Bupropion Hydrochloride

Product NDC: 68788-7793
Requested package NDC: 68788-7793-8
11-digit product format: 687887793
Labeler code: 68788
Product ID: 68788-7793_fe9c69c0-3a09-4dbe-b79f-f695468cbd1b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA205794
Marketing category: ANDA
Marketing start: 2020-10-13
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: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-7793	68788-7793-8	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 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	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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205794-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-03-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205794-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205794-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205794-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205794-001	AB1	1	`8072bd15b7f6…`

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	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
c0445fea-108f-4e00-a2ae-ebbdf2719947	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-7793-1	Bupropion HydrochlorideSR	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	100	7
68788-7793-2	Bupropion HydrochlorideSR	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	20	7
68788-7793-3	Bupropion HydrochlorideSR	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30	7
68788-7793-6	Bupropion HydrochlorideSR	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60	7
68788-7793-8	Bupropion HydrochlorideSR	120 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	120	7
68788-7793-9	Bupropion HydrochlorideSR	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	90	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7793	BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 6 package rows	20250112_c0445fea-108f-4e00-a2ae-ebbdf2719947.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 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	c76f2f9f-3999-4bdd-8ec3-e0066318d378	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	0865f8cf-1d7f-0e67-e063-6294a90a2f4d	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	6701af43-bf7d-45c4-a331-a18d16bd68f7	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	21be6b3b-add3-43e7-af93-30350aefc89e	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	a72db723-df4b-4bf4-9bdc-05ae82058696	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	c37bb183-f272-4cae-96e1-7042c1dd7bcf	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	fd153957-ff74-4134-8545-cdc0e5619906	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	c0445fea-108f-4e00-a2ae-ebbdf2719947	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794 ndc (package): 68788-7793-8 ndc (product): 68788-7793 ndc11 (package): 68788779308
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	d1d1ed19-e111-4652-a0d4-9406e6f73e9f	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	0b33fb1f-a7f0-4ab7-a882-eca2d2c77afa	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	b47c5515-a438-40bc-b8ad-26a6cf9676b7	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4bd469b8-fb35-0223-e063-6294a90ae7bc	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9d0608a1-0cc8-491a-ad91-238e0ea009fe	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Dr. Reddys Laboratories Inc.	ad784c8e-7201-4336-a310-616e3e979ca4	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	092da413-ec60-4577-ac57-51e3e42d55c9	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Radha Pharmaceuticals, Inc.	161637d2-bc9d-4a2b-ad1f-6cc39ffd69ce	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	eeb3fed1-2202-09fc-e053-2995a90a9f63	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Proficient Rx LP	1094ff8e-f5a5-4a72-8bf9-25e68f5c964a	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
BUPROPION HYDROCHLORIDE SR	BUPROPION HYDROCHLORIDE SR	DirectRx	dd4041cd-00e4-d10f-e053-2a95a90a5945	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205794 application number: ANDA205794
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	339c7157-1c65-40d1-bbcc-c10348d908d3	2024-05-01	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
993536	buPROPion HCl 200 MG 12HR Extended Release Oral Tablet	PSN	c0445fea-108f-4e00-a2ae-ebbdf2719947	7
993536	12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet	SCD	c0445fea-108f-4e00-a2ae-ebbdf2719947	7
993536	bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet	SY	c0445fea-108f-4e00-a2ae-ebbdf2719947	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7793-8	68788779308	120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-7793-8)	2020-10-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride SR	Preferred Pharmaceuticals, Inc.	2026-03-23	HUMAN PRESCRIPTION DRUG LABEL	7