sodium fluoride f 18

Generic: sodium fluoride f-18

Labeler: 3d imaging drug design and development 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 3d imaging drug design and development llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

sodium fluoride f-18 200 mCi/mL

Manufacturer
3D Imaging Drug Design and Development LLC

Identifiers & Regulatory

Product NDC 76451-018
Product ID 76451-018_47d2e765-1b9b-343d-e063-6394a90aa8d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203777
Listing Expiration 2027-12-31
Marketing Start 2012-01-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76451018
Hyphenated Format 76451-018

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 ANDA203777 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mCi/mL
source: ndc
Packaging
  • 10 mL in 1 VIAL, GLASS (76451-018-10)
source: ndc

Packages (1)

76451-018-10 10 mL in 1 VIAL, GLASS (76451-018-10)

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": "47d2e765-1b9b-343d-e063-6394a90aa8d2", "openfda": {"unii": ["9L75099X6R"], "spl_set_id": ["eeaf4f42-e3c6-4e0a-aa79-89722511eaea"], "manufacturer_name": ["3D Imaging Drug Design and Development LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, GLASS (76451-018-10)", "package_ndc": "76451-018-10", "marketing_start_date": "20120102"}], "brand_name": "Sodium Fluoride F 18", "product_id": "76451-018_47d2e765-1b9b-343d-e063-6394a90aa8d2", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "76451-018", "generic_name": "SODIUM FLUORIDE F-18", "labeler_name": "3D Imaging Drug Design and Development 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": "ANDA203777", "marketing_category": "ANDA", "marketing_start_date": "20120102", "listing_expiration_date": "20271231"}