bupropion hydrochloride

Product NDC: 70377-034
Requested package NDC: 70377-034-11
11-digit product format: 703770034
Labeler code: 70377
Product ID: 70377-034_1976a35a-d4d0-4a6a-b406-1821aba2e6c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Biocon Pharma Inc.,
Application: ANDA211020
Marketing category: ANDA
Marketing start: 2019-01-28
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70377-034	70377-034-11	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 · 18 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
A211020-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2019-01-28
A211020-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3		2019-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211020-001	AB3
A211020-002	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 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	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211020-001	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211020-002	BUPROPION HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2019-01-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211020-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211020-002	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211020-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211020-002	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211020-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211020-002	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211020-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211020-002	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211020-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211020-002	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211020-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211020-002	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211020-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211020-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211020-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211020-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211020-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211020-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211020-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211020-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211020-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211020-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211020-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211020-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211020-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211020-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211020-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211020-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211020-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211020-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211020-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211020-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211020-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211020-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211020-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211020-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211020-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211020-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211020-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211020-002	AB3	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70377-034-11	2025-01-21	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 for oral use Initial U.S. Approval: 1985
70377-034-12	2025-01-21	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 for oral use Initial U.S. Approval: 1985
70377-034-13	2025-01-21	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 for oral use Initial U.S. Approval: 1985
70377-034-11	2022-01-28	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 for oral use Initial U.S. Approval: 1985
70377-034-12	2022-01-28	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 for oral use Initial U.S. Approval: 1985
70377-034-13	2022-01-28	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 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
70377-034-11	EA - Each	70377-034	9b5f224f-8b4c-4374-8350-882489cca23b	1	2019-10-07
70377-034-12	EA - Each	70377-034	62612aa8-8a60-4f08-9c01-ab12e5d0f1cb	1	2019-10-07
70377-034-13	EA - Each	70377-034	38e84baf-114d-44a7-9cbd-332865b18874	1	2019-10-07

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	a613cfd3-1aa1-49c5-b742-b105c97d73f1	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	136f29fa-a859-4efb-8365-1382716d6f8f	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	Rising Pharma Holdings, Inc.	e4f4d3fa-ddf6-4125-8486-8157efc095c1	2026-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020
bupropion hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	d087222e-c5e9-4c48-b27f-e2e2944379c8	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	aeb506f8-97c2-409a-aac9-5a73c840e8f3	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211020 application number: ANDA211020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZG7E5POY8O	BUPROPION HYDROCHLORIDE	31677-93-7	BUPROPION HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70377-034-11	70377003411	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70377-034-11)	2019-01-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
bupropion hydrochloride	Biocon Pharma Inc., \| Graviti Pharmaceuticals Private Limited	2020-12-30	HUMAN PRESCRIPTION DRUG LABEL	3