FDA.reportPublic FDA data

NDC 45567-0455-01 - Kit for the Preparation of Technetium Tc 99m Mebrofenin

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
45567-0455
Requested NDC
45567-0455-01
Package NDCs from labels
45567-0455-1, 45567-0455-2, 45567-0455-01
Manufacturer
Sun Pharmaceutical Industries, Inc.
Effective date
2024-08-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Kit for the Preparation of Technetium Tc 99m MebrofeninSun Pharmaceutical Industries, Inc.2024-08-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45567-0455-1Kit for the Preparation of Technetium Tc 99m Mebrofenin5 in 1 KITINJECTION, POWDER, LYOPHILIZED,511
45567-0455-1Kit for the Preparation of Technetium Tc 99m Mebrofenin10 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,1011
45567-0455-2Kit for the Preparation of Technetium Tc 99m Mebrofenin30 in 1 KITINJECTION, POWDER, LYOPHILIZED,3011
45567-0455-2Kit for the Preparation of Technetium Tc 99m Mebrofenin10 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45567-0455KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]11Current NDC, Legacy NDC, 4 package rows20240907_11492bd5-2ade-4eb4-a23c-b9be99c0d51a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45567-0455-1EA - Each45567-045515c27d31-7144-4153-8364-2e9ff5a654a512015-10-02
45567-0455-2EA - Each45567-0455e2ef7722-3c50-440b-9abb-c14d14208ecb12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEBROFENINACTIVE INGREDIENT7PV0B6ED98KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.]3
MEBROFENINACTIVE MOIETY7PV0B6ED98KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TKIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHKIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.]3
STANNOUS FLUORIDEINACTIVE INGREDIENT3FTR44B32QKIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.]3

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 9 of 9 · 173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
unii: 3FTR44B32Q
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
unii: 3FTR44B32Q
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
unii: 3FTR44B32Q
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
unii: A2I8C7HI9T
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
BurkhartSTANNOUS FLUORIDEBurkhart Dental Supply Inc47142a7d-3095-4ea6-b977-80e9f2cc89582022-02-02WarningsExact identifier
unii: 3FTR44B32Q
BurkhartSTANNOUS FLUORIDEBurkhart Dental Supply Incde19f0ea-7446-493d-b766-c678c727a1af2022-02-02WarningsExact identifier
unii: 3FTR44B32Q
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T

Reported adverse events (FAERS/openFDA)#

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