fludeoxyglucose f-18

Generic: fludeoxyglucose f-18

Labeler: cardinal health 414, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludeoxyglucose f-18
Generic Name fludeoxyglucose f-18
Labeler cardinal health 414, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fludeoxyglucose f-18 500 mCi/mL

Manufacturer
Cardinal Health 414, LLC

Identifiers & Regulatory

Product NDC 65857-150
Product ID 65857-150_41abd652-7741-45e9-89a8-535a91d57f51
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203603
Listing Expiration 2026-12-31
Marketing Start 2019-01-02

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 65857150
Hyphenated Format 65857-150

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 ANDA203603 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mCi/mL
source: ndc
Packaging
  • 30 mL in 1 VIAL, GLASS (65857-150-30)
source: ndc

Packages (1)

65857-150-30 30 mL in 1 VIAL, GLASS (65857-150-30)

Ingredients (1)

fludeoxyglucose f-18 (500 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": "41abd652-7741-45e9-89a8-535a91d57f51", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["0Z5B2CJX4D"], "spl_set_id": ["08044d8f-036c-4809-997f-dd5180feebe6"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Cardinal Health 414, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL, GLASS (65857-150-30)", "package_ndc": "65857-150-30", "marketing_start_date": "20190102"}], "brand_name": "Fludeoxyglucose F-18", "product_id": "65857-150_41abd652-7741-45e9-89a8-535a91d57f51", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "65857-150", "generic_name": "Fludeoxyglucose F-18", "labeler_name": "Cardinal Health 414, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludeoxyglucose F-18", "active_ingredients": [{"name": "FLUDEOXYGLUCOSE F-18", "strength": "500 mCi/mL"}], "application_number": "ANDA203603", "marketing_category": "ANDA", "marketing_start_date": "20190102", "listing_expiration_date": "20261231"}