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 8 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEBryant Ranch Prepackfd153957-ff74-4134-8545-cdc0e56199062026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
LymphoplexMYRRHA, TRIGONELLA FOENUM-GRAECUM, PINUS SYLVESTRIS, LYMPH (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRANGEA ARBORESCENS, PHYTOLACCA DECANDRA, SILICEABioActive Nutritional, Inc.624f35db-291e-4e7f-a2c9-ae319717157a2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
Equisetum SiliceaEQUISETUM SILICEAUriel Pharmacy Inc.e88b820b-4a07-42e2-8fe2-b30729e91a8c2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
B Force HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEABioActive Nutritional, Inc.811c6f32-fcad-464c-bcf6-ae6a59195b1c2026-03-30WarningsExact identifier
unii: ETJ7Z6XBU4
LymphdrainexGERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA,Energique, Inc.c512f211-f4f8-46f6-87ed-dd50287359df2026-03-27WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEA-S Medication Solutions30c5b97c-b19d-4d27-bb1a-ab19b7dfccaa2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEMAJOR PHARMACEUTICALS3c6b5ab4-9671-4fcd-8b4c-7f230dcfe6c92026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
A plus AttentionBARYTA CARBONICA, CALCAREA PHOSPHORICA, SILICEA, GELSEMIUM SEMPERVIRENS, NUX VOMICA, SINAPIS NIGRANaturalCaree77c2661-7ddf-4b09-b2e3-b9db3911011a2026-03-24WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion hydrochlorideBUPROPION HYDROCHLORIDECamber Pharmaceuticals, Inc.f69b322b-93ab-407a-bf25-fe13c6896ca62026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals, Inc.c0445fea-108f-4e00-a2ae-ebbdf27199472026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals, Inc.d1d1ed19-e111-4652-a0d4-9406e6f73e9f2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.42e228a2-25b3-44a6-8da7-6616ca44ac7f2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals, Inc.0b33fb1f-a7f0-4ab7-a882-eca2d2c77afa2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals Inc.eabb54b7-164c-4de8-b91a-f2e65637b5fc2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Nail Fungus ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Natureb7239e23-326e-4c1d-a080-55f457f1c4542026-03-19WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion HydrochlorideBUPROPION HYDROCHLORIDECadila Pharmaceuticals Limited33210109-2ddb-4b0f-a45e-988e493ca6282026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLABioActive Nutritional, Inc.12f1ef62-93f3-45b8-885d-1b82f85a83552026-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO18CALC FLUOR, CALC SULF, SILICEA.BM Private Limited4d269a3b-18ba-3ad2-e063-6294a90a1fae2026-03-16WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEAsclemed USA, Inc.d1d0872c-5b11-4e13-a401-b122348e0fa72026-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
LigatoneARNICA MONTANA, BRYONIA, CALCAREA PHOSPHORICA, CAUSTICUM, KALI CARBONICUM, MANGANESE GLUCONATE, MEZEREUM, RHUS TOX, RUTA GRAVEOLENS, SILICEABioActive Nutritional, Inc.3a3bdd55-daec-43b9-a380-54a747fb7d102026-03-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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