fludeoxyglucose f-18

Generic: fludeoxyglucose f-18

Labeler: precision nuclear, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludeoxyglucose f-18
Generic Name fludeoxyglucose f-18
Labeler precision nuclear, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fludeoxyglucose f-18 500 mCi/mL

Manufacturer
Precision Nuclear, LLC

Identifiers & Regulatory

Product NDC 52768-001
Product ID 52768-001_34048aac-62bc-4f71-8592-5d685e2a0da5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204546
Listing Expiration 2026-12-31
Marketing Start 2010-10-10

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 52768001
Hyphenated Format 52768-001

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 ANDA204546 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mCi/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (52768-001-30) / 30 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (52768-001-50) / 50 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

52768-001-30 1 VIAL, MULTI-DOSE in 1 CARTON (52768-001-30) / 30 mL in 1 VIAL, MULTI-DOSE 52768-001-50 1 VIAL, MULTI-DOSE in 1 CARTON (52768-001-50) / 50 mL in 1 VIAL, MULTI-DOSE

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": "34048aac-62bc-4f71-8592-5d685e2a0da5", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["0Z5B2CJX4D"], "spl_set_id": ["09ae2a6d-673a-423a-ba45-3c543061b103"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Precision Nuclear, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (52768-001-30)  / 30 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "52768-001-30", "marketing_start_date": "20101010"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (52768-001-50)  / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "52768-001-50", "marketing_start_date": "20101010"}], "brand_name": "Fludeoxyglucose F-18", "product_id": "52768-001_34048aac-62bc-4f71-8592-5d685e2a0da5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "52768-001", "generic_name": "FLUDEOXYGLUCOSE F-18", "labeler_name": "Precision Nuclear, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludeoxyglucose F-18", "active_ingredients": [{"name": "FLUDEOXYGLUCOSE F-18", "strength": "500 mCi/mL"}], "application_number": "ANDA204546", "marketing_category": "ANDA", "marketing_start_date": "20101010", "listing_expiration_date": "20261231"}