CEPHALEXIN- cephalexin capsule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)
Available from:
Direct_Rx
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
1.1 Respiratory Tract Infections Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 1.2 Otitis Media Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella 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 treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. 1.5 Genitourinary Tract Infections Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Pro
Product summary:
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 Bottles of 100 Bottles of 500 Bottles of 1000 30 Capsules (3 x 10 Unit-Dose) 50 Capsules (5 x 10 Unit-Dose) 100 Capsules (10 x 10 Unit-Dose) The 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 Bottles of 100 Bottles of 500 Bottles of 1000 30 Capsules (3 x 10 Unit-Dose) 50 Capsules (5 x 10 Unit-Dose) 100 Capsules (10 x 10 Unit-Dose) The 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 Bottles of 100 Bottle of 500 Bottle of 1000 100 Capsules (10 X 10 Unit-Dose) The 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 Bottles of 50 Bottles of 100 Bottle of 500 Bottle of 1000 Store 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].
Authorization status:
Abbreviated New Drug Application
Authorization number:
61919-606-28

CEPHALEXIN- cephalexin capsule

Direct_Rx

----------

CEPHALEXIN

1.1 Respiratory Tract Infections

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

of Streptococcus pneumoniae and Streptococcus pyogenes.

1.2 Otitis Media

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

Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes,

and Moraxella 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 treatment of bone infections caused by susceptible isolates of

Staphylococcus aureus and Proteus mirabilis.

1.5 Genitourinary Tract Infections

Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis,

caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.

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 dose of oral Cephalexin capsules, USP for pediatric patients is 25 to 50

mg/kg given in equally divided doses for 7 to 14 days. In the treatment of β-hemolytic streptococcal

infections, duration of at least 10 days is recommended. In severe infections, a total daily dose of 50 to

100 mg/kg may be administered in equally divided doses.

For the treatment of otitis media, the recommended daily dose is 75 to 100 mg/kg given in 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 renal

impairment [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6 )].

Table 1. Recommended Dose Regimen for Patients with Renal Impairment

Renal function Dose regimen recommendation

Creatinine clearance >60mL/min. No dose adjustment

Creatinine clearance 30 to 59 mL / min

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

Creatinine clearance 15 to 29 mL / min

250 mg, every 8 hours or every 12 hours

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

250 mg, every 24 hours

Creatinine 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.

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.

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.

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 practice

In 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 (12.3)]

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

Risk Summary

Available data from published epidemiologic studies and pharmacovigilance case reports over several

decades with cephalosporin use, including cephalexin use in pregnant women have not established

drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see

Data).

Animal reproduction studies with mice and rats using oral doses of cephalexin that are 0.6- and 1.2-

times the maximum recommended human dose (MRHD) based on body surface area during

organogenesis revealed no evidence of harm to the fetus (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is

unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In

the U.S. general population, the estimated background risk of major birth defects and miscarriage in

clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Human Data

While available studies cannot definitively establish the absence of risk, published data from

epidemiologic studies and postmarketing case reports over several decades have not identified a

consistent association with cephalosporin use, including cephalexin, during pregnancy, and major birth

defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodologic

limitations, including small sample size, retrospective data collection, and inconsistent comparator

groups.

Animal Data

In animal reproduction studies, pregnant mice and rats administered oral cephalexin doses of 250 or 500

mg/kg/day (approximately 0.6 and 1.2 times the MRHD) based on body surface area, respectively during

the period of organogenesis showed no adverse effects on embryofetal development.

In a pre-and post-natal developmental toxicity study, pregnant rats that received oral doses of 250 or

500 mg/kg/day of cephalexin from Day 15 of pregnancy to litter Day 21 showed no adverse effects on

parturition, litter size, or growth of offspring.

8.2 Lactation

Risk Summary

Data from a published clinical lactation study reports that cephalexin is present in human milk. The

Relative Infant Dose (RID) is considered to be <1% of the maternal weight adjusted dose. There are no

data on the effects of cephalexin on the breastfed child or on milk production.

The development of health benefits of breastfeeding should be considered along with the mother’s

clinical need for cephalexin and any potential adverse effects on the breastfed child from cephalexin or

from the underlying maternal condition.

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 careful monitoring in the presence of renal impairment

(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)].Monitor patients

longer for toxicity and drug interactions due to delayed clearance.

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.

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 N3O4SH2O and the molecular weight

is 365.41.

Cephalexin has the following structural formula:

[cephalexin-str]

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 [see Microbiology (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 Interactions:

In 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 Action

Cephalexin is a bactericidal agent that acts by the inhibition of bacterial cell-wall synthesis.

Resistance

Methicillin-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 Activity

Cephalexin 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 bacteria

Staphylococcus aureus (methicillin-susceptible isolates only)

Streptococcus pneumoniae (penicillin-susceptible isolates)

Gram-negative bacteria

Escherichia coli

Haemophilus influenzae

Klebsiella pneumoniae

Moraxella catarrhalis

Proteus mirabilis

Susceptibility Testing

For specific information regarding susceptibility test interpretive criteria and associated test methods

and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

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 performance were not affected by cephalexin oral doses up to

1.5 times the highest recommended human dose based upon body surface area.

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

Bottles of 100

Bottles of 500

Bottles of 1000

30 Capsules (3 x 10 Unit-Dose)

50 Capsules (5 x 10 Unit-Dose)

100 Capsules (10 x 10 Unit-Dose)

The 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

Bottles of 100

Bottles of 500

Bottles of 1000

30 Capsules (3 x 10 Unit-Dose)

50 Capsules (5 x 10 Unit-Dose)

100 Capsules (10 x 10 Unit-Dose)

The 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

Bottles of 100

Bottle of 500

Bottle of 1000

100 Capsules (10 X 10 Unit-Dose)

The 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

Bottles of 50

Bottles of 100

Bottle of 500

Bottle of 1000

Store 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].

Allergic Reactions

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)

Diarrhea

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

Antibacterial Resistance

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, India

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: January, 2019

PT 1199-10

CEPHALEXIN

cephalexin capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 19 19 -6 0 6 (NDC:6 78 77-219 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6 6 77)

CEPHALEXIN ANHYDROUS

50 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

GELATIN (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SHELLAC (UNII: 46 N10 7B71O)

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

AMMO NIA (UNII: 5138 Q19 F1X)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

Product Characteristics

Color

green ((light green cap and bo dy))

S core

no sco re

S hap e

CAPSULE

S iz e

22mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 19 -6 0 6 -28

28 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /14/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 0 8 36

0 8 /14/20 19

Labeler -

Direct_Rx (079254320)

Registrant -

Direct_Rx (079254320)

Establishment

Dire ct_Rx

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dire c t_Rx

0 79 254320

re pa c k(6 19 19 -6 0 6 )

Revised: 8/2019

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