FDA.reportPublic FDA data

NDC 11994-002 - NEUROLITE

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
11994-002
Package NDCs from labels
11994-002-01
Manufacturer
Lantheus Medical Imaging, Inc. | Jubilant HollisterStier
Effective date
2022-11-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NEUROLITE - Lantheus Medical Imaging, Inc. | Jubilant HollisterStierLantheus Medical Imaging, Inc. | Jubilant HollisterStier2022-11-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11994-002-01NEUROLITE1 in 1 VIALINJECTION10.9 mg12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11994-002NEUROLITE (BICISATE DIHYDROCHLORIDE) KIT [LANTHEUS MEDICAL IMAGING, INC.]12Unmatched20221129_f9adbcd5-1ac1-42d8-b18a-a76c9204014c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BICISATE DIHYDROCHLORIDEACTIVE INGREDIENTB005P07V07NEUROLITE (BICISATE DIHYDROCHLORIDE) KIT [LANTHEUS MEDICAL IMAGING, INC.]7
BICISATEACTIVE MOIETY3JXF0Z0XOINEUROLITE (BICISATE DIHYDROCHLORIDE) KIT [LANTHEUS MEDICAL IMAGING, INC.]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNEUROLITE (BICISATE DIHYDROCHLORIDE) KIT [LANTHEUS MEDICAL IMAGING, INC.]7
MANNITOLINACTIVE INGREDIENT3OWL53L36ANEUROLITE (BICISATE DIHYDROCHLORIDE) KIT [LANTHEUS MEDICAL IMAGING, INC.]7
STANNOUS CHLORIDEINACTIVE INGREDIENT1BQV3749L5NEUROLITE (BICISATE DIHYDROCHLORIDE) KIT [LANTHEUS MEDICAL IMAGING, INC.]7