BRIXADI

Product NDC: 58284-208
11-digit product format: 582840208
Labeler code: 58284
Product ID: 58284-208_4e1985eb-1302-42e0-ac79-10b0a492966a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPRENORPHINE
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Braeburn Inc.
Application: NDA210136
Marketing category: NDA
Marketing start: 2023-06-06
Substance: BUPRENORPHINE
Active strength: 8 mg/.16mL
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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210136-001	BRIXADI	BUPRENORPHINE	8MG/0.16ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-05-23
N210136-002	BRIXADI	BUPRENORPHINE	16MG/0.32ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-05-23
N210136-003	BRIXADI	BUPRENORPHINE	24MG/0.48ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-05-23
N210136-004	BRIXADI	BUPRENORPHINE	32MG/0.64ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-05-23
N210136-005	BRIXADI	BUPRENORPHINE	64MG/0.18ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-05-23
N210136-006	BRIXADI	BUPRENORPHINE	96MG/0.27ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-05-23
N210136-007	BRIXADI	BUPRENORPHINE	128MG/0.36ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-05-23

Orange Book patents#

Current patent rows page 1 of 1 · 56 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210136-001	8236755	2026-07-31	U-3620	Drug product	2023-06-06
N210136-001	8236292	2027-01-10	U-3619	Drug product	2023-06-06
N210136-001	10912772	2032-07-26	U-3617		2023-06-06
N210136-001	11110084	2032-07-26	U-3616	Drug product	2023-06-06
N210136-001	11135215	2032-07-26		Drug product	2023-06-06
N210136-001	12161640	2032-07-26	U-4100	Drug product	2025-01-08
N210136-001	12318379	2032-07-26	U-4100	Drug product	2025-06-30
N210136-001	9937164	2032-07-26	U-3618	Drug product	2023-06-06
N210136-002	8236755	2026-07-31	U-3620	Drug product	2023-06-06
N210136-002	8236292	2027-01-10	U-3619	Drug product	2023-06-06
N210136-002	10912772	2032-07-26	U-3617		2023-06-06
N210136-002	11110084	2032-07-26	U-3616	Drug product	2023-06-06
N210136-002	11135215	2032-07-26		Drug product	2023-06-06
N210136-002	12161640	2032-07-26	U-4100	Drug product	2025-01-08
N210136-002	12318379	2032-07-26	U-4100	Drug product	2025-06-30
N210136-002	9937164	2032-07-26	U-3618	Drug product	2023-06-06
N210136-003	8236755	2026-07-31	U-3620	Drug product	2023-06-06
N210136-003	8236292	2027-01-10	U-3619	Drug product	2023-06-06
N210136-003	10912772	2032-07-26	U-3617		2023-06-06
N210136-003	11110084	2032-07-26	U-3616	Drug product	2023-06-06
N210136-003	11135215	2032-07-26		Drug product	2023-06-06
N210136-003	12161640	2032-07-26	U-4100	Drug product	2025-01-08
N210136-003	12318379	2032-07-26	U-4100	Drug product	2025-06-30
N210136-003	9937164	2032-07-26	U-3618	Drug product	2023-06-06
N210136-004	8236755	2026-07-31	U-3620	Drug product	2023-06-06
N210136-004	8236292	2027-01-10	U-3619	Drug product	2023-06-06
N210136-004	10912772	2032-07-26	U-3617		2023-06-06
N210136-004	11110084	2032-07-26	U-3616	Drug product	2023-06-06
N210136-004	11135215	2032-07-26		Drug product	2023-06-06
N210136-004	12161640	2032-07-26	U-4100	Drug product	2025-01-08
N210136-004	12318379	2032-07-26	U-4100	Drug product	2025-06-30
N210136-004	9937164	2032-07-26	U-3618	Drug product	2023-06-06
N210136-005	8236755	2026-07-31	U-3620	Drug product	2023-06-06
N210136-005	8236292	2027-01-10	U-3619	Drug product	2023-06-06
N210136-005	10912772	2032-07-26	U-3617		2023-06-06
N210136-005	11110084	2032-07-26	U-3616	Drug product	2023-06-06
N210136-005	11135215	2032-07-26		Drug product	2023-06-06
N210136-005	12161640	2032-07-26	U-4100	Drug product	2025-01-08
N210136-005	12318379	2032-07-26	U-4100	Drug product	2025-06-30
N210136-005	9937164	2032-07-26	U-3618	Drug product	2023-06-06
N210136-006	8236755	2026-07-31	U-3620	Drug product	2023-06-06
N210136-006	8236292	2027-01-10	U-3619	Drug product	2023-06-06
N210136-006	10912772	2032-07-26	U-3617		2023-06-06
N210136-006	11110084	2032-07-26	U-3616	Drug product	2023-06-06
N210136-006	11135215	2032-07-26		Drug product	2023-06-06
N210136-006	12161640	2032-07-26	U-4100	Drug product	2025-01-08
N210136-006	12318379	2032-07-26	U-4100	Drug product	2025-06-30
N210136-006	9937164	2032-07-26	U-3618	Drug product	2023-06-06
N210136-007	8236755	2026-07-31	U-3620	Drug product	2023-06-06
N210136-007	8236292	2027-01-10	U-3619	Drug product	2023-06-06
N210136-007	10912772	2032-07-26	U-3617		2023-06-06
N210136-007	11110084	2032-07-26	U-3616	Drug product	2023-06-06
N210136-007	11135215	2032-07-26		Drug product	2023-06-06
N210136-007	12161640	2032-07-26	U-4100	Drug product	2025-01-08
N210136-007	12318379	2032-07-26	U-4100	Drug product	2025-06-30
N210136-007	9937164	2032-07-26	U-3618	Drug product	2023-06-06

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 7 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210136-001	NP	2026-05-23
N210136-002	NP	2026-05-23
N210136-003	NP	2026-05-23
N210136-004	NP	2026-05-23
N210136-005	NP	2026-05-23
N210136-006	NP	2026-05-23
N210136-007	NP	2026-05-23

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 4 · 154 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210136-001	BRIXADI	8MG/0.16ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-002	BRIXADI	16MG/0.32ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-003	BRIXADI	24MG/0.48ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-004	BRIXADI	32MG/0.64ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-005	BRIXADI	64MG/0.18ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-006	BRIXADI	96MG/0.27ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-007	BRIXADI	128MG/0.36ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210136-001	BRIXADI	8MG/0.16ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210136-002	BRIXADI	16MG/0.32ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210136-003	BRIXADI	24MG/0.48ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210136-004	BRIXADI	32MG/0.64ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210136-005	BRIXADI	64MG/0.18ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210136-006	BRIXADI	96MG/0.27ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210136-007	BRIXADI	128MG/0.36ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210136-001	BRIXADI	8MG/0.16ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210136-002	BRIXADI	16MG/0.32ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210136-003	BRIXADI	24MG/0.48ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210136-004	BRIXADI	32MG/0.64ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210136-005	BRIXADI	64MG/0.18ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210136-006	BRIXADI	96MG/0.27ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210136-007	BRIXADI	128MG/0.36ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210136-001	BRIXADI	8MG/0.16ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210136-002	BRIXADI	16MG/0.32ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210136-003	BRIXADI	24MG/0.48ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210136-004	BRIXADI	32MG/0.64ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210136-005	BRIXADI	64MG/0.18ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210136-006	BRIXADI	96MG/0.27ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210136-007	BRIXADI	128MG/0.36ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210136-001	BRIXADI	8MG/0.16ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210136-002	BRIXADI	16MG/0.32ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210136-003	BRIXADI	24MG/0.48ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210136-004	BRIXADI	32MG/0.64ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210136-005	BRIXADI	64MG/0.18ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210136-006	BRIXADI	96MG/0.27ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210136-007	BRIXADI	128MG/0.36ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2023-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210136-001	BRIXADI	8MG/0.16ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210136-002	BRIXADI	16MG/0.32ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210136-003	BRIXADI	24MG/0.48ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210136-004	BRIXADI	32MG/0.64ML (50MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210136-005	BRIXADI	64MG/0.18ML (356MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2023-05-23	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 29 · 1,134 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	N210136-001	8236755	2026-07-31	U-3620	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-001	8236292	2027-01-10	U-3619	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-001	10912772	2032-07-26	U-3617		2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-001	11110084	2032-07-26	U-3616	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-001	11135215	2032-07-26		Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-001	12161640	2032-07-26	U-4100	Drug product	2025-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-001	12318379	2032-07-26	U-4100	Drug product	2025-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-001	9937164	2032-07-26	U-3618	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-002	8236755	2026-07-31	U-3620	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-002	8236292	2027-01-10	U-3619	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-002	10912772	2032-07-26	U-3617		2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-002	11110084	2032-07-26	U-3616	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-002	11135215	2032-07-26		Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-002	12161640	2032-07-26	U-4100	Drug product	2025-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-002	12318379	2032-07-26	U-4100	Drug product	2025-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-002	9937164	2032-07-26	U-3618	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-003	8236755	2026-07-31	U-3620	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-003	8236292	2027-01-10	U-3619	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-003	10912772	2032-07-26	U-3617		2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-003	11110084	2032-07-26	U-3616	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-003	11135215	2032-07-26		Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-003	12161640	2032-07-26	U-4100	Drug product	2025-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-003	12318379	2032-07-26	U-4100	Drug product	2025-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-003	9937164	2032-07-26	U-3618	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-004	8236755	2026-07-31	U-3620	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-004	8236292	2027-01-10	U-3619	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-004	10912772	2032-07-26	U-3617		2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-004	11110084	2032-07-26	U-3616	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-004	11135215	2032-07-26		Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-004	12161640	2032-07-26	U-4100	Drug product	2025-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-004	12318379	2032-07-26	U-4100	Drug product	2025-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-004	9937164	2032-07-26	U-3618	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-005	8236755	2026-07-31	U-3620	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-005	8236292	2027-01-10	U-3619	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-005	10912772	2032-07-26	U-3617		2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-005	11110084	2032-07-26	U-3616	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-005	11135215	2032-07-26		Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-005	12161640	2032-07-26	U-4100	Drug product	2025-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-005	12318379	2032-07-26	U-4100	Drug product	2025-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-005	9937164	2032-07-26	U-3618	Drug product	2023-06-06	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210136-001	NP	2026-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-002	NP	2026-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-003	NP	2026-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-004	NP	2026-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-005	NP	2026-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-006	NP	2026-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210136-007	NP	2026-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210136-001	NP	2026-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210136-002	NP	2026-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210136-003	NP	2026-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210136-004	NP	2026-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210136-005	NP	2026-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210136-006	NP	2026-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210136-007	NP	2026-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210136-001	NP	2026-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210136-002	NP	2026-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210136-003	NP	2026-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210136-004	NP	2026-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210136-005	NP	2026-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210136-006	NP	2026-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210136-007	NP	2026-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210136-001	NP	2026-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210136-002	NP	2026-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210136-003	NP	2026-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210136-004	NP	2026-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210136-005	NP	2026-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210136-006	NP	2026-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210136-007	NP	2026-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210136-001	NP	2026-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210136-002	NP	2026-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210136-003	NP	2026-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210136-004	NP	2026-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210136-005	NP	2026-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210136-006	NP	2026-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210136-007	NP	2026-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210136-001	NP	2026-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210136-002	NP	2026-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210136-003	NP	2026-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210136-004	NP	2026-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210136-005	NP	2026-05-23	`03ed91905a0d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPRENORPHINE	8 mg/.16mL

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 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2639021	Internal RxNorm lookup
2639027	Internal RxNorm lookup
2639029	Internal RxNorm lookup
2639030	Internal RxNorm lookup
2639031	Internal RxNorm lookup
2639032	Internal RxNorm lookup
2639033	Internal RxNorm lookup
2639034	Internal RxNorm lookup
2639036	Internal RxNorm lookup
2639039	Internal RxNorm lookup
2639041	Internal RxNorm lookup
2639042	Internal RxNorm lookup
2639043	Internal RxNorm lookup
2639044	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
5d8a8fd0-8619-422a-a664-d1d2e8970f48	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
58284-208-01	BRIXADI	1 in 1 CARTON	INJECTION	1		6
58284-208-01	BRIXADI	0.16 mL in 1 SYRINGE, GLASS	INJECTION	0.16		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58284-208-01	ML - Milliliter	58284-208	6b1b4d41-b77d-4762-8d28-9c02230cef1c	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58284-208	BRIXADI (BUPRENORPHINE) INJECTION [BRAEBURN INC.]	5	Current NDC, 2 package rows	20250112_5d8a8fd0-8619-422a-a664-d1d2e8970f48.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
BRIXADI	BUPRENORPHINE	Braeburn Inc.	5d8a8fd0-8619-422a-a664-d1d2e8970f48	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210136 application number: NDA210136 ndc (product): 58284-208

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
2639044	Brixadi 128 MG in 0.36 ML Monthly Extended Release Prefilled Syringe	PSN	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639030	Brixadi 16 MG in 0.32 ML Weekly Extended Release Prefilled Syringe	PSN	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639032	Brixadi 24 MG in 0.48 ML Weekly Extended Release Prefilled Syringe	PSN	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639034	Brixadi 32 MG in 0.64 ML Weekly Extended Release Prefilled Syringe	PSN	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639039	Brixadi 64 MG in 0.18 ML Monthly Extended Release Prefilled Syringe	PSN	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639027	Brixadi 8 MG in 0.16 ML Weekly Extended Release Prefilled Syringe	PSN	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639042	Brixadi 96 MG in 0.27 ML Monthly Extended Release Prefilled Syringe	PSN	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639043	buprenorphine 128 MG in 0.36 ML Monthly Extended Release Prefilled Syringe	PSN	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639029	buprenorphine 16 MG in 0.32 ML Weekly Extended Release Prefilled Syringe	PSN	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639031	buprenorphine 24 MG in 0.48 ML Weekly Extended Release Prefilled Syringe	PSN	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639033	buprenorphine 32 MG in 0.64 ML Weekly Extended Release Prefilled Syringe	PSN	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639036	buprenorphine 64 MG in 0.18 ML Monthly Extended Release Prefilled Syringe	PSN	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639021	buprenorphine 8 MG in 0.16 ML Weekly Extended Release Prefilled Syringe	PSN	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639041	buprenorphine 96 MG in 0.27 ML Monthly Extended Release Prefilled Syringe	PSN	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639027	0.16 ML buprenorphine 50 MG/ML Prefilled Syringe [Brixadi]	SBD	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639039	0.18 ML buprenorphine 356 MG/ML Prefilled Syringe [Brixadi]	SBD	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639042	0.27 ML buprenorphine 356 MG/ML Prefilled Syringe [Brixadi]	SBD	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639030	0.32 ML buprenorphine 50 MG/ML Prefilled Syringe [Brixadi]	SBD	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639044	0.36 ML buprenorphine 356 MG/ML Prefilled Syringe [Brixadi]	SBD	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639032	0.48 ML buprenorphine 50 MG/ML Prefilled Syringe [Brixadi]	SBD	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639034	0.64 ML buprenorphine 50 MG/ML Prefilled Syringe [Brixadi]	SBD	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639021	0.16 ML buprenorphine 50 MG/ML Prefilled Syringe	SCD	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639036	0.18 ML buprenorphine 356 MG/ML Prefilled Syringe	SCD	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639041	0.27 ML buprenorphine 356 MG/ML Prefilled Syringe	SCD	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639029	0.32 ML buprenorphine 50 MG/ML Prefilled Syringe	SCD	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639043	0.36 ML buprenorphine 356 MG/ML Prefilled Syringe	SCD	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639031	0.48 ML buprenorphine 50 MG/ML Prefilled Syringe	SCD	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639033	0.64 ML buprenorphine 50 MG/ML Prefilled Syringe	SCD	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639027	0.16 ML Brixadi 50 MG/ML Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639039	0.18 ML Brixadi 356 MG/ML Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639042	0.27 ML Brixadi 356 MG/ML Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639030	0.32 ML Brixadi 50 MG/ML Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639044	0.36 ML Brixadi 356 MG/ML Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639032	0.48 ML Brixadi 50 MG/ML Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639034	0.64 ML Brixadi 50 MG/ML Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639044	Brixadi 128 MG per 0.36 ML extended release Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639030	Brixadi 16 MG per 0.32 ML extended release Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639032	Brixadi 24 MG per 0.48 ML extended release Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639034	Brixadi 32 MG per 0.64 ML extended release Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639039	Brixadi 64 MG per 0.18 ML extended release Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639027	Brixadi 8 MG per 0.16 ML extended release Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639042	Brixadi 96 MG per 0.27 ML extended release Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639043	buprenorphine 128 MG per 0.36 ML extended release Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639029	buprenorphine 16 MG per 0.32 ML extended release Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639031	buprenorphine 24 MG per 0.48 ML extended release Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639033	buprenorphine 32 MG per 0.64 ML extended release Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639036	buprenorphine 64 MG per 0.18 ML extended release Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639021	buprenorphine 8 MG per 0.16 ML extended release Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6
2639041	buprenorphine 96 MG per 0.27 ML extended release Prefilled Syringe	SY	5d8a8fd0-8619-422a-a664-d1d2e8970f48	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
58284-208-01	58284020801	1 SYRINGE, GLASS in 1 CARTON (58284-208-01) / .16 mL in 1 SYRINGE, GLASS	2023-06-06	No	No	Current