Prescription drug · ANDA
Sodium Fluoride F 18 NDC 40028-512
Sodium fluoride f-18 200 mCi/mL · Injection, Solution · Intravenous · PETNET Solutions, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 40028-512-30 | 40028051230 | 1 VIAL, MULTI-DOSE in 1 CAN (40028-512-30) / 30 mL in 1 VIAL, MULTI-DOSEMarketed from Jan 26, 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, Solution
- Route
- Intravenous
- Labeler
- PETNET Solutions, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203890
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 40028-512_53cdbece-6719-47f1-8bc0-da2d326f5802SPL ID 53cdbece-6719-47f1-8bc0-da2d326f5802SPL set ID 9a186741-f26c-4261-b1cb-25495497c7a2UNII 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.
- NDC on a medical claim
N440028051230followed by a unit qualifier and the quantityPackage 40028-0512-30. 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 .
Indications (excerpt from the label)
Sodium Fluoride F 18 Injection is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. Sodium Fluoride F 18 Injection 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.