Prescription drug · NDA
Axumin (fluciclovine f-18) NDC 69932-001
Fluciclovine f-18 221 mCi/mL · Injection, Solution · Intravenous · Blue Earth Diagnostics
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69932-001-30 | 69932000130 | 30 mL in 1 VIAL, MULTI-DOSE (69932-001-30)Marketed from May 27, 2016 | |
| 69932-001-50 | 69932000150 | 50 mL in 1 VIAL, MULTI-DOSE (69932-001-50)Marketed from May 27, 2016 |
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)
- Axumin
- Generic name (nonproprietary)
- fluciclovine f-18
- Active ingredients
- Fluciclovine f-18 — 221 mCi/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Blue Earth Diagnostics
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208054
- Marketing start
- Listing expires
- Other FDA classes
- Positron Emitting Activity (Mechanism)
- Identifiers
- Product ID 69932-001_2f9c7d6f-7f0f-f9dd-e063-6294a90abf59SPL ID 2f9c7d6f-7f0f-f9dd-e063-6294a90abf59SPL set ID 389a502e-a7d5-43dd-b6bf-f022ff23f3b9UNII 38R1Q0L1ZE
- 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
N469932000130followed by a unit qualifier and the quantityPackage 69932-0001-30. 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)
Axumin is indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment ( 1 ).
Excerpt only. Read the full label for complete information.