buprenorphine hydrochloride

Product NDC: 63629-7125
Requested package NDC: 63629-7125-8
11-digit product format: 636297125
Labeler code: 63629
Product ID: 63629-7125_047cf3bf-65d9-4d3e-aaaa-4f5c5c9364a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: buprenorphine hydrochloride
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: Bryant Ranch Prepack
Application: ANDA090622
Marketing category: ANDA
Marketing start: 2010-09-24
Marketing end: 0000-00-00
Substance: BUPRENORPHINE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-7125	63629-7125-8	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
A090622-001	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB		2010-09-24
A090622-002	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB		2010-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090622-001	AB
A090622-002	AB

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090622-001	BUPRENORPHINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090622-002	BUPRENORPHINE HYDROCHLORIDE	EQ 8MG BASE	TABLET / SUBLINGUAL	AB	2010-09-24	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090622-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090622-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090622-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090622-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090622-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090622-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090622-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090622-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090622-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090622-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090622-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090622-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090622-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090622-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090622-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090622-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090622-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090622-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090622-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090622-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090622-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090622-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090622-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090622-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090622-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090622-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090622-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090622-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090622-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090622-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090622-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090622-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090622-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090622-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090622-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090622-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090622-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090622-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090622-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090622-002	AB	1	`bb7c543d1eb4…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	REMEDYREPACK INC.	11686845-f5fd-4e96-8a4f-9b132bf48840	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090622 application number: ANDA090622
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	442831cf-9636-433a-9a12-e9a8cd31f72a	2026-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090622 application number: ANDA090622
buprenorphine hydrochloride	BUPRENORPHINE HYDROCHLORIDE	A-S Medication Solutions	c1398d85-d4bb-4426-8ecf-a50400910d81	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090622 application number: ANDA090622

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
56W8MW3EN1	BUPRENORPHINE HYDROCHLORIDE	53152-21-9	BUPRENORPHINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-7125-8	63629712508	120 TABLET in 1 BOTTLE (63629-7125-8)	120 tablet	2022-09-02	0000-00-00	No	No	Current