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 3 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.84cecab3-d0e6-436b-996b-0b598e9723082025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMNatco Pharma USA LLC19d0e3e5-f081-4574-9f0a-e7e97a88c7a92025-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMA-S Medication Solutionsec433be5-d84d-425f-9edf-71263f885eec2025-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197590
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMPrecision Dose Inc.78d5a77d-5ca7-4f16-b4d0-fce86456593c2025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMFresenius Kabi USA, LLCae52866a-0b9a-4baf-af1b-f9d5e00c0e562025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMMylan Institutional Inc.b326c66d-5762-4d16-933c-619fa2088ccd2025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
rxcui: 197590
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMA-S Medication Solutionsb47dc708-e83b-4224-bdb5-c9b7abd35cfb2025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMNatco Pharma USA LLCa14f5930-a3ac-4996-9778-df5baa3d0bab2025-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DIAZEPAMDIAZEPAMAdvanced Rx of Tennessee, LLC32c3af91-a57a-1278-e063-6294a90ae5ec2025-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217843
ndc (package): 80425-0511-1
ndc (package): 80425-0511-2
ndc (package): 80425-0511-3
ndc (product): 80425-0511
ndc11 (package): 80425051101
rxcui: 197589
spl id: 32c39455-1398-b87a-e063-6394a90a9597
spl set id: 32c3af91-a57a-1278-e063-6294a90ae5ec
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMAdvanced Rx of Tennessee, LLC2d322c6a-7f7e-1cc4-e063-6294a90a8e2e2025-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMCivica, Inc.83646a0f-eb43-4871-b95e-683c2533d2be2025-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMAsclemed USA, Inc.32e7bfa1-6060-4041-a0e5-249cacb84ebc2025-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
rxcui: 197590
rxcui: 197589
unii: Q3JTX2Q7TU
DIAZEPAMDIAZEPAMProficient Rx LP9322b0bc-e9fa-4c89-808b-110decf6db582025-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217843
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMAdvanced Rx Pharmacy of Tennessee, LLCb7002d26-3856-4c2f-e053-2995a90aea602024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197589
unii: Q3JTX2Q7TU
DIAZEPAMDIAZEPAMNuCare Pharmaceuticals, Inc.21785bb2-cc96-7973-e063-6294a90ab1b82024-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217843
rxcui: 197591
unii: Q3JTX2Q7TU
DIAZEPAMDIAZEPAMSunrise Pharmaceutical, Inc.34ac0b9d-d4ad-4aaa-8bee-902365f4e9a82024-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
rxcui: 197590
rxcui: 197589
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMHikma Pharmaceuticals USA Inc.9e85abed-1a8b-4762-a31f-f2c7f196b8af2024-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: Q3JTX2Q7TU
DIAZEPAMDIAZEPAMNuCare Pharmaceuticals, Inc22688087-27ad-620c-e063-6394a90a134c2024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217843
rxcui: 197591
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMBryant Ranch Prepack9424ce71-f04c-4d70-89de-b7858931c53d2024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197591
unii: Q3JTX2Q7TU
DiazepamDIAZEPAMBryant Ranch Prepack632d7e96-d32c-45b8-86cf-f18ec2b354852024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197590
unii: Q3JTX2Q7TU

Reported adverse events (FAERS/openFDA)#

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