FDA.reportPublic FDA data

NDC 68071-3121-06 - 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
68071-3121
Requested NDC
68071-3121-06
Package NDCs from labels
68071-3121-6, 68071-3121-06
Manufacturer
NuCare Pharmaceuticals, Inc. | .
Effective date
2024-07-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lorazepam Tablets, USP CIV Rx onlyNuCare Pharmaceuticals, Inc. | .2024-07-19HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-07-03Lorazepam Tablets, USP CIV Rx only
2023-01-30Lorazepam Tablets, USP CIV Rx only
2021-02-11Lorazepam Tablets, USP CIV Rx only
2021-01-29Lorazepam Tablets, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3121-6Lorazepam6 in 1 BOTTLETABLET65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3121LORAZEPAM TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 1 package rows20240720_4ab77192-8fe9-2965-e054-00144ff88e88.zip

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
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
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
application number: ANDA078203
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
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMA-S Medication Solutions8361519b-be1a-4542-a782-d7cdfa153e862026-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078203
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.a0a33933-f697-4d3b-ba99-8a995a4b6c6b2026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078203
rxcui: 197901
unii: O26FZP769L
LORAZEPAMLORAZEPAMDIRECT RX4832f02d-289c-2fe6-e054-00144ff8d46c2026-01-08Warnings, Adverse reactionsExact identifier
application number: ANDA078203
rxcui: 197900
unii: O26FZP769L
LORAZEPAMLORAZEPAMAurolife Pharma LLC5b851f67-309d-4ef3-8b4b-ade8908256ea2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
rxcui: 197900
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMRedPharm Drug, Inc.891b2c10-942f-0e4d-e053-2995a90af0282025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078203
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMPharmPak, Inc.b6e4d2c7-10c0-4d77-be7b-caa3d3b869972025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078203
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
application number: ANDA078203
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
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.