Bupropion hydrochloride

Product NDC: 63304-724
Requested package NDC: 63304-724-30
11-digit product format: 633040724
Labeler code: 63304
Product ID: 63304-724_338f1a13-8703-43d6-bc64-2f28f74bc1c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA203650
Marketing category: ANDA
Marketing start: 2021-01-01
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63304-724	63304-724-30	D	Discontinued by firm		2026-10-12

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203650-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL			2020-12-31

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2020-12-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2020-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2020-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2020-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2020-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2020-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2020-12-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203650-001	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2020-12-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203650-001	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203650-001	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203650-001	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203650-001	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203650-001	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203650-001	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203650-001	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203650-001	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203650-001	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203650-001	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203650-001	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203650-001	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203650-001	AB3	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203650-001	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203650-001	AB3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203650-001	AB3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203650-001	AB3	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203650-001	AB3	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203650-001	AB3	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203650-001	AB3	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203650-001	AB3	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203650-001	AB3	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203650-001	AB3	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203650-001	AB3	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203650-001	AB3	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203650-001	AB3	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203650-001	AB3	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203650-001	AB3	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203650-001	AB3	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203650-001	AB3	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4eceb285-f3c7-4092-a21a-4c9f3169f20c	Product name	5	20260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8	Product name	3	20240209
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
b8ee525f-67fb-39fb-91da-7e47ac54581d	Product name	5	20200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284	Product name	9	20190211
e4d463bc-c674-43cb-be06-82786f310d01	Product name	1	20150326
0916dcfb-331f-89b1-8eac-6f7dc76d82da	Product name	1	20140508
d7fc3d53-5a6c-de82-2808-1780f175f17e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63304-724-05	Bupropion hydrochloride	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	13
63304-724-30	Bupropion hydrochloride	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	13
63304-724-90	Bupropion hydrochloride	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-724-05	EA - Each	63304-724	65bb0161-6393-45b5-8e1a-ba407b5705a5	1	2021-02-05
63304-724-30	EA - Each	63304-724	1864f206-2ff1-4082-b4bb-876b3ad3a335	1	2021-02-05
63304-724-90	EA - Each	63304-724	b804bf78-72f2-40ba-9568-6c09ee07f8b7	1	2021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-724	BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	12	Legacy NDC, 3 package rows	20240604_fddb7191-c4f9-4e82-bd7d-259c3767710a.zip

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	fddb7191-c4f9-4e82-bd7d-259c3767710a	13
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	fddb7191-c4f9-4e82-bd7d-259c3767710a	13
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	fddb7191-c4f9-4e82-bd7d-259c3767710a	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-724-30	63304072430	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-724-30)	2021-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion hydrochloride	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2025-12-15	HUMAN PRESCRIPTION DRUG LABEL	13