BUPROPION HYDROCHLORIDE

Product NDC: 59651-848
Requested package NDC: 59651-848-60
11-digit product format: 596510848
Labeler code: 59651
Product ID: 59651-848_b9ab1deb-dba4-4403-9121-936278cc4cfe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPROPION HYDROCHLORIDE
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA090325
Marketing category: ANDA
Marketing start: 2025-06-03
Substance: BUPROPION HYDROCHLORIDE
Active strength: 200 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: 2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090325-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08
A090325-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08
A090325-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090325-001	AB1
A090325-002	AB1
A090325-003	AB1

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 4 · 129 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	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2010-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090325-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090325-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090325-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL		2010-04-08	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090325-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090325-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090325-003	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090325-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090325-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090325-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090325-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090325-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090325-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090325-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090325-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090325-003	AB1	1	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	A090325-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090325-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090325-003	AB1	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A090325-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090325-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090325-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090325-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090325-002	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090325-003	AB1	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090325-001	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090325-002	AB1	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090325-003	AB1	1	`a50c72e98297…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPROPION HYDROCHLORIDE	200 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993503	Internal RxNorm lookup
993518	Internal RxNorm lookup
993536	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
8f86f677-2ebd-43c4-b2dd-2e07d4d54147	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
59651-848-01	BUPROPION HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		2
59651-848-60	BUPROPION HYDROCHLORIDE	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-848-01	EA - Each	59651-848	c0a165ca-1a7d-414d-a259-b1c4c481fee2	1	2026-02-05
59651-848-60	EA - Each	59651-848	1d442dd4-e6e8-4ec2-aa31-4148200648da	1	2026-02-05

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Aurobindo Pharma Limited	8f86f677-2ebd-43c4-b2dd-2e07d4d54147	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090325 application number: ANDA090325 ndc (package): 59651-848-60 ndc (product): 59651-848 ndc11 (package): 59651084860

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
993503	buPROPion HCl 100 MG 12HR Extended Release Oral Tablet	PSN	8f86f677-2ebd-43c4-b2dd-2e07d4d54147	2
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	8f86f677-2ebd-43c4-b2dd-2e07d4d54147	2
993536	buPROPion HCl 200 MG 12HR Extended Release Oral Tablet	PSN	8f86f677-2ebd-43c4-b2dd-2e07d4d54147	2
993503	12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet	SCD	8f86f677-2ebd-43c4-b2dd-2e07d4d54147	2
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	8f86f677-2ebd-43c4-b2dd-2e07d4d54147	2
993536	12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet	SCD	8f86f677-2ebd-43c4-b2dd-2e07d4d54147	2
993503	bupropion HCl 100 MG 12 HR Extended Release Oral Tablet	SY	8f86f677-2ebd-43c4-b2dd-2e07d4d54147	2
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	8f86f677-2ebd-43c4-b2dd-2e07d4d54147	2
993536	bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet	SY	8f86f677-2ebd-43c4-b2dd-2e07d4d54147	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
59651-848-60	59651084860	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-848-60)	2025-06-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUPROPION HYDROCHLORIDE	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-11-14	Human Prescription Drug Label	2