NDC 70518-1810 Cephalexin

Cephalexin

NDC Product Code 70518-1810

NDC Code: 70518-1810

Proprietary Name: Cephalexin Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Cephalexin Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Product Characteristics
Color(s):
GREEN (C48329 - LIGHT GREEN CAP AND BODY)
Shape: CAPSULE (C48336)
Size(s):
22 MM
Imprint(s):
219
Score: 1

Code Structure
  • 70518 - Remedyrepack Inc.
    • 70518-1810 - Cephalexin

NDC 70518-1810-0

Package Description: 14 CAPSULE in 1 BOTTLE, PLASTIC

NDC Product Information

Cephalexin with NDC 70518-1810 is a a human prescription drug product labeled by Remedyrepack Inc.. The generic name of Cephalexin is cephalexin. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Cephalexin Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CEPHALEXIN 500 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SHELLAC (UNII: 46N107B71O)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • GELATIN (UNII: 2G86QN327L)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • AMMONIA (UNII: 5138Q19F1X)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

Additional informationCallout TooltipWhat is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Cephalosporin Antibacterial - [EPC] (Established Pharmacologic Class)
  • Cephalosporins - [CS]

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: ANDA090836 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-22-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cephalexin Product Label Images

Cephalexin Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1.1 Respiratory Tract Infections

Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of





Streptococcus pneumoniae and





Streptococcuspyogenes.

1.2 Otitis Media

Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of





Streptococcuspneumoniae, Haemophilus infl uenz ae, Staphylococcus aureus, Streptococcuspyogenes, and





Mo raxella catarrhalis.

1.3 Skin And Skin Structure Infections

Cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria:





Staphylococcus aureus and





Streptococcus pyogenes.

1.4 Bone Infections

Cephalexin is indicated for the treat ment of bone infections caused by susceptible isolates of





Staphylococcusaureus and





Proteus mi rabilis.

1.5 Genitourinary Tract Infections

Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of





Escheric hia c oli, Proteus mirabilis, and





Klebsiella pneumonia e.

1.6 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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.

2.1 Adults And Pediatric Patients At Least 15 Years Of Age

The usual dose of oral Cephalexin capsule, USP is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered. Treatment is administered for 7 to 14 days.For more severe infections larger doses of oral Cephalexin capsules, USP may be needed, up to 4 grams daily in two to four equally divided doses.

2.2 Pediatric Patients (Over 1 Year Of Age)

The recommended total daily doseof oral Cephalexin capsules, USP for pediatric patients is 25 to 50 mg/kg givenin equally divided doses for 7 to 14 days. In the treatment of β-hemolyticstreptococcal infections, duration of at least 10 days is recommended. Insevere infections, a total daily dose of 50 to 100 mg/kg may be administered inequally divided doses.For thetreatment of otitis media, the recommended daily dose is 75 to 100 mg/kg givenin equally divided doses.

2.3 Dosage Adjustments In Adult And Pediatric Patients At Least 15 Years Of Age With Renal Impairment

Administer the following dosing regimens for Cephalexin capsules, USP to patients with impaired renal function [see





War nin gsand Precautions (5.4) and





Use inSpecific Populations (8.6 )].





Table 1. Recommended Dose Regimen for Patients with Renal ImpairmentRenal FunctionDose regimen recommendationCreatinine cleartance ≥ 60mL/min.No dose adjustment





Creatinine clearance 30 to 59 mL / min





No dose adjustment; maximum daily dose should not exceed 1 g





Creati nine clearance 15 to 29 mL / min





250 mg, every 8 hours or every 12 hours





Creati nine clearance 5 to 14 mL / min not yet on dialysis*





250 mg, every 24 hours





Creati nine clearance 1 to 4 mL / min not yet on dialysis*





250 mg, every 48 hours or every 60 hours





*There is insufficient information to make dose adjustment recommendations in patients on hemodialysis.

3 Dosage Forms & Strengths

250 mg capsules: a white to off white powder filled into size 2 capsules (dark green cap and dark green body) that are imprinted with “220” on the both cap and body in edible black ink.





500 mg capsules: a white to off white powder filled into size 0 capsules (light green cap and light green body) that are imprinted with “219” on the both cap and body in edible black ink.





333 mg capsules: a white to off white powder filled into size 1 capsules (light green cap and light green body) that are imprinted “CEP” on cap and “333” on body in edible black ink.





750 mg capsules: a white to off white powder filled into size '00 Elongated' capsules (dark green cap and dark green body) that are imprinted “CEP” on cap and “750” on body in edible white ink.

4 Contraindications

Cephalexin is contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.

5.1 Hypersensitivity Reactions

Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens- Johnson syndrome, or toxic epidermal necrolysis have been reported with the use of cephalexin. Before therapy with cephalexin is instituted, inquire whether the patient has a history of hypersensitivity reactions to cephalexin, cephalosporins, penicillins, or other drugs. Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy.





If an allergic reaction to cephalexin occurs, discontinue the drug and institute appropriate treatment.

5.2 Clostridium Difficile-Associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cephalexin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.





C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.





If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

5.3 Direct Coombs’ Test Seroconversion

Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibacterial drugs including cephalexin. Acute intravascular hemolysis induced by cephalexin therapy has been reported. If anemia develops during or after cephalexin therapy, perform a diagnostic work-up for drug-induced hemolytic anemia, discontinue cephalexin and institute appropriate therapy.

5.4 Seizure Potential

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures occur, discontinue cephalexin. Anticonvulsant therapy can be given if clinically indicated.

5.5 Prolonged Prothrombin Time

Cephalosporins may be associated with prolonged prothrombin time. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antibacterial therapy, and patients receiving anticoagulant therapy. Monitor prothrombin time in patients at risk and manage as indicated.

5.6 Development Of Drug-Resistant Bacteria

Prescribing cephalexin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.Prolonged use of cephalexin may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

6 Adverse Reactions

  • The following serious events are described in greater detail in the Warning and Precautions section:Hypersensitivity reactions [
  • See Warning and Precautions (
  • 5.1 )
  • ]
  • Clostridium difficile-associated diarrhea [
  • See Warnings and Precautions (
  • 5.2 )
  • ]
  • Direct Coombs’ Test Seroconversion [
  • See Warnings and Precautions (
  • 5.3 )
  • ]
  • Seizure Potential [
  • See Warnings and Precautions (
  • 5.4 )
  • ]
  • Effect on Prothrombin Activity [
  • See Warnings and Precautions (
  • 5.5 )
  • ]
  • Development of Drug-Resistant Bacteria [
  • See Warnings and Precautions (
  • 5.6 )
  • ]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practiceIn clinical trials, the most frequent adverse reaction was diarrhea. Nausea and vomiting, dyspepsia, gastritis, and abdominal pain have also occurred. As with penicillins and other cephalosporins, transient hepatitis and cholestatic jaundice have been reported.Other reactions have included hypersensitivity reactions, genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported. Eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in aspartate transaminase (AST) and alanine transaminase (ALT) have been reported.In addition to the adverse reactions listed above that have been observed in patients treated with cephalexin, the following adverse reactions and other altered laboratory tests have been reported for cephalosporin class antibacterial drugs:Other Adverse Reactions: Fever, colitis, aplastic anemia, hemorrhage, renal dysfunction, and toxic nephropathy.





Altered Laboratory Tests:Prolonged prothrombin time, increased blood urea nitrogen (BUN), increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated lactate dehydrogenase (LDH), pancytopenia, leukopenia, and agranulocytosis.

7.1 Metformin

Administration of cephalexin with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin.Careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking cephalexin and metformin [





see Clinical Pharmacology (12.2) ].

7.2 Probenecid

The renal excretion of cephalexin is inhibited by probenecid. Co-administration of probenecid with cephalexin is not recommended.

7.3 Interaction With Laboratory Or Diagnostic Testing

A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict’s solution or Fehling’s solution.

8.1 Pregnancy

Pregnancy Category BThere are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.Reproduction studies have been performed on mice and rats using oral doses of cephalexin monohydrate 0.6 and 1.5 times the maximum daily human dose (66 mg/kg/day) based upon body surface area basis, and have revealed no evidence of impaired fertility or harm to the fetus.

8.3 Nursing Mothers

Cephalexin is excreted in human milk. Caution should be exercised when Cephalexin is administered to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of cephalexin in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section





[see Dosage and Administration (





2.2 )





]





.

8.5 Geriatric Use

Of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.This drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [





see Warnings and Precautions (





5.4 )





].

8.6 Renal Impairment

Cephalexin should be administered with caution in the presence of impaired renal function (creatinine clearance < 30 mL/min, with or without dialysis). Under such conditions, careful clinical observation and laboratory studies renal function monitoring should be conducted because safe dosage may be lower than that usually recommended





[see Dosage and Administration (





2.3 ) ]





.

10 Overdosage

Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. In the event of an overdose, institute general supportive measures.Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of cephalexin.

11 Description

Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C





16 H





17 N





3O





4S•H





2Oand the molecular weight is 365.41.





Cephalexin has the following structural formula:





Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of cephalexin. The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD & C Blue No. 1, D & C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD & C Red No. 40; 333 mg and 750 mg Capsules contains FD & C Yellow No. 6. The imprinting ink contains; shellac, propylene glycol, strong ammonia solution and potassium hydroxide. Also black Iron oxide is used in 250mg, 333mg and 500mg and titanium dioxide is used in 750mg.

12.1 Mechanism Of Action

Cephalexin is a cephalosporin antibacterial drug





[seeMicrobiology (





12.4 ) ]





.

12.3 Pharmacokinetics

Absorption:Cephalexin is acid stable and may be given without regard to meals. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of approximately 9, 18, and 32 mcg/mL, respectively, were obtained at 1 hour. Serum levels were detectable 6 hours after administration (at a level of detection of 0.2 mcg/mL).Distribution:Cephalexin is approximately 10% to 15% bound to plasma proteins.Excretion:Cephalexin is excreted in the urine by glomerular filtration and tubular secretion. Studies showed that over 90% of the drug was excreted unchanged in the urine within 8 hours. During this period, peak urine concentrations following the 250 mg, 500 mg, and 1 g doses were approximately 1000, 2200, and 5000 mcg/mL respectively.Drug InteractionsIn healthy subjects given single 500 mg doses of cephalexin and metformin, plasma metformin mean Cmax and AUC increased by an average of 34% and 24%, respectively, and metformin mean renal clearance decreased by 14%. No information is available about the interaction of cephalexin and metformin following multiple doses of either drug.

12.4 Microbiology

Mechanism of ActionCephalexin is a bactericidal agent that acts by the inhibition of bacterial cell-wall synthesis.ResistanceMethicillin-resistant staphylococci and most isolates of enterococci are resistant to cephalexin. Cephalexin is not active against most isolates of





Enterobacter spp., Morganella morganii, and





Proteus vulgaris. Cephalexin has no activity against





Pseudomonas spp., or





Acinetobacter calcoaceticus. Penicillin-resistant





Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibacterial drugs.





Antimicrobial ActivityCephalexin has been shown to be active against most isolates of the following bacteria both





in vitro and in clinical infections [





see Indications and Usage





(1) ].





Gram-positive bacteriaStaphylococcus aureus (methicillin-susceptible isolates only)





Streptococcus pneumoniae (penicillin-susceptible isolates)





Streptococcus pyogenesGram-negative bacteriaEscheric h ia coliHaemophilusinfl uenzaeKlebsiellapneumoniaeMoraxella catarrhalisProteusmi rabilisSusceptibility Tests MethodsWhen available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drug products used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug product for treatment. In cases of uncomplicated urinary tract infection only, susceptibility of





E. coli, K. pneumoniae, and





P. mirabilis to cephalexin may be inferred by testing cefazolin2.





Dilution TechniquesQuantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test methods (broth or agar)1,2.Diffusion Techniques Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method2,3.A report of Susceptible (S) indicates that the antimicrobial drug is likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the site of infection. A report of Intermediate (I) indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where a high dosage of the drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant (R) indicates that the antimicrobial drug is not likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentrations usually achievable at the infection site; other therapy should be selected. Quality Co n t r ol Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individual performing the test





1,2,3,.

13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility

Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of cephalexin. Tests to determine the mutagenic potential of cephalexin have not been performed. In male and female rats, fertility and reproductive peLifetime studies in animals have not been performed to evaluate the carcinogenic potential of cephalexin. Tests to determine the mutagenic potential of cephalexin have not been performed. In male and female rats, fertility and reproductive performance were not affected by cephalexin oral doses up to 1.5 times the highest recommended human dose based upon body surface area.rformance were not affected by cephalexin oral doses up to 1.5 times the highest recommended human dose based upon mg/m2.

15 References

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Tenth Edition. CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.





2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobials Susceptibility Tests; Twenty-Fifth Informational Supplement. CLSI document M100-S25, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.





3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard - Twelfth Edition. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

16 How Supplied/Storage And Handling

Cephalexin capsules, USP, are supplied as follows:The 250 mg capsules are a white to off white powder filled into size 2 capsules (dark green cap and dark green body) that are imprinted with “220” on the both cap and body in edible black ink. They are available as follows:Bottles of 20                                                                 NDC-67877-220-20Bottles of 100                                                               NDC-67877-220-01Bottles of 500                                                               NDC-67877-220-05Bottles of 1000                                                             NDC-67877-220-1030 Capsules (3 x 10 Unit-Dose)                                   NDC67877-220-8450 Capsules (5 x 10 Unit-Dose)                                   NDC-67877-220-74100 Capsules (10 x 10 Unit-Dose)                               NDC-67877-220-38The 500 mg capsules are a white to off white powder filled into size 0 capsules (light green cap and light green body) that are imprinted with “219” on the both cap and body in edible black ink. They are available as follows:Bottles of 20                                                                NDC-67877-219-20Bottles of 100                                                              NDC-67877-219-01Bottles of 500                                                              NDC-67877-219-05Bottles of 1000                                                            NDC-67877-219-1030 Capsules (3 x 10 Unit-Dose)                                  NDC67877-219-8450 Capsules (5 x 10 Unit-Dose)                                  NDC-67877-219-74100 Capsules (10 x 10 Unit-Dose)                              NDC-67877-219-38The 333 mg capsules are a white to off white powder filled into size 1 capsules (light green cap and light green body) that are imprinted “CEP” on cap and “333” on body in edible black ink. They are available as follows:Bottles of 20                                                               NDC-67877-254-20Bottles of 100                                                             NDC-67877-254-01Bottle of 500                                                               NDC-67877-254-05Bottle of 1000                                                             NDC-67877-254-10100 Capsules (10 X 10 Unit-Dose)                             NDC-67877-254-38The 750 mg capsules are a white to off white powder filled into size '00 Elongated' capsules (dark green cap and dark green body) that are imprinted “CEP” on cap and “750” on body in edible white ink. They are available as follows:Bottles of 20                                                               NDC-67877-255-20Bottles of 50                                                               NDC-67877-255-23Bottles of 100                                                             NDC-67877-255-01Bottle of 500                                                               NDC-67877-255-05Bottle of 1000                                                             NDC-67877-255-10Store at 20°C to 25°C (68°F to77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

17 Patient Counseling Information

  • Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to cephalexin, other beta-lactams (including cephalosporins) or other allergens (5.1)Advise patients that diarrhea is a common problem caused by antibacterial drugs and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, advise patients to contact their healthcare provider
  • Counsel patients that antibacterial drugs including cephalexin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cephalexin is prescribed to treat a bacterial infection, tell patients that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cephalexin or other antibacterial drugs in the future.
  • Manufactured by:Alkem Laboratories ltd.Mumbai - 400 013, IndiaDistributed by:Ascend Laboratories, LLCParsippany, NJ 07054Revised: July 2016PT 1199-08

* Please review the disclaimer below.

Previous Code
70518-1809
Next Code
70518-1811