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 4 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepacka613cfd3-1aa1-49c5-b742-b105c97d73f12026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDECoupler LLC5604eb14-bab4-4f06-e063-6294a90a69202026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.867d3876-6974-4e89-bc45-9e60e84b401c2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs4fbe64aa-f8f4-45fa-88ae-e844997703ae2026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion HydrochlorideBUPROPION HYDROCHLORIDESt. Mary's Medical Park Pharmacy362504fd-2f0a-c097-e063-6394a90ac0fc2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmerican Health Packaging88c980c8-aaa8-4378-9ac2-24d588640caa2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
BuPROPion HydrochlorideBUPROPION HYDROCHLORIDEAmerican Health Packaging1af890f7-1db8-4dd2-bf66-2b1e0c93a3d82026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDEREMEDYREPACK INC.c76f2f9f-3999-4bdd-8ec3-e0066318d3782026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion Hydrochloride SRBUPROPION HYDROCHLORIDENorthwind Health Company, LLC0865f8cf-1d7f-0e67-e063-6294a90a2f4d2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Scar ControlCALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDEForces of Nature595c3423-6b52-48fc-8a95-00b53c1ecc7b2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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