Bupropion Hydrochloride

Product NDC: 64679-101
11-digit product format: 646790101
Labeler code: 64679
Product ID: 64679-101_d98a3061-36af-4f3a-9076-016c45dda3da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Wockhardt USA LLC.
Application: ANDA201331
Marketing category: ANDA
Marketing start: 2012-05-15
Marketing end: 0000-00-00
Substance: BUPROPION HYDROCHLORIDE
Active strength: 100 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: 2020-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64679-101		D	Discontinued by firm	2026-08-03
excluded package	package	64679-101	64679-101-01	D	Discontinued by firm	2026-08-03
excluded package	package	64679-101	64679-101-02	D	Discontinued by firm	2026-08-03
excluded package	package	64679-101	64679-101-03	D	Discontinued by firm	2026-08-03
excluded package	package	64679-101	64679-101-05	D	Discontinued by firm	2026-08-03
excluded package	package	64679-101	64679-101-07	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 2 · 90 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-101-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-101-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-101-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-101-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-101-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-101-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-101-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-101-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-101-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-101-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-101-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-101-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-101-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-101-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-101-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-101-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-101-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-101-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-101-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-101-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-101-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-101-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-101-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-101-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-101-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-101-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-101-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-101-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-101-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-101-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-101-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-101-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-101-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-101-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-101-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-101-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-101-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-101-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-101-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-101-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-101-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-101-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-101-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-101-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-101-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-101-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-101-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-101-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-101-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-101-05	`ad56d346431e…`	`cc804d4bbf1e…`

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	Approval date
A201331-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30
A201331-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30
A201331-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201331-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201331-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201331-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2012-08-30	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64679-101-01	2025-12-19	These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-02	2025-12-19	These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-03	2025-12-19	These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-05	2025-12-19	These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-07	2025-12-19	These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-01	2023-01-30	These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-02	2023-01-30	These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-03	2023-01-30	These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-05	2023-01-30	These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985
64679-101-07	2023-01-30	These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (SR) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (SR). Bupropion Hydrochloride Extended-Release Tablets, USP (SR), for oral use Initial U.S. Approval: 1985

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64679-101-02	EA - Each	64679-101	9f7d9cd6-2eeb-42c8-bdfb-3d1f9b5fdc29	1	2013-02-13
64679-101-03	EA - Each	64679-101	7d4c6ad1-00ef-44df-be4d-2f038fbf0cc6	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
AMMONIUM CHLORIDE	INACTIVE INGREDIENT	01Q9PC255D	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64679-101	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]	4	Legacy NDC	20191128_3ff63de9-3750-46b9-829e-76e6f7b33542.zip

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64679-101-01	64679010101	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-101-01)		2012-05-15	0000-00-00	No	No	Current
64679-101-02	64679010102	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-101-02)		2012-05-15	0000-00-00	No	No	Current
64679-101-03	64679010103	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-101-03)		2012-05-15	0000-00-00	No	No	Current
64679-101-05	64679010105	10 BLISTER PACK in 1 CARTON (64679-101-05) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (64679-101-08)	10 blister pack	2012-05-15	0000-00-00	No	No	Current
64679-101-07	64679010107	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-101-07)		2012-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride (SR)	Wockhardt USA LLC. \| Wockhardt Limited	2019-11-26	HUMAN PRESCRIPTION DRUG LABEL	4