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 3 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LorazepamLORAZEPAMRising Pharma Holdings, Inc.386255e2-65aa-48ce-9eb1-246f1493cc142025-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
rxcui: 197900
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMPreferred Pharmaceuticals, Inc.00960fbd-a5da-408b-9867-62982f20906f2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMPreferred Pharmaceuticals, Inc.6cc1f35d-ff33-404e-aa5e-b01eab89863e2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
rxcui: 197902
unii: O26FZP769L
AtivanLORAZEPAMBausch Health US LLC89057c93-8155-4040-acec-64e877bd2b4c2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
rxcui: 197900
rxcui: 197902
unii: O26FZP769L
LOREEV XRLORAZEPAMA-S Medication Solutionsc470fdee-8e18-4da9-b072-943d6b2518cf2025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC3c20c89f-c8c3-43b3-837e-da413f4497952025-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
rxcui: 197900
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC17919c82-87f2-5030-e063-6294a90ac91a2025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMGolden State Medical Supply, Inc.32fb5628-bf80-0135-e063-6294a90aa3ab2025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
rxcui: 197900
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC1791d5c9-9004-5c4b-e063-6294a90adf3d2025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.8aaf9bcb-7a4e-ffaa-e053-2995a90a39132025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
rxcui: 197901
unii: O26FZP769L
LORAZEPAMLORAZEPAMDirectRxddcc0b2b-4be2-6d18-e053-2a95a90af9872025-01-22Warnings, Adverse reactionsExact identifier
application number: ANDA203572
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.4a66b854-4dd6-3746-e054-00144ff8d46c2025-01-20Warnings, Adverse reactionsExact identifier
rxcui: 197900
unii: O26FZP769L
LORAZEPAMLORAZEPAMAdvanced Rx of Tennessee, LLC2a57e549-390b-5482-e063-6394a90aeb3b2024-12-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
ndc (package): 80425-0465-2
ndc (package): 80425-0465-1
ndc (package): 80425-0465-3
ndc (product): 80425-0465
ndc11 (package): 80425046501
rxcui: 197901
spl id: 2a57e551-1ed3-718f-e063-6394a90a30e1
spl set id: 2a57e549-390b-5482-e063-6394a90aeb3b
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.29f63525-2839-946c-e063-6294a90aebb12024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMFresenius Kabi USA, LLCb2487467-a63f-48b5-b0de-3a6ce6672d502024-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.503834f9-fa2e-5e23-e054-00144ff88e882024-11-13Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMA-S Medication Solutionsbe85b116-9f09-403a-8e0d-e77e344d3a9a2024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMChartwell RX, LLC6b0619c5-b9e9-47e7-97b5-7e581e67cf5f2024-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
rxcui: 197900
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMAsclemed USA, Inc.ebdf72f7-7462-4b83-81b4-c7988860c7282024-11-05Boxed 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.