bupropion Hydrochloride

Product NDC: 58118-0191
11-digit product format: 581180191
Labeler code: 58118
Product ID: 58118-0191_b0160a1f-f637-c1f0-e053-2a95a90a7873
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Clinical Solutions Wholesale, LLC
Application: ANDA206975
Marketing category: ANDA
Marketing start: 2016-08-19
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: No
Listing certified through: 2021-12-31
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	58118-0191		D	Discontinued by firm		2026-08-03
excluded package	package	58118-0191	58118-0191-8	D	Discontinued by firm		2026-08-03

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	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58118-0191-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58118-0191-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58118-0191-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58118-0191-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58118-0191-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58118-0191-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58118-0191-8	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58118-0191-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58118-0191-8	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58118-0191-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58118-0191-8	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58118-0191-8	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58118-0191-8	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58118-0191-8	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58118-0191-8	`1332a3947898…`	`d4bfe170f9cd…`

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
A206975-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2016-08-19
A206975-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2016-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206975-001	AB
A206975-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206975-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2016-08-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206975-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2016-08-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206975-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206975-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206975-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206975-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206975-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206975-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206975-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206975-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206975-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206975-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206975-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206975-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206975-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206975-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206975-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206975-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206975-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206975-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206975-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206975-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206975-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206975-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206975-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206975-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206975-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206975-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206975-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206975-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206975-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206975-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206975-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206975-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206975-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206975-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206975-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206975-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206975-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206975-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206975-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206975-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58118-0191-8	2024-01-30	C162847	48780-1	1030e365-37f4-111a-e063-dadaa90a10e2	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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58118-0191	BUPROPION HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]	4	Legacy NDC	20200925_b2711a32-37a1-44c4-9dee-2e299daff0ae.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	434aacf8-87f1-44fc-a66b-92ae0022de0e	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	507112bd-a082-e85a-e063-6294a90ab2ac	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	MAJOR PHARMACEUTICALS	3c6b5ab4-9671-4fcd-8b4c-7f230dcfe6c9	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	90cc4f07-e0a3-4d50-a10a-8f6a7f9c5140	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	d9bbacb3-63b4-2922-e053-2a95a90a6085	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	e2a988f2-f8d3-4de0-b9f1-49d8c2e4180f	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	e4c450ff-32bd-4359-8449-0b0d0b89a78c	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	3eec57be-b8ae-cdf8-e063-6394a90a694d	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	9196568e-aec8-4d56-993e-4cbb78d4a3a6	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	744f7394-aac9-4864-9436-e5b0b35a6148	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	144379e1-93b7-41c1-bc3a-7bdec5afa309	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	35a873c5-4aa8-b3c7-e063-6394a90a35ec	2025-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	334e5635-e4cc-cf2a-e063-6294a90ae1e1	2025-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	4971c3cb-07c4-4c65-a16a-f1700e523147	2025-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	bd99969d-03d5-4609-88e8-a9ae93a83907	2025-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d0eada89-e302-4ba3-bef0-e8c69af8206e	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Chartwell RX, LLC	620fab1e-aafb-444d-ab81-63281cd139c5	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206975 application number: ANDA206975

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58118-0191-8	58118019108	30 TABLET in 1 BLISTER PACK (58118-0191-8)	30 tablet	2018-02-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
bupropion Hydrochloride	Clinical Solutions Wholesale, LLC	2020-09-24	HUMAN PRESCRIPTION DRUG LABEL	4