FDA.reportPublic FDA data

NDC 45567-0040-01 - Kit for the Preparation of Technetium Tc 99M Medronate

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
45567-0040
Requested NDC
45567-0040-01
Package NDCs from labels
45567-0040-1, 45567-0040-2, 45567-0040-01
Manufacturer
Sun Pharmaceutical Industries, Inc.
Effective date
2025-03-11
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 Medronate for InjectionSun Pharmaceutical Industries, Inc.2025-03-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45567-0040-1Kit for the Preparation of Technetium Tc 99M Medronate10 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,1011
45567-0040-1Kit for the Preparation of Technetium Tc 99M Medronate5 in 1 KITINJECTION, POWDER, LYOPHILIZED,511
45567-0040-2Kit for the Preparation of Technetium Tc 99M Medronate30 in 1 KITINJECTION, POWDER, LYOPHILIZED,3011
45567-0040-2Kit for the Preparation of Technetium Tc 99M Medronate10 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45567-0040KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TC 99M MEDRONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]11Current NDC, Legacy NDC, 4 package rows20250412_703d347c-e240-408a-b69d-9713e958a201.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45567-0040-1EA - Each45567-00406b211ba6-8f87-4a89-bf23-98437153e06612015-10-02
45567-0040-2EA - Each45567-00405bee36fb-3983-46f8-8ab8-a524e1a93ec812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TECHNETIUM TC-99M MEDRONATEACTIVE INGREDIENTX89XV46R07KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TC 99M MEDRONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.]3
TECHNETIUM TC-99M MEDRONATEACTIVE MOIETYX89XV46R07KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TC 99M MEDRONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.]3
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RKIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TC 99M MEDRONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.]3
STANNOUS FLUORIDEINACTIVE INGREDIENT3FTR44B32QKIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TC 99M MEDRONATE) 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 19 · 361 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro Health Advanced Whitening CharcoalSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd6f68485-b92f-41c7-e053-2995a90a4fe52026-01-08WarningsExact identifier
unii: 3FTR44B32Q
KIDS Crest Advanced Enamel Plus Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd837ecde-249a-7868-e053-2a95a90a56ae2026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro Health Advanced Whitening Intensive CleaningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd6fa4187-a651-647b-e053-2995a90a85672026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro Health Advanced Gum ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd7729dde-c828-34e6-e053-2a95a90a5ee62026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Densify Daily WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd811306f-4994-7a5a-e053-2995a90adf162026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Densify Daily ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd810d4e5-ba66-efe1-e053-2995a90abfc02026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Braces Care Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd823cba4-c4cf-7d7a-e053-2995a90a01f02026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro Health Advanced Sensitive ReliefSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd7730674-7513-52cf-e053-2995a90ab32c2026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro Health Advanced Deep Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd774295f-8ebd-9877-e053-2a95a90a9a0e2026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro Health Advanced Enamel RestoreSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd813f5f0-3135-4a8f-e053-2a95a90a55622026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Premium Plus Breath Bacteria BlastSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc3f1d477-6dd8-0ac4-e053-2a95a90a37422026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro-Health Advanced Gum Restore Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc5745cc4-213d-1dde-e053-2995a90af5622026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro-Health Advanced Gum Restore WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc574b51d-07bd-b363-e053-2995a90a7c0e2026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro Health Breath Purify and Gum Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc60fdacf-d997-19a5-e053-2a95a90a96a32026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro-Health Gum Detoxify UltraSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc73ed36a-0e2f-a137-e053-2a95a90a43e02026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro-Health Advanced Extra WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc688d37e-9e80-4599-e053-2a95a90a19162026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro-Health Bacteria Shield and Gum Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc74229c4-b095-df32-e053-2a95a90a4aec2026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Premium Plus Anti-BacterialSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyb7af946e-1cac-b8c0-e053-2a95a90afa4a2026-01-08WarningsExact identifier
unii: 3FTR44B32Q
H E B Restore and DefendFLUORIDEHEB56080493-9ab8-4b4f-be5f-7df22dee133f2026-01-08WarningsExact identifier
unii: 3FTR44B32Q
Crest Pro-Health Gum Rescue Pro Soothing CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2f10c7ac-eb60-011e-e063-6394a90aca132026-01-08WarningsExact identifier
unii: 3FTR44B32Q

Reported adverse events (FAERS/openFDA)#

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