Bupropion Hydrochloride

Product NDC: 53217-358
11-digit product format: 532170358
Labeler code: 53217
Product ID: 53217-358_0710aa1d-c69e-4ac6-ab40-2bfd51935180
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA076143
Marketing category: ANDA
Marketing start: 2017-12-26
Marketing end: 0000-00-00
Substance: BUPROPION HYDROCHLORIDE
Active strength: 100 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: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53217-358		I	Inactivated by FDA		2026-08-17
excluded package	package	53217-358	53217-358-90	I	Inactivated by FDA		2026-08-17

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-358-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-358-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-358-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-358-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-358-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-358-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-358-90	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-358-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-358-90	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-358-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53217-358-90	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53217-358-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53217-358-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53217-358-90	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53217-358-90	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53217-358-90	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53217-358-90	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53217-358-90	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53217-358-90	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53217-358-90	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53217-358-90	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076143-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17
A076143-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076143-001	AB
A076143-002	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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076143-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2006-01-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076143-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RS	2006-01-17	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076143-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076143-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076143-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076143-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076143-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076143-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076143-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076143-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076143-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076143-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076143-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076143-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076143-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076143-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076143-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076143-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076143-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076143-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076143-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076143-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076143-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076143-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076143-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076143-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076143-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076143-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076143-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076143-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076143-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076143-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076143-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076143-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076143-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076143-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076143-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076143-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076143-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076143-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076143-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076143-002	AB	1	`bb7c543d1eb4…`

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
53217-358-90	2020-01-31	C162847	48780-1	9d75b9cf-df73-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, 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
53217-358-90	Bupropion Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-358	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20180820_5e85b398-206e-44fd-a64e-852b2e0f8985.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	5829a2aa-4845-b58b-e063-6294a90ad2f4	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	867d3876-6974-4e89-bc45-9e60e84b401c	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	362504fd-2f0a-c097-e063-6394a90ac0fc	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	American Health Packaging	88c980c8-aaa8-4378-9ac2-24d588640caa	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b5c12c9a-62eb-481a-8099-7ad35242f7bf	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Cardinal Health 107, LLC	64934ca2-5655-45a2-9016-ad65b5abf5d3	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	5038440c-1f32-715a-e063-6294a90a889d	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Cardinal Health 107, LLC	ec4d2256-0340-4166-90ee-c264eef3ac82	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	eabb54b7-164c-4de8-b91a-f2e65637b5fc	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Major Pharmaceuticals	b127d3fc-be5e-4c12-8026-205766bf8e7f	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	AvPAK	bcb4ef83-f272-4090-8547-9aaf4ab63667	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	3b73d56e-e558-49de-8126-d7ec9b67a086	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	BluePoint Laboratories	7d035056-44ab-444d-9d27-125b3f571140	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Golden State Medical Supply, Inc.	9490d611-b679-45c7-e053-2a95a90afb87	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	f566f8b5-b3c1-4234-88bd-59a7b8dc801a	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	fa5fa0d8-d27f-44e1-8868-dfa7206524e2	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Apotex Corp	86530199-999b-9f92-b1bc-b8515ec829f3	2025-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	2a13267f-c47f-4791-a8f9-4bbb5c804027	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	1d722dc2-7909-454e-b989-095677079044	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	d1043c87-0abe-ee8e-e053-2a95a90a419a	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076143 application number: ANDA076143

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	5e85b398-206e-44fd-a64e-852b2e0f8985	1
993687	bupropion hydrochloride 100 MG Oral Tablet	SCD	5e85b398-206e-44fd-a64e-852b2e0f8985	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-358-90	53217035890	90 in 1 BOTTLE	Historical