Prescription drug · ANDA
Sodium Fluoride F 18 (Sodium fluoride f-18) NDC 49609-102
Sodium fluoride f-18 200 mCi/mL · Injection · Intravenous · SOFIE Co.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49609-102-01 | 4960901020149609010201 | 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.NDC labeler code 49609
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203592
- Marketing start
- Listing expires
- 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.
- NDC on a medical claim
N449609010201followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 49609-102
- What is NDC 49609-102?
- 49609-102 is the product NDC for Sodium Fluoride F 18 (sodium fluoride f-18), Sodium fluoride f-18 200 mCi/mL injection, listed with the FDA by SOFIE Co.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Fluoride F 18 (Sodium fluoride f-18).
- What is the active ingredient?
- Sodium fluoride f-18.
- Who is the labeler?
- SOFIE Co., NDC labeler code 49609. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium Fluoride F 18?
- 9 other product NDCs are listed under this name. See all Sodium Fluoride F 18 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sodium Fluoride F 18 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sodium Fluoride F 18sodium fluoride f-18 | Sodium fluoride f-18 200 mCi/mL | InjectionIntravenous | BAMF Health Inc. | 81759-002 | 81759-0002-30 |
| Sodium Fluoride F 18sodium fluoride f-18 | Sodium fluoride f-18 200 mCi/mL | InjectionIntravenous | Kreitchman PET Center | 62072-500 | 62072-0500-30 |
| Sodium Fluoride F 18sodium fluoride f-18 | Sodium fluoride f-18 200 mCi/mL | Injection, SolutionIntravenous | Biomedical Research Foundation of Northwest Louisiana | 24562-002 | 24562-0002-30 |
| Sodium Fluoride F 18 | Sodium fluoride f-18 600 mCi/mL | InjectionIntravenous | THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH | 13267-542 | 13267-0542-42 |
| Sodium Fluoride F 18 | Sodium fluoride f-18 91.5 mCi/mL | InjectionIntravenous | Mayo Clinic | 52670-550 | 52670-0550-30 |
| Sodium Fluoride F 18 | Sodium fluoride f-18 200 mCi/mL | InjectionIntravenous | The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute | 67939-020 | 67939-0020-10 |
| Sodium Fluoride F 18sodium fluoride f-18 | Sodium fluoride f-18 200 mCi/mL | InjectionIntravenous | 3D Imaging Drug Design and Development LLC | 76451-018 | 76451-0018-10 |
| Sodium Fluoride F 18 | Sodium fluoride f-18 200 mCi/mL | Injection, SolutionIntravenous | PETNET Solutions, Inc. | 40028-512 | 40028-0512-30 |
| Sodium Fluoride F 18sodium fluoride f-18 | Sodium fluoride f-18 200 mCi/mL | InjectionIntravenous | Precision Nuclear LLC | 52768-125 | 52768-0125-3052768-0125-50 |