kit for the preparation of technetium tc 99m medronate (65857-505)

Drug Facts

Product Profile

Brand Name kit for the preparation of technetium tc 99m medronate

Generic Name technetium tc 99m medronate

Labeler cardinal health 414, llc

Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Routes

INTRAVENOUS

Active Ingredients

technetium tc-99m medronate 20 mg/1

Manufacturer

Cardinal Health 414, LLC

Identifiers & Regulatory

Product NDC 65857-505

Product ID 65857-505_d54cd404-317c-4a70-a22d-1667550ab5bc

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA018107

Listing Expiration 2026-12-31

Marketing Start 2020-12-01

Pharmacologic Class

Established (EPC)

radioactive diagnostic agent [epc]

Mechanism of Action

radiopharmaceutical activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65857505

Hyphenated Format 65857-505

Supplemental Identifiers

UNII

X89XV46R07

NUI

N0000177914 N0000000205

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kit for the preparation of technetium tc 99m medronate (source: ndc)

Generic Name technetium tc 99m medronate (source: ndc)

Application Number NDA018107 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

20 mg/1

source: ndc

Packaging

10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (65857-505-10)

source: ndc

Packages (1)

65857-505-10 10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (65857-505-10)

Ingredients (1)

technetium tc-99m medronate (20 mg/1)

Linked Drug Pages (1)

Kit for the Preparation of Technetium Tc 99m Medronate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "d54cd404-317c-4a70-a22d-1667550ab5bc", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["X89XV46R07"], "spl_set_id": ["54608807-4df6-49ba-b065-59a19ef224c4"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Cardinal Health 414, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (65857-505-10)", "package_ndc": "65857-505-10", "marketing_start_date": "20201201"}], "brand_name": "Kit for the Preparation of Technetium Tc 99m Medronate", "product_id": "65857-505_d54cd404-317c-4a70-a22d-1667550ab5bc", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "65857-505", "generic_name": "technetium tc 99m medronate", "labeler_name": "Cardinal Health 414, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kit for the Preparation of Technetium Tc 99m Medronate", "active_ingredients": [{"name": "TECHNETIUM TC-99M MEDRONATE", "strength": "20 mg/1"}], "application_number": "NDA018107", "marketing_category": "NDA", "marketing_start_date": "20201201", "listing_expiration_date": "20261231"}