sodium fluoride f 18

Generic: sodium fluoride f-18

Labeler: precision nuclear llc
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 precision nuclear llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

sodium fluoride f-18 200 mCi/mL

Manufacturer
Precision Nuclear LLC

Identifiers & Regulatory

Product NDC 52768-125
Product ID 52768-125_2d6a7d5c-cf38-4ef7-b70b-86b58d37b905
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204542
Listing Expiration 2026-12-31
Marketing Start 2011-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52768125
Hyphenated Format 52768-125

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 ANDA204542 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mCi/mL
source: ndc
Packaging
  • 30 mL in 1 VIAL, MULTI-DOSE (52768-125-30)
  • 50 mL in 1 VIAL, MULTI-DOSE (52768-125-50)
source: ndc

Packages (2)

52768-125-30 30 mL in 1 VIAL, MULTI-DOSE (52768-125-30) 52768-125-50 50 mL in 1 VIAL, MULTI-DOSE (52768-125-50)

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": "2d6a7d5c-cf38-4ef7-b70b-86b58d37b905", "openfda": {"unii": ["9L75099X6R"], "spl_set_id": ["d834721b-b624-4b27-9009-95e09827122e"], "manufacturer_name": ["Precision Nuclear LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL, MULTI-DOSE (52768-125-30)", "package_ndc": "52768-125-30", "marketing_start_date": "20110101"}, {"sample": false, "description": "50 mL in 1 VIAL, MULTI-DOSE (52768-125-50)", "package_ndc": "52768-125-50", "marketing_start_date": "20110101"}], "brand_name": "Sodium Fluoride F 18", "product_id": "52768-125_2d6a7d5c-cf38-4ef7-b70b-86b58d37b905", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "52768-125", "generic_name": "SODIUM FLUORIDE F-18", "labeler_name": "Precision Nuclear LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Fluoride", "brand_name_suffix": "F 18", "active_ingredients": [{"name": "SODIUM FLUORIDE F-18", "strength": "200 mCi/mL"}], "application_number": "ANDA204542", "marketing_category": "ANDA", "marketing_start_date": "20110101", "listing_expiration_date": "20261231"}