ioflupane i 123

Generic: ioflupane i-123

Labeler: curium us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ioflupane i 123
Generic Name ioflupane i-123
Labeler curium us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ioflupane i-123 2 mCi/mL

Manufacturer
Curium US LLC

Identifiers & Regulatory

Product NDC 69945-166
Product ID 69945-166_c6a56613-3636-4736-bdaf-db89d8a8448b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213792
Listing Expiration 2026-12-31
Marketing Start 2022-03-31

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 69945166
Hyphenated Format 69945-166

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 ioflupane i 123 (source: ndc)
Generic Name ioflupane i-123 (source: ndc)
Application Number ANDA213792 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mCi/mL
source: ndc
Packaging
  • 2.5 mL in 1 VIAL, SINGLE-DOSE (69945-166-05)
source: ndc

Packages (1)

69945-166-05 2.5 mL in 1 VIAL, SINGLE-DOSE (69945-166-05)

Ingredients (1)

ioflupane i-123 (2 mCi/mL)

Linked Drug Pages (1)

Ioflupane I 123 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c6a56613-3636-4736-bdaf-db89d8a8448b", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["3MM99T8R5Q"], "spl_set_id": ["66d20aee-4530-48dd-a483-ed7604b36d97"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Curium US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2.5 mL in 1 VIAL, SINGLE-DOSE (69945-166-05)", "package_ndc": "69945-166-05", "marketing_start_date": "20220331"}], "brand_name": "Ioflupane I 123", "product_id": "69945-166_c6a56613-3636-4736-bdaf-db89d8a8448b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "69945-166", "generic_name": "IOFLUPANE I-123", "labeler_name": "Curium US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ioflupane I 123", "active_ingredients": [{"name": "IOFLUPANE I-123", "strength": "2 mCi/mL"}], "application_number": "ANDA213792", "marketing_category": "ANDA", "marketing_start_date": "20220331", "listing_expiration_date": "20261231"}