FDA.reportPublic FDA data

NDC 80425-0468-01 - Bupropion Hydrochloride XL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0468
Requested NDC
80425-0468-01
Package NDCs from labels
80425-0468-3, 80425-0468-2, 80425-0468-1, 80425-0468-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bupropion Hydrochloride XL - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-01-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0468-1Bupropion HydrochlorideXL30 in 1 BOTTLETABLET, EXTENDED RELEASE301
80425-0468-2Bupropion HydrochlorideXL60 in 1 BOTTLETABLET, EXTENDED RELEASE601
80425-0468-3Bupropion HydrochlorideXL90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0468BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20250103_2aabf040-16a6-b772-e063-6294a90afd70.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0468-1EA - Each80425-046851d7548e-3c4e-406c-bf0d-d5e459be9b7212025-02-10
80425-0468-2EA - Each80425-0468ccf79932-e8da-4024-a173-ea991adb2ea812025-02-10
80425-0468-3EA - Each80425-046819753bbe-f626-413b-9457-aae7db07320d12025-02-10

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 7 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC507112bd-a082-e85a-e063-6294a90ab2ac2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECardinal Health 107, LLC64934ca2-5655-45a2-9016-ad65b5abf5d32026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECoupler LLC5038440c-1f32-715a-e063-6294a90a889d2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDECamber Pharmaceuticals, Inc.c71f18b7-36a3-4489-96b4-e8fbec4f73a12026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEEpic Pharma, LLCf8ad76a2-9f75-4660-973d-34402f314e9c2026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECardinal Health 107, LLCec4d2256-0340-4166-90ee-c264eef3ac822026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, PALLADIUM METALLICUM, PHOSPHORUS, SILICEA, TITANIUM METALLICUM, ZINCUM METALLICUM, PLATINUM METALLICUM, PYROGENIUMEnergique, Inc.7f6d360b-9fee-4374-a47c-847806d54fa02026-04-13WarningsExact identifier
unii: ETJ7Z6XBU4
Animal Hair and DanderADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, CAT (DANDER), DOG (DANDER), EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, SABADILLA, SHEEP WOOL, SILICEANaturalCaref0067255-9310-43a0-b415-c03a0f554bcc2026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.f94a10bd-1c40-42c7-b458-b580706145492026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEBryant Ranch Prepack96e78f74-fad0-4ae1-9e68-55e4c6ab2d602026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepackc37bb183-f272-4cae-96e1-7042c1dd7bcf2026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEBryant Ranch Prepack03b1b0a9-0aa2-4039-acce-68ca54abaae42026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEBryant Ranch Prepacka5417808-f767-48fc-9f5d-c1aeee4e57c32026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus DefenseLAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODEMicro Balance Health Products LLC9c2f51c5-aa41-414e-a966-32e02e9e79a22026-04-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEBryant Ranch Prepacka7553281-be90-47e3-8d2b-b027f6d18d3a2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
Acne HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMBioActive Nutritional, Inc.2ab4ff53-4274-40c7-b05c-44d918d809be2026-03-31WarningsExact identifier
unii: ETJ7Z6XBU4
bupropion hydrochloride SRBUPROPION HYDROCHLORIDESolco Healthcare US LLC39b2d509-1281-4464-9cf1-a94bbc18b84b2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O

Reported adverse events (FAERS/openFDA)#

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