Prescription drug · NDA
Drax Exametazime NDC 65174-200
kit for the preparation of technetium tc 99m exametazime for leukocyte labeling · Technetium tc-99m exametazime .5 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Jubilant DraxImage Inc., dba Jubilant Radiopharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65174-200-05 | 65174020005 | 5 VIAL in 1 CARTON (65174-200-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-200-01)Marketed from Aug 17, 2017 |
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)
- Drax Exametazime
- Generic name (nonproprietary)
- kit for the preparation of technetium tc 99m exametazime for leukocyte labeling
- Active ingredients
- Technetium tc-99m exametazime — .5 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208870
- Marketing start
- Listing expires
- Other FDA classes
- Radiopharmaceutical Activity (Mechanism)
- Identifiers
- Product ID 65174-200_9799f139-0c16-4cf0-8a7d-e9668ec3f146SPL ID 9799f139-0c16-4cf0-8a7d-e9668ec3f146SPL set ID fa7811f9-2803-4126-8037-8f3e56462f9cUNII 3B744AG22N
- 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
N465174020005followed by a unit qualifier and the quantityPackage 65174-0200-05. 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)
Drax Exametazime is indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease. Drax Exametazime is a radioactive diagnostic agent indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease. ( 1 )
Excerpt only. Read the full label for complete information.