Bupropion Hydrochloride

Product NDC: 50228-175
11-digit product format: 502280175
Labeler code: 50228
Product ID: 50228-175_1961deb2-5ed0-474b-a2f3-24556855d2ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: ScieGen Pharmaceuticals, Inc.
Application: ANDA205794
Marketing category: ANDA
Marketing start: 2018-04-20
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A205794-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01
A205794-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01
A205794-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205794-001	AB1
A205794-002	AB1
A205794-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A205794-001	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205794-002	AB1	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205794-003	AB1	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205794-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205794-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205794-003	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205794-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205794-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205794-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205794-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205794-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205794-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205794-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205794-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205794-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205794-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205794-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205794-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205794-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205794-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205794-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205794-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205794-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205794-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205794-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-001	AB1	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Bupropion Hydrochloride
Brand name suffix: SR
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPROPION HYDROCHLORIDE	150 mg/1

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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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
50228-175-01	2023-03-16	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-01	2023-03-16	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-05	2023-03-16	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-05	2023-03-16	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-10	2023-03-16	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-10	2023-03-16	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-30	2023-03-16	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-30	2023-03-16	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-60	2023-03-16	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-60	2023-03-16	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-01	2023-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-01	2023-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-05	2023-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-05	2023-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-10	2023-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-10	2023-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-30	2023-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-30	2023-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-60	2023-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985
50228-175-60	2023-01-30	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (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
50228-175-01	Bupropion HydrochlorideSR	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	100	18
50228-175-05	Bupropion HydrochlorideSR	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	500	18
50228-175-10	Bupropion HydrochlorideSR	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	1000	18
50228-175-30	Bupropion HydrochlorideSR	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30	18
50228-175-60	Bupropion HydrochlorideSR	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50228-175-01	EA - Each	50228-175	30a07938-fe24-4ef3-b31a-17751b881ff7	1	2020-05-08
50228-175-05	EA - Each	50228-175	861ce7fa-9e38-49aa-9639-f0f669822eb3	1	2020-05-08
50228-175-60	EA - Each	50228-175	d4a92df8-0b36-46e6-bf57-ccda82ca6451	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50228-175	BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS, INC.]	17	Current NDC, Legacy NDC, 5 package rows	20240830_092da413-ec60-4577-ac57-51e3e42d55c9.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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	73167de9-948d-465c-88c0-c7743a79e7f5	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	6dc4a55b-c0c0-4cbe-988e-da81f0c4f75e	2024-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Dr. Reddys Laboratories Inc.	6948f63b-599c-4956-a249-e9544beda9fc	2022-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794

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
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	a72db723-df4b-4bf4-9bdc-05ae82058696	108
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	a72db723-df4b-4bf4-9bdc-05ae82058696	108
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	a72db723-df4b-4bf4-9bdc-05ae82058696	108
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	c37bb183-f272-4cae-96e1-7042c1dd7bcf	105
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	c37bb183-f272-4cae-96e1-7042c1dd7bcf	105
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	c37bb183-f272-4cae-96e1-7042c1dd7bcf	105
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	fd153957-ff74-4134-8545-cdc0e5619906	104
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	fd153957-ff74-4134-8545-cdc0e5619906	104
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	fd153957-ff74-4134-8545-cdc0e5619906	104
993503	buPROPion HCl 100 MG 12HR Extended Release Oral Tablet	PSN	092da413-ec60-4577-ac57-51e3e42d55c9	18
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	092da413-ec60-4577-ac57-51e3e42d55c9	18
993536	buPROPion HCl 200 MG 12HR Extended Release Oral Tablet	PSN	092da413-ec60-4577-ac57-51e3e42d55c9	18
993503	12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet	SCD	092da413-ec60-4577-ac57-51e3e42d55c9	18
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	092da413-ec60-4577-ac57-51e3e42d55c9	18
993536	12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet	SCD	092da413-ec60-4577-ac57-51e3e42d55c9	18
993503	bupropion HCl 100 MG 12 HR Extended Release Oral Tablet	SY	092da413-ec60-4577-ac57-51e3e42d55c9	18
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	092da413-ec60-4577-ac57-51e3e42d55c9	18
993536	bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet	SY	092da413-ec60-4577-ac57-51e3e42d55c9	18
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	0b33fb1f-a7f0-4ab7-a882-eca2d2c77afa	8
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	0b33fb1f-a7f0-4ab7-a882-eca2d2c77afa	8
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	0b33fb1f-a7f0-4ab7-a882-eca2d2c77afa	8
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	b47c5515-a438-40bc-b8ad-26a6cf9676b7	7
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	b47c5515-a438-40bc-b8ad-26a6cf9676b7	7
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	b47c5515-a438-40bc-b8ad-26a6cf9676b7	7
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	0865f8cf-1d7f-0e67-e063-6294a90a2f4d	6
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	0865f8cf-1d7f-0e67-e063-6294a90a2f4d	6
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	0865f8cf-1d7f-0e67-e063-6294a90a2f4d	6
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	73167de9-948d-465c-88c0-c7743a79e7f5	4
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	dd4041cd-00e4-d10f-e053-2a95a90a5945	4
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	339c7157-1c65-40d1-bbcc-c10348d908d3	4
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	dd4041cd-00e4-d10f-e053-2a95a90a5945	4
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	73167de9-948d-465c-88c0-c7743a79e7f5	4
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	339c7157-1c65-40d1-bbcc-c10348d908d3	4
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	339c7157-1c65-40d1-bbcc-c10348d908d3	4
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	dd4041cd-00e4-d10f-e053-2a95a90a5945	4
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	73167de9-948d-465c-88c0-c7743a79e7f5	4
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	b1169882-c785-62ab-e053-2995a90ae641	3
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	1094ff8e-f5a5-4a72-8bf9-25e68f5c964a	3
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	eeb3fed1-2202-09fc-e053-2995a90a9f63	3
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	b1169882-c785-62ab-e053-2995a90ae641	3
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	1094ff8e-f5a5-4a72-8bf9-25e68f5c964a	3
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	eeb3fed1-2202-09fc-e053-2995a90a9f63	3
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	1094ff8e-f5a5-4a72-8bf9-25e68f5c964a	3
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	b1169882-c785-62ab-e053-2995a90ae641	3
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	eeb3fed1-2202-09fc-e053-2995a90a9f63	3
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	4bd469b8-fb35-0223-e063-6294a90ae7bc	1
993518	buPROPion HCl 150 MG 12HR Extended Release Oral Tablet	PSN	ea3c460f-521e-7da9-e053-2a95a90a37ca	1
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	4bd469b8-fb35-0223-e063-6294a90ae7bc	1
993518	12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	ea3c460f-521e-7da9-e053-2a95a90a37ca	1
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	ea3c460f-521e-7da9-e053-2a95a90a37ca	1
993518	bupropion HCl 150 MG 12 HR Extended Release Oral Tablet	SY	4bd469b8-fb35-0223-e063-6294a90ae7bc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50228-175-01	50228017501	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-175-01)	2018-04-20	0000-00-00	No	No	Current
50228-175-05	50228017505	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-175-05)	2018-04-20	0000-00-00	No	No	Current
50228-175-10	50228017510	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-175-10)	2018-04-20	0000-00-00	No	No	Current
50228-175-30	50228017530	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-175-30)	2018-04-20	0000-00-00	No	No	Current
50228-175-60	50228017560	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-175-60)	2018-04-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride SR	ScieGen Pharmaceuticals, Inc.	2026-10-08	HUMAN PRESCRIPTION DRUG LABEL	19
Bupropion Hydrochloride SR	REMEDYREPACK INC.	2026-08-27	HUMAN PRESCRIPTION DRUG LABEL	8
Bupropion Hydrochloride SR	Northwind Health Company, LLC	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL	7
Bupropion Hydrochloride SR	Bryant Ranch Prepack	2026-05-14	HUMAN PRESCRIPTION DRUG LABEL	108
Bupropion Hydrochloride SR	Bryant Ranch Prepack	2026-04-08	HUMAN PRESCRIPTION DRUG LABEL	105
Bupropion Hydrochloride SR	Bryant Ranch Prepack	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	104
Bupropion Hydrochloride SR	Preferred Pharmaceuticals, Inc.	2026-03-20	HUMAN PRESCRIPTION DRUG LABEL	8
Bupropion Hydrochloride SR	Aphena Pharma Solutions - Tennessee, LLC	2026-02-27	HUMAN PRESCRIPTION DRUG LABEL	1
Bupropion Hydrochloride SR	NuCare Pharmaceuticals,Inc.	2025-08-26	HUMAN PRESCRIPTION DRUG LABEL	3
Bupropion Hydrochloride SR	Proficient Rx LP	2025-07-01	HUMAN PRESCRIPTION DRUG LABEL	3
BUPROPION HCL ER (SR)	DirectRx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	4
Bupropion Hydrochloride SR	A-S Medication Solutions	2024-05-01	HUMAN PRESCRIPTION DRUG LABEL	4
Bupropion Hydrochloride SR	A-S Medication Solutions	2024-05-01	HUMAN PRESCRIPTION DRUG LABEL	4
Bupropion Hydrochloride SR	NuCare Pharmaceuticals,Inc.	2022-10-04	HUMAN PRESCRIPTION DRUG LABEL	1
Bupropion Hydrochloride SR	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2021-04-29	HUMAN PRESCRIPTION DRUG LABEL	3