Bupropion Hydrochloride

Product NDC: 68071-5213
Requested package NDC: 68071-5213-1
11-digit product format: 680715213
Labeler code: 68071
Product ID: 68071-5213_d7749c32-51c4-95a4-e053-2a95a90a44d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupropion Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA203013
Marketing category: ANDA
Marketing start: 2018-06-18
Marketing end: 0000-00-00
Substance: BUPROPION HYDROCHLORIDE
Active strength: 75 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-5213	68071-5213-1	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A203013-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB		2018-06-08
A203013-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2018-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203013-001	AB
A203013-002	AB

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203013-001	BUPROPION HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2018-06-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203013-002	BUPROPION HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-08	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203013-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203013-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203013-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203013-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203013-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203013-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203013-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203013-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203013-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203013-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203013-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203013-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203013-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203013-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203013-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203013-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203013-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203013-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203013-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203013-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203013-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203013-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203013-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203013-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203013-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203013-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203013-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203013-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203013-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203013-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203013-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203013-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203013-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203013-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203013-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203013-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203013-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203013-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203013-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203013-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-5213-1	2022-02-07	C162847	48780-1	d6a99b39-538f-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
68071-5213-1	2022-01-28	C162847	48780-1	d6a99b39-538f-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	990587bd-4c7d-4a36-8a38-3104648ab3a2	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203013 application number: ANDA203013
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	81d251aa-a8e8-493e-94ed-12f6fb8902e6	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203013 application number: ANDA203013
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	b303a0ad-5971-44ab-937c-bcf3ff650358	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203013 application number: ANDA203013
Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE	Alembic Pharmaceuticals Limited	ef0bb8f2-7710-4236-8b47-57b74c8bca3e	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203013 application number: ANDA203013

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
68071-5213-1	68071521301	100 TABLET, FILM COATED in 1 BOTTLE (68071-5213-1)	2020-03-17	0000-00-00	No	No	Current