Factive
Product Images NDC 44004-321

13 FDA label images from Vansen Pharma Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Factive (NDC 44004-321). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Vansen Pharma Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

Product Images & Figures Index

FDA Label Image

Factive 5 Count Label (Favtive 5 Count Label)

Factive 5 Count Label (Favtive 5 Count Label)
The packaging label for Factive 320 mg gemifloxacin mesylate tablets by Vansen Pharma Inc. The unit-of-use package contains 5 tablets for a 5-day therapy. The label includes storage instructions (25°C, excursions permitted), and a designated area for the pharmacy label. NDC 44004-321-05 is visible along with barcodes and manufacturer details.*
FDA Label Image

Factive 7 Count Label (Favtive 7 Count Label)

Factive 7 Count Label (Favtive 7 Count Label)
Packaging label for FACTIVE gemifloxacin mesylate tablets 320 mg by Vansen Pharma Inc. The label indicates a 7-day therapy supply with 7 tablets in a unit-of-use package. Storage instructions, dosage directions, and markings for pharmacy label placement are also shown, along with the NDC 44004-321-07 and barcode.*
FDA Label Image

Table 11 (Table 11)

Table 11 (Table 11)
A data table showing screening susceptibility and corresponding clinical and bacteriological success rates for various antibiotic-resistant strains, including penicillin-resistant, 2nd generation cephalosporin-resistant, macrolide-resistant, trimethoprim/sulfamethoxazole-resistant, and tetracycline-resistant bacteria. Success rates are displayed as both numbers and percentages.*
FDA Label Image

Table 12 (Table 12)

Table 12 (Table 12)
A data table showing clinical cure rate and bacteriological eradication rate for Streptococcus pneumoniae with MDRSP. It presents cure and eradication rates based on resistance to 2 to 5 antimicrobials and bacteremia with MDRSP, displaying both fractions (n/N) and percentages (%) for each category.*
FDA Label Image

Table 2 (Table 2)

Table 2 (Table 2)
A data table showing the duration of FACTIVE therapy across different gender and age categories. It details the number and percentage of patients treated with FACTIVE for 5, 7, 10, and 14 days, segmented by female and male groups under and over 40 years of age, with total counts and percentages provided for each therapy duration.*
FDA Label Image

Table 3 (Table 3)

Table 3 (Table 3)
Data table presenting percentages of outcomes or events over different durations (5 or 7 days) of treatment with ABECB and CAP in various age and gender groups, including totals and subcategories of males and females below and above 40 years of age.*
FDA Label Image

Table 4 (Table 4)

Table 4 (Table 4)
A table listing indications and corresponding doses/duration for FACTIVE. It includes acute bacterial exacerbation of chronic bronchitis and community-acquired pneumonia of mild to moderate severity caused by specified bacteria. Dosage information specifies one 320 mg tablet daily for 5 or 7 days depending on the infection type. The table also includes notes on multidrug-resistant strains and antibiotic resistance.*
FDA Label Image

Table 6 (Table 6)

Table 6 (Table 6)
A data table comparing drug regimens including FACTIVE 320 mg x 5 days versus other antibiotic treatments across three studies (068, 070, and 212). It presents success rates as percentages with corresponding sample sizes and treatment differences with 95% confidence intervals.*
FDA Label Image

Table 7 (Table 7)

Table 7 (Table 7)
A data table presenting the success rate and treatment difference with 95% confidence interval for FACTIVE 320 mg dosed over 5 days versus 7 days from Study OP-634-001. The 5-day regimen shows a 95.0% success rate (230/242), and the 7-day regimen shows a 92.1% success rate (209/227) with a treatment difference of 3.0 (-1.5, 7.4).*
FDA Label Image

Table 8 (Table 8)

Table 8 (Table 8)
A data table comparing the effectiveness of a treatment against four pathogens over 5-day and 7-day periods. It lists Streptococcus pneumoniae, Mycoplasma pneumoniae, Haemophilus influenzae, and Chlamydia pneumoniae with corresponding sample sizes and percentage effectiveness values for each time point.*
FDA Label Image

Table 9 (Table 9)

Table 9 (Table 9)
A data table presenting success rates and treatment differences for different drug regimens involving FACTIVE 320 mg over 7 days and Amoxicillin/clavulanate 1 g/125 mg TID for 10 days across three studies (011, 061, 287). The table shows percentage success rates (n/N) and treatment difference with 95% confidence intervals.*
FDA Label Image

Gemifloxacin Mesylate (Factive 1)

Gemifloxacin Mesylate (Factive 1)
Chemical structure of the active ingredient of FACTIVE by Vansen Pharma Inc., depicting a fluorinated quinolone carboxylic acid moiety with various nitrogen and oxygen functional groups and a methanesulfonic acid component.*
FDA Label Image

Creatinine Clearance Formula (Factive 2)

Creatinine Clearance Formula (Factive 2)
An illustration showing the formula to calculate creatinine clearance (mL/min) in men. The formula is: Weight (kg) times (140 minus age) divided by 72 times serum creatinine (mg/dL).*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.