fludeoxyglucose f 18

Generic: fludeoxyglucose f-18

Labeler: sofie co.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fludeoxyglucose f 18
Generic Name fludeoxyglucose f-18
Labeler sofie co.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fludeoxyglucose f-18 300 mCi/mL

Manufacturer
SOFIE Co.

Identifiers & Regulatory

Product NDC 49609-101
Product ID 49609-101_43f8e45a-9c5d-81fa-e063-6394a90acbf4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203591
Listing Expiration 2026-12-31
Marketing Start 2011-12-08

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 49609101
Hyphenated Format 49609-101

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 ANDA203591 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mCi/mL
source: ndc
Packaging
  • 30 mL in 1 VIAL, MULTI-DOSE (49609-101-01)
  • 50 mL in 1 VIAL, MULTI-DOSE (49609-101-02)
source: ndc

Packages (2)

49609-101-01 30 mL in 1 VIAL, MULTI-DOSE (49609-101-01) 49609-101-02 50 mL in 1 VIAL, MULTI-DOSE (49609-101-02)

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": "43f8e45a-9c5d-81fa-e063-6394a90acbf4", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["0Z5B2CJX4D"], "spl_set_id": ["2028be0c-333c-4e0c-be57-099276c725d7"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["SOFIE Co."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL, MULTI-DOSE (49609-101-01)", "package_ndc": "49609-101-01", "marketing_start_date": "20111208"}, {"sample": false, "description": "50 mL in 1 VIAL, MULTI-DOSE (49609-101-02)", "package_ndc": "49609-101-02", "marketing_start_date": "20111208"}], "brand_name": "Fludeoxyglucose F 18", "product_id": "49609-101_43f8e45a-9c5d-81fa-e063-6394a90acbf4", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "49609-101", "generic_name": "Fludeoxyglucose F-18", "labeler_name": "SOFIE Co.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fludeoxyglucose F 18", "active_ingredients": [{"name": "FLUDEOXYGLUCOSE F-18", "strength": "300 mCi/mL"}], "application_number": "ANDA203591", "marketing_category": "ANDA", "marketing_start_date": "20111208", "listing_expiration_date": "20261231"}