Bupropion Hydrochloride

Product NDC: 50228-145
11-digit product format: 502280145
Labeler code: 50228
Product ID: 50228-145_1105c206-a0be-4ea0-a6e3-1371ac2df153
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: ScieGen Pharmaceuticals,Inc.
Application: ANDA207479
Marketing category: ANDA
Marketing start: 2017-04-12
Substance: BUPROPION HYDROCHLORIDE
Active strength: 300 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 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
A207479-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-04-12
A207479-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2017-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207479-001	AB3
A207479-002	AB3

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207479-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207479-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-04-12	`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	A207479-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207479-002	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207479-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207479-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207479-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207479-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207479-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207479-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207479-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207479-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207479-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207479-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207479-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207479-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207479-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207479-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207479-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207479-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207479-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207479-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207479-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207479-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207479-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207479-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207479-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207479-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207479-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207479-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207479-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207479-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207479-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207479-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207479-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207479-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207479-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207479-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207479-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207479-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207479-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207479-002	AB3	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPROPION HYDROCHLORIDE	300 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993541	Internal RxNorm lookup
993557	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
05f82eca-cc87-4580-acd7-e6491c651881	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50228-145-05	Bupropion Hydrochloride(XL)	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	500	11
50228-145-30	Bupropion Hydrochloride(XL)	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30	11
50228-145-90	Bupropion Hydrochloride(XL)	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	90	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50228-145-05	EA - Each	50228-145	b7c20074-81e3-471c-a4e7-a38d445b21e5	1	2020-07-13
50228-145-30	EA - Each	50228-145	e040c74a-4b8e-4a09-b3c5-099a0b3d4ab0	1	2020-07-13
50228-145-90	EA - Each	50228-145	289b79a9-f8b3-4203-8977-415798392a9e	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50228-145	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS,INC.]	8	Current NDC, Legacy NDC, 3 package rows	20220409_05f82eca-cc87-4580-acd7-e6491c651881.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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	4cc3327b-92c5-4667-ae16-3e95eafcf4d8	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	30c370c2-f2b7-4335-ba55-e8c8f4059092	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	8499470a-8d01-4348-b67b-8f49728031cb	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	cefaaa17-f79a-4ba6-8f97-a59f60e07b75	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	0cd6e0e2-6b2c-4e0d-b5b2-ebfe0d5e31c4	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	96e78f74-fad0-4ae1-9e68-55e4c6ab2d60	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	03b1b0a9-0aa2-4039-acce-68ca54abaae4	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	a5417808-f767-48fc-9f5d-c1aeee4e57c3	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	a7553281-be90-47e3-8d2b-b027f6d18d3a	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	RADHA PHARMACEUTICALS, INC.	16a788ff-8bd5-4f70-a3fd-a89db019e435	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	ScieGen Pharmaceuticals,Inc.	05f82eca-cc87-4580-acd7-e6491c651881	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479 ndc (product): 50228-145
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	4ddf6ba2-c020-7912-e063-6394a90a7964	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	459bd1c9-d7a5-8bc9-e063-6394a90a8ecd	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	722650d8-5ee4-48ba-9827-7c86b1283522	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	16ffe2ac-4f71-4843-99df-611f53c2f3cd	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	3d826804-6427-aae1-e063-6394a90a6593	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Quality Care Products, LLC	57a9f4d3-0c41-4978-b81e-cf3059bc8c42	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	0ac739de-ad59-4882-810e-f52db22ac96f	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	d6efb695-c439-48d7-a155-5c661a5049af	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Cipla USA., Inc.	0abd64f7-5142-48f6-a487-3f5bdc3400de	2023-10-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207479 application number: ANDA207479

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
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	96e78f74-fad0-4ae1-9e68-55e4c6ab2d60	105
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	96e78f74-fad0-4ae1-9e68-55e4c6ab2d60	105
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	96e78f74-fad0-4ae1-9e68-55e4c6ab2d60	105
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	a5417808-f767-48fc-9f5d-c1aeee4e57c3	104
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	a5417808-f767-48fc-9f5d-c1aeee4e57c3	104
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	a5417808-f767-48fc-9f5d-c1aeee4e57c3	104
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	8499470a-8d01-4348-b67b-8f49728031cb	102
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	8499470a-8d01-4348-b67b-8f49728031cb	102
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	8499470a-8d01-4348-b67b-8f49728031cb	102
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	a7553281-be90-47e3-8d2b-b027f6d18d3a	101
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	a7553281-be90-47e3-8d2b-b027f6d18d3a	101
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	a7553281-be90-47e3-8d2b-b027f6d18d3a	101
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	05f82eca-cc87-4580-acd7-e6491c651881	11
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	05f82eca-cc87-4580-acd7-e6491c651881	11
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	05f82eca-cc87-4580-acd7-e6491c651881	11
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	05f82eca-cc87-4580-acd7-e6491c651881	11
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	05f82eca-cc87-4580-acd7-e6491c651881	11
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	05f82eca-cc87-4580-acd7-e6491c651881	11
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	4cc3327b-92c5-4667-ae16-3e95eafcf4d8	6
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	4cc3327b-92c5-4667-ae16-3e95eafcf4d8	6
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	4cc3327b-92c5-4667-ae16-3e95eafcf4d8	6
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	3d826804-6427-aae1-e063-6394a90a6593	1
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	0ac739de-ad59-4882-810e-f52db22ac96f	1
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	d6efb695-c439-48d7-a155-5c661a5049af	1
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	3d826804-6427-aae1-e063-6394a90a6593	1
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	0ac739de-ad59-4882-810e-f52db22ac96f	1
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	d6efb695-c439-48d7-a155-5c661a5049af	1
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	3d826804-6427-aae1-e063-6394a90a6593	1
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	0ac739de-ad59-4882-810e-f52db22ac96f	1
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	d6efb695-c439-48d7-a155-5c661a5049af	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50228-145-05	50228014505	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-145-05)	2017-04-12	0000-00-00	No	No	Current
50228-145-30	50228014530	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-145-30)	2017-04-12	0000-00-00	No	No	Current
50228-145-90	50228014590	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-145-90)	2017-04-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride (XL)	REMEDYREPACK INC.	2026-07-27	HUMAN PRESCRIPTION DRUG LABEL	8
Bupropion Hydrochloride (XL)	Preferred Pharmaceuticals Inc.	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	1
Bupropion Hydrochloride (XL)	Bryant Ranch Prepack	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	103
Bupropion Hydrochloride (XL)	Bryant Ranch Prepack	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	105
Bupropion Hydrochloride (XL)	Bryant Ranch Prepack	2026-04-08	HUMAN PRESCRIPTION DRUG LABEL	104
Bupropion Hydrochloride (XL)	Bryant Ranch Prepack	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	101
Bupropion Hydrochloride (XL)	ScieGen Pharmaceuticals,Inc. \| ScieGen Pharmaceuticals,Inc	2026-02-02	HUMAN PRESCRIPTION DRUG LABEL	11
Bupropion Hydrochloride (XL)	Advanced Rx of Tennessee, LLC	2025-08-29	HUMAN PRESCRIPTION DRUG LABEL	1
Bupropion Hydrochloride (XL)	A-S Medication Solutions	2024-10-16	HUMAN PRESCRIPTION DRUG LABEL	1
Bupropion Hydrochloride (XL)	A-S Medication Solutions	2024-10-16	HUMAN PRESCRIPTION DRUG LABEL	1