fludeoxyglucose f18

Generic: fludeoxyglucose f18

Labeler: mips cyclotron & radiochemistry facility
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludeoxyglucose f18
Generic Name fludeoxyglucose f18
Labeler mips cyclotron & radiochemistry facility
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fludeoxyglucose f-18 300 mCi/mL

Manufacturer
MIPS Cyclotron & Radiochemistry Facility

Identifiers & Regulatory

Product NDC 69587-001
Product ID 69587-001_2baf0278-7e18-4db0-e063-6294a90ae9de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204472
Listing Expiration 2026-12-31
Marketing Start 2015-02-28

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 69587001
Hyphenated Format 69587-001

Supplemental Identifiers

UNII
0Z5B2CJX4D
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 fludeoxyglucose f18 (source: ndc)
Generic Name fludeoxyglucose f18 (source: ndc)
Application Number ANDA204472 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mCi/mL
source: ndc
Packaging
  • 30 mL in 1 VIAL, GLASS (69587-001-01)
source: ndc

Packages (1)

69587-001-01 30 mL in 1 VIAL, GLASS (69587-001-01)

Ingredients (1)

fludeoxyglucose f-18 (300 mCi/mL)

Linked Drug Pages (1)

Fludeoxyglucose F18 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2baf0278-7e18-4db0-e063-6294a90ae9de", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["0Z5B2CJX4D"], "spl_set_id": ["0ec2d4d1-b295-18dc-e054-00144ff88e88"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["MIPS Cyclotron & Radiochemistry Facility"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL, GLASS (69587-001-01)", "package_ndc": "69587-001-01", "marketing_start_date": "20181221"}], "brand_name": "Fludeoxyglucose F18", "product_id": "69587-001_2baf0278-7e18-4db0-e063-6294a90ae9de", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "69587-001", "generic_name": "Fludeoxyglucose F18", "labeler_name": "MIPS Cyclotron & Radiochemistry Facility", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludeoxyglucose", "brand_name_suffix": "F18", "active_ingredients": [{"name": "FLUDEOXYGLUCOSE F-18", "strength": "300 mCi/mL"}], "application_number": "ANDA204472", "marketing_category": "ANDA", "marketing_start_date": "20150228", "listing_expiration_date": "20261231"}