Butrans

Product NDC: 59011-752
11-digit product format: 590110752
Labeler code: 59011
Product ID: 59011-752_cf5d162f-a313-4f27-a292-3ecf640fbea7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buprenorphine
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Knoa Pharma LLC
Application: NDA021306
Marketing category: NDA
Marketing start: 2011-02-14
Substance: BUPRENORPHINE
Active strength: 20 ug/h
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 · 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPRENORPHINE	20 ug/h

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
40D3SCR4GZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904870	Internal RxNorm lookup
904874	Internal RxNorm lookup
904876	Internal RxNorm lookup
904878	Internal RxNorm lookup
904880	Internal RxNorm lookup
904882	Internal RxNorm lookup
1432969	Internal RxNorm lookup
1432971	Internal RxNorm lookup
1542997	Internal RxNorm lookup
1542999	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
794aa355-66de-41b8-aedf-f2c40f6bc664	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
68654759-f50b-79ef-24c5-544d94fe7d87	Product name	3	20251114
08a295bb-88df-4ab0-a120-a75a789a74f1	Product name	1	20231013
ab841ac7-728a-4fc9-be0a-35b96cecbf39	Product name	4	20230306
100316cc-94a9-474e-97ad-9b5c6ddec605	Product name	5	20230125
539bc5d3-546b-4af6-9c31-058ce6c459d3	Product name	2	20220210
b871fccd-1de6-4c7f-b9e5-045304641ee6	Product name	8	20220118
31e16ab2-c562-4617-a3e8-ed285320e16e	Product name	1	20180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaef	Product name	1	20170706
a5920611-4285-f024-69b9-39ff338b81ea	Product name	5	20170609
3df867ed-9d48-45cf-bded-1394beaea0b1	Product name	3	20161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4	Product name	1	20160712

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59011-752-04	Butrans	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1		32
59011-752-04	Butrans	4 in 1 CARTON	PATCH, EXTENDED RELEASE	4		32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59011-752-04	EA - Each	59011-752	06c48e99-38e7-45b2-b67e-e697a6f8c487	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
buprenorphine	ACTIVE INGREDIENT	40D3SCR4GZ	BUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [PURDUE PHARMA LP]	15
buprenorphine	ACTIVE MOIETY	40D3SCR4GZ	BUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [PURDUE PHARMA LP]	15
ETHYL LEVULINATE	INACTIVE INGREDIENT	7BU24CSS2G	BUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [PURDUE PHARMA LP]	15
OLEYL OLEATE	INACTIVE INGREDIENT	3X3L452Y85	BUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [PURDUE PHARMA LP]	15
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	BUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [PURDUE PHARMA LP]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59011-752	BUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [PURDUE PHARMA LP]	29	Current NDC, Legacy NDC, 2 package rows	20240619_794aa355-66de-41b8-aedf-f2c40f6bc664.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 · 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 ndc (product): 59011-752

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
904870	buprenorphine 10 MCG/HR 7 Day Transdermal System	PSN	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1432969	buprenorphine 15 MCG/HR 7 Day Transdermal System	PSN	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904876	buprenorphine 20 MCG/HR 7 Day Transdermal System	PSN	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904880	buprenorphine 5 MCG/HR 7 Day Transdermal System	PSN	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1542997	buprenorphine 7.5 MCG/HR 7 Day Transdermal System	PSN	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904874	Butrans 10 MCG/HR 7 Day Transdermal System	PSN	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1432971	Butrans 15 MCG/HR 7 Day Transdermal System	PSN	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904878	Butrans 20 MCG/HR 7 Day Transdermal System	PSN	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904882	Butrans 5 MCG/HR 7 Day Transdermal System	PSN	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1542999	Butrans 7.5 MCG/HR 7 Day Transdermal System	PSN	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904882	168 HR buprenorphine 0.005 MG/HR Transdermal System [BuTrans]	SBD	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1542999	168 HR buprenorphine 0.0075 MG/HR Transdermal System [BuTrans]	SBD	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904874	168 HR buprenorphine 0.01 MG/HR Transdermal System [BuTrans]	SBD	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1432971	168 HR buprenorphine 0.015 MG/HR Transdermal System [BuTrans]	SBD	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904878	168 HR buprenorphine 0.02 MG/HR Transdermal System [BuTrans]	SBD	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904880	168 HR buprenorphine 0.005 MG/HR Transdermal System	SCD	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1542997	168 HR buprenorphine 0.0075 MG/HR Transdermal System	SCD	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904870	168 HR buprenorphine 0.01 MG/HR Transdermal System	SCD	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1432969	168 HR buprenorphine 0.015 MG/HR Transdermal System	SCD	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904876	168 HR buprenorphine 0.02 MG/HR Transdermal System	SCD	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904882	168 HR BuTrans 0.005 MG/HR Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1542999	168 HR BuTrans 0.0075 MG/HR Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904874	168 HR BuTrans 0.01 MG/HR Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1432971	168 HR BuTrans 0.015 MG/HR Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904878	168 HR BuTrans 0.02 MG/HR Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904870	buprenorphine 10 MCG/HR 7 Day Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904870	buprenorphine 10 MCG/HR Weekly Transdermal Patch	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1432969	buprenorphine 15 MCG/HR 7 Day Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1432969	buprenorphine 15 MCG/HR Weekly Transdermal Patch	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904876	buprenorphine 20 MCG/HR 7 Day Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904876	buprenorphine 20 MCG/HR Weekly Transdermal Patch	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904880	buprenorphine 5 MCG/HR 7 Day Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904880	buprenorphine 5 MCG/HR Weekly Transdermal Patch	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1542997	buprenorphine 7.5 MCG/HR 7 Day Transdermal Patch	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1542997	buprenorphine 7.5 MCG/HR 7 Day Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904874	Butrans 10 MCG/HR 7 Day Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904874	BuTrans 10 MCG/HR Weekly Transdermal Patch	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1432971	Butrans 15 MCG/HR 7 Day Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1432971	BuTrans 15 MCG/HR Weekly Transdermal Patch	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904878	Butrans 20 MCG/HR 7 Day Transdermal Patch	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904878	Butrans 20 MCG/HR 7 Day Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904882	Butrans 5 MCG/HR 7 Day Transdermal Patch	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
904882	Butrans 5 MCG/HR 7 Day Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1542999	BuTrans 7.5 MCG/HR 7 Day Transdermal Patch	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32
1542999	Butrans 7.5 MCG/HR 7 Day Transdermal System	SY	794aa355-66de-41b8-aedf-f2c40f6bc664	32

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59011-752-04	59011075204	4 POUCH in 1 CARTON (59011-752-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH	4 pouch	2011-02-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Butrans - Knoa Pharma LLC \| Lohman Therapie System	Knoa Pharma LLC \| Lohman Therapie System	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	32