bupropion

Product NDC: 71335-0801
Requested package NDC: 71335-0801-2
11-digit product format: 713350801
Labeler code: 71335
Product ID: 71335-0801_645edeba-9a73-4d0a-ac84-2de98e89b760
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202304
Marketing category: ANDA
Marketing start: 2014-11-01
Substance: BUPROPION HYDROCHLORIDE
Active strength: 200 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	71335-0801	71335-0801-2	D	Discontinued by firm		2026-07-31

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

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	TE codes	Approval date
A202304-001	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26
A202304-002	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26
A202304-003	BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202304-001	AB1
A202304-002	AB1
A202304-003	AB1

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A202304-001	BUPROPION HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202304-002	BUPROPION HYDROCHLORIDE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202304-003	BUPROPION HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2015-05-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A202304-001	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202304-002	AB1	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A202304-003	AB1	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	Major Pharmaceuticals	67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	Cardinal Health 107, LLC	439a7e93-f578-434f-943f-4b93c35450f5	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	Solco Healthcare US LLC	39b2d509-1281-4464-9cf1-a94bbc18b84b	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion hydrochloride SR	BUPROPION HYDROCHLORIDE	REMEDYREPACK INC.	850ac56a-ba50-4e61-b1ee-805e17735b5c	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion	BUPROPION HYDROCHLORIDE	Northwind Health Company, LLC	ab6cd2ea-507c-35e5-e053-2a95a90ac5cb	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
BUPROPION HYDROCHLORIDE	BUPROPION HYDROCHLORIDE	DIRECT RX	96d87edc-d12b-44b2-e053-2995a90a4e63	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304
bupropion	BUPROPION HYDROCHLORIDE	Bryant Ranch Prepack	7ded4fa6-e637-4d59-a1b1-286854d4fe3a	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304 ndc (package): 71335-0801-2 ndc (product): 71335-0801 ndc11 (package): 71335080102
bupropion	BUPROPION HYDROCHLORIDE	Proficient Rx LP	909204fc-ff55-43d9-b9ee-e607ef60965e	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202304 application number: ANDA202304

Additional Listing Data#

Finished product: Yes
Brand name base: bupropion
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPROPION HYDROCHLORIDE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ZG7E5POY8O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
993536	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7ded4fa6-e637-4d59-a1b1-286854d4fe3a	Available on FDA.report

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711
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
71335-0801-1	2024-05-22	C162847	48780-1	1030e365-4722-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-2	2024-05-22	C162847	48780-1	1030e365-4722-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-3	2024-05-22	C162847	48780-1	1030e365-4722-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-4	2024-05-22	C162847	48780-1	1030e365-4722-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-5	2024-05-22	C162847	48780-1	1030e365-4722-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-6	2024-05-22	C162847	48780-1	1030e365-4722-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-1	2024-01-30	C162847	48780-1	1030e365-4722-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-2	2024-01-30	C162847	48780-1	1030e365-4722-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-3	2024-01-30	C162847	48780-1	1030e365-4722-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-4	2024-01-30	C162847	48780-1	1030e365-4722-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-5	2024-01-30	C162847	48780-1	1030e365-4722-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
71335-0801-6	2024-01-30	C162847	48780-1	1030e365-4722-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE (SR) TABLETS. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0801-1	bupropion	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	103
71335-0801-2	bupropion	180 in 1 BOTTLE	TABLET, EXTENDED RELEASE	180	103
71335-0801-3	bupropion	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	103
71335-0801-4	bupropion	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	103
71335-0801-5	bupropion	120 in 1 BOTTLE	TABLET, EXTENDED RELEASE	120	103
71335-0801-6	bupropion	28 in 1 BOTTLE	TABLET, EXTENDED RELEASE	28	103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0801	BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 6 package rows	20240822_7ded4fa6-e637-4d59-a1b1-286854d4fe3a.zip

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
993536	buPROPion HCl 200 MG 12HR Extended Release Oral Tablet	PSN	7ded4fa6-e637-4d59-a1b1-286854d4fe3a	103
993536	12 HR bupropion hydrochloride 200 MG Extended Release Oral Tablet	SCD	7ded4fa6-e637-4d59-a1b1-286854d4fe3a	103
993536	bupropion hydrochloride 200 MG 12 HR Extended Release Oral Tablet	SY	7ded4fa6-e637-4d59-a1b1-286854d4fe3a	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0801-2	71335080102	180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-2)	2024-08-09	0000-00-00	No	No	Current