Bupropion Hydrobromide

Product NDC: 68682-582
Requested package NDC: 68682-582-30
11-digit product format: 686820582
Labeler code: 68682
Product ID: 68682-582_361893cf-be64-4b2c-a70e-e3ba68e69309
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion Hydrobromide
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Oceanside Pharmaceuticals
Application: NDA022108
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2026-06-29
Substance: BUPROPION HYDROBROMIDE
Active strength: 522 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022108-001	APLENZIN	BUPROPION HYDROBROMIDE	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23
N022108-002	APLENZIN	BUPROPION HYDROBROMIDE	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23
N022108-003	APLENZIN	BUPROPION HYDROBROMIDE	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status
N022108-001	7241805	2026-06-27		Drug product
N022108-001	7569610	2026-06-27	U-997
N022108-001	7572935	2026-06-27		Drug product
N022108-001	7585897	2026-06-27		Drug product
N022108-001	7645802	2026-06-27		Drug product
N022108-001	7649019	2026-06-27		Drug product
N022108-001	7662407	2026-06-27		Drug product
N022108-001	7671094	2026-06-27		Drug product
N022108-002	7241805	2026-06-27		Drug product
N022108-002	7569610	2026-06-27	U-997
N022108-002	7572935	2026-06-27		Drug product
N022108-002	7585897	2026-06-27		Drug product
N022108-002	7645802	2026-06-27		Drug product
N022108-002	7649019	2026-06-27		Drug product
N022108-002	7662407	2026-06-27		Drug product
N022108-002	7671094	2026-06-27		Drug product
N022108-003	7241805	2026-06-27		Drug product
N022108-003	7569610	2026-06-27	U-997
N022108-003	7572935	2026-06-27		Drug product
N022108-003	7585897	2026-06-27		Drug product
N022108-003	7645802	2026-06-27		Drug product
N022108-003	7649019	2026-06-27		Drug product
N022108-003	7662407	2026-06-27		Drug product
N022108-003	7671094	2026-06-27		Drug product

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 26 · 1,032 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2026-09-14 22:38:34	2026-08	N022108-001	7241805	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-001	7569610	2026-06-27	U-997		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-001	7572935	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-001	7585897	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-001	7645802	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-001	7649019	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-001	7662407	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-001	7671094	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-002	7241805	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-002	7569610	2026-06-27	U-997		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-002	7572935	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-002	7585897	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-002	7645802	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-002	7649019	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-002	7662407	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-002	7671094	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-003	7241805	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-003	7569610	2026-06-27	U-997		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-003	7572935	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-003	7585897	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-003	7645802	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-003	7649019	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-003	7662407	2026-06-27		Drug product	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022108-003	7671094	2026-06-27		Drug product	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022108-001	7241805	2026-06-27		Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-001	7569610	2026-06-27	U-997		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-001	7572935	2026-06-27		Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-001	7585897	2026-06-27		Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-001	7645802	2026-06-27		Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-001	7649019	2026-06-27		Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-001	7662407	2026-06-27		Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-001	7671094	2026-06-27		Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-002	7241805	2026-06-27		Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-002	7569610	2026-06-27	U-997		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-002	7572935	2026-06-27		Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-002	7585897	2026-06-27		Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-002	7645802	2026-06-27		Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-002	7649019	2026-06-27		Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-002	7662407	2026-06-27		Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022108-002	7671094	2026-06-27		Drug product	`caaa826d4ba7…`

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 Hydrobromide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPROPION HYDROBROMIDE	522 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
E70G3G5863	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993550	Internal RxNorm lookup
993567	Internal RxNorm lookup
993681	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
3ec04240-baef-44d7-8d73-a181171eec43	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrobromide	BUPROPION HYDROBROMIDE	Oceanside Pharmaceuticals	3ec04240-baef-44d7-8d73-a181171eec43	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022108 application number: NDA022108 ndc (package): 68682-582-30 ndc (product): 68682-582 ndc11 (package): 68682058230
Aplenzin	BUPROPION HYDROBROMIDE	Bausch Health US, LLC	6494d2d9-0ce4-4126-b1c7-49684395942b	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022108 application number: NDA022108

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
E70G3G5863	BUPROPION HYDROBROMIDE	905818-69-1	BUPROPION HYDROBROMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68682-582-30	68682058230	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-582-30)	2026-06-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrobromide	Oceanside Pharmaceuticals \| Bausch Health Companies Inc.	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	3