FDA.reportPublic FDA data

NDC 0641-6047-01 - 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
0641-6047
Requested NDC
0641-6047-01
Package NDCs from labels
0641-6047-01, 0641-6047-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-04-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lorazepam Injection, USPHikma Pharmaceuticals USA Inc.2024-04-09HUMAN 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
0641-6047-01Lorazepam10 mL in 1 VIALINJECTION1010
0641-6047-10Lorazepam10 in 1 CARTONINJECTION1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6047LORAZEPAM 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
0641-6047-01ML - Milliliter0641-60478236abc8-8066-4251-928d-f551b354b87e12012-07-24
0641-6047-10ML - Milliliter0641-60474806abd7-fd27-4b81-a0b8-48d219f10fb012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]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 10 of 15 · 296 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LorazepamLORAZEPAMAsclemed USA, Inc.ebdf72f7-7462-4b83-81b4-c7988860c7282024-11-05Boxed warning, Warnings, 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.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: LKG8494WBH
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.8fa33078-c379-41f5-e053-2995a90acced2024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.4a66b854-4dc1-3746-e054-00144ff8d46c2024-10-08Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
unii: LKG8494WBH
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
unii: LKG8494WBH
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 6DC9Q167V3
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated10fcf407-6eaf-4730-9ed0-9b7715cf57012024-09-20WarningsExact identifier
unii: B697894SGQ
blink gel tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated6f7e06c3-204d-459a-af8f-c46be9ad0e8d2024-09-20WarningsExact identifier
unii: B697894SGQ
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: 6DC9Q167V3
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
LorazepamLORAZEPAMBryant Ranch Prepack853c762d-0772-4f02-99ca-0bc2911f09f02024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.4ab77192-8fe9-2965-e054-00144ff88e882024-07-19Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.a4fe8df0-3ce8-b8b8-e053-2995a90a28f42024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
unii: LKG8494WBH
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.50379c41-2676-590c-e054-00144ff8d46c2024-07-08Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC1bcf608a-11c1-ec7d-e063-6394a90ab7102024-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.8aace309-f3ef-6aef-e053-2995a90aa1972024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.933b5ef3-ec29-1a96-e053-2995a90a2d332024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMBryant Ranch Prepackaac672f9-0ba7-4852-b8a7-caac9e4b1e772024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L

Reported adverse events (FAERS/openFDA)#

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