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  5. NDC Package Code: 46708-619-31 Cyclophosphamide

NDC Package 46708-619-31 Cyclophosphamide

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
46708-619-31
Package Description:
100 CAPSULE in 1 BOTTLE
Product Code:
46708-619
Proprietary Name:
Cyclophosphamide
Non-Proprietary Name:
Cyclophosphamide
Substance Name:
Cyclophosphamide
Usage Information:
Cyclophosphamide is used to treat various types of cancer. It is a chemotherapy drug that works by slowing or stopping cell growth. Cyclophosphamide also works by decreasing your immune system's response to various diseases. It is used to treat a certain type of kidney disease in children after other treatments have not worked.
11-Digit NDC Billing Format:
46708061931
NDC to RxNorm Crosswalk:
  • RxCUI: 1437968 - cycloPHOSphamide 25 MG Oral Capsule
  • RxCUI: 1437968 - cyclophosphamide 25 MG Oral Capsule
  • RxCUI: 1437969 - cycloPHOSphamide 50 MG Oral Capsule
  • RxCUI: 1437969 - cyclophosphamide 50 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Alembic Pharmaceuticals Limited
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CYCLOPHOSPHAMIDE 50 mg/1
    • Pharmacologic Class(es):
  • Alkylating Activity - [MoA] (Mechanism of Action)
  • Alkylating Drug - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA215892
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-23-2022
    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.

    Frequently Asked Questions

    What is NDC 46708-619-31?

    The NDC Packaged Code 46708-619-31 is assigned to a package of 100 capsule in 1 bottle of Cyclophosphamide, a human prescription drug labeled by Alembic Pharmaceuticals Limited. The product's dosage form is capsule and is administered via oral form.

    Is NDC 46708-619 included in the NDC Directory?

    Yes, Cyclophosphamide with product code 46708-619 is active and included in the NDC Directory. The product was first marketed by Alembic Pharmaceuticals Limited on November 23, 2022 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 11-digit format for NDC 46708-619-31?

    The 11-digit format is 46708061931. 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
    5-3-246708-619-315-4-246708-0619-31