Prescription drug · NDA
Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) NDC 65857-425
tilmanocept · Kit · Cardinal Health 414, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65857-425-05 | 65857042505 | 1 KIT in 1 CARTON (65857-425-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01)Marketed from Sep 20, 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)
- Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)
- Generic name (nonproprietary)
- tilmanocept
- Dosage form
- Kit
- Labeler
- Cardinal Health 414, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202207
- Marketing start
- Listing expires
- Identifiers
- Product ID 65857-425_dd40946b-b83f-48fe-8946-16e7c35e183bSPL ID dd40946b-b83f-48fe-8946-16e7c35e183bSPL set ID 72f31b09-4d7b-475c-b37a-9daf2ad80240
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.
- NDC on a medical claim
N465857042505followed by a unit qualifier and the quantityPackage 65857-0425-05. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under NDA 202207
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)tilmanocept | — | Kit | Cardinal Health 414, LLC | 65857-450 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.