Bupropion Hydrochloride

Product NDC: 72789-120
11-digit product format: 727890120
Labeler code: 72789
Product ID: 72789-120_314559d4-a78d-7a4a-e063-6294a90a6910
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA210081
Marketing category: ANDA
Marketing start: 2018-08-30
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: 2026-12-31
Current FDA listing: Yes

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	72789-120		D	Discontinued by firm		2026-08-17
excluded package	package	72789-120	72789-120-90	D	Discontinued by firm		2026-08-17

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
A210081-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL			2017-11-03
A210081-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL			2017-11-03

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	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2017-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2017-11-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2017-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2017-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL		2017-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL		2017-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210081-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210081-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2017-11-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A210081-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210081-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210081-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210081-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210081-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210081-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210081-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210081-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210081-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210081-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210081-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210081-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210081-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210081-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210081-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210081-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210081-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210081-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210081-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210081-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210081-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210081-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210081-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210081-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210081-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210081-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210081-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210081-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210081-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210081-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210081-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210081-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210081-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210081-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210081-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210081-002	AB3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210081-001	AB3	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210081-002	AB3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210081-001	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210081-002	AB3	1	`5aa47cf7b7d7…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72789-120-90	Bupropion Hydrochloride(XL)	90 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	90		17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-120	BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]	17	Current NDC, Legacy NDC, 1 package rows	20250328_a2602a1a-9138-44c5-a032-4f911fff828c.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	9d5360f5-f747-4baf-8e6c-ddca1a9c871a	2024-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210081 application number: ANDA210081
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	64be3113-837a-48f3-9f9e-400529c9ee94	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210081 application number: ANDA210081
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	62d0dcb5-c70b-4884-9755-740f62a8b31a	2024-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210081 application number: ANDA210081
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	8ae81b03-b447-4a3f-8ed9-ebf75ee52b49	2024-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210081 application number: ANDA210081
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	ef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a	2023-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210081 application number: ANDA210081
Bupropion Hydrochloride (XL)	BUPROPION HYDROCHLORIDE	Proficient Rx LP	2af578d8-a7f8-4da3-b126-390a0e950fad	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210081 application number: ANDA210081

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	a2602a1a-9138-44c5-a032-4f911fff828c	17
993541	24 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet	SCD	a2602a1a-9138-44c5-a032-4f911fff828c	17
993541	bupropion HCl XL 150 MG 24 HR Extended Release Oral Tablet	SY	a2602a1a-9138-44c5-a032-4f911fff828c	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-120-90	72789012090	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-120-90)	2020-09-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupropion Hydrochloride (XL)	PD-Rx Pharmaceuticals, Inc.	2025-03-26	HUMAN PRESCRIPTION DRUG LABEL	17