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 1 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LorazepamLORAZEPAMClinical Solutions Wholesale, LLCc0810422-b732-4c04-97d8-c1521c401ef42026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.86630bdd-13ad-4ab5-9e94-fcf2ea2113e12026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.5a02c97d-637d-43f7-803c-afe4381ccc592026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.6c5356b1-c199-49ad-bb00-fd67c6691f742026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.ed37d304-04cf-43ec-a58d-d72002ff889b2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197902
unii: O26FZP769L
LORAZEPAMLORAZEPAMPreferred Pharmaceuticals Inc.903351ae-1bb0-4ac0-8430-df24cf2eee762026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.be9f8bda-1cd9-40a6-a4da-b5961389fb5b2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078203
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMANI Pharmaceuticals, Inc.787240e9-67b5-4af3-b16d-7cf314e3f2e32026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
rxcui: 197900
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMHospira, Inc.20140b19-846b-425f-b191-670e178099452026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.d6364be4-056b-4ebe-83bc-3fc85e8f488c2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078203
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMSt. Mary's Medical Park Pharmacy56093df3-10f6-e747-e063-6294a90a65642026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMSt. Mary's Medical Park Pharmacy569e8a5a-ddf7-ebbc-e063-6294a90ab7a42026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.b707ecb2-644c-4323-ab0e-7bc5929cd5602026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078203
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMUnit Dose Solutions, Inc.5519bba8-9eb7-a3e0-e063-6294a90afd942026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197900
unii: O26FZP769L
LorazepamLORAZEPAMUnit Dose Solutions, Inc.551a1b7f-d342-2c53-e063-6394a90a9a2a2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197902
unii: O26FZP769L
LorazepamLORAZEPAMREMEDYREPACK INC.0cd02e52-ead5-4b2a-9708-c7c4be7b79952026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078203
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMCoupler LLC54d72943-f8d1-5a78-e063-6294a90a059b2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LorazepamLORAZEPAMRedpharm Drug5407f327-3a22-8c15-e063-6294a90a31692026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197900
unii: O26FZP769L
LORAZEPAMLORAZEPAMREMEDYREPACK INC.7fa1a011-5e28-4b13-bcd2-5c5fc9b663b22026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197901
unii: O26FZP769L
LORAZEPAMLORAZEPAMBryant Ranch Prepack46af8e93-3169-408a-b4d8-b8498642801d2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197902
unii: O26FZP769L

Reported adverse events (FAERS/openFDA)#

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