Bupropion Hydrochloride

Product NDC: 10370-102
11-digit product format: 103700102
Labeler code: 10370
Product ID: 10370-102_a9a1f889-378e-4569-be40-a816d914ec6e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA077284
Marketing category: ANDA
Marketing start: 2007-06-12
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10370-102		D	Discontinued by firm	2026-08-17
excluded package	package	10370-102	10370-102-03	D	Discontinued by firm	2026-08-17
excluded package	package	10370-102	10370-102-50	D	Discontinued by firm	2026-08-17

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 · 21 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10370-102-50	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10370-102-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10370-102-50	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10370-102-03	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10370-102-50	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10370-102-03	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10370-102-50	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10370-102-03	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10370-102-50	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10370-102-03	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10370-102-50	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10370-102-03	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10370-102-03	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10370-102-50	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077284-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL			2006-12-14
A077284-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL			2006-12-14

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 3 · 84 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
2026-08-18 06:07:40	2026-07	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2006-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2006-12-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2006-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2006-12-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2006-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2006-12-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2006-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2006-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2006-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077284-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2006-12-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077284-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2006-12-14	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077284-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077284-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077284-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077284-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077284-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077284-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077284-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077284-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077284-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077284-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077284-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077284-002	AB3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077284-001	AB3	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077284-002	AB3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077284-001	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077284-002	AB3	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077284-001	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077284-002	AB3	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077284-001	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077284-002	AB3	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077284-001	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077284-002	AB3	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077284-001	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077284-002	AB3	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077284-001	AB3	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077284-002	AB3	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A077284-002	AB3	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077284-002	AB3	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077284-002	AB3	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077284-001	AB3	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077284-002	AB3	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077284-001	AB3	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077284-002	AB3	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077284-001	AB3	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077284-002	AB3	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077284-001	AB3	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077284-002	AB3	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077284-001	AB3	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077284-002	AB3	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077284-001	AB3	1	`f41ea6bd6efb…`

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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, Related label table
NDC	Effective	Related label
10370-102-03	2022-09-23	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 (XL), for oral use Initial U.S. Approval: 1985
10370-102-50	2022-09-23	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 (XL), for oral use Initial U.S. Approval: 1985
10370-102-03	2022-07-29	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 (XL), for oral use Initial U.S. Approval: 1985
10370-102-50	2022-07-29	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 (XL), 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
10370-102-00	EA - Each	10370-102	328d3e74-1799-4ef4-a898-87b7b3970509	1	2012-07-24
10370-102-03	EA - Each	10370-102	2fa616a4-d56f-4137-8d78-900f63586b06	1	2012-07-24
10370-102-50	EA - Each	10370-102	03a5b08f-2727-4de5-b39d-cac85dd25e53	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	21
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	21
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	21
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	21
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	21
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	21
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	21
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	21
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	21
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	21
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	21
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	16
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	6
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	6
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	6
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	6
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	6
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	6
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10370-102	BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	37	Legacy NDC	20231208_a5ddc0dc-c176-4705-a9a0-e4ecaf1f5667.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	bd3f1706-e6e0-4db1-b09e-5e718976766a	104
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	bd3f1706-e6e0-4db1-b09e-5e718976766a	104
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	bd3f1706-e6e0-4db1-b09e-5e718976766a	104
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	49b86092-60a9-486e-98ca-ecd77e38c5dc	18
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	49b86092-60a9-486e-98ca-ecd77e38c5dc	18
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	49b86092-60a9-486e-98ca-ecd77e38c5dc	18
993541	buPROPion HCl 150 MG 24HR Extended Release Oral Tablet	PSN	0bff4522-330e-4f75-929f-5e9f0d75a33f	1
993557	buPROPion HCl 300 MG 24HR Extended Release Oral Tablet	PSN	0bff4522-330e-4f75-929f-5e9f0d75a33f	1
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	0bff4522-330e-4f75-929f-5e9f0d75a33f	1
993557	24 HR bupropion hydrochloride 300 MG Extended Release Oral Tablet	SCD	0bff4522-330e-4f75-929f-5e9f0d75a33f	1
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	0bff4522-330e-4f75-929f-5e9f0d75a33f	1
993557	bupropion HCl XL 300 MG 24 HR Extended Release Oral Tablet	SY	0bff4522-330e-4f75-929f-5e9f0d75a33f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
10370-102-03	10370010203	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-102-03)	2007-06-12	0000-00-00	No	No	Current
10370-102-50	10370010250	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10370-102-50)	2007-06-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL	36
Bupropion Hydrochloride	Major Pharmaceuticals	2024-06-27	HUMAN PRESCRIPTION DRUG LABEL	6
Bupropion Hydrochloride	American Health Packaging	2024-05-03	HUMAN PRESCRIPTION DRUG LABEL	14
Bupropion Hydrochloride	AvPAK	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	10
Bupropion Hydrochloride	AvKARE	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	6
Bupropion Hydrochloride	Bryant Ranch Prepack	2023-11-29	HUMAN PRESCRIPTION DRUG LABEL	104
Bupropion Hydrochloride	Bryant Ranch Prepack	2023-08-25	HUMAN PRESCRIPTION DRUG LABEL	101
Bupropion Hydrochloride	Bryant Ranch Prepack	2023-03-02	HUMAN PRESCRIPTION DRUG LABEL	103
Bupropion Hydrochloride	Par Pharmaceutical, Inc.	2022-07-20	HUMAN PRESCRIPTION DRUG LABEL	37
Bupropion Hydrochloride	A-S Medication Solutions	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	18
Bupropion Hydrochloride	REMEDYREPACK INC.	2019-09-18	HUMAN PRESCRIPTION DRUG LABEL	3
Bupropion Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC \| Lake Erie Medical DBA Quality Care Prodcuts LLC	2019-03-18	HUMAN PRESCRIPTION DRUG LABEL	3
Bupropion Hydrochloride Extended-Release Tablets USP (XL)	Aidarex Pharmaceuticals LLC	2013-12-14	HUMAN PRESCRIPTION DRUG LABEL	1