ACYCLOVIR- acyclovir tablet

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

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Active ingredient:
ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)
Available from:
PharmPak, Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella). Acyclovir tablets are contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
Product summary:
Acyclovir tablets USP, 400 mg containing 400 mg of acyclovir USP are pink, shield shaped, flat tablets debossed with 'J' on one side and '49' in triangle on the other. They are supplied as follows: Acyclovir 400mg, 10ct 54348-627-10 Acyclovir 400mg, 15ct 54348-627-15 Acyclovir 400mg, 20ct 54348-627-20 Acyclovir 400mg, 21ct 54348-627-21 Acyclovir 400mg, 25ct 54348-627-25 Acyclovir 400mg, 30ct 54348-627-30 Acyclovir 400mg, 60ct 54348-627-60 Store between 15º and 25ºC. Protect from light and moisture. Manufactured By: HETERO TM                                                                            Hetero Labs Limited, Unit V, Polepally,                 2022708                        Jadcherla, Mahaboob Nagar-509 301, India.                                           Barcode Revised: June 2013
Authorization status:
Abbreviated New Drug Application
Authorization number:
54348-627-10, 54348-627-15, 54348-627-20, 54348-627-21, 54348-627-25, 54348-627-30, 54348-627-60

ACYCLOVIR- acyclovir tablet

PharmPak, Inc.

----------

Acyclovir Tablets, USP

Rx only

DESCRIPTION

Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets, USP is a

formulation for oral administration.

Each Acyclovir Tablet contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the

inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone

and sodium starch glycolate. The 400 mg and 800 mg tablet also contains ferric oxide and FD&C blue

lake # 2 Indigo carmine AL, respectively.

Acyclovir USP is a white to off white crystalline powder, slightly hygroscopic with the molecular

formula C

and a molecular weight of 225.20. The maximum solubility in water at 37°C is

2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25.

The chemical name of acyclovir is 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-

hydroxyethoxy)methyl]-. It has the following structural formula:

VIROLOGY

Mechanism of Antiviral Action: Acyclovir is a synthetic purine nucleoside analogue with in vitro and

in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster

virus (VZV).

The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine

kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir

monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by

cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir

triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive

inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA

chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir

against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK.

Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses

to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity

testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug

required to inhibit by 50% the growth of virus in cell culture (IC

), vary greatly depending upon a

number of factors. Using plaque-reduction assays, the IC

against herpes simplex virus isolates

ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC

acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL.

Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC

of 1.35

mcg/mL.

Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative

changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced

susceptibility to acyclovir have been recovered from immunocompromised patients, especially with

advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from

immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the

viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative

mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral

resistance to acyclovir should be considered in patients who show poor clinical response during

therapy.

CLINICAL PHARMACOLOGY

Pharmacokinetics

The pharmacokinetics of acyclovir after oral administration have been evaluated in healthy volunteers

and in immunocompromised patients with herpes simplex or varicella-zoster virus infection. Acyclovir

pharmacokinetic parameters are summarized in Table 1.

Table 1. Acyclovir Pharmacokinetic Characteristics (Range)

Parameter

Range

Plasma protein binding

9% to 33%

Plasma elemination half-life

2.5 to 3.3 hr

Average oral bioavailability

10% to 20%*

*Bioavailability decreases with increasing dose.

In one multiple-dose, crossover study in healthy subjects (n = 23), it was shown that increases in plasma

acyclovir concentrations were less than dose proportional with increasing dose, as shown in Table 2.

The decrease in bioavailability is a function of the dose and not the dosage form.

Table 2. Acyclovir Peak and Trough Concentrations at Steady State

Parameter

200 mg

400 mg

800 mg

0.83 mcg/mL

1.21 mcg/mL

1.61 mcg/mL

0.46 mcg/mL

0.63 mcg/mL

0.83 mcg/mL

There was no effect of food on the absorption of acyclovir (n = 6); therefore, acyclovir tablets may be

administered with or without food.

The only known urinary metabolite is 9-[(carboxymethoxy)methyl]guanine.

Special Populations

trough

Adults With Impaired Renal Function:The half-life and total body clearance of acyclovir are dependent

on renal function. A dosage adjustment is recommended for patients with reduced renal function (see

DOSAGE AND ADMINISTRATION).

Geriatrics: Acyclovir plasma concentrations are higher in geriatric patients compared with younger

adults, in part due to age-related changes in renal function. Dosage reduction may be required in

geriatric patients with underlying renal impairment (see PRECAUTIONS: Geriatric Use).

Pediatrics: In general, the pharmacokinetics of acyclovir in pediatric patients is similar to that of adults.

Mean half-life after oral doses of 300 mg/m

and 600 mg/m

in pediatric patients aged 7 months to 7

years was 2.6 hours (range 1.59 to 3.74 hours).

Drug Interactions

Coadministration of probenecid with intravenous acyclovir has been shown to increase the mean

acyclovir half-life and the area under the concentration-time curve. Urinary excretion and renal

clearance were correspondingly reduced.

Clinical Trials

Initial Genital Herpes: Double-blind, placebo-controlled studies have demonstrated that orally

administered acyclovir tablets significantly reduced the duration of acute infection and duration of

lesion healing. The duration of pain and new lesion formation was decreased in some patient groups.

Recurrent Genital Herpes: Double-blind, placebo-controlled studies in patients with frequent

recurrences (6 or more episodes per year) have shown that orally administered acyclovir tablets given

daily for 4 months to 10 years prevented or reduced the frequency and/or severity of recurrences in

greater than 95% of patients.

In a study of patients who received acyclovir tablets 400 mg twice daily for 3 years, 45%, 52%, and

63% of patients remained free of recurrences in the first, second, and third years, respectively. Serial

analyses of the 3-month recurrence rates for the patients showed that 71% to 87% were recurrence free

in each quarter.

Herpes Zoster Infections: In a double-blind, placebo-controlled study of immunocompetent patients with

localized cutaneous zoster infection, acyclovir tablets (800 mg 5 times daily for 10 days) shortened the

times to lesion scabbing, healing, and complete cessation of pain, and reduced the duration of viral

shedding and the duration of new lesion formation.

In a similar double-blind, placebo-controlled study, acyclovir tablets (800 mg 5 times daily for 7 days)

shortened the times to complete lesion scabbing, healing, and cessation of pain; reduced the duration of

new lesion formation; and reduced the prevalence of localized zoster-associated neurologic symptoms

(paresthesia, dysesthesia, or hyperesthesia).

Treatment was begun within 72 hours of rash onset and was most effective if started within the first 48

hours.

Adults greater than 50 years of age showed greater benefit.

Chickenpox: Three randomized, double-blind, placebo-controlled trials were conducted in 993

pediatric patients aged 2 to 18 years with chickenpox. All patients were treated within 24 hours after the

onset of rash. In 2 trials, acyclovir tablets were administered at 20 mg/kg 4 times daily (up to 3,200 mg

per day) for 5 days. In the third trial, doses of 10, 15, or 20 mg/kg were administered 4 times daily for 5

to 7 days. Treatment with acyclovir tablets shortened the time to 50% healing; reduced the maximum

number of lesions; reduced the median number of vesicles; decreased the median number of residual

lesions on day 28; and decreased the proportion of patients with fever, anorexia, and lethargy by day 2.

Treatment with acyclovir tablets did not affect varicella-zoster virus-specific humoral or cellular

immune responses at 1 month or 1 year following treatment.

INDICATIONS & USAGE

Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes

zoster (shingles).

Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the

management of recurrent episodes of genital herpes.

Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).

CONTRAINDICATIONS

Acyclovir tablets are contraindicated for patients who develop hypersensitivity to acyclovir or

valacyclovir.

WARNINGS

Acyclovir tablets are intended for oral ingestion only. Renal failure, in some cases resulting in death,

has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed During Clinical

Practice and OVERDOSAGE). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome

(TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving

acyclovir therapy.

PRECAUTIONS

Dosage adjustment is recommended when administering acyclovir tablets to patients with renal

impairment (see DOSAGE AND ADMINISTRATION). Caution should also be exercised when

administering acyclovir tablets to patients receiving potentially nephrotoxic agents since this may

increase the risk of renal dysfunction and/or the risk of reversible central nervous system symptoms

such as those that have been reported in patients treated with intravenous acyclovir. Adequate hydration

should be maintained.

Information for Patients

Patients are instructed to consult with their physician if they experience severe or troublesome adverse

reactions, they become pregnant or intend to become pregnant, they intend to breastfeed while taking

orally administered acyclovir tablets or they have any other questions.

Patients should be advised to maintain adequate hydration.

Herpes Zoster: There are no data on treatment initiated more than 72 hours after onset of the zoster rash.

Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster.

Genital Herpes Infections: Patients should be informed that acyclovir tablets is not a cure for genital

herpes. There are no data evaluating whether acyclovir tablets will prevent transmission of infection to

others. Because genital herpes is a sexually transmitted disease, patients should avoid contact with

lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital

herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding. If

medical management of a genital herpes recurrence is indicated, patients should be advised to initiate

therapy at the first sign or symptom of an episode.

Chickenpox: Chickenpox in otherwise healthy children is usually a self-limited disease of mild to

moderate severity. Adolescents and adults tend to have more severe disease. Treatment was initiated

within 24 hours of the typical chickenpox rash in the controlled studies, and there is no information

regarding the effects of treatment begun later in the disease course.

Drug Interactions

See CLINICAL PHARMACOLOGY: Pharmacokinetics.

Carcinogenesis & Mutagenesis & Impairment Of Fertility

The data presented below include references to peak steady-state plasma acyclovir concentrations

observed in humans treated with 800 mg given orally 5 times a day (dosing appropriate for treatment of

herpes zoster) or 200 mg given orally 5 times a day (dosing appropriate for treatment of genital herpes).

Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir

at the higher and lower dosing schedules (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

Acyclovir was tested in lifetime bioassays in rats and mice at single daily doses of up to 450 mg/kg

administered by gavage. There was no statistically significant difference in the incidence of tumors

between treated and control animals, nor did acyclovir shorten the latency of tumors. Maximum plasma

concentrations were 3 to 6 times human levels in the mouse bioassay and 1 to 2 times human levels in the

rat bioassay.

Acyclovir was tested in 16 in vitro and in vivo genetic toxicity assays. Acyclovir was positive in 5 of the

assays.

Acyclovir did not impair fertility or reproduction in mice (450 mg/kg/day, p.o.) or in rats (25 mg/kg/day,

s.c.). In the mouse study, plasma levels were 9 to 18 times human levels, while in the rat study, they

were 8 to 15 times human levels. At higher doses (50 mg/kg/day, s.c.) in rats and rabbits (11 to 22 and 16

to 31 times human levels, respectively) implantation efficacy, but not litter size, was decreased. In a rat

peri- and post-natal study at 50 mg/kg/day, s.c., there was a statistically significant decrease in group

mean numbers of corpora lutea, total implantation sites, and live fetuses.

No testicular abnormalities were seen in dogs given 50 mg/kg/day, IV for 1 month (21 to 41 times human

levels) or in dogs given 60 mg/kg/day orally for 1 year (6 to 12 times human levels). Testicular atrophy

and aspermatogenesis were observed in rats and dogs at higher dose levels.

Pregnancy

Teratogenic Effects: Pregnancy Category B. Acyclovir administered during organogenesis was not

teratogenic in the mouse (450 mg/kg/day, p.o.), rabbit (50 mg/kg/day, s.c. and IV), or rat (50 mg/kg/day,

s.c.). These exposures resulted in plasma levels 9 and 18, 16 and 106, and 11 and 22 times, respectively,

human levels.

There are no adequate and well-controlled studies in pregnant women. A prospective epidemiologic

registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999.

There were 749 pregnancies followed in women exposed to systemic acyclovir during the first

trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximates

that found in the general population. However, the small size of the registry is insufficient to evaluate

the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of

acyclovir in pregnant women and their developing fetuses. Acyclovir should be used during pregnancy

only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Acyclovir concentrations have been documented in breast milk in 2 women following oral administration

of acyclovir tablets and ranged from 0.6 to 4.1 times corresponding plasma levels. These

concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0.3 mg/kg/day.

Acyclovir tablets should be administered to a nursing mother with caution and only when indicated.

Pediatric Use

Safety and effectiveness of oral formulations of acyclovir in pediatric patients younger than 2 years of

age have not been established.

Geriatric Use

Of 376 subjects who received acyclovir tablets in a clinical study of herpes zoster treatment in

immunocompetent subjects ≥50 years of age, 244 were 65 and over while 111 were 75 and over. No

overall differences in effectiveness for time to cessation of new lesion formation or time to healing

were reported between geriatric subjects and younger adult subjects. The duration of pain after healing

was longer in patients 65 and over. Nausea, vomiting, and dizziness were reported more frequently in

elderly subjects. Elderly patients are more likely to have reduced renal function and require dose

reduction. Elderly patients are also more likely to have renal or CNS adverse events. With respect to

CNS adverse events observed during clinical practice, somnolence, hallucinations, confusion, and coma

were reported more frequently in elderly patients (see CLINICAL PHARMACOLOGY, ADVERSE

REACTIONS: Observed During Clinical Practice, and DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

Herpes Simplex

Short-Term Administration: The most frequent adverse events reported during clinical trials of treatment

of genital herpes with acyclovir tablets 200 mg administered orally 5 times daily every 4 hours for 10

days were nausea and/or vomiting in 8 of 298 patient treatments (2.7%). Nausea and/or vomiting

occurred in 2 of 287 (0.7%) patients who received placebo.

Long-Term Administration: The most frequent adverse events reported in a clinical trial for the

prevention of recurrences with continuous administration of 400 mg (two 200-mg capsules) 2 times

daily for 1 year in 586 patients treated with acyclovir tablets were nausea (4.8%) and diarrhea (2.4%).

The 589 control patients receiving intermittent treatment of recurrences with acyclovir tablets for 1

year reported diarrhea (2.7%), nausea (2.4%), and headache (2.2%).

Herpes Zoster

The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster

(shingles) with 800 mg of oral acyclovir tablets 5 times daily for 7 to 10 days in 323 patients was

malaise (11.5%). The 323 placebo recipients reported malaise (11.1%).

Chickenpox

The most frequent adverse event reported during 3 clinical trials of treatment of chickenpox with oral

acyclovir tablets at doses of 10 to 20 mg/kg 4 times daily for 5 to 7 days or 800 mg 4 times daily for 5

days in 495 patients was diarrhea (3.2%). The 498 patients receiving placebo reported diarrhea (2.2%).

Observed During Clinical Practice

In addition to adverse events reported from clinical trials, the following events have been identified

during post-approval use of acyclovir tablets. Because they are reported voluntarily from a population

of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion

due to either their seriousness, frequency of reporting, potential causal connection to acyclovir tablets

or a combination of these factors.

General: Anaphylaxis, angioedema, fever, headache, pain, peripheral edema.

Nervous: Aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium,

dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence,

tremors. These symptoms may be marked, particularly in older adults or in patients with renal impairment

(see PRECAUTIONS).

Digestive: Diarrhea, gastrointestinal distress, nausea.

Hematologic and Lymphatic: Anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy,

thrombocytopenia.

Hepatobiliary Tract and Pancreas: Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice.

Musculoskeletal: Myalgia.

Skin: Alopecia, erythema multiforme, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome,

toxic epidermal necrolysis, urticaria.

Special Senses: Visual abnormalities.

Urogenital: Renal failure, renal pain (may be associated with renal failure), elevated blood urea

nitrogen, elevated creatinine, hematuria (see WARNINGS).

OVERDOSAGE

Overdoses involving ingestion of up to 100 capsules (20 g) have been reported. Adverse events that

have been reported in association with overdosage include agitation, coma, seizures, and lethargy.

Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the

intratubular fluid. Overdosage has been reported following bolus injections or inappropriately high

doses and in patients whose fluid and electrolyte balance were not properly monitored. This has

resulted in elevated BUN and serum creatinine and subsequent renal failure. In the event of acute renal

failure and anuria, the patient may benefit from hemodialysis until renal function is restored (see

DOSAGE AND ADMINISTRATION).

DOSAGE & ADMINISTRATION

Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days.

Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days.

Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed

by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200

mg 5 times daily.

The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year

of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to

assess the need for continuation of therapy with acyclovir tablets.

Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the

earliest sign or symptom (prodrome) of recurrence.

Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily

(80 mg/kg/day) for 5 days. Children over 40 kg should receive the adult dose for chickenpox.

Adults and Children over 40 kg: 800 mg 4 times daily for 5 days.

Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in

immunocompromised patients.

When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is

no information about the efficacy of therapy initiated more than 24 hours after onset of signs and

symptoms.

Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of

acyclovir tablets should be modified as shown in Table 3.

Table 3. Dosage Modification for Renal Impairment

Normal Dosage Regimen

Creatinine Clearance

(mL/min/1.73 m

Adjusted Dosage Regimen

Dose (mg)

Dosing Interval

200 mg every 4 hours

> 10

0-10

every 4 hours, 5x daily

every 12 hours

400 mg every 12 hours

> 10

0-10

every 12 hours

every 12 hours

800 mg every 4 hours

> 25

10-25

0-10

every 4 hours, 5x daily

every 8 hours

every 12 hours

Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during

hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations

following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that

an additional dose is administered after each dialysis.

Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing

interval.

HOW SUPPLIED

Acyclovir tablets USP, 400 mg containing 400 mg of acyclovir USP are pink, shield shaped, flat tablets

debossed with 'J' on one side and '49' in triangle on the other. They are supplied as follows:

Acyclovir 400mg, 10ct 54348-627-10

Acyclovir 400mg, 15ct 54348-627-15

Acyclovir 400mg, 20ct 54348-627-20

Acyclovir 400mg, 21ct 54348-627-21

Acyclovir 400mg, 25ct 54348-627-25

Acyclovir 400mg, 30ct 54348-627-30

Acyclovir 400mg, 60ct 54348-627-60

Store between 15º and 25ºC. Protect from light and moisture.

Manufactured By:

HETERO

Hetero Labs Limited, Unit V, Polepally, 2022708

Jadcherla, Mahaboob Nagar-509 301, India.

Barcode

Revised: June 2013

Acyclovir 400mg 10ct 54348-627-10

Acyclovir 400mg 15ct 54348-627-15

Acyclovir 400mg 20ct 54348-627-20

Acyclovir 400mg 21ct 54348-627-21

Acyclovir 400mg 25ct 54348-627-25

Acyclovir 400mg 30ct 54348-627-30

Acyclovir 400mg 60ct 54348-627-60

ACYCLOVIR

acyclovir tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:54348 -6 27(NDC:31722-777)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACYCLO VIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)

ACYCLOVIR

40 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

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

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

Product Characteristics

Color

pink

S core

no sco re

S hap e

HEXAGON (6 sided) (shield,flat)

S iz e

12mm

Flavor

Imprint Code

J;49

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

PharmPak, Inc.

1

NDC:54348 -6 27-10

1 in 1 BOX

0 8 /0 8 /20 19

1

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

2

NDC:54348 -6 27-15

1 in 1 BOX

0 8 /0 8 /20 19

2

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

3

NDC:54348 -6 27-20

1 in 1 BOX

0 8 /0 8 /20 19

3

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

4

NDC:54348 -6 27-21

1 in 1 BOX

0 8 /0 8 /20 19

4

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

5

NDC:54348 -6 27-25

1 in 1 BOX

0 8 /0 8 /20 19

5

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

6

NDC:54348 -6 27-30

1 in 1 BOX

0 8 /0 8 /20 19

6

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

7

NDC:54348 -6 27-6 0

1 in 1 BOX

0 8 /0 8 /20 19

7

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 38 34

11/29 /20 13

Labeler -

PharmPak, Inc. (175493840)

Registrant -

PharmPak, Inc. (175493840)

Revised: 8/2019

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