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 4 of 19 · 361 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepackb7f1c321-5a00-4b89-8cb4-fa250e74d9db2026-03-17Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae8badf-f960-62fd-e054-00144ff8d46c2026-03-11WarningsExact identifier
unii: 3FTR44B32Q
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae71258-a8c2-6eb5-e054-00144ff88e882026-03-11WarningsExact identifier
unii: 3FTR44B32Q
OsteoplexEQUISETUM HYEMALE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, MANGANUM MURIATICUM, SYMPHYTUM OFFICINALE, MEDULLA OSSIS SUIS, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA, PARATHYROID GLAND (SUIS), LIGAMENT (SUIS)BioActive Nutritional, Inc.8a7e1397-a387-4f2c-ab4f-7f1a7f1a849b2026-03-05WarningsExact identifier
unii: PQ6CK8PD0R
PNV-DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CALCIUM, FERROUS FUMARATE, DOCONEXENTAcella Pharmaceuticals, LLC576e8bbb-1625-493c-85da-43caf2f02e3c2026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
FolartexMULTIVITAMINOncora Pharma, LLC0a4cb0ab-565f-45e8-a989-740bccef21cd2026-02-25Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: PQ6CK8PD0R
AfloraMULTIVITAMINOncora Pharma, LLC38e463d1-f608-7cb5-e063-6294a90a4abb2026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
FolixiaMULTIVITAMINOncora Pharma, LLC413945b5-116b-d8b6-e063-6394a90a55e82026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
NutralynMULTIVITAMINOncora Pharma, LLC33da017b-1e8c-d41c-e063-6394a90aab8c2026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
FolatenMULTIVITAMINOncora Pharma, LLC93086235-2c33-424d-b0c3-2130319885812026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Floravita MiniFLORAVITA MINIFlorrax Pharmaceutical682bda57-21e0-47df-9596-78846d4d97c02026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
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
Vitamin C SerumVITAMIN CFlexiGo Inc496e7d41-2176-7b0c-e063-6394a90a98f12026-01-28WarningsExact identifier
unii: PQ6CK8PD0R
Dialyvite 5000ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUMHillestad Pharmaceuticals USA97791f73-e0c5-45a6-8aed-f456a5466eaf2026-01-27Adverse reactionsExact identifier
unii: PQ6CK8PD0R
DialyviteASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACIDHillestad Pharmaceuticals USA7a5e6dd6-5687-44bb-8964-841961c0e64a2026-01-27Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Dialyvite Supreme DASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUMHillestad Pharmaceuticals USA46fc3acf-1e6d-4830-ae9a-abd9c1132fca2026-01-27Adverse reactionsExact identifier
unii: PQ6CK8PD0R
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

Reported adverse events (FAERS/openFDA)#

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