fludeoxyglucose f-18

Generic: fludeoxyglucose f-18

Labeler: pharmalogic south carolina, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludeoxyglucose f-18
Generic Name fludeoxyglucose f-18
Labeler pharmalogic south carolina, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fludeoxyglucose f-18 300 mCi/mL

Manufacturer
Pharmalogic South Carolina, LLC

Identifiers & Regulatory

Product NDC 16129-001
Product ID 16129-001_6b336343-8985-4174-a82a-f9e95994064b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204264
Listing Expiration 2026-12-31
Marketing Start 2006-03-29

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 16129001
Hyphenated Format 16129-001

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 ANDA204264 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mCi/mL
source: ndc
Packaging
  • 10 mL in 1 VIAL, MULTI-DOSE (16129-001-10)
  • 30 mL in 1 VIAL, MULTI-DOSE (16129-001-30)
source: ndc

Packages (2)

16129-001-10 10 mL in 1 VIAL, MULTI-DOSE (16129-001-10) 16129-001-30 30 mL in 1 VIAL, MULTI-DOSE (16129-001-30)

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": "6b336343-8985-4174-a82a-f9e95994064b", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["0Z5B2CJX4D"], "spl_set_id": ["3535020f-26c3-40b8-bdb5-1aaa1857ba57"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Pharmalogic South Carolina, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, MULTI-DOSE (16129-001-10)", "package_ndc": "16129-001-10", "marketing_start_date": "20060329"}, {"sample": false, "description": "30 mL in 1 VIAL, MULTI-DOSE (16129-001-30)", "package_ndc": "16129-001-30", "marketing_start_date": "20060329"}], "brand_name": "Fludeoxyglucose F-18", "product_id": "16129-001_6b336343-8985-4174-a82a-f9e95994064b", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "16129-001", "generic_name": "Fludeoxyglucose F-18", "labeler_name": "Pharmalogic South Carolina, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludeoxyglucose F-18", "active_ingredients": [{"name": "FLUDEOXYGLUCOSE F-18", "strength": "300 mCi/mL"}], "application_number": "ANDA204264", "marketing_category": "ANDA", "marketing_start_date": "20060329", "listing_expiration_date": "20261231"}