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  5. NDC Package Code: 44004-801-20 Spectracef

NDC Package 44004-801-20 Spectracef

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
44004-801-20
Package Description:
20 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
44004-801
Proprietary Name:
Spectracef
Usage Information:
SPECTRACEF® (cefditoren pivoxil) is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below.Acute Bacterial Exacerbation of Chronic Bronchitis caused by Haemophilus influenzae (including ß-lactamase-producing strains), Haemophilus parainfluenzae (including ß-lactamase producing strains), Streptococcus pneumoniae (penicillin susceptible strains only), or Moraxella catarrhalis (including ß-lactamase-producing strains).Community-Acquired Pneumonia caused by Haemophilus influenzae (including ß-lactamase-producing strains), Haemophilus parainfluenzae (including ß-lactamase-producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), or Moraxella catarrhalis (including ß-lactamase producing strains).Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. NOTE: SPECTRACEF® is effective in the eradication of Streptococcus pyogenes from the oropharynx. SPECTRACEF® has not been studied for the prevention of rheumatic fever following Streptococcus pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including ß-lactamase-producing strains) or Streptococcus pyogenes.To reduce the development of drug-resistant bacteria and maintain the effectiveness of SPECTRACEF® and other antibacterial drugs, SPECTRACEF® 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:
44004080120
NDC to RxNorm Crosswalk:
  • RxCUI: 351127 - cefditoren pivoxil 200 MG Oral Tablet
  • RxCUI: 847360 - cefditoren pivoxil 400 MG Oral Tablet
  • RxCUI: 847362 - Spectracef 400 MG Oral Tablet
  • RxCUI: 847362 - cefditoren pivoxil 400 MG Oral Tablet [Spectracef]
  • RxCUI: 847365 - Spectracef 200 MG Oral Tablet
    • Labeler Name:
    Vansen Pharma Inc.
    Sample Package:
    No
    Start Marketing Date:
    02-05-2013
    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.

    Frequently Asked Questions

    What is NDC 44004-801-20?

    The NDC Packaged Code 44004-801-20 is assigned to a package of 20 tablet, film coated in 1 blister pack of Spectracef, labeled by Vansen Pharma Inc.. The product's dosage form is and is administered via form.

    Is NDC 44004-801 included in the NDC Directory?

    No, Spectracef with product code 44004-801 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 February 05, 2013 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 44004-801-20?

    The 11-digit format is 44004080120. 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
    5-3-244004-801-205-4-244004-0801-20