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  5. NDC Package Code: 44004-321-05 Factive

NDC Package 44004-321-05 Factive

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
44004-321-05
Package Description:
5 TABLET in 1 BLISTER PACK
Product Code:
44004-321
Proprietary Name:
Factive
Usage Information:
FACTIVE is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES.)Acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.Community-acquired pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP])*, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.*MDRSP: multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥2 μg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.To reduce the development of drug-resistant bacteria and maintain the effectiveness of FACTIVE and other antibacterial drugs, FACTIVE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
11-Digit NDC Billing Format:
44004032105
NDC to RxNorm Crosswalk:
  • RxCUI: 637560 - gemifloxacin mesylate 320 MG Oral Tablet
  • RxCUI: 637560 - gemifloxacin 320 MG Oral Tablet
  • RxCUI: 637562 - Factive 320 MG Oral Tablet
  • RxCUI: 637562 - gemifloxacin 320 MG Oral Tablet [Factive]
  • RxCUI: 637562 - Factive 320 MG (as gemifloxacin mesylate) Oral Tablet
    • Labeler Name:
    Vansen Pharma Inc.
    Sample Package:
    No
    Start Marketing Date:
    04-04-2003
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    44004-321-077 TABLET in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 44004-321-05?

    The NDC Packaged Code 44004-321-05 is assigned to a package of 5 tablet in 1 blister pack of Factive, labeled by Vansen Pharma Inc.. The product's dosage form is and is administered via form.

    Is NDC 44004-321 included in the NDC Directory?

    No, Factive with product code 44004-321 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Vansen Pharma Inc. on April 04, 2003 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 44004-321-05?

    The 11-digit format is 44004032105. 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
    5-3-244004-321-055-4-244004-0321-05