FDA.reportPublic FDA data

NDC 0641-6044-01 - 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
0641-6044
Requested NDC
0641-6044-01
Package NDCs from labels
0641-6044-01, 0641-6044-25
Manufacturer
REMEDYREPACK INC.
Effective date
2024-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lorazepam Injection, USPREMEDYREPACK INC.2024-06-07HUMAN PRESCRIPTION DRUG LABEL
Lorazepam Injection, USPHikma Pharmaceuticals USA Inc.2024-04-09HUMAN PRESCRIPTION DRUG LABEL
Lorazepam - TYA PharmaceuticalsTYA Pharmaceuticals2011-11-15HUMAN 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
0641-6044-01Lorazepam1 mL in 1 VIALINJECTION110
0641-6044-25Lorazepam25 in 1 CARTONINJECTION2510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6044LORAZEPAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20240410_e9b54e42-04cf-4c62-90e1-36f7b31a4e81.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6044-01ML - Milliliter0641-60449c10d57c-be4d-4e5c-bd04-680c477d6ef812012-07-24
0641-6044-25ML - Milliliter0641-60446e34d5a1-9495-43ce-a1cb-9f6626a83af712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM INJECTION [TYA PHARMACEUTICALS]2
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM INJECTION [TYA PHARMACEUTICALS]2
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLORAZEPAM INJECTION [TYA PHARMACEUTICALS]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLORAZEPAM INJECTION [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LORAZEPAM INJECTION [TYA PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2

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 8 of 15 · 298 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
LorazepamLORAZEPAMPreferred Pharmaceuticals, Inc.00960fbd-a5da-408b-9867-62982f20906f2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMPreferred Pharmaceuticals, Inc.6cc1f35d-ff33-404e-aa5e-b01eab89863e2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
AtivanLORAZEPAMBausch Health US LLC89057c93-8155-4040-acec-64e877bd2b4c2025-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LOREEV XRLORAZEPAMA-S Medication Solutionsc470fdee-8e18-4da9-b072-943d6b2518cf2025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Morning Star OTCdcd4164c-aa1e-4f07-ab2c-b439275629db2025-06-16WarningsExact identifier
unii: B697894SGQ
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC3c20c89f-c8c3-43b3-837e-da413f4497952025-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC17919c82-87f2-5030-e063-6294a90ac91a2025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMGolden State Medical Supply, Inc.32fb5628-bf80-0135-e063-6294a90aa3ab2025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC1791d5c9-9004-5c4b-e063-6294a90adf3d2025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: 6DC9Q167V3
FEELSHION Glycolic Acid Exfoliating Face PadsPROPYLENE GLYCOL,ARGININE,LACTIC ACID,SALICYLIC ACID,GLYCOLIC ACIDBeijing JUNGE Technology Co., Ltd.2e79678c-1ce4-25cf-e063-6394a90a133c2025-02-19WarningsExact identifier
unii: 6DC9Q167V3
Code Red Eye Drops Redness ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL4 Trees, LLC0aa08018-cc2d-d947-e063-6394a90a914a2025-02-07WarningsExact identifier
unii: B697894SGQ
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.8aaf9bcb-7a4e-ffaa-e053-2995a90a39132025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LORAZEPAMLORAZEPAMDirectRxddcc0b2b-4be2-6d18-e053-2a95a90af9872025-01-22Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.4a66b854-4dd6-3746-e054-00144ff8d46c2025-01-20Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: LKG8494WBH
VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 mlPROPYLENE GLYCOLRed Wedding LLCb2c2fd0f-b944-6b0b-e053-2995a90aa2162025-01-01WarningsExact identifier
unii: 6DC9Q167V3
Pain Relieving Cream LidocaineBENZYL ALCOHOL, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC039a2036-54b2-cf28-e063-6294a90a8ce62024-12-31WarningsExact identifier
unii: LKG8494WBH
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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