Home NDC 65857-505 Kit for the Preparation of Technetium Tc 99m Medronate
Product NDC 65857-505
11-digit product format 658570505
Labeler code 65857
Product ID 65857-505_d54cd404-317c-4a70-a22d-1667550ab5bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name technetium tc 99m medronate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Cardinal Health 414, LLC
Application NDA018107
Marketing category NDA
Marketing start 2020-12-01
Substance TECHNETIUM TC-99M MEDRONATE
Active strength 20 mg/1
Pharmacologic classes Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Kit for the Preparation of Technetium Tc 99m Medronate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TECHNETIUM TC-99M MEDRONATE 20 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii X89XV46R07
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65857-505-10 Kit for the Preparation of Technetium Tc 99m Medronate 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65857-505 KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TECHNETIUM TC 99M MEDRONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH 414, LLC] 4 Current NDC, Legacy NDC, 1 package rows 20250226_54608807-4df6-49ba-b065-59a19ef224c4.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65857-505-10 65857050510 10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (65857-505-10) 2020-12-01 0000-00-00 No No Current