NDC Package 16729-050-53 Temozolomide

Capsule Oral - 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:
16729-050-53
Package Description:
1 BOTTLE, GLASS in 1 CARTON / 5 CAPSULE in 1 BOTTLE, GLASS
Product Code:
Proprietary Name:
Temozolomide
Non-Proprietary Name:
Temozolomide
Substance Name:
Temozolomide
Usage Information:
This medication is used to treat certain types of brain cancer. Temozolomide belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.
11-Digit NDC Billing Format:
16729005053
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: 313209 - temozolomide 20 MG Oral Capsule
  • RxCUI: 313210 - temozolomide 250 MG Oral Capsule
  • RxCUI: 313211 - temozolomide 5 MG Oral Capsule
  • RxCUI: 317160 - temozolomide 100 MG Oral Capsule
  • RxCUI: 700883 - temozolomide 140 MG Oral Capsule
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Accord Healthcare Inc.
    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):
    Sample Package:
    No
    FDA Application Number:
    ANDA201528
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-07-2017
    Listing Expiration Date:
    12-31-2025
    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.

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    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 16729-050-53 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    16729005053J8700Temozolomide5 MG1520100

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    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    16729-050-541 BOTTLE, GLASS in 1 CARTON / 14 CAPSULE in 1 BOTTLE, GLASS

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    Frequently Asked Questions

    What is NDC 16729-050-53?

    The NDC Packaged Code 16729-050-53 is assigned to a package of 1 bottle, glass in 1 carton / 5 capsule in 1 bottle, glass of Temozolomide, a human prescription drug labeled by Accord Healthcare Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 16729-050 included in the NDC Directory?

    Yes, Temozolomide with product code 16729-050 is active and included in the NDC Directory. The product was first marketed by Accord Healthcare Inc. on March 07, 2017 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 16729-050-53?

    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 16729-050-53?

    The 11-digit format is 16729005053. 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
    5-3-216729-050-535-4-216729-0050-53