Prescription drug · ANDA
Fludeoxyglucose F 18 (Fludeoxyglucose f-18) NDC 60055-334
Fludeoxyglucose f-18 300 mCi/mL · Injection, Solution · Intravenous · Jubilant DraxImage Inc., dba Jubilant Radiopharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60055-334-30 | 6005503343060055033430 | 30 mL in 1 VIAL (60055-334-30)Marketed from Sep 1, 2015 |
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, Solution
- Route
- Intravenous
- Labeler
- Jubilant DraxImage Inc., dba Jubilant RadiopharmaNDC labeler code 60055
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203920
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 60055-334_7e9d26cc-5aee-4724-a5c5-535e70d234c5SPL ID 7e9d26cc-5aee-4724-a5c5-535e70d234c5SPL set ID 5d05df4a-463e-4e66-9387-f3a842e20cd0UNII 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
N460055033430followed by a unit qualifier and the quantityPackage 60055-0334-30. 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 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 ventricular dysfunction, when…
Excerpt only. Read the full label for complete information.
About NDC 60055-334
- What is NDC 60055-334?
- 60055-334 is the product NDC for Fludeoxyglucose F 18 (fludeoxyglucose f-18), Fludeoxyglucose f-18 300 mCi/mL injection, solution, listed with the FDA by Jubilant DraxImage Inc., dba Jubilant Radiopharma. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fludeoxyglucose F 18 (Fludeoxyglucose F-18).
- What is the active ingredient?
- Fludeoxyglucose f-18.
- Who is the labeler?
- Jubilant DraxImage Inc., dba Jubilant Radiopharma, NDC labeler code 60055. 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 |