bupropion Hydrochloride

Product NDC: 71335-0943
Requested package NDC: 71335-0943-2
11-digit product format: 713350943
Labeler code: 71335
Product ID: 71335-0943_54094d85-96a6-49c2-a58c-4d4fcfb3c0ad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA207389
Marketing category: ANDA
Marketing start: 2018-05-26
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-0943	71335-0943-2	D	Discontinued by firm		2026-09-14

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 43.

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
A207389-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL			2017-09-18
A207389-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL			2017-09-18

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 · 86 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
2026-09-14 22:38:34	2026-08	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2017-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2017-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207389-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-09-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207389-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-09-18	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

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	A207389-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207389-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207389-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207389-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207389-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207389-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207389-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207389-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207389-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207389-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207389-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207389-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207389-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207389-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207389-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207389-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207389-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207389-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207389-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207389-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207389-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207389-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207389-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207389-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207389-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207389-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207389-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207389-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207389-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207389-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207389-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207389-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207389-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207389-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207389-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207389-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207389-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207389-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207389-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207389-002	AB	1	`3f0d92c62455…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	c1fa6fce-272b-4497-a958-177f0bafdfc7	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207389 application number: ANDA207389
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	CIPLA USA INC.,	e4100232-a25d-4468-9057-af7e66205154	2023-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207389 application number: ANDA207389

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
71335-0943-2	71335094302	60 TABLET in 1 BOTTLE (71335-0943-2)	60 tablet	2018-05-26	0000-00-00	No	No	Current