bupropion hydrochloride

Product NDC: 43547-288
11-digit product format: 435470288
Labeler code: 43547
Product ID: 43547-288_e8f3396b-251b-4218-9dd8-4ad0a0f8f2a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Solco Healthcare US LLC
Application: ANDA202304
Marketing category: ANDA
Marketing start: 2014-11-01
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202304-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26
A202304-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26
A202304-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202304-001	AB1
A202304-002	AB1
A202304-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202304-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202304-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202304-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202304-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202304-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202304-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202304-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202304-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202304-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202304-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202304-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202304-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202304-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202304-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202304-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202304-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202304-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202304-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202304-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202304-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202304-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202304-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202304-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202304-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202304-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202304-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202304-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202304-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202304-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202304-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202304-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202304-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202304-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202304-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202304-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202304-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202304-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202304-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202304-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202304-001	AB1	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: bupropion hydrochloride
Brand name suffix: SR
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 · 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
39b2d509-1281-4464-9cf1-a94bbc18b84b	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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711
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	SPL version
43547-288-06	bupropion hydrochlorideSR	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	15
43547-288-09	bupropion hydrochlorideSR	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	15
43547-288-10	bupropion hydrochlorideSR	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	15
43547-288-50	bupropion hydrochlorideSR	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-288-09	EA - Each	43547-288	12e0aa6c-c36c-4b8c-9f2a-e19a2281a492	1	2015-08-04
43547-288-10	EA - Each	43547-288	d05b2176-2cc6-488a-b6cc-b84fdc98695c	1	2016-04-04
43547-288-50	EA - Each	43547-288	27235088-a04a-452c-b078-9cdfa115e8f8	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	3
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	3
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	3
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-288	BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SOLCO HEALTHCARE US LLC]	15	Current NDC, Legacy NDC, 4 package rows	20250511_39b2d509-1281-4464-9cf1-a94bbc18b84b.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	Major Pharmaceuticals	67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	Cardinal Health 107, LLC	439a7e93-f578-434f-943f-4b93c35450f5	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	Solco Healthcare US LLC	39b2d509-1281-4464-9cf1-a94bbc18b84b	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304 ndc (product): 43547-288
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	850ac56a-ba50-4e61-b1ee-805e17735b5c	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	ab6cd2ea-507c-35e5-e053-2a95a90ac5cb	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	96d87edc-d12b-44b2-e053-2995a90a4e63	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	7ded4fa6-e637-4d59-a1b1-286854d4fe3a	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion	BUPROPION HYDROCHLORIDE	Proficient Rx LP	909204fc-ff55-43d9-b9ee-e607ef60965e	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304

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	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993503	12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet	SCD	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993503	bupropion HCl 100 MG 12 HR Extended Release Oral Tablet	SY	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	96d87edc-d12b-44b2-e053-2995a90a4e63	18
993503	buPROPion HCl 100 MG 12HR Extended Release Oral Tablet	PSN	39b2d509-1281-4464-9cf1-a94bbc18b84b	15
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	39b2d509-1281-4464-9cf1-a94bbc18b84b	15
993536	buPROPion HCl 200 MG 12HR Extended Release Oral Tablet	PSN	39b2d509-1281-4464-9cf1-a94bbc18b84b	15
993503	12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet	SCD	39b2d509-1281-4464-9cf1-a94bbc18b84b	15
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	39b2d509-1281-4464-9cf1-a94bbc18b84b	15
993536	12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet	SCD	39b2d509-1281-4464-9cf1-a94bbc18b84b	15
993503	bupropion HCl 100 MG 12 HR Extended Release Oral Tablet	SY	39b2d509-1281-4464-9cf1-a94bbc18b84b	15
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	39b2d509-1281-4464-9cf1-a94bbc18b84b	15
993536	bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet	SY	39b2d509-1281-4464-9cf1-a94bbc18b84b	15
993503	buPROPion HCl 100 MG 12HR Extended Release Oral Tablet	PSN	67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad	3
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad	3
993503	12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet	SCD	67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad	3
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad	3
993503	bupropion HCl 100 MG 12 HR Extended Release Oral Tablet	SY	67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad	3
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad	3
993503	buPROPion HCl 100 MG 12HR Extended Release Oral Tablet	PSN	850ac56a-ba50-4e61-b1ee-805e17735b5c	1
993503	12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet	SCD	850ac56a-ba50-4e61-b1ee-805e17735b5c	1
993503	bupropion HCl 100 MG 12 HR Extended Release Oral Tablet	SY	850ac56a-ba50-4e61-b1ee-805e17735b5c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-288-06	43547028806	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-288-06)	2014-11-01	0000-00-00	No	No	Current
43547-288-09	43547028809	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-288-09)	2014-11-01	0000-00-00	No	No	Current
43547-288-10	43547028810	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-288-10)	2014-11-01	0000-00-00	No	No	Current
43547-288-50	43547028850	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-288-50)	2014-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
bupropion hydrochloride SR	Major Pharmaceuticals	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	4
bupropion hydrochloride SR	Solco Healthcare US LLC	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	16
bupropion hydrochloride SR	REMEDYREPACK INC.	2026-03-20	HUMAN PRESCRIPTION DRUG LABEL	1
bupropion	REMEDYREPACK INC.	2025-03-24	HUMAN PRESCRIPTION DRUG LABEL	7
BUPROPION	DIRECT RX	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	18
bupropion	NCS HealthCare of KY, LLC dba Vangard Labs	2024-10-07	HUMAN PRESCRIPTION DRUG LABEL	9