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  5. NDC Package Code: 0069-0454-30 Talzenna

NDC Package 0069-0454-30 Talzenna

Talazoparib Capsule, Liquid Filled 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:
0069-0454-30
Package Description:
30 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code:
0069-0454
Proprietary Name:
Talzenna
Non-Proprietary Name:
Talazoparib
Substance Name:
Talazoparib Tosylate
Usage Information:
This medication is used to treat breast cancer. It works by slowing or stopping the growth of cancer cells.
11-Digit NDC Billing Format:
00069045430
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2099946 - talazoparib 0.25 MG Oral Capsule
  • RxCUI: 2099946 - talazoparib 0.25 MG (as talazoparib tosylate 0.363 MG) Oral Capsule
  • RxCUI: 2099952 - Talzenna 0.25 MG Oral Capsule
  • RxCUI: 2099952 - talazoparib 0.25 MG Oral Capsule [Talzenna]
  • RxCUI: 2099952 - talazoparib 0.25 MG (as talazoparib tosylate 0.363 MG) Oral Capsule [Talzenna]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pfizer Laboratories Div Pfizer Inc
    Dosage Form:
    Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • TALAZOPARIB TOSYLATE .35 mg/1
    • Pharmacologic Class(es):
  • Poly(ADP-Ribose) Polymerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Poly(ADP-Ribose) Polymerase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA217439
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-17-2024
    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.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0069-0454-30?

    The NDC Packaged Code 0069-0454-30 is assigned to a package of 30 capsule, liquid filled in 1 bottle of Talzenna, a human prescription drug labeled by Pfizer Laboratories Div Pfizer Inc. The product's dosage form is capsule, liquid filled and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

    Is NDC 0069-0454 included in the NDC Directory?

    Yes, Talzenna with product code 0069-0454 is active and included in the NDC Directory. The product was first marketed by Pfizer Laboratories Div Pfizer Inc on April 17, 2024 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 0069-0454-30?

    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 30.

    What is the 11-digit format for NDC 0069-0454-30?

    The 11-digit format is 00069045430. 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
    4-4-20069-0454-305-4-200069-0454-30