sodium fluoride f 18

Generic: sodium fluoride f 18

Labeler: the feinstein institutes for medical research
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium fluoride f 18
Generic Name sodium fluoride f 18
Labeler the feinstein institutes for medical research
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

sodium fluoride f-18 600 mCi/mL

Manufacturer
THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH

Identifiers & Regulatory

Product NDC 13267-542
Product ID 13267-542_2e4dae7b-58ec-4b60-bff5-a1ecf6147d18
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204328
Listing Expiration 2026-12-31
Marketing Start 2014-11-19

Pharmacologic Class

Classes
radioactive diagnostic agent [epc] radiopharmaceutical activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13267542
Hyphenated Format 13267-542

Supplemental Identifiers

UNII
9L75099X6R

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 sodium fluoride f 18 (source: ndc)
Generic Name sodium fluoride f 18 (source: ndc)
Application Number ANDA204328 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 600 mCi/mL
source: ndc
Packaging
  • 20 mL in 1 VIAL, GLASS (13267-542-42)
source: ndc

Packages (1)

13267-542-42 20 mL in 1 VIAL, GLASS (13267-542-42)

Ingredients (1)

sodium fluoride f-18 (600 mCi/mL)

Linked Drug Pages (1)

Sodium Fluoride F 18 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2e4dae7b-58ec-4b60-bff5-a1ecf6147d18", "openfda": {"unii": ["9L75099X6R"], "spl_set_id": ["f8afb06c-f4c3-46f0-8f8b-0bc9e072ce47"], "manufacturer_name": ["THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 mL in 1 VIAL, GLASS (13267-542-42)", "package_ndc": "13267-542-42", "marketing_start_date": "20141119"}], "brand_name": "Sodium Fluoride F 18", "product_id": "13267-542_2e4dae7b-58ec-4b60-bff5-a1ecf6147d18", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "13267-542", "generic_name": "Sodium Fluoride F 18", "labeler_name": "THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Fluoride", "brand_name_suffix": "F 18", "active_ingredients": [{"name": "SODIUM FLUORIDE F-18", "strength": "600 mCi/mL"}], "application_number": "ANDA204328", "marketing_category": "ANDA", "marketing_start_date": "20141119", "listing_expiration_date": "20261231"}