kit for the preparation of lymphoseek (technetium tc 99m tilmanocept)

Generic: tilmanocept

Labeler: cardinal health 414, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name kit for the preparation of lymphoseek (technetium tc 99m tilmanocept)
Generic Name tilmanocept
Labeler cardinal health 414, llc
Dosage Form KIT
Manufacturer
Cardinal Health 414, LLC

Identifiers & Regulatory

Product NDC 65857-425
Product ID 65857-425_9a68964f-0f50-414d-a7c9-29b6677df463
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202207
Listing Expiration 2026-12-31
Marketing Start 2017-09-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65857425
Hyphenated Format 65857-425

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kit for the preparation of lymphoseek (technetium tc 99m tilmanocept) (source: ndc)
Generic Name tilmanocept (source: ndc)
Application Number NDA202207 (source: ndc)

Resolved Composition

Strengths
  • 250 mcg
  • 4.5 ml
  • 0.5 ml
  • 5 ml
source: label
Packaging
  • 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)
source: ndc

Packages (1)

65857-425-05 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)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "9a68964f-0f50-414d-a7c9-29b6677df463", "openfda": {"spl_set_id": ["72f31b09-4d7b-475c-b37a-9daf2ad80240"], "manufacturer_name": ["Cardinal Health 414, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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)", "package_ndc": "65857-425-05", "marketing_start_date": "20170920"}], "brand_name": "Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)", "product_id": "65857-425_9a68964f-0f50-414d-a7c9-29b6677df463", "dosage_form": "KIT", "product_ndc": "65857-425", "generic_name": "tilmanocept", "labeler_name": "Cardinal Health 414, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)", "application_number": "NDA202207", "marketing_category": "NDA", "marketing_start_date": "20170920", "listing_expiration_date": "20261231"}