Bupropion Hydrochloride

Product NDC: 82804-013
11-digit product format: 828040013
Labeler code: 82804
Product ID: 82804-013_80f4a4ef-8190-458d-af2e-5daaf32abc01
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA206556
Marketing category: ANDA
Marketing start: 2016-08-29
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: 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206556-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL			2016-08-26
A206556-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL			2016-08-26

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 3 · 82 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	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206556-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206556-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206556-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206556-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206556-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206556-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206556-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206556-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206556-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206556-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206556-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206556-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206556-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206556-002	AB3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206556-001	AB3	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206556-002	AB3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206556-001	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206556-002	AB3	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206556-001	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206556-002	AB3	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206556-001	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206556-002	AB3	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206556-001	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206556-002	AB3	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206556-001	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206556-002	AB3	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206556-001	AB3	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206556-002	AB3	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206556-001	AB3	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206556-002	AB3	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206556-001	AB3	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A206556-002	AB3	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206556-001	AB3	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A206556-002	AB3	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206556-001	AB3	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206556-002	AB3	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206556-001	AB3	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206556-002	AB3	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206556-001	AB3	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206556-002	AB3	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206556-001	AB3	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206556-002	AB3	1	`3f0d92c62455…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bupropion Hydrochloride
Brand name suffix: (XL)
Listing expiration: 2026-12-31

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
80f4a4ef-8190-458d-af2e-5daaf32abc01	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
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8	Product name	3	20240209
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
b8ee525f-67fb-39fb-91da-7e47ac54581d	Product name	5	20200611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284	Product name	9	20190211
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
e4d463bc-c674-43cb-be06-82786f310d01	Product name	1	20150326
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
82804-013-30	Bupropion Hydrochloride(XL)	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30	1
82804-013-60	Bupropion Hydrochloride(XL)	60 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	60	1
82804-013-90	Bupropion Hydrochloride(XL)	90 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-013	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PROFICIENT RX LP]	1	Current NDC, 3 package rows	20230923_80f4a4ef-8190-458d-af2e-5daaf32abc01.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Proficient Rx LP	80f4a4ef-8190-458d-af2e-5daaf32abc01	2023-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206556 application number: ANDA206556 ndc (product): 82804-013
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Exelan Pharmaceuticals Inc.	8a0781c0-e7d5-498e-b7d3-d6bd457f175f	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206556 application number: ANDA206556
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	CIPLA USA INC.,	c2cf79d7-1aba-4391-980b-5e218781f7c6	2020-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206556 application number: ANDA206556

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
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	80f4a4ef-8190-458d-af2e-5daaf32abc01	1
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	80f4a4ef-8190-458d-af2e-5daaf32abc01	1
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	80f4a4ef-8190-458d-af2e-5daaf32abc01	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82804-013-30	82804001330	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-30)	2023-09-21	No	No	Current
82804-013-60	82804001360	60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-60)	2023-09-21	No	No	Current
82804-013-90	82804001390	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-90)	2023-09-21	No	No	Current