Prescription drug · ANDA
Fludeoxyglucose F 18 NDC 75913-647
Fludeoxyglucose f-18 300 mCi/mL · Injection · Intravenous · Washington University School of Medicine
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75913-647-30 | 7591306473075913064730 | 30 mL in 1 VIAL, GLASS (75913-647-30)Marketed from Jan 2, 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
- Washington University School of MedicineNDC labeler code 75913
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203935
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 75913-647_cf858070-65a1-61fd-e053-2995a90a6b86SPL ID cf858070-65a1-61fd-e053-2995a90a6b86SPL set ID ae48ac7d-1c50-4b32-a3e6-c2e5de5b63edUNII 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
N475913064730followed by a unit qualifier and the quantityPackage 75913-0647-30. 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.
About NDC 75913-647
- What is NDC 75913-647?
- 75913-647 is the product NDC for Fludeoxyglucose F 18, Fludeoxyglucose f-18 300 mCi/mL injection, listed with the FDA by Washington University School of Medicine. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fludeoxyglucose F 18.
- What is the active ingredient?
- Fludeoxyglucose f-18.
- Who is the labeler?
- Washington University School of Medicine, NDC labeler code 75913. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fludeoxyglucose F 18?
- 16 other product NDCs are listed under this name. See all Fludeoxyglucose F 18 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fludeoxyglucose F 18 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fludeoxyglucose F 18fludeoxyglucose f-18 | Fludeoxyglucose f-18 400 mCi/mL | InjectionIntravenous | BAMF Health Inc. | 81759-001 | 81759-0001-30 |
| Fludeoxyglucose F-18 | Fludeoxyglucose f-18 300 mCi/mL | InjectionIntravenous | Barbara Ann Karmanos Cancer Hospital | 78714-001 | 78714-0001-30 |
| Fludeoxyglucose F 18 | Fludeoxyglucose f-18 20 mCi/mL | InjectionIntravenous | SOFIE Co. dba SOFIE | 73410-003 | 73410-0003-01 |
| Fludeoxyglucose F-18 | Fludeoxyglucose f-18 500 mCi/mL | InjectionIntravenous | Cardinal Health 414, LLC | 65857-150 | 65857-0150-30 |
| Fludeoxyglucose F 18fludeoxyglucose f-18 | Fludeoxyglucose f-18 300 mCi/mL | Injection, SolutionIntravenous | Biomedical Research Foundation of Northwest Louisiana | 24562-001 | 24562-0001-30 |
| Fludeoxyglucose F-18 | Fludeoxyglucose f-18 300 mCi/mL | InjectionIntravenous | BRIGHAM AND WOMEN`S HOSPITAL, INC., THE | 24450-647 | 24450-0647-30 |
| Fludeoxyglucose F-18 | Fludeoxyglucose f-18 200 mCi/mL | Injection, SolutionIntravenous | Trustees of the University of Pennsylvania | 40098-101 | 40098-0101-19 |
| Fludeoxyglucose F 18 | Fludeoxyglucose f-18 300 mCi/mL | InjectionIntravenous | The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute | 67939-010 | 67939-0010-50 |
| Fludeoxyglucose F 18fludeoxyglucose f-18 | Fludeoxyglucose f-18 240 mCi/mL | InjectionIntravenous | Mayo Clinic | 52670-551 | 52670-0551-30 |
| Fludeoxyglucose F 18fludeoxyglucose f-18 | Fludeoxyglucose f-18 300 mCi/mL | InjectionIntravenous | UIHC-P E T IMAGING CENTER | 24417-001 | 24417-0001-30 |