Bupropion Hydrochloride

Product NDC: 0904-7084
11-digit product format: 009047084
Labeler code: 0904
Product ID: 0904-7084_817668bf-0adf-42e9-ad65-d2f28fcdd09b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA210015
Marketing category: ANDA
Marketing start: 2018-12-01
Marketing end: 0000-00-00
Substance: BUPROPION HYDROCHLORIDE
Active strength: 150 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: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0904-7084		D	Discontinued by firm	2026-08-03
excluded package	package	0904-7084	0904-7084-04	D	Discontinued by firm	2026-08-03
excluded package	package	0904-7084	0904-7084-61	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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-7084	0904-7084-04	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A210015-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-06-14
A210015-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-06-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210015-001	AB3
A210015-002	AB3

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	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210015-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210015-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-06-14	`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	A210015-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210015-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210015-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210015-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210015-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210015-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210015-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210015-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210015-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210015-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210015-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210015-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210015-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210015-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210015-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210015-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210015-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210015-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210015-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210015-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210015-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210015-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210015-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210015-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210015-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210015-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210015-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210015-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210015-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210015-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210015-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210015-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210015-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210015-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210015-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210015-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210015-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210015-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210015-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210015-002	AB3	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7084-04	EA - Each	0904-7084	23ae1280-3721-4d00-a641-d4d5f575589a	1	2021-11-09
0904-7084-61	EA - Each	0904-7084	3d4e7f94-8fb0-408c-9e0d-75f651919bfd	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7084	BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	5	Legacy NDC	20250316_1f9811c7-be3d-4f72-bea7-04a25a4b0635.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	eb946d81-b4f4-42e9-aa7a-31d76d15629c	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	9aa3753f-1a0e-4faa-995f-67e29b320737	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	b2e6c30f-a33c-4854-ab19-bc9f65880374	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	02275c51-6b3e-434a-bdb5-99135e73f1a4	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	eb25adb1-9841-42ce-aa22-718fb0fba5dd	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Epic Pharma, LLC	f79d1422-a9b6-41c2-a46d-22886605f94d	2026-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	06d4d890-11ed-4f31-8778-c73432e3ea69	2024-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion HCL ER (XL)	BUPROPION HCL ER (XL)	Direct_RX	129ce80c-0333-873e-e063-6394a90a33e0	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	NuCare Pharmacueticals, Inc.	15ad0c66-1829-59c3-e063-6394a90a4384	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Proficient Rx LP	dfd5f264-d4fd-4441-88b1-48086c7c0616	2024-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015
Bupropion Hydrochloride XL	BUPROPION HYDROCHLORIDE	Proficient Rx LP	4a2be6af-e256-4fa9-bfa9-5300d52cdaf4	2020-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210015 application number: ANDA210015

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
0904-7084-04	00904708404	30 BLISTER PACK in 1 CARTON (0904-7084-04) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	30 blister pack	2018-12-01	0000-00-00	No	No	Current
0904-7084-61	00904708461	100 BLISTER PACK in 1 CARTON (0904-7084-61) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	100 blister pack	2018-12-01	0000-00-00	No	No	Current