datscan

Generic: ioflupane i-123

Labeler: medi-physics inc. dba ge healthcare.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name datscan
Generic Name ioflupane i-123
Labeler medi-physics inc. dba ge healthcare.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ioflupane i-123 2 mCi/mL

Manufacturer
Medi-Physics Inc. dba GE Healthcare.

Identifiers & Regulatory

Product NDC 17156-210
Product ID 17156-210_fd67b7dc-7c58-47ee-a7d1-51555c103555
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022454
Listing Expiration 2026-12-31
Marketing Start 2011-03-01

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 17156210
Hyphenated Format 17156-210

Supplemental Identifiers

UNII
3MM99T8R5Q
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 datscan (source: ndc)
Generic Name ioflupane i-123 (source: ndc)
Application Number NDA022454 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mCi/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CONTAINER (17156-210-01) / 2.5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

17156-210-01 1 VIAL, GLASS in 1 CONTAINER (17156-210-01) / 2.5 mL in 1 VIAL, GLASS

Ingredients (1)

ioflupane i-123 (2 mCi/mL)

Linked Drug Pages (1)

DaTscan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fd67b7dc-7c58-47ee-a7d1-51555c103555", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["3MM99T8R5Q"], "spl_set_id": ["ef7804d7-c691-495b-8aaf-5bc54fd5d9f6"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Medi-Physics Inc. dba GE Healthcare."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CONTAINER (17156-210-01)  / 2.5 mL in 1 VIAL, GLASS", "package_ndc": "17156-210-01", "marketing_start_date": "20110301"}], "brand_name": "DaTscan", "product_id": "17156-210_fd67b7dc-7c58-47ee-a7d1-51555c103555", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "17156-210", "generic_name": "Ioflupane I-123", "labeler_name": "Medi-Physics Inc. dba GE Healthcare.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DaTscan", "active_ingredients": [{"name": "IOFLUPANE I-123", "strength": "2 mCi/mL"}], "application_number": "NDA022454", "marketing_category": "NDA", "marketing_start_date": "20110301", "listing_expiration_date": "20261231"}