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 5 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCTotal Operations Management LLC DBA:Bestmade Natural Products Micro540e4ee3-596f-4cea-e063-6294a90a6a602026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEREMEDYREPACK INC.02275c51-6b3e-434a-bdb5-99135e73f1a42026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackbf5e933c-8a84-4dd7-a05d-6c4a82b6c9652026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack350336bf-57b1-4d2f-bf25-956bb6023c072026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Jacksons Cell Salts SKIN BALANCECALC SULPH, KALI SULPH, SILICEAZettl Health Inc.54012f03-4c34-42f5-e063-6394a90aacc52026-06-11WarningsExact identifier
unii: ETJ7Z6XBU4
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEBryant Ranch Prepack82bcdd72-9146-4c8d-a8aa-f920158646052026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepackaf5b1cc8-f078-4a7b-b64a-4cb2de1e57212026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEBryant Ranch Prepackeb25adb1-9841-42ce-aa22-718fb0fba5dd2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride (XL)BUPROPION HYDROCHLORIDEBryant Ranch Prepack8499470a-8d01-4348-b67b-8f49728031cb2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCBM Private Limited53e763ee-9a44-a914-e063-6394a90aeb3c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
GUNA-AWARENESSBETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -Guna spa10e46b39-7903-4390-b72d-865291245b4c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack5c111cf0-0199-4a4d-8138-81579af4c14d2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepack4c9a5dc3-bebe-431a-b550-ce46c6c6b01e2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO18CALC FLUOR, CALC SULF, SILICEA.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d3c1d6-d0ba-5ea7-e063-6394a90a02942026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
BM SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro53bb3927-6053-eb3d-e063-6394a90a5ddf2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEUnit Dose Solutions, Inc.53c192ca-ac51-cb87-e063-6394a90a6c082026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.434aacf8-87f1-44fc-a66b-92ae0022de0e2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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