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  5. NDC Package Code: 0703-4004-01 Romidepsin

NDC Package 0703-4004-01 Romidepsin

Injection, Solution, Concentrate Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

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:
0703-4004-01
Package Description:
1 VIAL in 1 CARTON / 5.5 mL in 1 VIAL
Product Code:
0703-4004
Proprietary Name:
Romidepsin
Non-Proprietary Name:
Romidepsin
Substance Name:
Romidepsin
Usage Information:
Romidepsin is used to treat certain types of cancer (cutaneous or peripheral T-cell lymphoma). Romidepsin works by stopping the growth of cancer cells.
11-Digit NDC Billing Format:
00703400401
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2289413 - romiDEPsin 27.5 MG in 5.5 ML Injection
  • RxCUI: 2289413 - 5.5 ML romidepsin 5 MG/ML Injection
  • RxCUI: 2289413 - romidepsin 27.5 MG per 5.5 ML Injection
  • RxCUI: 2289413 - romidepsin 5 MG/ML per 5.5 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Teva Parenteral Medicines, Inc.
    Dosage Form:
    Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • ROMIDEPSIN 5 mg/mL
    • Pharmacologic Class(es):
  • Bile Salt Export Pump Inhibitors - [MoA] (Mechanism of Action)
  • Histone Deacetylase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Histone Deacetylase Inhibitors - [MoA] (Mechanism of Action)
  • Organic Anion Transporter 1 Inhibitors - [MoA] (Mechanism of Action)
  • Organic Anion Transporting Polypeptide 1B1 Inhibitors - [MoA] (Mechanism of Action)
  • Organic Anion Transporting Polypeptide 1B3 Inhibitors - [MoA] (Mechanism of Action)
  • Organic Cation Transporter 2 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA208574
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-14-2020
    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 0703-4004-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00703400401J9318Inj romidepsin non-lyo 0.1mg0.1 MG5.51275275

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0703-4004-01?

    The NDC Packaged Code 0703-4004-01 is assigned to a package of 1 vial in 1 carton / 5.5 ml in 1 vial of Romidepsin, a human prescription drug labeled by Teva Parenteral Medicines, Inc.. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.

    Is NDC 0703-4004 included in the NDC Directory?

    Yes, Romidepsin with product code 0703-4004 is active and included in the NDC Directory. The product was first marketed by Teva Parenteral Medicines, Inc. on April 14, 2020 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 0703-4004-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0703-4004-01?

    The 11-digit format is 00703400401. 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 4-4-2 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
    4-4-20703-4004-015-4-200703-4004-01