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 2 of 9 · 173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIVFRESH GUM PROTECTSTANNOUS FLUORIDELivionex Inc.1da7dcf9-e675-4b4b-8286-bdaa6e59eb0f2026-02-02WarningsExact identifier
unii: 3FTR44B32Q
ARU GUM HEALTHSTANNOUS FLUORIDEAshtel Studios, Inc.d8e8b92e-d8cb-45ad-8353-7dbe43c3dcd32026-01-30WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro-Health Advanced Max Cavity and Erosion PreventionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company48eb0bdc-7399-745d-e063-6294a90a98092026-01-21WarningsExact identifier
unii: 3FTR44B32Q
Colgate Total Gum Protect WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companydcf81dcb-b26b-4411-82d4-5f7e9d3fc0f32026-01-20WarningsExact identifier
unii: 3FTR44B32Q
Enamelon Preventive TreatmentSTANNOUS FLUORIDEPremier Dental Products Company04c3f178-7905-404d-9ac2-67c453287ddf2026-01-13WarningsExact identifier
unii: 3FTR44B32Q
EnamelonSTANNOUS FLUORIDEPremier Dental Products Company1626375a-f78b-4192-b7f3-ca932acab7fb2026-01-13WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro-Health Densify Active RepairSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4487d78-1da8-3f33-e053-2a95a90a6d922026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro-Health Densify Sensitive CareSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf435c1fe-7fbb-1b25-e053-2995a90aca112026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro-Health Densify Pro Intensive RepairSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf45c9c89-f294-deca-e053-2a95a90ae5572026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro-health Gum Detoxify Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf49a00de-b16a-66e6-e053-2995a90aedc62026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro-Health Gum Detoxify Gentle WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf49a7dc7-77f3-3911-e053-2a95a90ad55c2026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro Health Enamel Repair and Gum Intensive CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c2118d-1216-d0d0-e053-2995a90a70882026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro Health Gum Detoxify and Restore Pro Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c3ad36-72d8-16e8-e053-2a95a90a87022026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro Health Gum Detoxify and Restore Pro WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d65b58-9818-820d-e053-2995a90a9f002026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro-Health Sensitive and Gum All Day ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d775a1-a4f6-cd69-e053-2995a90a5f642026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro Health Enamel Repair and Gum Advanced WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4ead762-17b2-22a0-e053-2a95a90ac8662026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro Health Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb466fb4-0915-a41f-e053-6294a90a2dfb2026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro Health Clean and FreeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb4771cd-f478-e2bd-e053-6394a90aa83e2026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro Health Sensitive and Enamel ShieldSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb48b15c-f821-e5cd-e053-6294a90ac64c2026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro Health with a Touch of ScopeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb572b41-36cd-55d7-e053-6394a90a71c82026-01-08WarningsExact identifier
unii: 3FTR44B32Q

Reported adverse events (FAERS/openFDA)#

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