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 8 of 9 · 173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total SF Advanced WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companyf8aeac8e-6a3e-4ada-bb13-db337b934ba32024-09-27WarningsExact identifier
unii: 3FTR44B32Q
Colgate Total SF Advanced Deep CleanSTANNOUS FLUORIDEColgate-Palmolive Company92642408-4465-4f8f-85f9-cf12aadc147b2024-09-27WarningsExact identifier
unii: 3FTR44B32Q
Kit for the Preparation of Technetium Tc 99m MebrofeninKIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENINSun Pharmaceutical Industries, Inc.11492bd5-2ade-4eb4-a23c-b9be99c0d51a2024-08-28Warnings, Adverse reactionsExact identifier
application number: ANDA078242
ndc (package): 45567-0455-1
ndc (package): 45567-0455-2
ndc (product): 45567-0455
ndc11 (package): 45567045501
spl id: 20bf6038-c480-0b7f-e063-6394a90a8d65
spl set id: 11492bd5-2ade-4eb4-a23c-b9be99c0d51a
unii: 7PV0B6ED98
OMNISTANNOUS FLUORIDESolventum US LLC0c2a81b1-65b5-432b-8e66-30432a245aba2024-08-01WarningsExact identifier
unii: 3FTR44B32Q
Just For KidsSTANNOUS FLUORIDESolventum US LLC0f1afc36-f699-4072-b90b-c9f5be989a492024-08-01WarningsExact identifier
unii: 3FTR44B32Q
PerioMedSTANNOUS FLUORIDESolventum US LLC7f79eb00-86df-4284-b415-47f45e4849da2024-08-01WarningsExact identifier
unii: 3FTR44B32Q
SmileSenseSTANNOUS FLUORIDESGII, INC1c371393-da75-c9c8-e063-6294a90a58402024-07-01WarningsExact identifier
unii: 3FTR44B32Q
Gelato HomecareSTANNOUS FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf2024-04-22WarningsExact identifier
unii: 3FTR44B32Q
Gelato Perio Maintenance RinseSTANNOUS FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.f8721665-b304-4b1c-9bda-385d7671d0992024-04-22WarningsExact identifier
unii: 3FTR44B32Q
Gelato HomecareSTANNOUS FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db2024-04-19WarningsExact identifier
unii: 3FTR44B32Q
SENSODYNE Sensitivity and Gum MintSTANNOUS FLUORIDEHaleon US Holdings LLCed093acd-255c-40ff-a010-d276f58444532024-03-07WarningsExact identifier
unii: 3FTR44B32Q
SENSODYNE Sensitivity Gum and Enamel MintSTANNOUS FLUORIDEHaleon US Holdings LLCd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e22024-03-07WarningsExact identifier
unii: 3FTR44B32Q
SENSODYNE Rapid ReliefSTANNOUS FLUORIDEHaleon US Holdings LLCf9589e7c-c5ca-4465-8d37-47ad6c69249f2024-03-06WarningsExact identifier
unii: 3FTR44B32Q
SENSODYNE Repair and Protect Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLC34260c69-d829-46c0-b12a-5136ee073ba12024-03-06WarningsExact identifier
unii: 3FTR44B32Q
Polident ProPartialSTANNOUS FLUORIDEHaleon US Holdings LLC557eeb32-64f4-41e8-ada4-91bd39ae29202024-02-07WarningsExact identifier
unii: 3FTR44B32Q
Gel-Kam Fruit and BerrySTANNOUS FLUORIDEColgate Oral Pharmaceuticals, Inc.8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c2024-01-18WarningsExact identifier
unii: 3FTR44B32Q
GINGIMEDSTANNOUS FLUORIDEMassco Dentale07e291b-2cdd-444a-a510-1e9199323f382023-12-17WarningsExact identifier
unii: 3FTR44B32Q
Pro-Den RxSTANNOUS FLUORIDEDen-mat Holdings, Llc9036aa8a-59b1-41b0-b3cb-529d3303a1c02023-11-20WarningsExact identifier
unii: 3FTR44B32Q
FluoridexSTANNOUS FLUORIDE RINSEDEN-MAT HOLDINGS, LLC5e81f073-c0ca-aa38-e053-2a91aa0ab37b2023-11-20WarningsExact identifier
unii: 3FTR44B32Q
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
unii: 3FTR44B32Q

Reported adverse events (FAERS/openFDA)#

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