Prescription drug · ANDA
Fludeoxyglucose F 18 (fludeoxyglucose f-18) NDC 52670-551
Fludeoxyglucose f-18 240 mCi/mL · Injection · Intravenous · Mayo Clinic
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52670-551-30 | 52670055130 | 30 mL in 1 VIAL, MULTI-DOSE (52670-551-30)Marketed from Aug 5, 2013 |
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)
- Fludeoxyglucose F 18
- Generic name (nonproprietary)
- fludeoxyglucose f-18
- Active ingredients
- Fludeoxyglucose f-18 — 240 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Mayo Clinic
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203612
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 52670-551_46dfe404-a820-7746-e063-6394a90afb00SPL ID 46dfe404-a820-7746-e063-6394a90afb00SPL set ID 153b650d-7b69-4880-a72a-a5f13059d248UNII 0Z5B2CJX4D
- 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
N452670055130followed by a unit qualifier and the quantityPackage 52670-0551-30. 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)
Fludeoxyglucose F 18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings: Fludeoxyglucose F 18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings: Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when …
Excerpt only. Read the full label for complete information.