FDA.reportPublic FDA data

bupropion

Product NDC
71335-0801
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0801DDiscontinued by firm2026-07-31
excluded packagepackage71335-080171335-0801-1DDiscontinued by firm2026-07-31
excluded packagepackage71335-080171335-0801-2DDiscontinued by firm2026-07-31
excluded packagepackage71335-080171335-0801-3DDiscontinued by firm2026-07-31
excluded packagepackage71335-080171335-0801-4DDiscontinued by firm2026-07-31
excluded packagepackage71335-080171335-0801-5DDiscontinued by firm2026-07-31
excluded packagepackage71335-080171335-0801-6DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202304-001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26
A202304-002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26
A202304-003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202304-001BUPROPION HYDROCHLORIDE100MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26a50c72e98297…
2026-08-01 22:54:322026-06A202304-002BUPROPION HYDROCHLORIDE150MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26a50c72e98297…
2026-08-01 22:54:322026-06A202304-003BUPROPION HYDROCHLORIDE200MGTABLET, EXTENDED RELEASE / ORALAB12015-05-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202304-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A202304-002AB11a50c72e98297…
2026-08-01 22:54:322026-06A202304-003AB11a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bupropion hydrochloride SRBUPROPION HYDROCHLORIDEMajor Pharmaceuticals67b6bcf8-0e7c-4e74-ad72-54f1bd6e65ad2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropion hydrochloride SRBUPROPION HYDROCHLORIDECardinal Health 107, LLC439a7e93-f578-434f-943f-4b93c35450f52026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropion hydrochloride SRBUPROPION HYDROCHLORIDESolco Healthcare US LLC39b2d509-1281-4464-9cf1-a94bbc18b84b2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropion hydrochloride SRBUPROPION HYDROCHLORIDEREMEDYREPACK INC.850ac56a-ba50-4e61-b1ee-805e17735b5c2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropionBUPROPION HYDROCHLORIDENorthwind Health Company, LLCab6cd2ea-507c-35e5-e053-2a95a90ac5cb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEDIRECT RX96d87edc-d12b-44b2-e053-2995a90a4e632025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
bupropionBUPROPION HYDROCHLORIDEBryant Ranch Prepack7ded4fa6-e637-4d59-a1b1-286854d4fe3a2024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202304
application number: ANDA202304
ndc (product): 71335-0801
bupropionBUPROPION HYDROCHLORIDEProficient Rx LP909204fc-ff55-43d9-b9ee-e607ef60965e2022-04-01Boxed warning, Warnings, Adverse reactionsExact 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
IngredientStrength
BUPROPION HYDROCHLORIDE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZG7E5POY8OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ded4fa6-e637-4d59-a1b1-286854d4fe3aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0801-12024-05-22C16284748780-11030e365-4722-111a-e063-dadaa90a10e2These 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
71335-0801-22024-05-22C16284748780-11030e365-4722-111a-e063-dadaa90a10e2These 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
71335-0801-32024-05-22C16284748780-11030e365-4722-111a-e063-dadaa90a10e2These 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
71335-0801-42024-05-22C16284748780-11030e365-4722-111a-e063-dadaa90a10e2These 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
71335-0801-52024-05-22C16284748780-11030e365-4722-111a-e063-dadaa90a10e2These 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
71335-0801-62024-05-22C16284748780-11030e365-4722-111a-e063-dadaa90a10e2These 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
71335-0801-12024-01-30C16284748780-11030e365-4722-111a-e063-dadaa90a10e2These 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
71335-0801-22024-01-30C16284748780-11030e365-4722-111a-e063-dadaa90a10e2These 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
71335-0801-32024-01-30C16284748780-11030e365-4722-111a-e063-dadaa90a10e2These 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
71335-0801-42024-01-30C16284748780-11030e365-4722-111a-e063-dadaa90a10e2These 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
71335-0801-52024-01-30C16284748780-11030e365-4722-111a-e063-dadaa90a10e2These 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
71335-0801-62024-01-30C16284748780-11030e365-4722-111a-e063-dadaa90a10e2These 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 NDCProductDescriptionFormQuantityStrengthSPL version
71335-0801-1bupropion60 in 1 BOTTLETABLET, EXTENDED RELEASE60103
71335-0801-2bupropion180 in 1 BOTTLETABLET, EXTENDED RELEASE180103
71335-0801-3bupropion30 in 1 BOTTLETABLET, EXTENDED RELEASE30103
71335-0801-4bupropion90 in 1 BOTTLETABLET, EXTENDED RELEASE90103
71335-0801-5bupropion120 in 1 BOTTLETABLET, EXTENDED RELEASE120103
71335-0801-6bupropion28 in 1 BOTTLETABLET, EXTENDED RELEASE28103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0801BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20240822_7ded4fa6-e637-4d59-a1b1-286854d4fe3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN7ded4fa6-e637-4d59-a1b1-286854d4fe3a103
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD7ded4fa6-e637-4d59-a1b1-286854d4fe3a103
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY7ded4fa6-e637-4d59-a1b1-286854d4fe3a103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0801-17133508010160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-1) 2018-05-010000-00-00NoNoCurrent
71335-0801-271335080102180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-2) 2024-08-090000-00-00NoNoCurrent
71335-0801-37133508010330 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-3) 2024-08-090000-00-00NoNoCurrent
71335-0801-47133508010490 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-4) 2024-08-090000-00-00NoNoCurrent
71335-0801-571335080105120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-5) 2024-08-090000-00-00NoNoCurrent
71335-0801-67133508010628 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0801-6) 2024-08-090000-00-00NoNoCurrent