Prescription drug · ANDA
Fludeoxyglucose F 18 (fludeoxyglucose f-18) NDC 49609-101
Fludeoxyglucose f-18 300 mCi/mL · Injection · Intravenous · SOFIE Co.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49609-101-01 | 49609010101 | 30 mL in 1 VIAL, MULTI-DOSE (49609-101-01)Marketed from Dec 8, 2011 | |
| 49609-101-02 | 49609010102 | 50 mL in 1 VIAL, MULTI-DOSE (49609-101-02)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)
- Fludeoxyglucose F 18
- Generic name (nonproprietary)
- fludeoxyglucose f-18
- Active ingredients
- Fludeoxyglucose f-18 — 300 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- SOFIE Co.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203591
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 49609-101_43f8e45a-9c5d-81fa-e063-6394a90acbf4SPL ID 43f8e45a-9c5d-81fa-e063-6394a90acbf4SPL set ID 2028be0c-333c-4e0c-be57-099276c725d7UNII 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
N449609010101followed by a unit qualifier and the quantityPackage 49609-0101-01. 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)
1. INDICATIONS AND USAGE Fludeoxyglucose F18 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 ven…
Excerpt only. Read the full label for complete information.