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 6 of 9 · 173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gum DetoxifySTANNOUS FLUORIDERite Aidccad4383-4479-6175-e053-2a95a90a13a22025-11-13WarningsExact identifier
unii: 3FTR44B32Q
Restore and Defend Whitening TPSTANNOUS FLUORIDEKroger253ba5c0-f2ef-46e6-e063-6394a90ad9d52025-11-13WarningsExact identifier
unii: 3FTR44B32Q
Care One Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDEFoodhold U.S.A.81a380eb-8605-b280-e053-2a91aa0abd4b2025-11-12WarningsExact identifier
unii: 3FTR44B32Q
CVS Rapid Protection SensitiveSTANNOUS FLUORIDECVS Pharmacy8162fcc0-7a24-678c-e053-2a91aa0af2fe2025-11-12WarningsExact identifier
unii: 3FTR44B32Q
Rite Aid Sensitive Rapid ProtectionSTANNOUS FLUORIDERite Aid8335dd4d-62a0-6861-e053-2a91aa0a82832025-11-12WarningsExact identifier
unii: 3FTR44B32Q
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.51f1d84c-809a-4c96-a117-7a8d8aa1e6b42025-11-04WarningsExact identifier
unii: 3FTR44B32Q
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.c44686f8-93ee-4a8f-8481-3439d123f6d22025-11-04WarningsExact identifier
unii: 3FTR44B32Q
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.16ebcb37-5703-4e10-b965-570e18434b522025-11-04WarningsExact identifier
unii: 3FTR44B32Q
Plak SmackerSTANNOUS FLUORIDEYoung Innovations, Inc.e65fa41e-ce2e-53e4-e053-2995a90a24d22025-11-04WarningsExact identifier
unii: 3FTR44B32Q
Plak SmackerSTANNOUS FLUORIDEYoung Innovations, Inc.e65c62d9-e8a6-3101-e053-2995a90a14942025-11-04WarningsExact identifier
unii: 3FTR44B32Q
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.15bdc03e-2cc7-4b7d-96fc-4f3236ed5c752025-11-04WarningsExact identifier
unii: 3FTR44B32Q
Colgate Total Plaque Pro Release Fresh MintSTANNOUS FLUORIDEColgate-Palmolive Company9b1671c4-8680-6e2a-9f10-0400840ca5a92025-09-12WarningsExact identifier
unii: 3FTR44B32Q
Colgate Total Plaque Pro Release WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companyddc09ce5-181a-1b50-7094-314bb58a15cf2025-09-12WarningsExact identifier
unii: 3FTR44B32Q
Colgate Total Gum Protect Fresh MintSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY570e3bd6-eede-4270-9d78-055aeb2b8c172025-07-14WarningsExact identifier
unii: 3FTR44B32Q
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, 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, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Hello Mighty Multi taskerSTANNOUS FLUORIDEColgate-Palmolive Company48e36e06-3666-9032-b9c8-4be035e751f22025-04-15WarningsExact identifier
unii: 3FTR44B32Q
Sensodyne Complete Protection Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLCe3cc3146-8aed-4f6b-a252-e379418c2b8d2025-03-26WarningsExact identifier
unii: 3FTR44B32Q
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
BurkhartSTANNOUS FLUORIDEBurkhart Dental Supply Inc6d8078e9-b0d8-4220-b90a-3f14fa0e43f42025-01-09WarningsExact identifier
unii: 3FTR44B32Q
BurkhartSTANNOUS FLUORIDEBurkhart Dental Supply Inc048c9978-e32e-4f77-9a4e-40acd5fcdfaf2025-01-09WarningsExact identifier
unii: 3FTR44B32Q

Reported adverse events (FAERS/openFDA)#

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