL EQ 4.2MG BASE;EQ 0.7MG BASE FILM / BUCCAL RLD 2014-06-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205637-003 BUNAVAIL EQ 6.3MG BASE;EQ 1MG BASE FILM / BUCCAL RLD 2014-06-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205637-001 BUNAVAIL EQ 2.1MG BASE;EQ 0.3MG BASE FILM / BUCCAL RLD 2014-06-06 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 13 · 510 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 N205637-001 8147866 2027-07-23 U-1521 Drug product 2014-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205637-001 9655843 2027-07-23 U-2017 Drug product 2017-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205637-001 8703177 2032-08-20 Drug product 2014-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205637-001 9522188 2035-04-24 Drug product 2016-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205637-002 8147866 2027-07-23 U-1521 Drug product 2014-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205637-002 9655843 2027-07-23 U-2017 Drug product 2017-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205637-002 8703177 2032-08-20 Drug product 2014-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205637-002 9522188 2035-04-24 Drug product 2016-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205637-003 8147866 2027-07-23 U-1521 Drug product 2014-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205637-003 9655843 2027-07-23 U-2017 Drug product 2017-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205637-003 8703177 2032-08-20 Drug product 2014-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205637-003 9522188 2035-04-24 Drug product 2016-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-001 8147866 2027-07-23 U-1521 Drug product 2014-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-001 9655843 2027-07-23 U-2017 Drug product 2017-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-001 8703177 2032-08-20 Drug product 2014-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-001 9522188 2035-04-24 Drug product 2016-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-002 8147866 2027-07-23 U-1521 Drug product 2014-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-002 9655843 2027-07-23 U-2017 Drug product 2017-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-002 8703177 2032-08-20 Drug product 2014-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-002 9522188 2035-04-24 Drug product 2016-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-003 8147866 2027-07-23 U-1521 Drug product 2014-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-003 9655843 2027-07-23 U-2017 Drug product 2017-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-003 8703177 2032-08-20 Drug product 2014-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205637-003 9522188 2035-04-24 Drug product 2016-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205637-001 8147866 2027-07-23 U-1521 Drug product 2014-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205637-001 9655843 2027-07-23 U-2017 Drug product 2017-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205637-001 8703177 2032-08-20 Drug product 2014-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205637-001 9522188 2035-04-24 Drug product 2016-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205637-002 8147866 2027-07-23 U-1521 Drug product 2014-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205637-002 9655843 2027-07-23 U-2017 Drug product 2017-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205637-002 8703177 2032-08-20 Drug product 2014-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205637-002 9522188 2035-04-24 Drug product 2016-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205637-003 8147866 2027-07-23 U-1521 Drug product 2014-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205637-003 9655843 2027-07-23 U-2017 Drug product 2017-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205637-003 8703177 2032-08-20 Drug product 2014-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205637-003 9522188 2035-04-24 Drug product 2016-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205637-001 8147866 2027-07-23 U-1521 Drug product 2014-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205637-001 9655843 2027-07-23 U-2017 Drug product 2017-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205637-001 8703177 2032-08-20 Drug product 2014-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205637-001 9522188 2035-04-24 Drug product 2016-12-20 fd3edfee7708…
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59385-012-30 59385001230 30 POUCH in 1 BOX (59385-012-30) > 1 FILM in 1 POUCH (59385-012-01) 30 pouch 2014-09-30 2021-02-28 No No Current