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  5. NDC Package Code: 0310-1349-30 Tagrisso

NDC Package 0310-1349-30 Tagrisso

Osimertinib Tablet, Film Coated 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:
0310-1349-30
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
0310-1349
Proprietary Name:
Tagrisso
Non-Proprietary Name:
Osimertinib
Substance Name:
Osimertinib
Usage Information:
This medication is used to treat lung cancer. Osimertinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells. It binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors.
11-Digit NDC Billing Format:
00310134930
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: 1721565 - osimertinib 40 MG Oral Tablet
  • RxCUI: 1721565 - osimertinib 40 MG (as osimertinib mesylate 47.7 MG) Oral Tablet
  • RxCUI: 1721571 - Tagrisso 40 MG Oral Tablet
  • RxCUI: 1721571 - osimertinib 40 MG Oral Tablet [Tagrisso]
  • RxCUI: 1721571 - Tagrisso 40 MG (as osimertinib mesylate 47.7 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Astrazeneca Pharmaceuticals Lp
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • OSIMERTINIB 40 mg/1
    • Pharmacologic Class(es):
  • Breast Cancer Resistance Protein Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 1A2 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A4 Inducers - [MoA] (Mechanism of Action)
  • Kinase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Kinase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA208065
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-13-2015
    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 0310-1349-30?

    The NDC Packaged Code 0310-1349-30 is assigned to a package of 30 tablet, film coated in 1 bottle of Tagrisso, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. The product's dosage form is tablet, film coated 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 0310-1349 included in the NDC Directory?

    Yes, Tagrisso with product code 0310-1349 is active and included in the NDC Directory. The product was first marketed by Astrazeneca Pharmaceuticals Lp on November 13, 2015 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 0310-1349-30?

    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 0310-1349-30?

    The 11-digit format is 00310134930. 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
    4-4-20310-1349-305-4-200310-1349-30