FDA.reportPublic FDA data

NDC 80425-0120-02 - 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
80425-0120
Requested NDC
80425-0120-02
Package NDCs from labels
80425-0120-2, 80425-0120-02
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diazepam - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0120-2Diazepam60 in 1 BOTTLETABLET606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0120DIAZEPAM TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 1 package rows20250101_b7002d26-3856-4c2f-e053-2995a90aea60.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0120-2EA - Each80425-0120d63d8189-3986-4d3d-849b-0dede35c676d12023-03-13

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 1 of 5 · 90 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMCardinal Health 107, LLCba953b22-f0cd-4be5-9e0e-178bded887272026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMCivica, Inc.cf7bd9ba-5030-479a-8448-3a99395b0d0c2026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
ValiumDIAZEPAMWaylis Therapuetics LLC260e2041-2bb3-482f-850e-b5d47a7bdbe62026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
rxcui: 197590
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMREMEDYREPACK INC.c57af2a2-aa9a-4dac-a200-e0d845005d052026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMREMEDYREPACK INC.b4a045e4-d6ce-475d-abe4-590941bd38152026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMREMEDYREPACK INC.20e08b97-bb89-4129-a228-8ad9cf35a1d32026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMHikma Pharmaceuticals USA Inc.f466f8a3-f31c-44f4-b0e8-444464f20f662026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMREMEDYREPACK INC.5ebef149-1858-4199-aaed-7b9341fae63d2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071322
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMUnit Dose Solutions, Inc.547c2ad4-113c-7771-e063-6394a90a20732026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
rxcui: 197589
unii: Q3JTX2Q7TU
ValtocoDIAZEPAMNeurelis, Inc1a8bcc90-68fa-474d-832c-0df01e825f392026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMNavinta LLCb5b17a28-2cab-4c0d-8f9d-7b224e4d09892026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMHospira, Inc.7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMCoupler LLC5111654f-a026-71b2-e063-6294a90ab49b2026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA071322
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMCoupler LLC5114ae6e-8cae-e96f-e063-6294a90a9e602026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMBaxter Healthcare Corporationa0813073-d0b0-4fd7-b307-56f69c910c822026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMZydus Pharmaceuticals USA Inc.652714c7-25c4-4d05-979d-8eee3b6f2f4d2026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMDr. Reddy's Laboratories Inc2a633cef-6dfc-4186-b595-174db2d8330e2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMDr. Reddy's Laboratories Inc9a860a4e-d670-d050-499d-eb1fd6b161762026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMPreferred Pharmaceuticals Inc.6dcbb5e9-1e8f-4069-9244-adb46356714d2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMPreferred Pharmaceuticals Inc.7646785b-dabc-482d-bf42-06177f00aca22026-04-01Boxed 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.