fludeoxyglucose f 18

Generic: fludeoxyglucose f-18

Labeler: bamf health inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludeoxyglucose f 18
Generic Name fludeoxyglucose f-18
Labeler bamf health inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fludeoxyglucose f-18 400 mCi/mL

Manufacturer
BAMF Health Inc.

Identifiers & Regulatory

Product NDC 81759-001
Product ID 81759-001_347c6beb-499f-af61-e063-6394a90a6011
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216125
Listing Expiration 2026-12-31
Marketing Start 2025-03-11

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 81759001
Hyphenated Format 81759-001

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 f 18 (source: ndc)
Generic Name fludeoxyglucose f-18 (source: ndc)
Application Number ANDA216125 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 400 mCi/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CONTAINER (81759-001-30) / 30 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

81759-001-30 1 VIAL, GLASS in 1 CONTAINER (81759-001-30) / 30 mL in 1 VIAL, GLASS

Ingredients (1)

fludeoxyglucose f-18 (400 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": "347c6beb-499f-af61-e063-6394a90a6011", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["0Z5B2CJX4D"], "spl_set_id": ["347c6beb-499e-af61-e063-6394a90a6011"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["BAMF Health Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CONTAINER (81759-001-30)  / 30 mL in 1 VIAL, GLASS", "package_ndc": "81759-001-30", "marketing_start_date": "20250311"}], "brand_name": "Fludeoxyglucose F 18", "product_id": "81759-001_347c6beb-499f-af61-e063-6394a90a6011", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "81759-001", "generic_name": "Fludeoxyglucose F-18", "labeler_name": "BAMF Health Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludeoxyglucose", "brand_name_suffix": "F 18", "active_ingredients": [{"name": "FLUDEOXYGLUCOSE F-18", "strength": "400 mCi/mL"}], "application_number": "ANDA216125", "marketing_category": "ANDA", "marketing_start_date": "20250311", "listing_expiration_date": "20261231"}