kit for the preparation of technetium tc99m sestamibi

Generic: technetium tc-99m sestamibi

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

Drug Facts

Product Profile

Brand Name kit for the preparation of technetium tc99m sestamibi
Generic Name technetium tc-99m sestamibi
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

technetium tc-99m sestamibi 1 mg/10mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 45567-0555
Product ID 45567-0555_21ca8de4-28b7-425f-e063-6394a90a3340
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079157
Listing Expiration 2026-12-31
Marketing Start 2009-07-10

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 455670555
Hyphenated Format 45567-0555

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 kit for the preparation of technetium tc99m sestamibi (source: ndc)
Generic Name technetium tc-99m sestamibi (source: ndc)
Application Number ANDA079157 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/10mL
source: ndc
Packaging
  • 5 VIAL in 1 CARTON (45567-0555-1) / 10 mL in 1 VIAL
  • 30 VIAL in 1 CARTON (45567-0555-2) / 10 mL in 1 VIAL
source: ndc

Packages (2)

45567-0555-1 5 VIAL in 1 CARTON (45567-0555-1) / 10 mL in 1 VIAL 45567-0555-2 30 VIAL in 1 CARTON (45567-0555-2) / 10 mL in 1 VIAL

Ingredients (1)

technetium tc-99m sestamibi (1 mg/10mL)

Linked Drug Pages (1)

Kit for the Preparation of Technetium Tc99m Sestamibi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "21ca8de4-28b7-425f-e063-6394a90a3340", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["971Z4W1S09"], "spl_set_id": ["e545ac6a-83dc-485a-8bb4-c0b9d8f3d144"], "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 in 1 CARTON (45567-0555-1)  / 10 mL in 1 VIAL", "package_ndc": "45567-0555-1", "marketing_start_date": "20090710"}, {"sample": false, "description": "30 VIAL in 1 CARTON (45567-0555-2)  / 10 mL in 1 VIAL", "package_ndc": "45567-0555-2", "marketing_start_date": "20090710"}], "brand_name": "Kit for the Preparation of Technetium Tc99m Sestamibi", "product_id": "45567-0555_21ca8de4-28b7-425f-e063-6394a90a3340", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "45567-0555", "generic_name": "TECHNETIUM TC-99M SESTAMIBI", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kit for the Preparation of Technetium Tc99m Sestamibi", "active_ingredients": [{"name": "TECHNETIUM TC-99M SESTAMIBI", "strength": "1 mg/10mL"}], "application_number": "ANDA079157", "marketing_category": "ANDA", "marketing_start_date": "20090710", "listing_expiration_date": "20261231"}