FDA.reportPublic FDA data

NDC 0904-6007-40 - 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
0904-6007
Requested NDC
0904-6007-40
Package NDCs from labels
0904-6007-60, 0904-6007-61, 0904-6007-40
Manufacturer
REMEDYREPACK INC.
Effective date
2025-06-30
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 onlyREMEDYREPACK INC.2025-06-30HUMAN PRESCRIPTION DRUG LABEL
Lorazepam - Cardinal Health 107, LLCCardinal Health 107, LLC2025-01-31HUMAN PRESCRIPTION DRUG LABEL
Lorazepam - Major PharmaceuticalsMajor Pharmaceuticals2025-01-21HUMAN PRESCRIPTION DRUG LABEL
Lorazepam - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2019-03-26HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6007-60Lorazepam100 in 1 BOTTLETABLET10011
0904-6007-61Lorazepam100 in 1 CARTONTABLET10011
0904-6007-61Lorazepam1 in 1 BLISTER PACKTABLET111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6007LORAZEPAM TABLET [MAJOR PHARMACEUTICALS]11Legacy NDC, 3 package rows20250122_62f6eb3b-813d-4890-aca9-799b7fa890df.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6007-40EA - Each0904-60075d2adda5-a9f8-4945-a6ed-a1ec637f032d12012-07-24
0904-6007-60EA - Each0904-6007d95213b6-761c-462c-b6f3-8719c9149c5e12012-07-24
0904-6007-61EA - Each0904-6007932a126c-c007-47b4-966b-63ae82cf578212016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1

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 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2028d925-a284-4106-8e42-742fdc15c10a13fc4e17-9394-4bc6-bf50-ac202348f4822026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 13fc4e17-9394-4bc6-bf50-ac202348f482
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
4b95efe3-7353-9bdc-e063-6294a90a6d2ef153d4fc-e33a-4582-be25-e397c45713e92026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: f153d4fc-e33a-4582-be25-e397c45713e9
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

Reported adverse events (FAERS/openFDA)#

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