sodium fluoride f 18

Generic: sodium fluoride f 18

Labeler: the university of utah dba cyclotron radiochemistry lab huntsman cancer institute
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 university of utah dba cyclotron radiochemistry lab huntsman cancer institute
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

sodium fluoride f-18 200 mCi/mL

Manufacturer
The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute

Identifiers & Regulatory

Product NDC 67939-020
Product ID 67939-020_d951aa31-f016-e2da-e053-2995a90a5b2d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204497
Listing Expiration 2026-12-31
Marketing Start 2012-07-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67939020
Hyphenated Format 67939-020

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 ANDA204497 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mCi/mL
source: ndc
Packaging
  • 10 mL in 1 VIAL, MULTI-DOSE (67939-020-10)
source: ndc

Packages (1)

67939-020-10 10 mL in 1 VIAL, MULTI-DOSE (67939-020-10)

Ingredients (1)

sodium fluoride f-18 (200 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": "d951aa31-f016-e2da-e053-2995a90a5b2d", "openfda": {"unii": ["9L75099X6R"], "spl_set_id": ["2144e4e4-4be5-4fc6-b966-bd525ac7e430"], "manufacturer_name": ["The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, MULTI-DOSE (67939-020-10)", "package_ndc": "67939-020-10", "marketing_start_date": "20120711"}], "brand_name": "Sodium Fluoride F 18", "product_id": "67939-020_d951aa31-f016-e2da-e053-2995a90a5b2d", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "67939-020", "generic_name": "Sodium Fluoride F 18", "labeler_name": "The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Fluoride F 18", "active_ingredients": [{"name": "SODIUM FLUORIDE F-18", "strength": "200 mCi/mL"}], "application_number": "ANDA204497", "marketing_category": "ANDA", "marketing_start_date": "20120711", "listing_expiration_date": "20261231"}