NDC Package 51144-003-01 Tivdak

Tisotumab Vedotin Injection, Powder, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
51144-003-01
Package Description:
1 VIAL in 1 CARTON / 4 mL in 1 VIAL
Product Code:
Proprietary Name:
Tivdak
Non-Proprietary Name:
Tisotumab Vedotin
Substance Name:
Tisotumab Vedotin
Usage Information:
TIVDAK™ is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.1)].Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
11-Digit NDC Billing Format:
51144000301
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2571099 - tisotumab vedotin-tftv 40 MG Injection
  • RxCUI: 2571104 - tivdak 40 MG Injection
  • RxCUI: 2571104 - tisotumab vedotin-tftv 40 MG Injection [Tivdak]
  • RxCUI: 2571104 - Tivdak 40 MG Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Seagen Inc.
    Dosage Form:
    Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    BLA761208
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    09-20-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 51144-003-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    51144000301J9273Inj tisotu vedotin-tftv, 1mg1 MG114040

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 51144-003-01?

    The NDC Packaged Code 51144-003-01 is assigned to a package of 1 vial in 1 carton / 4 ml in 1 vial of Tivdak, a human prescription drug labeled by Seagen Inc.. The product's dosage form is injection, powder, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 51144-003 included in the NDC Directory?

    Yes, Tivdak with product code 51144-003 is active and included in the NDC Directory. The product was first marketed by Seagen Inc. on September 20, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 51144-003-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 51144-003-01?

    The 11-digit format is 51144000301. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-251144-003-015-4-251144-0003-01