sodium fluoride f18 (65857-300)

Drug Facts

Product Profile

Brand Name sodium fluoride f18

Generic Name sodium fluoride f18

Labeler cardinal health 414, llc

Dosage Form INJECTION

Routes

INTRAVENOUS

Active Ingredients

sodium fluoride f-18 200 mCi/mL

Manufacturer

Cardinal Health 414, LLC

Identifiers & Regulatory

Product NDC 65857-300

Product ID 65857-300_56810233-d952-4904-a3e9-c3dc3aa480e6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA203780

Listing Expiration 2026-12-31

Marketing Start 2015-07-30

Pharmacologic Class

Classes

radioactive diagnostic agent [epc] radiopharmaceutical activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65857300

Hyphenated Format 65857-300

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 f18 (source: ndc)

Generic Name sodium fluoride f18 (source: ndc)

Application Number ANDA203780 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

200 mCi/mL

source: ndc

Packaging

30 mL in 1 VIAL, GLASS (65857-300-30)

source: ndc

Packages (1)

65857-300-30 30 mL in 1 VIAL, GLASS (65857-300-30)

Ingredients (1)

sodium fluoride f-18 (200 mCi/mL)

Linked Drug Pages (1)

Sodium Fluoride F18 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "56810233-d952-4904-a3e9-c3dc3aa480e6", "openfda": {"unii": ["9L75099X6R"], "spl_set_id": ["96e61ba1-30ca-4844-b503-056afd247e69"], "manufacturer_name": ["Cardinal Health 414, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL, GLASS (65857-300-30)", "package_ndc": "65857-300-30", "marketing_start_date": "20150730"}], "brand_name": "Sodium Fluoride F18", "product_id": "65857-300_56810233-d952-4904-a3e9-c3dc3aa480e6", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "65857-300", "generic_name": "Sodium Fluoride F18", "labeler_name": "Cardinal Health 414, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Fluoride", "brand_name_suffix": "F18", "active_ingredients": [{"name": "SODIUM FLUORIDE F-18", "strength": "200 mCi/mL"}], "application_number": "ANDA203780", "marketing_category": "ANDA", "marketing_start_date": "20150730", "listing_expiration_date": "20261231"}