Prescription drug · NDA
Vizamyl (Flutemetamol f-18) NDC 17156-067
Flutemetamol f-18 4.05 mCi/mL · Solution · Intravenous · GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17156-067-30 | 17156006730 | 1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) / 30 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 1, 2014 |
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)
- Vizamyl
- Generic name (nonproprietary)
- flutemetamol f-18
- Active ingredients
- Flutemetamol f-18 — 4.05 mCi/mL
- Dosage form
- Solution
- Route
- Intravenous
- Labeler
- GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare)NDC labeler code 17156
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203137
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 17156-067_4fda8ebc-b46e-4d12-9c45-8cbb3a2516bbSPL ID 4fda8ebc-b46e-4d12-9c45-8cbb3a2516bbSPL set ID b3558f16-8f9a-4e55-8d9c-836427ebaa57UNII L49M066S0O
- 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
N417156006730followed by a unit qualifier and the quantityPackage 17156-0067-30. 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)
VIZAMYL is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products VIZAMYL is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for …
Excerpt only. Read the full label for complete information.
About NDC 17156-067
- What is NDC 17156-067?
- 17156-067 is the product NDC for Vizamyl (flutemetamol f-18), Flutemetamol f-18 4.05 mCi/mL solution, listed with the FDA by GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare). It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vizamyl (Flutemetamol F-18).
- What is the active ingredient?
- Flutemetamol f-18.
- Who is the labeler?
- GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare), NDC labeler code 17156. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vizamyl?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.