Amoxicillin

Aurobindo Pharma Limited

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use amoxicillin for oral suspension safely and effectively. See full prescribing information for amoxicillin for oral suspension, USP. Amoxicillin for Oral Suspension, USPInitial U.S. Approval: 1974 MicrobiologyTo reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.INDICATIONS AND USAGEAmoxicillin for oral suspension, USP is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1 - 1.5) In combination for treatment of H. pylori infection and duodenal ulcer disease. (1.6, 1.7) DOSAGE AND ADMINISTRATION In adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours. In Pediatric Patients > 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 hours. Refer to full prescribing information for specific dosing regimens. (2.1, 2.2, 2.3) Treatment of gonorrhea is 3 grams as a single oral dose. (2.1) The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day divided every 12 hours. (2.2) Dosing for H. pylori Infection: Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. (2.3) Reduce the dose in patients with severe renal impairment (GFR < 30 mL/min). (2.4) DOSAGE FORMS AND STRENGTHS Powder for Oral Suspension: 200 mg/5 mL and 400 mg/5 mL (3) CONTRAINDICATIONS(4)WARNINGS AND PRECAUTIONS Anaphylactic Reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy. Serious anaphylactic reactions require immediate emergency treatment with supportive measures. (5.1) Clostridium difficile Associated Diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs. (5.2) Side Effects(6.1)To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .DRUG INTERACTIONS Probenicid decreases renal tubular secretion of amoxicillin which may result in increased blood levels of amoxicillin. (7.1) Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. (7.2) Coadministration with allopurinol increases the risk of rash. (7.3) Amoxicillin may reduce the efficacy of oral contraceptives. (7.4) USE IN SPECIFIC POPULATIONS Pediatric: Modify dose in patients 12 weeks or younger (≤ 3 months). (8.4)

FULL PRESCRIBING INFORMATION: CONTENTS*

• 1 AMOXICILLIN INDICATIONS AND USAGE
  • 1.1 Infections of the Ear, Nose, and Throat
  • 1.2 Infections of the Genitourinary Tract
  • 1.3 Infections of the Skin and Skin Structure
  • 1.4 Infections of the Lower Respiratory Tract
  • 1.5 Gonorrhea, Acute Uncomplicated (ano-genital and urethral infections)
  • 1.6 Triple Therapy for Helicobacter pylori with Clarithromycin and Lansoprazole
  • 1.7 Dual Therapy for H. pylori with Lansoprazole
• 2 AMOXICILLIN DOSAGE AND ADMINISTRATION
  • 2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age
  • 2.2 Dosing in Neonates and Infants Aged12 Weeks ( 3 Months)
  • 2.3 Dosing for H. pylori Infection
  • 2.4 Dosing in Renal Impairment
  • 2.5 Directions for Mixing Oral Suspension
• 3 DOSAGE FORMS AND STRENGTHS
• 4 AMOXICILLIN CONTRAINDICATIONS
• 5 WARNINGS AND PRECAUTIONS
  • 5.1 Anaphylactic Reactions
  • 5.2 Clostridium difficile Associated Diarrhea
  • 5.3 Potential for Microbial Overgrowth or Bacterial Resistance
  • 5.4 Amoxicillin Uses in Patients With Mononucleosis
  • 5.5 Phenylketonurics
• 6 AMOXICILLIN ADVERSE REACTIONS
  • 6.1 Clinical Trials Experience
  • 6.2 Postmarketing or Other Experience
• 7 DRUG INTERACTIONS
  • 7.1 Probenecid
  • 7.2 Oral Anticoagulants
  • 7.3 Allopurinol
  • 7.4 Oral Contraceptives
  • 7.5 Other Antibacterials
  • 7.6 Drug/Laboratory Interactions
• 8 USE IN SPECIFIC POPULATIONS
  • 8.1 Pregnancy
  • 8.2 Labor and Delivery
  • 8.3 Nursing Mothers
  • 8.4 Pediatric Use
  • 8.5 Geriatric Use
  • 8.6 Dosing in Renal Impairment
• 10 OVERDOSAGE
• 11 AMOXICILLIN DESCRIPTION
• 12 CLINICAL PHARMACOLOGY
  • 12.1 Mechanism of Action
  • 12.3 Pharmacokinetics
  • 12.4 Microbiology
• 13 NONCLINICAL TOXICOLOGY
  • 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
• 14 CLINICAL STUDIES
  • 14.1 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
• 15 REFERENCES
• 16 HOW SUPPLIED/STORAGE AND HANDLING
• 17 PATIENT COUNSELING INFORMATION
  • 17.1 Information for Patients
• PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/5 mL (50 mL Bottle)
• PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg/5 mL (50 mL Bottle)

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Amoxicillin for oral suspension, USP is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below:

1.1 Infections of the Ear, Nose, and Throat

1.2 Infections of the Genitourinary Tract

1.3 Infections of the Skin and Skin Structure

1.4 Infections of the Lower Respiratory Tract

1.5 Gonorrhea, Acute Uncomplicated (ano-genital and urethral infections)

1.6 Triple Therapy for Helicobacter pylori with Clarithromycin and Lansoprazole

1.7 Dual Therapy for H. pylori with Lansoprazole

2 DOSAGE AND ADMINISTRATION

2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

2.2 Dosing in Neonates and Infants Aged12 Weeks ( 3 Months)

2.3 Dosing for H. pylori Infection

Triple Therapy:

Dual Therapy:

2.4 Dosing in Renal Impairment

• Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
• Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 875 mg dose.
• Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection.
• Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.
• Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

2.5 Directions for Mixing Oral Suspension

Table 2. Amount of Water for Mixing Oral Suspension

Strength	Bottle Size	Amount of Water Required for Reconstitution
Oral Suspension 200 mg/5 mL	50 mL	35 mL
	75 mL	52 mL
	100 mL	69 mL
Oral Suspension 400 mg/5 mL	50 mL	35 mL
	75 mL	52 mL
	100 mL	69 mL

NOTE:

3 DOSAGE FORMS AND STRENGTHS

Powder for Oral Suspension:

4 CONTRAINDICATIONS

Amoxicillinfor oral suspension is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin for oral suspension or to other β-lactam antibiotics (e.g., penicillins and cephalosporins).

5 WARNINGS AND PRECAUTIONS

5.1 Anaphylactic Reactions

5.2 Clostridium difficile Associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin, 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 antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 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 Potential for Microbial Overgrowth or Bacterial Resistance

5.4 Uses in Patients With Mononucleosis

5.5 Phenylketonurics

The oral suspension of amoxicillin do not contain phenylalanine and can be used by phenylketonurics.

6 ADVERSE REACTIONS

• Anaphylactic reactions [see Warnings and Precautions (5.1)]
• CDAD [see Warnings and Precautions (5.2)]

6.1 Clinical Trials Experience

Triple Therapy:

Dual Therapy:

6.2 Postmarketing or Other Experience

• Infections and Infestations: Mucocutaneous candidiasis.
• Gastrointestinal: Black hairy tongue, and hemorrhagic/pseudomembranous colitis.  Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.2)].
• Hypersensitivity Reactions: Anaphylaxis [see Warnings and Precautions (5.1)]. Serum sickness–like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and urticaria have been reported.
• Liver: A moderate rise in AST and/or ALT has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.
• Renal: Crystalluria has been reported [see Overdosage (10)].
• Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
• Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported.
• Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

7 DRUG INTERACTIONS

7.1 Probenecid

7.2 Oral Anticoagulants

7.3 Allopurinol

The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

7.4 Oral Contraceptives

7.5 Other Antibacterials

in vitro

7.6 Drug/Laboratory Interactions

^®®

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects:

8.2 Labor and Delivery

Oral ampicillin is poorly absorbed during labor. It is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention.

8.3 Nursing Mothers

8.4 Pediatric Use

[See Dosage and Administration (2.2).]

8.5 Geriatric Use

8.6 Dosing in Renal Impairment

Dosage and Administration (2.4)

10 OVERDOSAGE

¹

11 DESCRIPTION

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

[see Clinical Pharmacology (12.4)].

12.3 Pharmacokinetics

Absorption

Mean amoxicillin pharmacokinetic parameters from an open, two-part, single-dose crossover bioequivalence study in 27 adults comparing 875 mg of amoxicillin with 875 mg of amoxicillin/clavulanate potassium showed that the 875 mg tablet of amoxicillin produces an AUC_0-∞ of 35.4 ± 8.1 mcg•hr/mL and a C_max of 13.8 ± 4.1 mcg/mL. Dosing was at the start of a light meal following an overnight fast.

Orally administered doses of amoxicillin suspension, 125 mg/5 mL and 250 mg/5 mL, result in average peak blood levels 1 to 2 hours after administration in the range of 1.5 mcg/mL to 3 mcg/mL and 3.5 mcg/mL to 5 mcg/mL, respectively.

Oral administration of single doses of 400 mg chewable tablets and 400 mg/5 mL suspension of amoxicillin to 24 adult volunteers yielded comparable pharmacokinetic data:

Table 3: Mean Pharmacokinetic Parameters of Amoxicillin (400 mg chewable tablets and 400 mg/5 mL suspension) in Healthy Adults

* Administered at the start of a light meal. † Mean values of 24 normal volunteers. Peak concentrations occurred approximately 1 hour after the dose.
Dose*	AUC0-∞ (mcg•hr/mL)	Cmax (mcg/mL)†
Amoxicillin	Amoxicillin (±S.D.)	Amoxicillin (±S.D.)
400 mg (5 mL of suspension)	17.1 (3.1)	5.92 (1.62)
400 mg (1 chewable tablet)	17.9 (2.4)	5.18 (1.64)

Distribution:

Metabolism and Excretion:[see Drug Interactions (7.1)]

12.4 Microbiology

Mechanism of Action



Method of Resistance



in vitro INDICATIONS AND USAGE

Gram-Positive Bacteria	Gram-Negative Bacteria
Enterococcus faecalis  Staphylococcusspp.  Streptococcus pneumoniae  Alpha and β-hemolytic streptococci.	Escherichia coli  Haemophilus influenzae  Neisseria gonorrhoeae  Proteus mirabilis  Helicobacter pylori

Susceptibility Test Methods:

in vitro

Dilution Techniques: ^2,3

Diffusion Techniques: ³

Table 4. Susceptibility Test Interpretive Criteria for Amoxicillin

	Minimum Inhibitory Concentration (mcg/mL)			Disk Diffusion (zone diameter in mm)
	Susceptible	Intermediate	Resistant	Susceptible	Intermediate	Resistant
* S. pneumoniae should be tested using a 1 mcg oxacillin disk. Isolates with oxacillin zone sizes of ≥ 20 mm are susceptible to amoxicillin. An amoxicillin MIC should be determined on isolates of S. pneumoniae with oxacillin zone sizes of ≤19 mm. ** A positive beta lactamase test indicates resistance to amoxicillin. Isolates that are resistant to penicillin by MIC testing are also expected to be resistant to amoxicillin.
Enterococcus spp.	≤ 8	-	≥ 16	≥ 17	-	≤ 16
Staphylococcus spp.	≤ 0.25		≥ 0.5	≥ 29		≤ 28
Streptococci, viridians group (alpha-hemolytic streptococci)	≤ 0.25	0.5 to 4	≥ 8	-	-	-
β-hemolytic streptococci	≤ 0.25	-	-	≥ 24	-	-
Streptococcus pneumoniae(non-meningitis isolates)*	≤ 2	4	≥ 8	-	-	-
Enterobacteriaceae	≤ 8	16	≥ 32	≥ 17	14 to 16	≤ 13
Haemophilus influenzae	≤ 1	2	≥ 4	≥ 22	19 to 21	≤ 18
Neisseria gonorrhoeae**	-	-	-	-	-	-

Quality Control
 
^2,3,4

Table 5. Acceptable QualityControlRanges for Amoxicillin

Bacteria	ATCC#	MICRange (mcg/mL)	DiskDiffusionZoneRange (mm)
# ATCC = American Type Culture Collection
Escherichia coli	25922	2 to 8	16 to 22
Enterococcus faecalis	29212	0.5 to 2
Haemophilus influenzae	49247	2 to 8	13 to 21
Staphylococcus aureus	29213	0.5 to 2
	25923		27 to 35
Streptococcus pneumoniae	49619	0.06 to 0.25

Susceptibility Testing for Helicobacter pylori:in vitroH. pyloriH. pylori

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

H. pyloriH. pylori

Triple Therapy:

Dual Therapy:H. pyloriH. pylori

Table 6. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Triple Therapy Regimen

Study	Triple Therapy	Triple Therapy
	Evaluable Analysisa [95% Confidence Interval] (number of patients)	Intent-to-Treat Analysisb [95% Confidence Interval] (number of patients)
a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.
Study 1	92 [80 - 97.7] (n = 48)	86 [73.3 - 93.5] (n = 55)
Study 2	86 [75.7 - 93.6] (n = 66)	83 [72 - 90.8] (n = 70)

Table 7. H. pylori Eradication Rates When Amoxicillin is Administered as Part of a Dual Therapy Regimen

Study	Dual Therapy	Dual Therapy
	Evaluable Analysisa [95% Confidence Interval] (number of patients)	Intent-to-Treat Analysisb [95% Confidence Interval] (number of patients)
a This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. b Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a confirmed duodenal ulcer (active or within 1 year). All dropouts were included as failures of therapy.
Study 1	77 [62.5 - 87.2] (n = 51)	70 [56.8 - 81.2] (n = 60)
Study 2	66 [51.9 - 77.5] (n = 58)	61 [48.5 - 72.9] (n = 67)

15 REFERENCES

• Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988; 30: 66-67.
• Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – 8^th ed. CLSI Document M7-A8, Vol. 29, No.2. CLSI, Wayne, PA, Jan. 2009.
• Clinical and Laboratory Standards Institute (CLSI). Performance Standard for Antimicrobial Disk Susceptibility Tests; Approved Standard – 10^th ed. CLSI Document M2-A10, Vol. 29, No. 1. CLSI, Wayne, PA, 2009.
• Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing: 21^st Informational Supplement. Approved Standard CLSI Document M100-S21 CLSI, Wayne, PA, January 2011.

16 HOW SUPPLIED/STORAGE AND HANDLING

Amoxicillin for Oral Suspension, USP:

               200 mg/5 mL





            400 mg/5 mL





Store dry powder at

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

• Patients should be advised that amoxicillin may be taken every 8 hours or every 12 hours, depending on the dose prescribed.
• Patients should be counseled that antibacterial drugs, including amoxicillin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin is prescribed to treat a bacterial infection, patients should be told 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 amoxicillin or other antibacterial drugs in the future.
• Patients should be counseled that diarrhea is a common problem caused by antibiotics, and it usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
• Patients should be aware that amoxicillin contains a penicillin class drug product that can cause allergic reactions in some individuals.

 

CLINITEST^® is a registered trademark of Siemens Medical Solutions Diagnostics, and Ames Company, Inc.
CLINISTIX^® is a registered trademark of Bayer Healthcare Llc, and Ames Company, Inc.
CLOtest^® is a registered trademark of Kimberly-Clark Worldwide, Inc.

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810 

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India

Revised: 12/2012

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/5 mL (50 mL Bottle)

NDC 65862-070-50
Amoxicillin for Oral Suspension, USP
200 mg/5 mL
50 mL when reconstituted
Rx only
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 400 mg/5 mL (50 mL Bottle)

NDC 65862-071-50
Amoxicillin for Oral Suspension, USP
400 mg/5 mL
50 mL when reconstituted
Rx only
AUROBINDO

Amoxicillin Amoxicillin POWDER, FOR SUSPENSION Product Information Product Type Human prescription drug label Item Code (Source) NDC:65862-070 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN amoxicillin anhydrous 200 mg Inactive Ingredients Ingredient Name Strength SUCROSE TRISODIUM CITRATE DIHYDRATE SODIUM BENZOATE EDETATE DISODIUM FD&C RED NO. 3 XANTHAN GUM SILICON DIOXIDE Product Characteristics Color PINK Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65862-070-50 50 in 1 BOTTLE 2 NDC:65862-070-75 75 in 1 BOTTLE 3 NDC:65862-070-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065334 2006-12-28

Amoxicillin Amoxicillin POWDER, FOR SUSPENSION Product Information Product Type Human prescription drug label Item Code (Source) NDC:65862-071 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN amoxicillin anhydrous 400 mg Inactive Ingredients Ingredient Name Strength SUCROSE TRISODIUM CITRATE DIHYDRATE SODIUM BENZOATE EDETATE DISODIUM FD&C RED NO. 3 XANTHAN GUM SILICON DIOXIDE Product Characteristics Color PINK Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65862-071-50 50 in 1 BOTTLE 2 NDC:65862-071-75 75 in 1 BOTTLE 3 NDC:65862-071-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065334 2006-12-28