bupropion hydrochloride

Product NDC: 47781-637
Requested package NDC: 47781-637-30
11-digit product format: 477810637
Labeler code: 47781
Product ID: 47781-637_ff963f16-8f76-66a6-25aa-fe2020be1fb0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Alvogen Inc.
Application: NDA022497
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-09-28
Marketing end: 0000-00-00
Substance: BUPROPION HYDROCHLORIDE
Active strength: 450 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	47781-637	47781-637-30	D	Discontinued by firm		2026-08-03

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

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
N022497-001	FORFIVO XL	BUPROPION HYDROCHLORIDE	450MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2011-11-10

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022497-001	7674479	2028-08-23		Drug product	2011-11-28

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2011-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022497-001	FORFIVO XL	450MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2011-11-10	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022497-001	7674479	2028-08-23	Drug product	2011-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022497-001	7674479	2028-08-23	Drug product	2011-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022497-001	7674479	2028-08-23	Drug product	2011-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022497-001	7674479	2027-06-25	Drug product	2011-11-28	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47781-637-30	EA - Each	47781-637	96c8b0fe-5486-4b56-a77b-00f0fce19850	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47781-637	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	5	Legacy NDC	20240430_a032e7c8-33f2-5fdb-62d7-8517072d1d10.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPROPION HCl ER (XL)	BUPROPION HCL ER	Lifestar Pharma LLC	df959e1b-3f6d-42cf-8521-fe03b5a4ceb8	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022497 application number: NDA022497
Forfivo XL	BUPROPION HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	80b01182-dc94-4990-8ebb-55c306d7e536	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022497 application number: NDA022497
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	98d5977f-9b32-46db-bd36-a2c4d1b0710a	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022497 application number: NDA022497

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZG7E5POY8O	BUPROPION HYDROCHLORIDE	31677-93-7	BUPROPION HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47781-637-30	47781063730	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47781-637-30)	2018-09-28	0000-00-00	No	No	Current