Bupropion Hydrochloride

Product NDC: 67544-406
Requested package NDC: 67544-406-94
11-digit product format: 675440406
Labeler code: 67544
Product ID: 67544-406_00ff6c58-e096-4d7a-8e7b-62d98946eac0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA075491
Marketing category: ANDA
Marketing start: 2000-05-11
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: 2020-12-31
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	67544-406	67544-406-94	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 · 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 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
A075491-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2000-04-17
A075491-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2000-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075491-001	AB
A075491-002	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	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2000-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2000-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2000-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2000-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2000-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2000-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2000-04-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2000-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2000-04-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2000-04-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 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	A075491-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075491-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075491-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075491-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075491-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075491-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075491-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075491-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075491-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075491-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075491-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075491-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075491-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075491-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075491-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075491-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075491-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075491-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075491-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075491-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075491-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075491-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075491-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075491-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075491-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075491-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075491-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075491-002	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A075491-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075491-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075491-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075491-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075491-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075491-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075491-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075491-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075491-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075491-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075491-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075491-002	AB	1	`3f01610625f2…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-406-51	EA - Each	67544-406	b7dbca56-5ac4-47c0-b637-6df1df9a8b62	1	2018-01-12
67544-406-53	EA - Each	67544-406	b344f844-571c-458f-9bfd-6ee4da07aa55	1	2018-01-12
67544-406-70	EA - Each	67544-406	54920d0f-906b-42cd-97ee-f74964b75fdf	1	2018-01-12
67544-406-80	EA - Each	67544-406	eb994377-8f67-4d39-8223-6fd9591944c6	1	2018-01-12
67544-406-94	EA - Each	67544-406	110cc97d-4949-4413-89fa-bd1e26985993	1	2018-01-12

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	4fbe64aa-f8f4-45fa-88ae-e844997703ae	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075491 application number: ANDA075491
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	d86e26e0-6e10-4d59-8cc8-94b551774b86	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075491 application number: ANDA075491
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Coupler LLC	47b96919-a8ea-b769-e063-6394a90aa34e	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075491 application number: ANDA075491
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Aurobindo Pharma Limited	6563b923-269f-40c3-b992-cbacdfca6e16	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075491 application number: ANDA075491
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	9a3b97be-afa3-49e6-962f-662b6807e607	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075491 application number: ANDA075491

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	Marketing start	Marketing end	Sample	Exclude flag	Status
67544-406-94	67544040694	360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-406-94)	2014-11-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2017-12-16	HUMAN PRESCRIPTION DRUG LABEL	1