Application 022410

Type: NDA
Sponsor: INDIVIOR INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	FILM;BUCCAL, SUBLINGUAL	EQ 2MG BASE;EQ 0.5MG BASE	Yes	No
002	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	FILM;BUCCAL, SUBLINGUAL	EQ 8MG BASE;EQ 2MG BASE	Yes	No
003	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	FILM;BUCCAL, SUBLINGUAL	EQ 4MG BASE;EQ 1MG BASE	Yes	No
004	SUBOXONE	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	FILM;BUCCAL, SUBLINGUAL	EQ 12MG BASE;EQ 3MG BASE	Yes	Yes

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…`

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 ndc (product): 12496-1202 ndc (product): 12496-1208 ndc (product): 12496-1212 ndc (product): 12496-1204

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 71 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA AUTHORIZED GENERIC	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	INDIVIOR INC.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	INDIVIOR INC.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	INDIVIOR INC.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1208	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	INDIVIOR INC.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
12496-1212	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Indivior Inc.	NDA	Current
53217-328	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Aidarex Pharmaceuticals LLC	NDA	Current
55700-147	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	Quality Care Products, LLC	NDA	Current
63629-4028	Suboxone	buprenorphine and naloxone	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84614	SUPPL	2025-12-31
84594	SUPPL	2025-12-29
82211	SUPPL	2025-05-21
82238	SUPPL	2025-05-19
81356	SUPPL	2025-02-25
77894	SUPPL	2024-03-21
76961	SUPPL	2023-12-18
76398	ORIG	2023-11-06
73757	SUPPL	2023-03-14
73744	SUPPL	2023-03-14
72978	SUPPL	2022-12-21
71394	SUPPL	2022-06-21
71393	SUPPL	2022-06-21
71392	SUPPL	2022-06-21
71370	SUPPL	2022-06-21
71369	SUPPL	2022-06-21
70986	SUPPL	2022-05-04
69380	SUPPL	2021-11-23
66619	SUPPL	2021-03-08
66618	SUPPL	2021-03-08
66566	SUPPL	2021-03-08
62028	SUPPL	2020-03-04
60769	SUPPL	2019-11-01
60763	SUPPL	2019-10-31
60475	SUPPL	2019-10-09
60474	SUPPL	2019-10-09
60443	SUPPL	2019-10-09
56141	SUPPL	2018-10-29
54621	SUPPL	2018-06-20
54610	SUPPL	2018-06-19
54593	SUPPL	2018-06-14
52288	SUPPL	2018-02-02
52245	SUPPL	2018-02-01
50046	APPL	2017-10-12
49839	SUPPL	2017-09-22
47248	SUPPL	2017-02-16
47196	SUPPL	2017-02-14
46380	SUPPL	2016-12-21
46379	SUPPL	2016-12-21
46335	SUPPL	2016-12-21
46334	SUPPL	2016-12-21
29699	SUPPL	2016-07-12
38673	SUPPL	2015-10-06
38672	SUPPL	2015-10-06
7347	SUPPL	2015-09-24
7346	SUPPL	2015-09-24
42515	SUPPL	2014-08-05
22015	SUPPL	2014-08-05
22014	SUPPL	2014-08-05
38671	SUPPL	2014-04-29
38670	SUPPL	2014-04-29
17556	SUPPL	2014-04-29
7345	SUPPL	2014-04-29
7344	SUPPL	2014-04-29
7342	SUPPL	2014-04-29
17555	SUPPL	2013-11-26
7343	SUPPL	2013-11-25
42514	SUPPL	2013-02-25
42513	SUPPL	2013-02-25
17554	SUPPL	2012-08-15
17553	SUPPL	2012-08-15
42512	ORIG	2011-08-12
24300	ORIG	2011-08-12
38669	ORIG	2010-09-10
7341	ORIG	2010-09-02