Prescription drug · ANDA
Fludeoxyglucose F 18 NDC 73410-003
Fludeoxyglucose f-18 20 mCi/mL · Injection · Intravenous · SOFIE Co. dba SOFIE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73410-003-01 | 73410000301 | 30 mL in 1 VIAL, MULTI-DOSE (73410-003-01)Marketed from Nov 6, 2019 |
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 — 20 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- SOFIE Co. dba SOFIE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204463
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 73410-003_34012195-5fcd-eff1-e063-6294a90a98deSPL ID 34012195-5fcd-eff1-e063-6294a90a98deSPL set ID 915b1f71-616d-4cd9-90a7-bc556736a3d1UNII 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
N473410000301followed by a unit qualifier and the quantityPackage 73410-0003-01. 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)
Fludeoxyglucose F18 Injection, USP is indicated for positron emission tomography (PET) imaging in the following settings: Fludeoxyglucose F18 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.