BUPROPION HYDROCHLORIDE

Product NDC: 64679-830
11-digit product format: 646790830
Labeler code: 64679
Product ID: 64679-830_a73acc01-a46f-4bd9-93bc-a0651059014e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Wockhardt USA LLC.
Application: NDA022497
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-08-09
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: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64679-830		D	Discontinued by firm	2026-08-03
excluded package	package	64679-830	64679-830-00	D	Discontinued by firm	2026-08-03
excluded package	package	64679-830	64679-830-01	D	Discontinued by firm	2026-08-03

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 · 3 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	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	64679-830		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-830	64679-830-00	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-830	64679-830-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64679-830-02	2020-01-31	C162847	48780-1	9d75b9d0-0a9f-f424-e053-dadaa90a57ce	b5d04313-790c-44a1-a5ca-4003491337b2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64679-830-01	EA - Each	64679-830	1395a804-d04a-4088-816e-4b77cab00603	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64679-830	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	5	Legacy NDC	20240701_2e3f36e9-1cb7-4987-92c9-2d9fc519c694.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
64679-830-01	64679083001	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-830-01)	2018-08-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUPROPION HYDROCHLORIDE	Wockhardt USA LLC. \| TWi Pharmaceuticals, Inc. \| Pillar5 Pharma, Inc. \| Reed-Land, Inc.	2024-07-01	HUMAN PRESCRIPTION DRUG LABEL	5