Bupropion Hydrochloride

Product NDC: 0615-7864
11-digit product format: 006157864
Labeler code: 0615
Product ID: 0615-7864_34555b87-bc4c-43ef-99b6-661a438e04ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA076143
Marketing category: ANDA
Marketing start: 2006-01-17
Marketing end: 0000-00-00
Substance: BUPROPION HYDROCHLORIDE
Active strength: 75 mg/1
Pharmacologic classes: Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0615-7864		D	Discontinued by firm		2026-08-17
excluded package	package	0615-7864	0615-7864-39	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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-7864-39	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-7864-39	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-7864-39	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-7864-39	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-7864-39	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-7864-39	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-7864-39	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-7864-39	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-7864-39	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-7864-39	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-7864-39	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-7864-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-7864-39	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-7864-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-7864-39	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A076143-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17
A076143-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076143-001	AB
A076143-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`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	A076143-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076143-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076143-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076143-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076143-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076143-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076143-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076143-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076143-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076143-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076143-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076143-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076143-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076143-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076143-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076143-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076143-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076143-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076143-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076143-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076143-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076143-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076143-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076143-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076143-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076143-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076143-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076143-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076143-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076143-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076143-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076143-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076143-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076143-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076143-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076143-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076143-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076143-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076143-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076143-002	AB	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-7864-39	2021-03-26	C162847	48780-1	9d75b9d0-3a42-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use bupropion hydrochloride tablets safely and effectively. See full prescribing information for bupropion hydrochloride tablets. BUPROPION hydrochloride tablets, for oral use Initial U.S. Approval: 1985
0615-7864-39	2020-01-31	C162847	48780-1	9d75b9d0-3a42-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use bupropion hydrochloride tablets safely and effectively. See full prescribing information for bupropion hydrochloride tablets. BUPROPION hydrochloride tablets, for oral use Initial U.S. Approval: 1985

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FUMARIC ACID	INACTIVE INGREDIENT	88XHZ13131	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
METHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	4GFU244C4J	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	5829a2aa-4845-b58b-e063-6294a90ad2f4	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	867d3876-6974-4e89-bc45-9e60e84b401c	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	362504fd-2f0a-c097-e063-6394a90ac0fc	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	American Health Packaging	88c980c8-aaa8-4378-9ac2-24d588640caa	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b5c12c9a-62eb-481a-8099-7ad35242f7bf	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Cardinal Health 107, LLC	64934ca2-5655-45a2-9016-ad65b5abf5d3	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	5038440c-1f32-715a-e063-6294a90a889d	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Cardinal Health 107, LLC	ec4d2256-0340-4166-90ee-c264eef3ac82	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	eabb54b7-164c-4de8-b91a-f2e65637b5fc	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Major Pharmaceuticals	b127d3fc-be5e-4c12-8026-205766bf8e7f	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	AvPAK	bcb4ef83-f272-4090-8547-9aaf4ab63667	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	3b73d56e-e558-49de-8126-d7ec9b67a086	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	BluePoint Laboratories	7d035056-44ab-444d-9d27-125b3f571140	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Golden State Medical Supply, Inc.	9490d611-b679-45c7-e053-2a95a90afb87	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	f566f8b5-b3c1-4234-88bd-59a7b8dc801a	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	fa5fa0d8-d27f-44e1-8868-dfa7206524e2	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Apotex Corp	86530199-999b-9f92-b1bc-b8515ec829f3	2025-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	2a13267f-c47f-4791-a8f9-4bbb5c804027	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	1d722dc2-7909-454e-b989-095677079044	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	d1043c87-0abe-ee8e-e053-2a95a90a419a	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZG7E5POY8O	BUPROPION HYDROCHLORIDE	31677-93-7	BUPROPION HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	2015-01-06	HUMAN PRESCRIPTION DRUG LABEL	2