fludeoxyglucose f 18 (60055-334)

Drug Facts

Product Profile

Brand Name fludeoxyglucose f 18

Generic Name fludeoxyglucose f-18

Labeler jubilant draximage inc., dba jubilant radiopharma

Dosage Form INJECTION, SOLUTION

Routes

INTRAVENOUS

Active Ingredients

fludeoxyglucose f-18 300 mCi/mL

Manufacturer

Jubilant DraxImage Inc., dba Jubilant Radiopharma

Identifiers & Regulatory

Product NDC 60055-334

Product ID 60055-334_7e9d26cc-5aee-4724-a5c5-535e70d234c5

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA203920

Listing Expiration 2027-12-31

Marketing Start 2010-11-20

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 60055334

Hyphenated Format 60055-334

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 ANDA203920 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

300 mCi/mL

source: ndc

Packaging

30 mL in 1 VIAL (60055-334-30)

source: ndc

Packages (1)

60055-334-30 30 mL in 1 VIAL (60055-334-30)

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": "7e9d26cc-5aee-4724-a5c5-535e70d234c5", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["0Z5B2CJX4D"], "spl_set_id": ["5d05df4a-463e-4e66-9387-f3a842e20cd0"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Jubilant DraxImage Inc., dba Jubilant Radiopharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL (60055-334-30)", "package_ndc": "60055-334-30", "marketing_start_date": "20150901"}], "brand_name": "Fludeoxyglucose F 18", "product_id": "60055-334_7e9d26cc-5aee-4724-a5c5-535e70d234c5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "60055-334", "generic_name": "Fludeoxyglucose F-18", "labeler_name": "Jubilant DraxImage Inc., dba Jubilant Radiopharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludeoxyglucose F 18", "active_ingredients": [{"name": "FLUDEOXYGLUCOSE F-18", "strength": "300 mCi/mL"}], "application_number": "ANDA203920", "marketing_category": "ANDA", "marketing_start_date": "20101120", "listing_expiration_date": "20271231"}