Sodium Fluoride F 18 (sodium fluoride f-18) NDC 49609-102

NDC codes

FDA NDC Directory

Product NDC (as listed)49609-102Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49609-0102Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
49609-102-01	49609010201	30 mL in 1 VIAL, MULTI-DOSE (49609-102-01)Marketed from Dec 8, 2011

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Sodium Fluoride F 18
Generic name (nonproprietary): sodium fluoride f-18
Active ingredients: Sodium fluoride f-18 — 200 mCi/mL
Dosage form: Injection
Route: Intravenous
Labeler: SOFIE Co.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203592
Marketing start: Dec 8, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Radiopharmaceutical Activity (Mechanism)
Identifiers: Product ID 49609-102_31e5cd99-015b-86fa-e063-6394a90ad41bSPL ID 31e5cd99-015b-86fa-e063-6394a90ad41bSPL set ID 2bbd8f48-fdf9-45cb-8305-124a03f7a52cUNII 9L75099X6R
Pharmacologic class: Radioactive Diagnostic Agent

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N449609010201 followed by a unit qualifier and the quantity

Package 49609-0102-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 3, 2025.

Indications (excerpt from the label)

Sodium Fluoride F 18 Injection, USP is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. Sodium Fluoride F 18 Injection, USP is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity (1) .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)