fludeoxyglucose f 18

Generic: fludeoxyglucose f-18

Labeler: massachusetts general hospital
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludeoxyglucose f 18
Generic Name fludeoxyglucose f-18
Labeler massachusetts general hospital
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fludeoxyglucose f-18 300 mCi/mL

Manufacturer
Massachusetts General Hospital

Identifiers & Regulatory

Product NDC 76318-334
Product ID 76318-334_d6019460-717e-4285-9582-06646e8f778a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204333
Listing Expiration 2026-12-31
Marketing Start 2011-10-30

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 76318334
Hyphenated Format 76318-334

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 f 18 (source: ndc)
Generic Name fludeoxyglucose f-18 (source: ndc)
Application Number ANDA204333 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mCi/mL
source: ndc
Packaging
  • 50 mL in 1 VIAL (76318-334-50)
source: ndc

Packages (1)

76318-334-50 50 mL in 1 VIAL (76318-334-50)

Ingredients (1)

fludeoxyglucose f-18 (300 mCi/mL)

Linked Drug Pages (1)

Fludeoxyglucose F 18 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d6019460-717e-4285-9582-06646e8f778a", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["0Z5B2CJX4D"], "spl_set_id": ["232fbb91-402e-44d8-a0cf-6813980b8ead"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Massachusetts General Hospital"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 VIAL (76318-334-50)", "package_ndc": "76318-334-50", "marketing_start_date": "20111030"}], "brand_name": "Fludeoxyglucose F 18", "product_id": "76318-334_d6019460-717e-4285-9582-06646e8f778a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "76318-334", "generic_name": "Fludeoxyglucose F-18", "labeler_name": "Massachusetts General Hospital", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludeoxyglucose F 18", "active_ingredients": [{"name": "FLUDEOXYGLUCOSE F-18", "strength": "300 mCi/mL"}], "application_number": "ANDA204333", "marketing_category": "ANDA", "marketing_start_date": "20111030", "listing_expiration_date": "20261231"}