Suboxone

Product NDC: 53217-328
11-digit product format: 532170328
Labeler code: 53217
Product ID: 53217-328_4f1210ae-a8ec-4253-b825-35e66ac93a1c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buprenorphine hydrochloride, naloxone hydrochloride
Dosage form: FILM, SOLUBLE
Route: SUBLINGUAL
Labeler: Aidarex Pharmaceuticals LLC
Application: NDA022410
Marketing category: NDA
Marketing start: 2010-09-13
Marketing end: 0000-00-00
Substance: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active strength: 8 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: 2019-12-31
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	53217-328		I	Inactivated by FDA		2026-08-03
excluded package	package	53217-328	53217-328-01	I	Inactivated by FDA		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 · 42 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	53217-328-01	`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	53217-328-01	`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	53217-328-01	`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	53217-328-01	`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	53217-328-01	`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	53217-328-01	`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	53217-328-01	`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	53217-328-01	`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	53217-328-01	`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	53217-328-01	`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	53217-328-01	`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	53217-328-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53217-328-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53217-328-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53217-328-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53217-328-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53217-328-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53217-328-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53217-328-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53217-328-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53217-328-01	`9bebd1f3094a…`	`5416666fcb17…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
68654759-f50b-79ef-24c5-544d94fe7d87	Product name	3	20251114
c955d208-c333-9bd7-be34-d7e12986d44e	Product name	6	20250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304	Product name	1	20250204
caa6391e-3db3-c912-335f-61b5fc00aa12	Product name	9	20240110
08a295bb-88df-4ab0-a120-a75a789a74f1	Product name	1	20231013
65a3bc34-04ff-4cf1-aad9-c7d92a062f6d	Product name	1	20231003
e951cdf3-f269-4d97-a7d5-c1c3d7283a7d	Product name	3	20230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39	Product name	4	20230306
100316cc-94a9-474e-97ad-9b5c6ddec605	Product name	5	20230125
f327b80c-8fa2-404b-838a-df3eec141cf2	Product name	1	20221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119	Product name	1	20220511
539bc5d3-546b-4af6-9c31-058ce6c459d3	Product name	2	20220210
b871fccd-1de6-4c7f-b9e5-045304641ee6	Product name	8	20220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9	Product name	1	20211026
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
0b8c7273-1da3-495f-909a-7cf1e96d2361	Product name	1	20161212
3df867ed-9d48-45cf-bded-1394beaea0b1	Product name	3	20161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4	Product name	1	20160712
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-328-01	2020-01-31	C162847	48780-1	9d75b9d0-5236-f424-e053-dadaa90a57ce	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 or buccal use CIII Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-328-01	Suboxone	30 in 1 CARTON	FILM, SOLUBLE	30		4
53217-328-01	Suboxone	1 in 1 POUCH	FILM, SOLUBLE	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-328	SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [AIDAREX PHARMACEUTICALS LLC]	4	Legacy NDC, 2 package rows	20180601_54c487ac-750b-462e-a4cb-dcab1dd43ba8.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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1010604	buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Film	PSN	54c487ac-750b-462e-a4cb-dcab1dd43ba8	4
1010606	Suboxone 8 MG / 2 MG Sublingual Film	PSN	54c487ac-750b-462e-a4cb-dcab1dd43ba8	4
1010606	buprenorphine 8 MG / naloxone 2 MG Sublingual Film [Suboxone]	SBD	54c487ac-750b-462e-a4cb-dcab1dd43ba8	4
1010604	buprenorphine 8 MG / naloxone 2 MG Sublingual Film	SCD	54c487ac-750b-462e-a4cb-dcab1dd43ba8	4
1010604	buprenorphine 8 MG / naloxone 2 MG Buccal Film	SY	54c487ac-750b-462e-a4cb-dcab1dd43ba8	4
1010604	buprenorphine 8 MG / naloxone 2 MG Sublingual Film	SY	54c487ac-750b-462e-a4cb-dcab1dd43ba8	4
1010606	Suboxone 8/2 (buprenorphine HCl / naloxone HCl dihydrate) Sublingual Film	SY	54c487ac-750b-462e-a4cb-dcab1dd43ba8	4
1010606	Suboxone 8/2 Sublingual Film	SY	54c487ac-750b-462e-a4cb-dcab1dd43ba8	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-328-01	53217032801	30 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Suboxone - Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-05-31	HUMAN PRESCRIPTION DRUG LABEL	4