FDA.reportPublic FDA data

NDC 68071-5250-06 - 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
68071-5250
Requested NDC
68071-5250-06
Package NDCs from labels
68071-5250-2, 68071-5250-6, 68071-5250-3, 68071-5250-06
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-07-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lorazepam Tablets USP CIVNuCare Pharmaceuticals,Inc.2024-07-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5250-2Lorazepam20 in 1 BOTTLETABLET207
68071-5250-3Lorazepam3 in 1 BOTTLETABLET37
68071-5250-6Lorazepam6 in 1 BOTTLETABLET67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5250LORAZEPAM TABLET [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 3 package rows20240719_a4fe8df0-3ce8-b8b8-e053-2995a90a28f4.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 4 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.8fa33078-c379-41f5-e053-2995a90acced2024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.4a66b854-4dc1-3746-e054-00144ff8d46c2024-10-08Warnings, Adverse reactionsExact identifier
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMBryant Ranch Prepack853c762d-0772-4f02-99ca-0bc2911f09f02024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.4ab77192-8fe9-2965-e054-00144ff88e882024-07-19Warnings, Adverse reactionsExact identifier
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.a4fe8df0-3ce8-b8b8-e053-2995a90a28f42024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
ndc (package): 68071-5250-2
ndc (package): 68071-5250-3
ndc (package): 68071-5250-6
ndc (product): 68071-5250
ndc11 (package): 68071525006
rxcui: 197901
spl id: 1d78c270-1e4b-c06a-e063-6394a90a992e
spl set id: a4fe8df0-3ce8-b8b8-e053-2995a90a28f4
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.50379c41-2676-590c-e054-00144ff8d46c2024-07-08Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC1bcf608a-11c1-ec7d-e063-6394a90ab7102024-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.8aace309-f3ef-6aef-e053-2995a90aa1972024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.933b5ef3-ec29-1a96-e053-2995a90a2d332024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMBryant Ranch Prepackaac672f9-0ba7-4852-b8a7-caac9e4b1e772024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMProficient Rx LPe9052b38-3c9f-4c84-9a0d-98bd99b9ddfd2024-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLCe563594e-212c-4f31-92ea-294aeab45df32024-04-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMHikma Pharmaceuticals USA Inc.4084fa74-9fd2-45ef-9d56-27bfa31d4e462024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMHikma Pharmaceuticals USA Inc.e9b54e42-04cf-4c62-90e1-36f7b31a4e812024-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMBryant Ranch Prepackba34ddd2-9a47-48bf-8e55-f05e9085e5a82024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMBryant Ranch Prepack8e3d44fb-24b7-4552-9e95-de3bf871a88b2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMInternational Medication Systems, Limited7dda070d-7809-46c4-8592-eb4e4c5097072024-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC82f79757-69f0-4a37-93a6-55b66ae86ad72024-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197902
unii: O26FZP769L
LORAZEPAMLORAZEPAMA-S Medication Solutions8602cef8-167e-4a8c-b10f-fc3295a3abcc2024-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203572
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC973eff80-b2cd-42ca-8e88-e0151e691e592024-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L

Reported adverse events (FAERS/openFDA)#

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