Application 075310

Type: ANDA
Sponsor: HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET;ORAL	75MG	No	No
002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	TABLET;ORAL	100MG	No	No

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

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
A075310-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL			1999-11-29
A075310-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL			1999-11-29

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 · 86 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	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075310-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	1999-11-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075310-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	1999-11-29	`74a2ff9319b5…`

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 8 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPROPION HYDROCHLORIDE (SR)	BUPROPION HYDROCHLORIDE	A-S Medication Solutions	994229b0-e190-49e3-83ce-6a2063f7335a	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	38f52cec-9534-dab8-e063-6294a90a0704	2025-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride SR	BUPROPION HYDROCHLORIDE	Proficient Rx LP	1094ff8e-f5a5-4a72-8bf9-25e68f5c964a	2025-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPROPION HYDROCHLORIDE
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	744f7394-aac9-4864-9436-e5b0b35a6148	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	144379e1-93b7-41c1-bc3a-7bdec5afa309	2025-06-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	HAWAII REPACK, INC.	b4a1d3b8-afcf-47e3-96d3-469d8f408a31	2025-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	c5d55b0c-8b81-476a-994e-1989e2a56255	2025-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	9a3b97be-afa3-49e6-962f-662b6807e607	2025-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	35a873c5-4aa8-b3c7-e063-6394a90a35ec	2025-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	fddc9630-2f9a-4104-888f-3714587d4fe7	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	AvPAK	2f9c5162-a6c5-e362-e063-6294a90a198d	2025-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Asclemed USA, Inc.	637e89e5-8f6e-4392-8045-a778cb9ed138	2025-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5dec4414-5595-46c9-ada9-3fbe98152040	2025-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Coupler LLC	2ccbf988-64b6-3a60-e063-6394a90ababa	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	d1043c87-0abe-ee8e-e053-2a95a90a419a	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	96d87edc-d12b-44b2-e053-2995a90a4e63	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: BUPROPION HYDROCHLORIDE generic name: BUPROPION HYDROCHLORIDE
Bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	1724f474-d6ab-46af-940f-7f874d4ff7fc	2025-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion hydrochloride generic name: BUPROPION HYDROCHLORIDE
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	4971c3cb-07c4-4c65-a16a-f1700e523147	2025-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	bd99969d-03d5-4609-88e8-a9ae93a83907	2025-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0e8b2109-8516-2d92-e063-6394a90a5d16	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupropion Hydrochloride generic name: BUPROPION HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53808-0213	Bupropion Hydrochloride	Bupropion Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44253	ORIG	2005-07-28