NDC 0591-3365 - 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
0591-3365
Package NDCs from labels
0591-3365-54, 0591-3365-45, 0591-3365-79, 0591-3365-70
Manufacturer
Watson Laboratories, Inc.
Effective date
2006-06-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LORAZEPAM INJECTION USP C-IV Rx onlyWatson Laboratories, Inc.2006-06-14HUMAN PRESCRIPTION DRUG LABELING

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LorazepamACTIVE INGREDIENTO26FZP769LLORAZEPAM (LORAZEPAM) INJECTION [WATSON LABORATORIES, INC.]1
LorazepamACTIVE MOIETYO26FZP769LLORAZEPAM (LORAZEPAM) INJECTION [WATSON LABORATORIES, INC.]1
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHLORAZEPAM (LORAZEPAM) INJECTION [WATSON LABORATORIES, INC.]1
Polyethylene Glycol 400INACTIVE INGREDIENTLORAZEPAM (LORAZEPAM) INJECTION [WATSON LABORATORIES, INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3LORAZEPAM (LORAZEPAM) INJECTION [WATSON LABORATORIES, INC.]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 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AE274B1F-27C3-483B-99F1-9A9249DC2459AE274B1F-27C3-483B-99F1-9A9249DC24592006-06-14Warnings, Adverse reactionsExact identifier
spl id: AE274B1F-27C3-483B-99F1-9A9249DC2459
spl set id: AE274B1F-27C3-483B-99F1-9A9249DC2459

Reported adverse events (FAERS/openFDA)#

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