sodium fluoride f 18

Generic: sodium fluoride f-18

Labeler: sofie co.
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 sofie co.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

sodium fluoride f-18 200 mCi/mL

Manufacturer
SOFIE Co.

Identifiers & Regulatory

Product NDC 49609-102
Product ID 49609-102_31e5cd99-015b-86fa-e063-6394a90ad41b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203592
Listing Expiration 2026-12-31
Marketing Start 2011-12-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49609102
Hyphenated Format 49609-102

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 ANDA203592 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mCi/mL
source: ndc
Packaging
  • 30 mL in 1 VIAL, MULTI-DOSE (49609-102-01)
source: ndc

Packages (1)

49609-102-01 30 mL in 1 VIAL, MULTI-DOSE (49609-102-01)

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": "31e5cd99-015b-86fa-e063-6394a90ad41b", "openfda": {"unii": ["9L75099X6R"], "spl_set_id": ["2bbd8f48-fdf9-45cb-8305-124a03f7a52c"], "manufacturer_name": ["SOFIE Co."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL, MULTI-DOSE (49609-102-01)", "package_ndc": "49609-102-01", "marketing_start_date": "20111208"}], "brand_name": "Sodium Fluoride F 18", "product_id": "49609-102_31e5cd99-015b-86fa-e063-6394a90ad41b", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "49609-102", "generic_name": "SODIUM FLUORIDE F-18", "labeler_name": "SOFIE Co.", "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": "ANDA203592", "marketing_category": "ANDA", "marketing_start_date": "20111208", "listing_expiration_date": "20261231"}