BUPROPION HYDROCHLORIDE

Product NDC: 45865-975
11-digit product format: 458650975
Labeler code: 45865
Product ID: 45865-975_9af0fadd-0efa-2317-e053-2a95a90a9a88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPROPION HYDROCHLORIDE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA210497
Marketing category: ANDA
Marketing start: 2018-11-08
Marketing end: 0000-00-00
Substance: BUPROPION HYDROCHLORIDE
Active strength: 150 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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	45865-975		I	Inactivated by FDA	2026-08-03
excluded package	package	45865-975	45865-975-30	I	Inactivated by FDA	2026-08-03
excluded package	package	45865-975	45865-975-60	I	Inactivated by FDA	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-975-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-975-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-975-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-975-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-975-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-975-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-975-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-975-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-975-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-975-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-975-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-975-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-975-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-975-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-975-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-975-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-975-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-975-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A210497-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-10-31
A210497-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2018-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210497-001	AB3
A210497-002	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 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	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210497-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210497-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2018-10-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210497-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210497-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210497-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210497-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210497-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210497-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210497-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210497-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210497-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210497-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210497-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210497-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210497-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210497-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210497-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210497-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210497-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210497-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210497-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210497-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210497-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210497-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210497-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210497-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210497-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210497-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210497-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210497-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210497-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210497-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210497-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210497-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210497-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210497-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210497-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210497-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210497-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210497-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210497-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210497-002	AB3	1	`782e0a99824c…`

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-975-30	2025-01-30	C162847	48780-1	2cef2736-a453-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE extended-release tablets (XL), for oral use Initial U.S. Approval: 1985
45865-975-60	2025-01-30	C162847	48780-1	2cef2736-a453-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE extended-release tablets (XL), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-975-30	BUPROPION HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		1
45865-975-60	BUPROPION HYDROCHLORIDE	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-975	BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 2 package rows	20191231_9af0fadd-0ef9-2317-e053-2a95a90a9a88.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	080853c0-fcab-4645-9ddc-4946e895ac5f	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	82bcdd72-9146-4c8d-a8aa-f92015864605	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	42e228a2-25b3-44a6-8da7-6616ca44ac7f	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ae3bcdf7-d7f3-4f07-8113-af08af20a0d4	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Accord Healthcare Inc.	34686e9d-c106-4276-8b47-7460cca8860e	2025-10-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5dec4414-5595-46c9-ada9-3fbe98152040	2025-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	96d87edc-d12b-44b2-e053-2995a90a4e63	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8af7829-8b61-6785-e053-6294a90af052	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	29a6c6e3-f30f-6541-e063-6394a90ae11d	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Quality Care Products, LLC	a225dbbb-86f0-4547-a1c8-68eb64cd6892	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	BluePoint Laboratories	5ccec958-998d-43a1-86fb-eb2b5e697b77	2024-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	7c46d95a-26f6-4364-8197-9e564e3405f2	2024-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	a18b5460-fcbb-42dd-8b87-197d11a08928	2024-05-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	77b78d35-40f5-4713-8468-aa09a6c2925d	2024-05-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Proficient Rx LP	5d40e301-7e06-4ecd-b7c6-3d7ac6a134d2	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Proficient Rx LP	42201f4a-8856-4499-8bc3-d18612b1ec34	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210497 application number: ANDA210497

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
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	9af0fadd-0ef9-2317-e053-2a95a90a9a88	1
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	9af0fadd-0ef9-2317-e053-2a95a90a9a88	1
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	9af0fadd-0ef9-2317-e053-2a95a90a9a88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-975-30	45865097530	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-975-30)	2019-12-11	0000-00-00	No	No	Current
45865-975-60	45865097560	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-975-60)	2019-12-11	0000-00-00	No	No	Current