Application Nr Approved Date Route Status External Links
ANDA090836 2013-03-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Cephalexin Capsules, Usp Is Indicated For The Treatment Of The Following Infections When Caused By Susceptible Strains Of The Designated Microorganisms: Respiratory Tract Infections Caused By Streptococcus Pneumoniae And Streptococcus Pyogenes (penicillin Is The Usual Drug Of Choice In The Treatment And Prevention Of Streptococcal Infections, Including The Prophylaxis Of Rheumatic Fever. Cephalexin Capsules, Usp Is Generally Effective In The Eradication Of Streptococci From The Nasopharynx; However, Substantial Data Establishing The Efficacy Of Cephalexin In The Subsequent Prevention Of Rheumatic Fever Are Not Available At Present.) Otitis Media Due To Streptococcus Pneumoniae, Haemophilus Influenzae, Staphylococcus Aureus, Streptococcus Pyogenes, And Moraxella Catarrhalis Skin And Skin Structure Infections Caused By Staphylococcus Aureus And/or Streptococcus Pyogenes Bone Infections Caused By Staphylococcus Aureus And/or Proteus Mirabilis Genitourinary Tract Infections, Including Acute Prostatitis, Caused By Escherichia Coli, Proteus Mirabilis, And Klebsiella Pneumoniae Note-Culture And Susceptibility Tests Should Be Initiated Prior To And During Therapy. Renal Function Studies Should Be Performed When Indicated. To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Cephalexin Capsules, Usp And Other Antibacterial Drugs, Cephalexin Capsules, Usp Should Be Used Only To Treat Or Prevent 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.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. D&c Yellow No. 10 D&C YELLOW NO. 10 Molecular DYE-Dye
4. Gelatin GELATIN Unresolved
5. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
6. Ammonia AMMONIA Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cephalexin CEPHALEXIN ZINC3830500

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