FDA.reportPublic FDA data

NDC 76329-8261-01 - 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
76329-8261
Requested NDC
76329-8261-01
Package NDCs from labels
76329-8261-1, 76329-8261-01
Manufacturer
REMEDYREPACK INC.
Effective date
2024-03-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lorazepam - REMEDYREPACK INC.REMEDYREPACK INC.2024-03-14HUMAN PRESCRIPTION DRUG LABEL
Lorazepam - International Medication Systems, LimitedInternational Medication Systems, Limited2024-03-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76329-8261-1Lorazepam10 mL in 1 VIALINJECTION1013
76329-8261-1Lorazepam10 in 1 CARTONINJECTION1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76329-8261LORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]13Current NDC, Legacy NDC, 2 package rows20240306_7dda070d-7809-46c4-8592-eb4e4c509707.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76329-8261-1ML - Milliliter76329-8261434a2601-7460-488b-b472-386a13aa934312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LorazepamACTIVE INGREDIENTO26FZP769LLORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]2
LorazepamACTIVE MOIETYO26FZP769LLORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]2
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHLORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]2
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQLORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]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 13 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LorazepamLORAZEPAMProficient Rx LP5b78f7af-0ad8-4fa1-a8c0-9308fe8d9b3a2022-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMHikma Pharmaceuticals USA Inc.b79b38ee-c29d-4099-964f-000031f47f5a2022-04-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238100
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC1c956cc1-9217-46e0-80a3-7c811163d3f12021-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMCivica, Inc.5140798d-8571-41fb-84a4-e182aac3f64c2021-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMHikma Pharmaceuticals USA Inc.5ff82103-cc57-4af9-9362-82a7c686271d2021-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLCe83ae439-3fa5-453f-9073-4bf8c797df472019-03-26Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLCa4fa14be-cef1-4b4b-b099-abde92f151452019-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC08bd30b0-a1c1-4ec3-bb9c-b1d55ac59f752018-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: O26FZP769L
Ivy-Dry SuperBENZYL ALCOHOL, CAMPHOR, MENTHOLIvy-Dry, Inc.4792a667-2378-4b3d-968d-9efb1866792f2017-12-27WarningsExact identifier
unii: LKG8494WBH
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: LKG8494WBH

Reported adverse events (FAERS/openFDA)#

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