FDA.reportPublic FDA data

NDC 80425-0465-01 - LORAZEPAM

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
80425-0465
Requested NDC
80425-0465-01
Package NDCs from labels
80425-0465-2, 80425-0465-1, 80425-0465-3, 80425-0465-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LORAZEPAM - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0465-1LORAZEPAM30 in 1 BOTTLETABLET301
80425-0465-2LORAZEPAM60 in 1 BOTTLETABLET601
80425-0465-3LORAZEPAM90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0465LORAZEPAM TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20241229_2a57e549-390b-5482-e063-6394a90aeb3b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0465-1EA - Each80425-0465c9a5c15d-634e-4151-9f9d-ac45e6e2ff5512025-02-10
80425-0465-2EA - Each80425-0465f1a7c740-4286-4317-b809-d7bdd589bada12025-02-10
80425-0465-3EA - Each80425-0465d0a1df18-ba50-4e23-81b5-85ef0801a80112025-02-10

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 2 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LorazepamLORAZEPAMPreferred Pharmaceuticals Inc.4a50329b-b272-4164-bddf-0d6cea3d7a232026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMRedpharm Drug52614947-c96c-3361-e063-6394a90ae1722026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMAmerican Health Packaging6dfbe8be-168c-44e9-acfa-fa838b92d3b72026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMBryant Ranch Prepack11372b3d-52c0-4694-8c88-4b72d3fda9d02026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMCoupler LLC51119efa-c1a3-71f0-e063-6394a90a9e2a2026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMCoupler LLC5114810c-025f-6113-e063-6294a90af5382026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMFresenius Kabi USA, LLC462a13da-259a-40e7-bd5b-f7f42ae025b72026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LORAZEPAMLORAZEPAMPD-Rx Pharmaceuticals, Inc.0418ad09-3069-4381-9a8f-e41b234fdac62026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMA-S Medication Solutions8361519b-be1a-4542-a782-d7cdfa153e862026-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.a0a33933-f697-4d3b-ba99-8a995a4b6c6b2026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LORAZEPAMLORAZEPAMDIRECT RX4832f02d-289c-2fe6-e054-00144ff8d46c2026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 197900
unii: O26FZP769L
LORAZEPAMLORAZEPAMAurolife Pharma LLC5b851f67-309d-4ef3-8b4b-ade8908256ea2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
ndc (product): 13107-084
rxcui: 197901
rxcui: 197900
rxcui: 197902
spl id: 67012944-0947-4e64-adab-869993f2f709
spl set id: 5b851f67-309d-4ef3-8b4b-ade8908256ea
unii: O26FZP769L
LorazepamLORAZEPAMRedPharm Drug, Inc.891b2c10-942f-0e4d-e053-2995a90af0282025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMPharmPak, Inc.b6e4d2c7-10c0-4d77-be7b-caa3d3b869972025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMPD-Rx Pharmaceuticals, Inc.1f79a5a1-0c40-45cf-8994-51f5ba3a59382025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMPD-Rx Pharmaceuticals, Inc.0681c8db-ff09-4258-a5e0-76a26b0ea0af2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMPD-Rx Pharmaceuticals, Inc.7afd9a59-3463-4eda-8cf3-ef90be05de3d2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMPD-Rx Pharmaceuticals, Inc.7999b9c3-6185-4e4e-a4c3-d5d33d6c31d62025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMAmerican Health Packaging45e31a87-a8db-4dda-b94b-83535b62e8e22025-09-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
rxcui: 197901
rxcui: 197900
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMPD-Rx Pharmaceuticals, Inc.08a30230-fc95-9025-e063-6394a90ae21b2025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
rxcui: 197900
rxcui: 197902
unii: O26FZP769L

Reported adverse events (FAERS/openFDA)#

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