bupropion

Product NDC: 71335-0801
11-digit product format: 713350801
Labeler code: 71335
Product ID: 71335-0801_645edeba-9a73-4d0a-ac84-2de98e89b760
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202304
Marketing category: ANDA
Marketing start: 2014-11-01
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

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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-0801		D	Discontinued by firm	2026-08-17
excluded package	package	71335-0801	71335-0801-1	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0801	71335-0801-2	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0801	71335-0801-3	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0801	71335-0801-4	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0801	71335-0801-5	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0801	71335-0801-6	D	Discontinued by firm	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 2 · 98 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	71335-0801-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0801-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0801-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0801-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0801-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0801-4	`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	71335-0801-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0801-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0801-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0801-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0801-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0801-4	`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	71335-0801-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0801-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0801-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0801-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0801-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0801-4	`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	71335-0801-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0801-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0801-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0801-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0801-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0801-4	`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	71335-0801-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0801-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0801-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0801-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0801-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0801-4	`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	71335-0801-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0801-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0801-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0801-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0801-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0801-4	`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	71335-0801-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0801-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0801-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0801-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0801-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0801-4	`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	71335-0801-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-0801-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-0801-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-0801-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-0801-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-0801-4	`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	71335-0801-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71335-0801-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71335-0801-5	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202304-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26
A202304-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26
A202304-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202304-001	AB1
A202304-002	AB1
A202304-003	AB1

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 4 · 126 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
2026-08-18 06:07:40	2026-07	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A202304-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202304-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202304-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202304-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202304-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202304-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202304-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202304-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202304-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202304-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202304-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202304-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202304-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202304-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202304-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202304-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202304-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202304-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202304-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202304-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202304-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202304-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202304-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202304-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202304-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202304-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202304-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202304-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202304-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202304-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202304-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202304-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202304-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202304-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202304-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202304-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202304-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202304-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202304-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202304-001	AB1	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: bupropion
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
7ded4fa6-e637-4d59-a1b1-286854d4fe3a	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
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, Related label table
NDC	Effective	Related label
71335-0801-1	2024-05-22	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-2	2024-05-22	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-3	2024-05-22	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-4	2024-05-22	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-5	2024-05-22	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-6	2024-05-22	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-1	2024-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-2	2024-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-3	2024-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-4	2024-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-5	2024-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-6	2024-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0801-1	bupropion	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	103
71335-0801-2	bupropion	180 in 1 BOTTLE	TABLET, EXTENDED RELEASE	180	103
71335-0801-3	bupropion	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	103
71335-0801-4	bupropion	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	103
71335-0801-5	bupropion	120 in 1 BOTTLE	TABLET, EXTENDED RELEASE	120	103
71335-0801-6	bupropion	28 in 1 BOTTLE	TABLET, EXTENDED RELEASE	28	103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0801	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 6 package rows	20240822_7ded4fa6-e637-4d59-a1b1-286854d4fe3a.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	Major Pharmaceuticals	67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	Cardinal Health 107, LLC	439a7e93-f578-434f-943f-4b93c35450f5	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	Solco Healthcare US LLC	39b2d509-1281-4464-9cf1-a94bbc18b84b	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	850ac56a-ba50-4e61-b1ee-805e17735b5c	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	ab6cd2ea-507c-35e5-e053-2a95a90ac5cb	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	96d87edc-d12b-44b2-e053-2995a90a4e63	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	7ded4fa6-e637-4d59-a1b1-286854d4fe3a	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304 ndc (product): 71335-0801
bupropion	BUPROPION HYDROCHLORIDE	Proficient Rx LP	909204fc-ff55-43d9-b9ee-e607ef60965e	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304

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	7ded4fa6-e637-4d59-a1b1-286854d4fe3a	103
993536	12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet	SCD	7ded4fa6-e637-4d59-a1b1-286854d4fe3a	103
993536	bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet	SY	7ded4fa6-e637-4d59-a1b1-286854d4fe3a	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0801-1	71335080101	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-1)	2018-05-01	0000-00-00	No	No	Current
71335-0801-2	71335080102	180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-2)	2024-08-09	0000-00-00	No	No	Current
71335-0801-3	71335080103	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-3)	2024-08-09	0000-00-00	No	No	Current
71335-0801-4	71335080104	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-4)	2024-08-09	0000-00-00	No	No	Current
71335-0801-5	71335080105	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-5)	2024-08-09	0000-00-00	No	No	Current
71335-0801-6	71335080106	28 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-6)	2024-08-09	0000-00-00	No	No	Current