NDC 65857-450

NDC codes

FDA NDC Directory

Product NDC (as listed)65857-450Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65857-0450Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65857-450-05	65857045005	1 KIT in 1 CARTON (65857-450-05) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01) * 1 INJECTION, SOLUTION in 1 VIAL (65857-401-45)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: Sep 20, 2017
Listing expires: Dec 31, 2027
Identifiers: Product ID 65857-450_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

N465857045005 followed by a unit qualifier and the quantity

Package 65857-0450-05. 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 Aug 28, 2026.

Indications (excerpt from the label)

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management. • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: • Lymphatic mapping using a handheld gamma counter to locate lymph nodes dra…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 202207

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 202207
Product	Strength	Form · route	Labeler	Product NDC
Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)tilmanocept	—	Kit	Cardinal Health 414, LLC	65857-425

Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) NDC 65857-450