BUPROPION HYDROCHLORIDE

Product NDC: 50090-7511
Requested package NDC: 50090-7511-3
11-digit product format: 500907511
Labeler code: 50090
Product ID: 50090-7511_50dbf53d-e998-4b27-98de-df9c41df3687
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPROPION HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA075491
Marketing category: ANDA
Marketing start: 2024-04-25
Substance: BUPROPION HYDROCHLORIDE
Active strength: 100 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: 2027-12-31
Current FDA listing: Yes

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
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 · 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	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075491-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075491-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075491-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075491-002	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: BUPROPION HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPROPION HYDROCHLORIDE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ZG7E5POY8O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993687	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d86e26e0-6e10-4d59-8cc8-94b551774b86	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4eceb285-f3c7-4092-a21a-4c9f3169f20c	Product name	5	20260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8	Product name	3	20240209
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
b8ee525f-67fb-39fb-91da-7e47ac54581d	Product name	5	20200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284	Product name	9	20190211
e4d463bc-c674-43cb-be06-82786f310d01	Product name	1	20150326
0916dcfb-331f-89b1-8eac-6f7dc76d82da	Product name	1	20140508
d7fc3d53-5a6c-de82-2808-1780f175f17e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-7511-0	BUPROPION HYDROCHLORIDE	60 in 1 BOTTLE	TABLET, FILM COATED	60		3
50090-7511-3	BUPROPION HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7511-0	EA - Each	50090-7511	35624653-8ee5-4218-b006-246585ec7468	1	2025-05-14
50090-7511-3	EA - Each	50090-7511	5dbc08ad-9dcb-48b6-8bd6-d77bd470aee0	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-7511	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	1	Current NDC, 2 package rows	20250227_d86e26e0-6e10-4d59-8cc8-94b551774b86.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 · 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 ndc (package): 50090-7511-3 ndc (product): 50090-7511 ndc11 (package): 50090751103
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
993687	buPROPion HCl 100 MG Oral Tablet	PSN	d86e26e0-6e10-4d59-8cc8-94b551774b86	3
993687	bupropion hydrochloride 100 MG Oral Tablet	SCD	d86e26e0-6e10-4d59-8cc8-94b551774b86	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-7511-3	50090751103	90 TABLET, FILM COATED in 1 BOTTLE (50090-7511-3)	2025-02-20	No	No	Current