Bupropion hydrochloride

Product NDC: 87441-014
11-digit product format: 874410014
Labeler code: 87441
Product ID: 87441-014_53c20efd-0b10-4cf8-e063-6294a90aed0f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Solutions, Inc.
Application: ANDA215568
Marketing category: ANDA
Marketing start: 2026-06-08
Substance: BUPROPION HYDROCHLORIDE
Active strength: 300 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
A215568-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-02-02
A215568-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215568-001	AB3
A215568-002	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 2 · 68 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	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215568-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215568-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-02-02	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 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	A215568-001	AB3	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215568-002	AB3	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215568-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215568-002	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215568-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215568-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215568-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215568-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215568-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215568-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215568-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215568-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215568-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215568-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215568-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215568-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215568-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215568-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215568-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215568-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215568-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215568-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215568-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215568-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215568-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215568-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215568-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215568-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215568-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215568-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215568-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215568-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215568-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215568-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215568-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215568-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215568-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215568-002	AB3	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215568-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215568-002	AB3	1	`bb7c543d1eb4…`

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	300 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
993557	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
53c192ca-ac51-cb87-e063-6394a90a6c08	Available on FDA.report

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Granules Pharmaceuticals Inc.	d9eb0939-63c1-48c4-a444-a899d7924d06	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	0b041720-a25d-403e-a72c-601a8bdd8051	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	c60855ca-4fa0-4004-ad19-4abb61100c43	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	bf5e933c-8a84-4dd7-a05d-6c4a82b6c965	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	af5b1cc8-f078-4a7b-b64a-4cb2de1e5721	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Unit Dose Solutions, Inc.	53c192ca-ac51-cb87-e063-6394a90a6c08	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568 ndc (product): 87441-014
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Proficient Rx LP	f1703bfd-be36-4fde-8e67-df0fb5d93369	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	BluePoint Laboratories	4956af38-182a-4015-a945-67e40bd38772	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	487271f1-c956-086a-e063-6394a90a2dc7	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	069e6828-e599-4614-9645-9cf1382ac93e	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	2ccbf988-64b6-3a60-e063-6394a90ababa	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	1724f474-d6ab-46af-940f-7f874d4ff7fc	2025-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215568 application number: ANDA215568

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	Sample	Exclude flag	Status
87441-014-01	87441001401	30 TABLET in 1 BLISTER PACK (87441-014-01)	30 tablet	2026-06-08	No	No	Current