Application 018401

Type: NDA
Sponsor: INDIVIOR INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPRENEX	BUPRENORPHINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 0.3MG BASE/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018401-001	BUPRENEX	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018401-001	BUPRENEX	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018401-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018401-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018401-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018401-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018401-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018401-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018401-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018401-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018401-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018401-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018401-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018401-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018401-001	AP	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018401-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018401-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018401-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018401-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018401-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018401-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018401-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018401-001	AP	1	`cb3db0bc1861…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Advagen Pharma Ltd	699638dd-3a53-445f-a545-d0e6eabfe1c9	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	REMEDYREPACK INC.	11686845-f5fd-4e96-8a4f-9b132bf48840	2026-07-07	Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	442831cf-9636-433a-9a12-e9a8cd31f72a	2026-02-28	Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	REMEDYREPACK INC.	9f7b0a28-f937-4d4d-b793-ca3468bd28e0	2026-02-10	Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
BELBUCA	BUPRENORPHINE HYDROCHLORIDE	BioDelivery Sciences International Inc	bc2b7a3d-72cf-497c-95b0-ba2b71f63c64	2026-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Hospira, Inc.	23aa1bb3-cecf-4e62-29bb-48488bb66fc3	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Par Health USA, LLC	34767dda-ce52-4f98-a45f-bb5cee0cd5e6	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	A-S Medication Solutions	c1398d85-d4bb-4426-8ecf-a50400910d81	2025-05-28	Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	adc1167e-910e-4d7b-abdc-751d3df0c3dc	2025-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Somerset Therapeutics, LLC	74e40c51-853b-4e7f-b3cb-a27af29e1cbf	2025-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPRENORPHINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
12496-0757	Buprenex	buprenorphine hydrochloride	Reckitt Benckiser Pharmaceuticals Inc	NDA	Current
12496-0757	Buprenex	buprenorphine hydrochloride	Indivior Inc.	NDA	Current
12496-0757	Buprenex	buprenorphine hydrochloride	Indivior Inc.	NDA	Current
12496-0757	Buprenex	buprenorphine hydrochloride	Indivior Inc.	NDA	Current
12496-0757	Buprenex	buprenorphine hydrochloride	Indivior Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76984	SUPPL	2023-12-19
76885	SUPPL	2023-12-18
71408	SUPPL	2022-06-21
71363	SUPPL	2022-06-21
60413	SUPPL	2019-10-09
60269	SUPPL	2019-10-07
46214	SUPPL	2016-12-19
40797	SUPPL	2006-10-26
20124	SUPPL	2006-05-10
14996	SUPPL	2003-06-22
14995	SUPPL	2002-03-08