BUPROPION HYDROCHLORIDE (SR)

Product NDC: 53002-1509
11-digit product format: 530021509
Labeler code: 53002
Product ID: 53002-1509_32d3c707-3dff-4134-b337-2552146b74c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA206674
Marketing category: ANDA
Marketing start: 2016-07-25
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53002-1509		I	Inactivated by FDA		2026-09-14
excluded package	package	53002-1509	53002-1509-6	I	Inactivated by FDA		2026-09-14

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 · 34 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	53002-1509-6	`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	53002-1509-6	`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	53002-1509-6	`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	53002-1509-6	`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	53002-1509-6	`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	53002-1509-6	`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	53002-1509-6	`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	53002-1509-6	`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	53002-1509-6	`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	53002-1509-6	`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	53002-1509-6	`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	53002-1509-6	`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	53002-1509-6	`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	53002-1509-6	`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	53002-1509-6	`1332a3947898…`	`d4bfe170f9cd…`
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	53002-1509-6	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-1509-6	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206674-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09
A206674-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09
A206674-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206674-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206674-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206674-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-02-09	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A206674-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206674-002	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206674-003	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206674-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206674-002	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206674-003	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206674-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206674-002	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206674-003	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206674-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206674-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206674-003	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206674-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206674-002	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206674-003	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206674-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206674-002	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206674-003	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206674-001	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206674-002	AB1	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206674-003	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206674-001	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206674-002	AB1	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206674-003	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206674-001	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206674-002	AB1	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206674-003	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206674-001	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206674-002	AB1	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206674-003	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206674-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206674-002	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206674-003	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206674-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206674-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206674-003	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206674-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206674-002	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206674-003	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206674-001	AB1	1	`6a51e52b5d6a…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
53002-1509-6	2023-01-30	C162847	48780-1	9d75b9d0-48fd-f424-e053-dadaa90a57ce	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 (SR), for oral use Initial U.S. Approval: 1985
53002-1509-6	2020-12-15	C162847	48780-1	9d75b9d0-48fd-f424-e053-dadaa90a57ce	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 (SR), for oral use Initial U.S. Approval: 1985
53002-1509-6	2020-01-31	C162847	48780-1	9d75b9d0-48fd-f424-e053-dadaa90a57ce	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 (SR), 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
53002-1509-6	BUPROPION HYDROCHLORIDE (SR)	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1509	BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.]	3	Legacy NDC, 1 package rows	20201217_c9d0e9cd-4776-47a2-96b8-b3a0ac2ee5f2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPROPION HYDROCHLORIDE SR	BUPROPION HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	f5d774dd-0f51-4a4f-a9d1-8b5f2364b1f7	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206674 application number: ANDA206674
BUPROPION HYDROCHLORIDE (SR)	BUPROPION HYDROCHLORIDE	Cipla USA Inc.,	9d2c209b-248e-4e26-9cde-fe0abe4428c1	2018-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206674 application number: ANDA206674

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
993503	buPROPion HCl 100 MG 12HR Extended Release Oral Tablet	PSN	c9d0e9cd-4776-47a2-96b8-b3a0ac2ee5f2	3
993503	12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet	SCD	c9d0e9cd-4776-47a2-96b8-b3a0ac2ee5f2	3
993503	bupropion HCl 100 MG 12 HR Extended Release Oral Tablet	SY	c9d0e9cd-4776-47a2-96b8-b3a0ac2ee5f2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1509-6	53002150906	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (53002-1509-6)	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUPROPION HYDROCHLORIDE (SR)	RPK Pharmaceuticals, Inc.	2020-12-15	HUMAN PRESCRIPTION DRUG LABEL	3