Aplenzin

Product NDC: 0187-5811
11-digit product format: 001875811
Labeler code: 0187
Product ID: 0187-5811_45372e42-065d-4d87-89af-d5dcf09c29fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrobromide
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bausch Health US, LLC
Application: NDA022108
Marketing category: NDA
Marketing start: 2008-04-23
Substance: BUPROPION HYDROBROMIDE
Active strength: 348 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 1.

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022108-002	APLENZIN	348MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022108-003	APLENZIN	522MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2008-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022108-001	APLENZIN	174MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2008-04-23	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 25 · 984 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022108-001	7241805	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-001	7569610	2026-06-27	U-997		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-001	7572935	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-001	7585897	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-001	7645802	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-001	7649019	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-001	7662407	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-001	7671094	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7241805	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7569610	2026-06-27	U-997		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7572935	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7585897	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7645802	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7649019	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7662407	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-002	7671094	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7241805	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7569610	2026-06-27	U-997		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7572935	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7585897	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7645802	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7649019	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7662407	2026-06-27		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022108-003	7671094	2026-06-27		Drug product	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7241805	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7569610	2026-06-27	U-997		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7572935	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7585897	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7645802	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7649019	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7662407	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-001	7671094	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7241805	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7569610	2026-06-27	U-997		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7572935	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7585897	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7645802	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7649019	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7662407	2026-06-27		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022108-002	7671094	2026-06-27		Drug product	`31067a03dcf5…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPROPION HYDROBROMIDE	348 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993550	Internal RxNorm lookup
993552	Internal RxNorm lookup
993567	Internal RxNorm lookup
993569	Internal RxNorm lookup
993681	Internal RxNorm lookup
993683	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
6494d2d9-0ce4-4126-b1c7-49684395942b	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
0187-5811-07	Aplenzin	7 in 1 BOTTLE	TABLET, EXTENDED RELEASE	7		27
0187-5811-30	Aplenzin	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-5811-07	EA - Each	0187-5811	25915162-f4d4-4578-a8d9-739017f19487	1	2021-09-07
0187-5811-30	EA - Each	0187-5811	fb3d1630-bf79-4be0-875c-bb5071951556	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPROPION HYDROBROMIDE	ACTIVE INGREDIENT	E70G3G5863	APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-5811	APLENZIN (BUPROPION HYDROBROMIDE) TABLET, EXTENDED RELEASE [BAUSCH HEALTH US, LLC]	21	Current NDC, Legacy NDC, 2 package rows	20240802_6494d2d9-0ce4-4126-b1c7-49684395942b.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 · 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
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 ndc (product): 0187-5811

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
993552	Aplenzin 174 MG 24HR Extended Release Oral Tablet	PSN	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993569	Aplenzin 348 MG 24HR Extended Release Oral Tablet	PSN	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993683	Aplenzin 522 MG 24HR Extended Release Oral Tablet	PSN	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993550	buPROPion HBr 174 MG 24HR Extended Release Oral Tablet	PSN	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993567	buPROPion HBr 348 MG 24HR Extended Release Oral Tablet	PSN	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993681	buPROPion HBr 522 MG 24HR Extended Release Oral Tablet	PSN	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993552	24 HR bupropion hydrobromide 174 MG Extended Release Oral Tablet [Aplenzin]	SBD	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993569	24 HR bupropion hydrobromide 348 MG Extended Release Oral Tablet [Aplenzin]	SBD	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993683	24 HR bupropion hydrobromide 522 MG Extended Release Oral Tablet [Aplenzin]	SBD	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993550	24 HR bupropion hydrobromide 174 MG Extended Release Oral Tablet	SCD	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993567	24 HR bupropion hydrobromide 348 MG Extended Release Oral Tablet	SCD	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993681	24 HR bupropion hydrobromide 522 MG Extended Release Oral Tablet	SCD	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993552	24 HR Aplenzin 174 MG Extended Release Oral Tablet	SY	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993569	24 HR Aplenzin 348 MG Extended Release Oral Tablet	SY	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993683	24 HR Aplenzin 522 MG Extended Release Oral Tablet	SY	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993552	Aplenzin 174 MG 24 HR Extended Release Oral Tablet	SY	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993569	Aplenzin 348 MG 24 HR Extended Release Oral Tablet	SY	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993683	Aplenzin 522 MG 24 HR Extended Release Oral Tablet	SY	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993550	bupropion hydrobromide 174 MG 24 HR Extended Release Oral Tablet	SY	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993567	bupropion hydrobromide 348 MG 24 HR Extended Release Oral Tablet	SY	6494d2d9-0ce4-4126-b1c7-49684395942b	27
993681	bupropion hydrobromide 522 MG 24 HR Extended Release Oral Tablet	SY	6494d2d9-0ce4-4126-b1c7-49684395942b	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-5811-07	00187581107	7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5811-07)	2008-04-23	0000-00-00	No	No	Current
0187-5811-30	00187581130	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-5811-30)	2008-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aplenzin	Bausch Health US, LLC \| Bausch Health Companies Inc.	2026-03-04	HUMAN PRESCRIPTION DRUG LABEL	27