FDA.reportPublic FDA data

NDC 80425-0511-01 - DIAZEPAM

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
80425-0511
Requested NDC
80425-0511-01
Package NDCs from labels
80425-0511-1, 80425-0511-2, 80425-0511-3, 80425-0511-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DIAZEPAM - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-04-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0511-1DIAZEPAM30 in 1 BOTTLETABLET301
80425-0511-2DIAZEPAM60 in 1 BOTTLETABLET601
80425-0511-3DIAZEPAM90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0511DIAZEPAM TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20250419_32c3af91-a57a-1278-e063-6294a90ae5ec.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0511-1EA - Each80425-0511d590c1ad-9bea-45bc-bbfb-1466c8a2390f12025-05-14
80425-0511-2EA - Each80425-0511f7d5cb53-d710-4c70-a53a-f753875cf39b12025-05-14
80425-0511-3EA - Each80425-0511227b7352-fb5f-494e-b31b-c5e1a6eca61712025-05-14

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 2 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIAZEPAMDIAZEPAMHenry Schein, Inc.52fc91f4-992f-47cb-a7d2-b26d745774812026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMREMEDYREPACK INC.d7a4b3c7-7021-4764-8c21-49e4bc6f60582026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMSafecor Health, LLC8b51f4b3-a5e8-4400-b624-ac0c47630c862026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
rxcui: 197590
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMHenry Schein, Inc.bfa85a63-967f-4176-a752-0bafabbaaae32026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMNatco Pharma USA LLC6b8dc373-fa01-42c9-89af-4e00bf00180a2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMSagent Pharmaceuticals7a912f1a-deee-46df-a8df-22a0afb065292026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMDirect_Rx181cc7ac-5129-2200-e063-6394a90afd3a2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197589
unii: Q3JTX2Q7TU
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
DIAZEPAMDIAZEPAMDirect_Rx4b0c9c0a-4274-4d56-a7a4-bc497916469c2026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 197591
rxcui: 197589
unii: Q3JTX2Q7TU
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
DiazepamDIAZEPAMLupin Pharmaceuticals,Inc.d99b68aa-b3dc-49c8-8894-3da255cd26b02025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAM ORALChartwell RX, LLCcdb839fb-27e5-4a11-aed6-da0a7ab6e9962025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
ValiumDIAZEPAMRoche Laboratories Inc.554baee5-b171-4452-a50a-41a0946f956c2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
rxcui: 197590
unii: Q3JTX2Q7TU
DIAZEPAMDIAZEPAMHenry Schein, Inc.dcf7bc20-6c57-491a-b9e3-f42bacff8b992025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAM ORALChartwell Governmental & Specialty RX, LLC.167ee280-be68-4a28-a7d8-de41df14bc482025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DIAZEPAMDIAZEPAMASCLEMED USA INC.426f3da1-4105-ba0a-e063-6294a90a7a862025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217843
rxcui: 197591
rxcui: 197590
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMA-S Medication Solutions01f04ee4-fff9-499a-8213-984e163680842025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197590
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.c2768add-5e01-4ff4-afa3-230380d59a1f2025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.1ad84940-40f7-457a-8ffa-53e1a7bfee162025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197590
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.2483426d-3782-432a-8b8d-86c06ef0de4a2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
unii: Q3JTX2Q7TU

Reported adverse events (FAERS/openFDA)#

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