SUBLOCADE

Product NDC: 12496-0300
11-digit product format: 124960300
Labeler code: 12496
Product ID: 12496-0300_a5971cb4-0e84-4bc6-a2ff-bbd668f2dbec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buprenorphine
Dosage form: SOLUTION
Route: SUBCUTANEOUS
Labeler: Indivior Inc.
Application: NDA209819
Marketing category: NDA
Marketing start: 2018-02-26
Substance: BUPRENORPHINE
Active strength: 300 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209819-001	SUBLOCADE	BUPRENORPHINE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2017-11-30
N209819-002	SUBLOCADE	BUPRENORPHINE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS		RLD, RS	2017-11-30

Orange Book patents#

Current patent rows page 1 of 1 · 49 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209819-001	10198218	2031-06-06	U-2489		2019-02-15
N209819-001	10592168	2031-06-06	U-2489		2020-03-19
N209819-001	9272044	2031-06-06	U-2176		2017-12-13
N209819-001	9272044	2031-06-06	U-2177		2017-12-13
N209819-001	9272044	2031-06-06	U-2178		2017-12-13
N209819-001	9272044	2031-06-06	U-2209		2017-12-13
N209819-001	9498432	2031-06-06	U-2179	Drug product	2017-12-13
N209819-001	9782402	2031-06-06	U-2176	Drug product	2017-12-13
N209819-001	9782402	2031-06-06	U-2180	Drug product	2017-12-13
N209819-001	9782402	2031-06-06	U-2207	Drug product	2017-12-13
N209819-001	9782402	2031-06-06	U-2208	Drug product	2017-12-13
N209819-001	9827241	2031-06-06	U-2174	Drug product	2017-12-13
N209819-001	9827241	2031-06-06	U-2181	Drug product	2017-12-13
N209819-001	9827241	2031-06-06	U-2206	Drug product	2017-12-13
N209819-001	9827241	2031-06-06	U-2210	Drug product	2017-12-13
N209819-001	9827241	2031-06-06	U-2211	Drug product	2017-12-13
N209819-001	10558394	2031-06-25		Drug product	2020-02-18
N209819-001	8975270	2031-09-05	U-2175	Drug product	2017-12-13
N209819-001	8975270	2031-09-05	U-2206	Drug product	2017-12-13
N209819-001	8921387	2032-01-06	U-2173	Drug product	2017-12-13
N209819-001	8921387	2032-01-06	U-2174	Drug product	2017-12-13
N209819-001	11000520	2035-11-06	U-3111		2021-05-20
N209819-001	11839611	2035-11-06	U-3111		2024-01-08
N209819-001	12622904	2035-11-06	U-4528		2026-06-05
N209819-002	10198218	2031-06-06	U-2489		2019-02-15
N209819-002	10592168	2031-06-06	U-2489		2020-03-19
N209819-002	9272044	2031-06-06	U-2176		2017-12-13
N209819-002	9272044	2031-06-06	U-2177		2017-12-13
N209819-002	9272044	2031-06-06	U-2178		2017-12-13
N209819-002	9272044	2031-06-06	U-2209		2017-12-13
N209819-002	9498432	2031-06-06	U-2179	Drug product	2017-12-13
N209819-002	9782402	2031-06-06	U-2176	Drug product	2017-12-13
N209819-002	9782402	2031-06-06	U-2180	Drug product	2017-12-13
N209819-002	9782402	2031-06-06	U-2207	Drug product	2017-12-13
N209819-002	9782402	2031-06-06	U-2208	Drug product	2017-12-13
N209819-002	9827241	2031-06-06	U-2174	Drug product	2017-12-13
N209819-002	9827241	2031-06-06	U-2181	Drug product	2017-12-13
N209819-002	9827241	2031-06-06	U-2206	Drug product	2017-12-13
N209819-002	9827241	2031-06-06	U-2210	Drug product	2017-12-13
N209819-002	9827241	2031-06-06	U-2211	Drug product	2017-12-13
N209819-002	10558394	2031-06-25		Drug product	2020-07-16
N209819-002	8975270	2031-09-05	U-2175	Drug product	2017-12-13
N209819-002	8975270	2031-09-05	U-2206	Drug product	2017-12-13
N209819-002	8921387	2032-01-06	U-2173	Drug product	2017-12-13
N209819-002	8921387	2032-01-06	U-2174	Drug product	2017-12-13
N209819-002	11000520	2035-11-06	U-3111		2021-05-20
N209819-002	11839611	2035-11-06	U-3111		2024-01-08
N209819-002	12622904	2035-11-06	U-4528		2026-06-05
N209819-002	10646484	2038-06-22	U-2489		2020-05-12

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209819-001	M-314	2028-02-21
N209819-002	M-314	2028-02-21

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 3 · 82 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	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 47 · 1,845 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	N209819-001	10198218	2031-06-06	U-2489		2019-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	10592168	2031-06-06	U-2489		2020-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9272044	2031-06-06	U-2176		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9272044	2031-06-06	U-2209		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9272044	2031-06-06	U-2178		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9272044	2031-06-06	U-2177		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9498432	2031-06-06	U-2179	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9782402	2031-06-06	U-2180	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9782402	2031-06-06	U-2176	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9782402	2031-06-06	U-2208	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9782402	2031-06-06	U-2207	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9827241	2031-06-06	U-2206	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9827241	2031-06-06	U-2211	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9827241	2031-06-06	U-2181	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9827241	2031-06-06	U-2210	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9827241	2031-06-06	U-2174	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	10558394	2031-06-25		Drug product	2020-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	8975270	2031-09-05	U-2206	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	8975270	2031-09-05	U-2175	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	8921387	2032-01-06	U-2174	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	8921387	2032-01-06	U-2173	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	11000520	2035-11-06	U-3111		2021-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	11839611	2035-11-06	U-3111		2024-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	10198218	2031-06-06	U-2489		2019-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	10592168	2031-06-06	U-2489		2020-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9272044	2031-06-06	U-2209		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9272044	2031-06-06	U-2178		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9272044	2031-06-06	U-2176		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9272044	2031-06-06	U-2177		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9498432	2031-06-06	U-2179	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9782402	2031-06-06	U-2208	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9782402	2031-06-06	U-2207	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9782402	2031-06-06	U-2180	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9782402	2031-06-06	U-2176	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9827241	2031-06-06	U-2181	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9827241	2031-06-06	U-2206	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9827241	2031-06-06	U-2211	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9827241	2031-06-06	U-2174	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9827241	2031-06-06	U-2210	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	10558394	2031-06-25		Drug product	2020-07-16	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209819-001	M-314	2028-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	M-314	2028-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209819-001	M-314	2028-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209819-002	M-314	2028-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209819-001	M-314	2028-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209819-002	M-314	2028-02-21	`6a471c1ec25d…`
2019-12-13 00:20 UTC	2019-12	N209819-001	NP	2020-11-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209819-002	NP	2020-11-30	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N209819-001	NP	2020-11-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209819-002	NP	2020-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209819-001	NP	2020-11-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209819-002	NP	2020-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209819-001	NP	2020-11-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209819-002	NP	2020-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209819-001	NP	2020-11-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209819-002	NP	2020-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209819-001	NP	2020-11-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209819-002	NP	2020-11-30	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209819-001	M-314	2028-02-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209819-002	M-314	2028-02-21	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPRENORPHINE	300 mg/1

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1996184	Internal RxNorm lookup
1996189	Internal RxNorm lookup
1996192	Internal RxNorm lookup
1996193	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
6189fb21-9432-45f8-8481-0bfaf3ccde95	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	SPL version
12496-0300-1	SUBLOCADE	1 in 1 CARTON	SOLUTION	1	42
12496-0300-2	SUBLOCADE	1 in 1 POUCH	SOLUTION	1	42
12496-0300-5	SUBLOCADE	1 in 1 SYRINGE	SOLUTION	1	42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
12496-0300-1	ML - Milliliter	12496-0300	9515aa65-919d-42f4-91ed-0dcaeeaab022	1	2018-01-12
12496-0300-2	ML - Milliliter	12496-0300	06fdd16b-12a7-4403-952c-174e26ce9527	1	2018-03-08
12496-0300-5	ML - Milliliter	12496-0300	9a40253b-b1a3-41f9-adf9-3d69c7476ea6	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12496-0300	SUBLOCADE (BUPRENORPHINE) SOLUTION [INDIVIOR INC.]	38	Current NDC, Legacy NDC, 3 package rows	20250309_6189fb21-9432-45f8-8481-0bfaf3ccde95.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
SUBLOCADE	BUPRENORPHINE	Indivior Inc.	6189fb21-9432-45f8-8481-0bfaf3ccde95	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209819 application number: NDA209819 ndc (product): 12496-0300

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
1996184	buprenorphine 100 MG in 0.5 mL Prefilled Syringe	PSN	6189fb21-9432-45f8-8481-0bfaf3ccde95	42
1996192	buprenorphine 300 MG in 1.5 mL Prefilled Syringe	PSN	6189fb21-9432-45f8-8481-0bfaf3ccde95	42
1996189	SUBLOCADE 100 MG in 0.5 mL Prefilled Syringe	PSN	6189fb21-9432-45f8-8481-0bfaf3ccde95	42
1996193	SUBLOCADE 300 MG in 1.5 mL Prefilled Syringe	PSN	6189fb21-9432-45f8-8481-0bfaf3ccde95	42
1996189	0.5 ML buprenorphine 200 MG/ML Prefilled Syringe [Sublocade]	SBD	6189fb21-9432-45f8-8481-0bfaf3ccde95	42
1996193	1.5 ML buprenorphine 200 MG/ML Prefilled Syringe [Sublocade]	SBD	6189fb21-9432-45f8-8481-0bfaf3ccde95	42
1996184	0.5 ML buprenorphine 200 MG/ML Prefilled Syringe	SCD	6189fb21-9432-45f8-8481-0bfaf3ccde95	42
1996192	1.5 ML buprenorphine 200 MG/ML Prefilled Syringe	SCD	6189fb21-9432-45f8-8481-0bfaf3ccde95	42
1996189	0.5 ML Sublocade 200 MG/ML Prefilled Syringe	SY	6189fb21-9432-45f8-8481-0bfaf3ccde95	42
1996193	1.5 ML Sublocade 200 MG/ML Prefilled Syringe	SY	6189fb21-9432-45f8-8481-0bfaf3ccde95	42
1996184	buprenorphine 100 MG per 0.5 ML Prefilled Syringe	SY	6189fb21-9432-45f8-8481-0bfaf3ccde95	42
1996192	buprenorphine 300 MG per 1.5 ML Prefilled Syringe	SY	6189fb21-9432-45f8-8481-0bfaf3ccde95	42
1996189	Sublocade 100 MG per 0.5 ML Prefilled Syringe	SY	6189fb21-9432-45f8-8481-0bfaf3ccde95	42
1996193	Sublocade 300 MG per 1.5 ML Prefilled Syringe	SY	6189fb21-9432-45f8-8481-0bfaf3ccde95	42

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12496-0300-1	12496030001	1 POUCH in 1 CARTON (12496-0300-1) / 1 SYRINGE in 1 POUCH (12496-0300-2) / 1 SOLUTION in 1 SYRINGE (12496-0300-5)	1 pouch	2018-02-26	0000-00-00	No	No	Current
12496-0300-2	12496030002	1 in 1 POUCH						Historical
12496-0300-5	12496030005	1 in 1 SYRINGE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SUBLOCADE	Indivior Inc. \| SGS North America Inc. \| Eurofins Lancaster Laboratories, LLC \| Curia New Mexico, LLC \| Curia New Mexico, LLC. \| Curia Global, Inc. \| Sharp Packaging Services, LLC \| Nelson Laboratories, LLC \| Indivior UK Limited \| Wickham Micro Limited \| QUOTIENT SCIENCES (ALNWICK) LIMITED \| Sterling Pharma Solutions Limited	2026-07-27	HUMAN PRESCRIPTION DRUG LABEL	43