kit for the preparation of technetium tc 99m medronate

Generic: tc 99m medronate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name kit for the preparation of technetium tc 99m medronate
Generic Name tc 99m medronate
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

technetium tc-99m medronate 20 mg/10mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 45567-0040
Product ID 45567-0040_3010d5a9-2402-c30a-e063-6394a90a73ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018124
Listing Expiration 2026-12-31
Marketing Start 1979-08-29

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 455670040
Hyphenated Format 45567-0040

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 tc 99m medronate (source: ndc)
Application Number NDA018124 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/10mL
source: ndc
Packaging
  • 5 VIAL, MULTI-DOSE in 1 KIT (45567-0040-1) / 10 mL in 1 VIAL, MULTI-DOSE
  • 30 VIAL, MULTI-DOSE in 1 KIT (45567-0040-2) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

45567-0040-1 5 VIAL, MULTI-DOSE in 1 KIT (45567-0040-1) / 10 mL in 1 VIAL, MULTI-DOSE 45567-0040-2 30 VIAL, MULTI-DOSE in 1 KIT (45567-0040-2) / 10 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

technetium tc-99m medronate (20 mg/10mL)

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": "3010d5a9-2402-c30a-e063-6394a90a73ab", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["X89XV46R07"], "spl_set_id": ["703d347c-e240-408a-b69d-9713e958a201"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, MULTI-DOSE in 1 KIT (45567-0040-1)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "45567-0040-1", "marketing_start_date": "19790829"}, {"sample": false, "description": "30 VIAL, MULTI-DOSE in 1 KIT (45567-0040-2)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "45567-0040-2", "marketing_start_date": "19790829"}], "brand_name": "Kit for the Preparation of Technetium Tc 99M Medronate", "product_id": "45567-0040_3010d5a9-2402-c30a-e063-6394a90a73ab", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "45567-0040", "generic_name": "TC 99M MEDRONATE", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "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/10mL"}], "application_number": "NDA018124", "marketing_category": "NDA", "marketing_start_date": "19790829", "listing_expiration_date": "20261231"}