Bupropion Hydrochloride

Product NDC: 0115-5445
11-digit product format: 001155445
Labeler code: 0115
Product ID: 0115-5445_cb660c34-cfd0-4598-a767-db8a82e087e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPROPION HYDROCHLORIDE
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA076711
Marketing category: ANDA
Marketing start: 2004-12-03
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076711-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL			2004-12-03

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2004-12-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076711-001	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL		2004-12-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076711-001	AB1	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076711-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076711-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076711-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076711-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076711-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076711-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076711-001	AB1	1	`ea99ee380514…`

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	Amneal Pharmaceuticals of New York LLC	e962fb9a-d9fb-49c5-a8b4-0b355b8f829b	2024-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076711 application number: ANDA076711 ndc (product): 0115-5445

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
e962fb9a-d9fb-49c5-a8b4-0b355b8f829b	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
0115-5445-13	Bupropion Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60		27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-5445-13	EA - Each	0115-5445	d261bb47-2bbe-4e2c-ab25-47b1322b5a22	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	6
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	6
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	6
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	6
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	6
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	6
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	6
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-5445	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	27	Current NDC, Legacy NDC, 1 package rows	20240517_e962fb9a-d9fb-49c5-a8b4-0b355b8f829b.zip

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
993536	buPROPion HCl 200 MG 12HR Extended Release Oral Tablet	PSN	e962fb9a-d9fb-49c5-a8b4-0b355b8f829b	27
993536	12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet	SCD	e962fb9a-d9fb-49c5-a8b4-0b355b8f829b	27
993536	bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet	SY	e962fb9a-d9fb-49c5-a8b4-0b355b8f829b	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-5445-13	00115544513	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-5445-13)	2004-12-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride	Amneal Pharmaceuticals of New York LLC	2024-05-09	HUMAN PRESCRIPTION DRUG LABEL	27