Prescription drug · ANDA
Fludeoxyglucose F18 NDC 69864-001
Fludeoxyglucose f-18 .3 Ci/mL · Injection, Solution · Intravenous · The Methodist Hospital Research Institute
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69864-001-30 | 6986400013069864000130 | 30 mL in 1 VIAL, MULTI-DOSE (69864-001-30)Marketed from Apr 23, 2012 |
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 F18
- Generic name (nonproprietary)
- fludeoxyglucose f18
- Active ingredients
- Fludeoxyglucose f-18 — .3 Ci/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- The Methodist Hospital Research InstituteNDC labeler code 69864
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203904
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 69864-001_c961907a-db84-c6f2-e053-2995a90aefd2SPL ID c961907a-db84-c6f2-e053-2995a90aefd2SPL set ID 195d1b07-5669-247f-e054-00144ff8d46cUNII 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
N469864000130followed by a unit qualifier and the quantityPackage 69864-0001-30. 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)
1. Indications and Usage 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 ventric…
Excerpt only. Read the full label for complete information.
About NDC 69864-001
- What is NDC 69864-001?
- 69864-001 is the product NDC for Fludeoxyglucose F18, Fludeoxyglucose f-18 .3 Ci/mL injection, solution, listed with the FDA by The Methodist Hospital Research Institute. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fludeoxyglucose F18.
- What is the active ingredient?
- Fludeoxyglucose f-18.
- Who is the labeler?
- The Methodist Hospital Research Institute, NDC labeler code 69864. 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 F18?
- 8 other product NDCs are listed under this name. See all Fludeoxyglucose F18 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fludeoxyglucose F18 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 F18 | Fludeoxyglucose f-18 100 mCi/mL | InjectionIntravenous | Kreitchman PET Center | 62072-008 | 62072-0008-30 |
| Fludeoxyglucose F18 | Fludeoxyglucose f-18 300 mCi/mL | InjectionIntravenous | The Regents of the University of Michigan | 76326-001 | 76326-0001-20 |
| Fludeoxyglucose F18fludeoxyglucose f-18 | Fludeoxyglucose f-18 300 mCi/mL | Injection, SolutionIntravenous | Biomedical Research Foundation of Northwest Louisiana | 24562-003 | 24562-0003-30 |
| Fludeoxyglucose F18 | Fludeoxyglucose f-18 300 mCi/mL | InjectionIntravenous | MIPS Cyclotron & Radiochemistry Facility | 69587-001 | 69587-0001-01 |
| Fludeoxyglucose F18 | Fludeoxyglucose f-18 300 mCi/mL | InjectionIntravenous | 3D Imaging Drug Design and Development LLC | 76451-118 | 76451-0118-1076451-0118-30 |
| Fludeoxyglucose F18 | Fludeoxyglucose f-18 300 mCi/mL | InjectionIntravenous | The University of Texas MD Anderson Cancer Center | 60215-411 | 60215-0411-30 |
| Fludeoxyglucose F18 | Fludeoxyglucose f-18 300 mCi/mL | InjectionIntravenous | UCSF Radiopharmaceutical Facility | 24275-0185 | 24275-0185-01 |
| Fludeoxyglucose F18 | Fludeoxyglucose f-18 400 mCi/mL | InjectionIntravenous | THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH | 13267-234 | 13267-0234-45 |