Bupropion Hydrochloride

Product NDC: 53808-0347
11-digit product format: 538080347
Labeler code: 53808
Product ID: 53808-0347_b5efba99-807d-4778-b769-e95c960a9e86
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA075491
Marketing category: ANDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: BUPROPION HYDROCHLORIDE
Active strength: 75 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: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53808-0347		D	Discontinued by firm	2026-08-03
excluded product	product	53808-0347		I	Inactivated by FDA	2026-08-03
excluded package	package	53808-0347	53808-0347-1	D	Discontinued by firm	2026-08-03
excluded package	package	53808-0347	53808-0347-1	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 2 · 68 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 product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0347-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0347-1	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 product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0347-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0347-1	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 product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0347-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0347-1	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 product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0347-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0347-1	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 product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0347-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0347-1	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 product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0347-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0347-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0347-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0347-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0347-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0347-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0347-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0347-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0347-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0347-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0347-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0347-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0347-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0347-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0347-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0347-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0347-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0347-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0347-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0347-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
A075491-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2000-04-17
A075491-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2000-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075491-001	AB
A075491-002	AB

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	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2000-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2000-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2000-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2000-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2000-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2000-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2000-04-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2000-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2000-04-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2000-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075491-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL		2000-04-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075491-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL		2000-04-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 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	A075491-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075491-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075491-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075491-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075491-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075491-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075491-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075491-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075491-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075491-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075491-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075491-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075491-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075491-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075491-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075491-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075491-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075491-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075491-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075491-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075491-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075491-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075491-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075491-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075491-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075491-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075491-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075491-002	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A075491-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075491-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075491-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075491-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075491-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075491-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075491-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075491-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075491-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075491-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075491-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075491-002	AB	1	`3f01610625f2…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0347-1	2019-10-21	C162847	48780-1	956f9ecf-cd8f-621f-e053-dbdaa90a74ad	8e9b33e3-beb8-4970-bba5-78fbde261ce5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0347-1	Bupropion Hydrochloride	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0347	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20100805_8e9b33e3-beb8-4970-bba5-78fbde261ce5.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	4fbe64aa-f8f4-45fa-88ae-e844997703ae	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075491 application number: ANDA075491
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	d86e26e0-6e10-4d59-8cc8-94b551774b86	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075491 application number: ANDA075491
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Coupler LLC	47b96919-a8ea-b769-e063-6394a90aa34e	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075491 application number: ANDA075491
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Aurobindo Pharma Limited	6563b923-269f-40c3-b992-cbacdfca6e16	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075491 application number: ANDA075491
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	9a3b97be-afa3-49e6-962f-662b6807e607	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075491 application number: ANDA075491

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
993687	buPROPion HCl 100 MG Oral Tablet	PSN	8e9b33e3-beb8-4970-bba5-78fbde261ce5	1
993691	buPROPion HCl 75 MG Oral Tablet	PSN	8e9b33e3-beb8-4970-bba5-78fbde261ce5	1
993687	bupropion hydrochloride 100 MG Oral Tablet	SCD	8e9b33e3-beb8-4970-bba5-78fbde261ce5	1
993691	bupropion hydrochloride 75 MG Oral Tablet	SCD	8e9b33e3-beb8-4970-bba5-78fbde261ce5	1
993691	bupropion HCl 75 MG Oral Tablet	SY	8e9b33e3-beb8-4970-bba5-78fbde261ce5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0347-1	53808034701	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride - State of Florida DOH Central Pharmacy	State of Florida DOH Central Pharmacy	2010-05-19	HUMAN PRESCRIPTION DRUG LABEL	1