technetium tc 99m sestamibi (45548-141)

Drug Facts

Product Profile

Brand Name technetium tc 99m sestamibi

Generic Name technetium tc 99m sestamibi

Labeler jubilant draximage (usa) inc.

Dosage Form INJECTION, POWDER, FOR SOLUTION

Routes

INTRAVENOUS

Active Ingredients

technetium tc-99m sestamibi 1 mg/mL

Manufacturer

Jubilant Draximage (USA) Inc.

Identifiers & Regulatory

Product NDC 45548-141

Product ID 45548-141_b089044e-6c93-4941-94e7-55786e5b57b8

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078806

Listing Expiration 2026-12-31

Marketing Start 2009-07-01

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 45548141

Hyphenated Format 45548-141

Supplemental Identifiers

UNII

971Z4W1S09

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 technetium tc 99m sestamibi (source: ndc)

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

Application Number ANDA078806 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

1 mg/mL

source: ndc

Packaging

5 VIAL in 1 KIT (45548-141-05) / 10 mL in 1 VIAL
10 VIAL in 1 KIT (45548-141-10) / 10 mL in 1 VIAL
30 VIAL in 1 KIT (45548-141-30) / 10 mL in 1 VIAL

source: ndc

Packages (3)

45548-141-05 5 VIAL in 1 KIT (45548-141-05) / 10 mL in 1 VIAL 45548-141-10 10 VIAL in 1 KIT (45548-141-10) / 10 mL in 1 VIAL 45548-141-30 30 VIAL in 1 KIT (45548-141-30) / 10 mL in 1 VIAL

Ingredients (1)

technetium tc-99m sestamibi (1 mg/mL)

Linked Drug Pages (1)

TECHNETIUM TC 99M SESTAMIBI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "b089044e-6c93-4941-94e7-55786e5b57b8", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["971Z4W1S09"], "spl_set_id": ["07c893fc-cfba-1d98-0232-6448463afb87"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Jubilant Draximage (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 KIT (45548-141-05)  / 10 mL in 1 VIAL", "package_ndc": "45548-141-05", "marketing_start_date": "20090701"}, {"sample": false, "description": "10 VIAL in 1 KIT (45548-141-10)  / 10 mL in 1 VIAL", "package_ndc": "45548-141-10", "marketing_start_date": "20090701"}, {"sample": false, "description": "30 VIAL in 1 KIT (45548-141-30)  / 10 mL in 1 VIAL", "package_ndc": "45548-141-30", "marketing_start_date": "20090701"}], "brand_name": "TECHNETIUM TC 99M SESTAMIBI", "product_id": "45548-141_b089044e-6c93-4941-94e7-55786e5b57b8", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "45548-141", "generic_name": "Technetium TC 99m Sestamibi", "labeler_name": "Jubilant Draximage (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TECHNETIUM TC 99M SESTAMIBI", "active_ingredients": [{"name": "TECHNETIUM TC-99M SESTAMIBI", "strength": "1 mg/mL"}], "application_number": "ANDA078806", "marketing_category": "ANDA", "marketing_start_date": "20090701", "listing_expiration_date": "20261231"}