Buprenorphine

Product NDC: 55700-579
11-digit product format: 557000579
Labeler code: 55700
Product ID: 55700-579_c5b43359-4dae-4292-a2ee-5f57813d7505
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buprenorphine
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: NDA021306
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-01-12
Marketing end: 0000-00-00
Substance: BUPRENORPHINE
Active strength: 5 ug/h
Pharmacologic classes: Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55700-579		D	Discontinued by firm		2026-08-11
excluded package	package	55700-579	55700-579-04	D	Discontinued by firm		2026-08-11

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	55700-579-04	`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	55700-579-04	`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	55700-579-04	`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	55700-579-04	`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	55700-579-04	`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	55700-579-04	`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	55700-579-04	`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	55700-579-04	`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	55700-579-04	`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	55700-579-04	`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	55700-579-04	`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	55700-579-04	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021306-001	BUTRANS	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30
N021306-002	BUTRANS	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30
N021306-003	BUTRANS	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30
N021306-004	BUTRANS	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25
N021306-005	BUTRANS	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N021306-001	AB
N021306-002	AB
N021306-003	AB
N021306-004	AB
N021306-005	AB

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 6 · 205 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	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-001	BUTRANS	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-002	BUTRANS	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2010-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-003	BUTRANS	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD, RS	2010-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-004	BUTRANS	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2013-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-005	BUTRANS	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	RLD	2014-06-30	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 201 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021306-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021306-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021306-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021306-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021306-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021306-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021306-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021306-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021306-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021306-005	AB	1	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2020-12-22 03:56 UTC	2020-12	N021306-001	M-250	2020-10-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021306-002	M-250	2020-10-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021306-003	M-250	2020-10-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021306-004	M-250	2020-10-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021306-005	M-250	2020-10-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021306-001	M-250	2020-10-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021306-002	M-250	2020-10-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021306-003	M-250	2020-10-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021306-004	M-250	2020-10-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021306-005	M-250	2020-10-13	`c0c555d07b60…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-579-04	EA - Each	55700-579	27d4e2fc-aca3-4411-9182-92105131ca79	1	2018-02-20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buprenorphine	BUPRENORPHINE	Rhodes Pharmaceuticals LLC	2738feae-316e-426f-971c-5f142ac01b60	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021306 application number: NDA021306
Butrans	BUPRENORPHINE	Knoa Pharma LLC	794aa355-66de-41b8-aedf-f2c40f6bc664	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021306 application number: NDA021306

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
40D3SCR4GZ	BUPRENORPHINE	52485-79-7	BUPRENORPHINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-579-04	55700057904	4 POUCH in 1 CARTON (55700-579-04) > 1 PATCH in 1 POUCH > 168 h in 1 PATCH	4 pouch	2018-01-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buprenorphine - Lake Erie Medical DBA Quality Care Products LLC	Lake Erie Medical DBA Quality Care Products LLC	2020-08-05	HUMAN PRESCRIPTION DRUG LABEL	2