Bupropion Hydrochloride

Product NDC: 55648-102
11-digit product format: 556480102
Labeler code: 55648
Product ID: 55648-102_e0163d85-d240-4908-8b50-c7f76ba704e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Wockhardt Limited
Application: ANDA202189
Marketing category: ANDA
Marketing start: 2012-11-21
Marketing end: 0000-00-00
Substance: BUPROPION HYDROCHLORIDE
Active strength: 150 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: 2019-12-31
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	55648-102		I	Inactivated by FDA	2026-08-03
excluded package	package	55648-102	55648-102-01	I	Inactivated by FDA	2026-08-03
excluded package	package	55648-102	55648-102-02	I	Inactivated by FDA	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 · 63 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	55648-102-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-102-02	`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	55648-102-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-102-02	`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	55648-102-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-102-02	`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	55648-102-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-102-02	`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	55648-102-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-102-02	`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	55648-102-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-102-02	`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	55648-102-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-102-02	`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	55648-102-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-102-02	`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	55648-102-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-102-02	`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	55648-102-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-102-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55648-102-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55648-102-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55648-102-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55648-102-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-102-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-102-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-102-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-102-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-102-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-102-02	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55648-102-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55648-102-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55648-102-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55648-102-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55648-102-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55648-102-02	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55648-102-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55648-102-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55648-102-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55648-102-02	`e2bbac7714bc…`	`27bdfed8d636…`

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

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
A202189-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2012-11-21
A202189-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2022-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202189-001	AB3
A202189-002	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 2 · 72 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
2026-02-19 14:30 UTC	2026-02	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202189-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2022-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202189-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2012-11-21	`8869cabd3fbd…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202189-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202189-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202189-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202189-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202189-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202189-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202189-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202189-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202189-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202189-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202189-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202189-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202189-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202189-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202189-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202189-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202189-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202189-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202189-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202189-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202189-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202189-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202189-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202189-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202189-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202189-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202189-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202189-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202189-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202189-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202189-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202189-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202189-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202189-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202189-001	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202189-001	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202189-001	AB3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202189-001	AB3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202189-001	AB3	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202189-001	AB3	1	`8869cabd3fbd…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55648-102-01	2020-01-31	C162847	48780-1	9d75b9d0-9e6b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (XL) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (XL). Bupropion Hydrochloride Extended-Release Tablets, USP (XL) for oral use Initial U.S. Approval: 1985
55648-102-02	2020-01-31	C162847	48780-1	9d75b9d0-9e6b-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use bupropion hydrochloride extended-release tablets (XL) safely and effectively. See full prescribing information for bupropion hydrochloride extended-release tablets (XL). Bupropion Hydrochloride Extended-Release Tablets, USP (XL) for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55648-102-01	Bupropion Hydrochloride(XL)	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		3
55648-102-02	Bupropion Hydrochloride(XL)	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
AMMONIUM CHLORIDE	INACTIVE INGREDIENT	01Q9PC255D	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55648-102	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]	3	Legacy NDC, 2 package rows	20150414_653cf774-2996-4bc2-b88f-8b4b0eb2e08c.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
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	653cf774-2996-4bc2-b88f-8b4b0eb2e08c	3
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	653cf774-2996-4bc2-b88f-8b4b0eb2e08c	3
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	653cf774-2996-4bc2-b88f-8b4b0eb2e08c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55648-102-01	55648010201	30 in 1 BOTTLE	Historical
55648-102-02	55648010202	90 in 1 BOTTLE	Historical