sodium fluoride f 18

Generic: sodium fluoride f 18

Labeler: mayo clinic
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 mayo clinic
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

sodium fluoride f-18 91.5 mCi/mL

Manufacturer
Mayo Clinic

Identifiers & Regulatory

Product NDC 52670-550
Product ID 52670-550_46dfe08c-b98e-3f3b-e063-6394a90a5f60
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203605
Listing Expiration 2026-12-31
Marketing Start 2013-06-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52670550
Hyphenated Format 52670-550

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 ANDA203605 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 91.5 mCi/mL
source: ndc
Packaging
  • 30 mL in 1 VIAL, MULTI-DOSE (52670-550-30)
source: ndc

Packages (1)

52670-550-30 30 mL in 1 VIAL, MULTI-DOSE (52670-550-30)

Ingredients (1)

sodium fluoride f-18 (91.5 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": "46dfe08c-b98e-3f3b-e063-6394a90a5f60", "openfda": {"unii": ["9L75099X6R"], "spl_set_id": ["e435568c-f8d2-4cee-aceb-c68b277ad8f5"], "manufacturer_name": ["Mayo Clinic"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL, MULTI-DOSE (52670-550-30)", "package_ndc": "52670-550-30", "marketing_start_date": "20130628"}], "brand_name": "Sodium Fluoride F 18", "product_id": "52670-550_46dfe08c-b98e-3f3b-e063-6394a90a5f60", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "52670-550", "generic_name": "sodium fluoride F 18", "labeler_name": "Mayo Clinic", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Fluoride F 18", "active_ingredients": [{"name": "SODIUM FLUORIDE F-18", "strength": "91.5 mCi/mL"}], "application_number": "ANDA203605", "marketing_category": "ANDA", "marketing_start_date": "20130628", "listing_expiration_date": "20261231"}