Suboxone

Product NDC: 63629-4028
11-digit product format: 636294028
Labeler code: 63629
Product ID: 63629-4028_897164c4-714d-4b8a-8b6a-9ffc7f3627a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buprenorphine and naloxone
Dosage form: FILM, SOLUBLE
Route: SUBLINGUAL
Labeler: Bryant Ranch Prepack
Application: NDA022410
Marketing category: NDA
Marketing start: 2010-09-13
Marketing end: 0000-00-00
Substance: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
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: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-4028		D	Discontinued by firm	2026-08-03
excluded package	package	63629-4028	63629-4028-1	D	Discontinued by firm	2026-08-03
excluded package	package	63629-4028	63629-4028-2	D	Discontinued by firm	2026-08-03

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 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4028-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-4028-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4028-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-4028-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4028-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-4028-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4028-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-4028-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4028-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-4028-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4028-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-4028-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4028-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-4028-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4028-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-4028-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4028-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-4028-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4028-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-4028-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-4028-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-4028-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-4028-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-4028-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4028-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4028-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4028-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4028-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-4028-2	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63629-4028-1	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022410-001	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30
N022410-002	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30
N022410-003	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2012-08-10
N022410-004	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD, RS	2012-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022410-001	AB
N022410-002	AB
N022410-003	AB
N022410-004	AB

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
N022410-001	11135216	2029-08-07	U-3111	Drug product	2021-10-21
N022410-001	9687454	2029-08-07	U-1464	Drug product	2017-07-14
N022410-001	8475832	2030-03-26	U-1411	Drug product	2013-07-03
N022410-002	11135216	2029-08-07	U-3111	Drug product	2021-10-21
N022410-002	9687454	2029-08-07	U-1464	Drug product	2017-07-14
N022410-002	8475832	2030-03-26	U-1411	Drug product
N022410-003	11135216	2029-08-07	U-3111	Drug product	2021-10-21
N022410-003	9687454	2029-08-07	U-1464	Drug product	2017-07-14
N022410-003	8475832	2030-03-26	U-1411	Drug product
N022410-004	11135216	2029-08-07	U-3111	Drug product	2021-10-21
N022410-004	9687454	2029-08-07	U-1464	Drug product	2017-07-14
N022410-004	8475832	2030-03-26	U-1411	Drug product

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 5 · 164 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	N022410-001	SUBOXONE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-002	SUBOXONE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-003	SUBOXONE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2012-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-004	SUBOXONE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD, RS	2012-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-001	SUBOXONE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-002	SUBOXONE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-003	SUBOXONE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2012-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-004	SUBOXONE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD, RS	2012-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022410-001	SUBOXONE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-002	SUBOXONE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-003	SUBOXONE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2012-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-004	SUBOXONE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD, RS	2012-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022410-001	SUBOXONE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022410-002	SUBOXONE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022410-003	SUBOXONE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2012-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022410-004	SUBOXONE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD, RS	2012-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022410-001	SUBOXONE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022410-002	SUBOXONE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022410-003	SUBOXONE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2012-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022410-004	SUBOXONE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD, RS	2012-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022410-001	SUBOXONE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022410-002	SUBOXONE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022410-003	SUBOXONE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2012-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022410-004	SUBOXONE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD, RS	2012-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022410-001	SUBOXONE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022410-002	SUBOXONE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022410-003	SUBOXONE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2012-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022410-004	SUBOXONE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD, RS	2012-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022410-001	SUBOXONE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022410-002	SUBOXONE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022410-003	SUBOXONE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2012-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022410-004	SUBOXONE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD, RS	2012-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022410-001	SUBOXONE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022410-002	SUBOXONE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022410-003	SUBOXONE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2012-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022410-004	SUBOXONE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD, RS	2012-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022410-001	SUBOXONE	EQ 2MG BASE;EQ 0.5MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022410-002	SUBOXONE	EQ 8MG BASE;EQ 2MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2010-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022410-003	SUBOXONE	EQ 4MG BASE;EQ 1MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD	2012-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022410-004	SUBOXONE	EQ 12MG BASE;EQ 3MG BASE	FILM / BUCCAL, SUBLINGUAL	AB	RLD, RS	2012-08-10	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	N022410-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022410-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022410-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022410-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022410-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022410-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022410-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022410-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022410-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022410-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022410-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022410-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022410-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022410-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022410-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022410-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022410-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022410-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022410-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022410-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022410-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022410-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022410-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022410-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022410-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022410-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022410-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022410-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022410-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022410-004	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 23 · 912 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	N022410-001	11135216	2029-08-07	U-3111	Drug product	2021-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-001	9687454	2029-08-07	U-1464	Drug product	2017-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-001	8475832	2030-03-26	U-1411	Drug product	2013-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-002	11135216	2029-08-07	U-3111	Drug product	2021-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-002	9687454	2029-08-07	U-1464	Drug product	2017-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-002	8475832	2030-03-26	U-1411	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-003	11135216	2029-08-07	U-3111	Drug product	2021-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-003	9687454	2029-08-07	U-1464	Drug product	2017-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-003	8475832	2030-03-26	U-1411	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-004	11135216	2029-08-07	U-3111	Drug product	2021-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-004	9687454	2029-08-07	U-1464	Drug product	2017-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022410-004	8475832	2030-03-26	U-1411	Drug product		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-001	11135216	2029-08-07	U-3111	Drug product	2021-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-001	9687454	2029-08-07	U-1464	Drug product	2017-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-001	8475832	2030-03-26	U-1411	Drug product	2013-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-002	11135216	2029-08-07	U-3111	Drug product	2021-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-002	9687454	2029-08-07	U-1464	Drug product	2017-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-002	8475832	2030-03-26	U-1411	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-003	11135216	2029-08-07	U-3111	Drug product	2021-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-003	9687454	2029-08-07	U-1464	Drug product	2017-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-003	8475832	2030-03-26	U-1411	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-004	11135216	2029-08-07	U-3111	Drug product	2021-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-004	9687454	2029-08-07	U-1464	Drug product	2017-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022410-004	8475832	2030-03-26	U-1411	Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022410-001	11135216	2029-08-07	U-3111	Drug product	2021-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-001	9687454	2029-08-07	U-1464	Drug product	2017-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-001	8475832	2030-03-26	U-1411	Drug product	2013-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-002	11135216	2029-08-07	U-3111	Drug product	2021-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-002	9687454	2029-08-07	U-1464	Drug product	2017-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-002	8475832	2030-03-26	U-1411	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-003	11135216	2029-08-07	U-3111	Drug product	2021-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-003	9687454	2029-08-07	U-1464	Drug product	2017-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-003	8475832	2030-03-26	U-1411	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-004	11135216	2029-08-07	U-3111	Drug product	2021-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-004	9687454	2029-08-07	U-1464	Drug product	2017-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022410-004	8475832	2030-03-26	U-1411	Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022410-001	11135216	2029-08-07	U-3111	Drug product	2021-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022410-001	9687454	2029-08-07	U-1464	Drug product	2017-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022410-001	8475832	2030-03-26	U-1411	Drug product	2013-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022410-002	11135216	2029-08-07	U-3111	Drug product	2021-10-21	`fd3edfee7708…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4028-1	2021-07-07	These highlights do not include all the information needed to use SUBOXONE sublingual film safely and effectively. See full prescribing information for SUBOXONE sublingual film. SUBOXONE (buprenorphine and naloxone) sublingual film for sublingual administration CIII Initial U.S. Approval: 2002
63629-4028-2	2021-07-07	These highlights do not include all the information needed to use SUBOXONE sublingual film safely and effectively. See full prescribing information for SUBOXONE sublingual film. SUBOXONE (buprenorphine and naloxone) sublingual film for sublingual administration CIII Initial U.S. Approval: 2002
63629-4028-1	2019-11-27	These highlights do not include all the information needed to use SUBOXONE sublingual film safely and effectively. See full prescribing information for SUBOXONE sublingual film. SUBOXONE (buprenorphine and naloxone) sublingual film for sublingual administration CIII Initial U.S. Approval: 2002
63629-4028-2	2019-11-27	These highlights do not include all the information needed to use SUBOXONE sublingual film safely and effectively. See full prescribing information for SUBOXONE sublingual film. SUBOXONE (buprenorphine and naloxone) sublingual film for sublingual administration CIII Initial U.S. Approval: 2002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-4028-1	EA - Each	63629-4028	1279a442-1497-42a4-b2ff-089ce8b2214b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPRENORPHINE HYDROCHLORIDE	ACTIVE INGREDIENT	56W8MW3EN1	SUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]	2
NALOXONE HYDROCHLORIDE	ACTIVE INGREDIENT	F850569PQR	SUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]	2
BUPRENORPHINE	ACTIVE MOIETY	40D3SCR4GZ	SUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]	2
NALOXONE	ACTIVE MOIETY	36B82AMQ7N	SUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	SUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]	2
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	SUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	SUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]	2

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
Suboxone	BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE	INDIVIOR INC.	8a5edcf9-828c-4f97-b671-268ab13a8ecd	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022410 application number: NDA022410

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
56W8MW3EN1	BUPRENORPHINE HYDROCHLORIDE	53152-21-9	BUPRENORPHINE HYDROCHLORIDE
F850569PQR	NALOXONE HYDROCHLORIDE	357-08-4	NALOXONE HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Suboxone - Bryant Ranch Prepack \| Monosol Rx LLC \| Reckitt Benckiser Healthcare (UK) Ltd	Bryant Ranch Prepack \| Monosol Rx LLC \| Reckitt Benckiser Healthcare (UK) Ltd	2012-10-12	HUMAN PRESCRIPTION DRUG LABEL	2