Ziprasidone Hydrochloride (Page 10 of 10)

14 CLINICAL STUDIES

14.1 Schizophrenia

The efficacy of oral ziprasidone in the treatment of schizophrenia was evaluated in five placebo-controlled studies, four short-term (4- and 6-week) trials and one maintenance trial. All trials were in adult inpatients, most of whom met DSM III-R criteria for schizophrenia. Each study included 2 to 3 fixed doses of ziprasidone as well as placebo. Four of the five trials were able to distinguish ziprasidone from placebo; one short-term study did not. Although a single fixed-dose haloperidol arm was included as a comparative treatment in one of the three short-term trials, this single study was inadequate to provide a reliable and valid comparison of ziprasidone and haloperidol.

Several instruments were used for assessing psychiatric signs and symptoms in these studies. The Brief Psychiatric Rating Scale (BPRS) and the Positive and Negative Syndrome Scale (PANSS) are both multi-item inventories of general psychopathology usually used to evaluate the effects of drug treatment in schizophrenia. The BPRS psychosis cluster (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content) is considered a particularly useful subset for assessing actively psychotic schizophrenic patients. A second widely used assessment, the Clinical Global Impression (CGI), reflects the impression of a skilled observer, fully familiar with the manifestations of schizophrenia, about the overall clinical state of the patient. In addition, the Scale for Assessing Negative Symptoms (SANS) was employed for assessing negative symptoms in one trial.

The results of the oral ziprasidone trials in schizophrenia follow:

  • In a 4-week, placebo-controlled trial (n = 139) comparing two fixed doses of ziprasidone (20 mg and 60 mg twice daily) with placebo, only the 60 mg dose was superior to placebo on the BPRS total score and the CGI severity score. This higher dose group was not superior to placebo on the BPRS psychosis cluster or on the SANS.
  • In a 6-week, placebo-controlled trial (n = 302) comparing two fixed doses of ziprasidone (40 mg and 80 mg twice daily) with placebo, both dose groups were superior to placebo on the BPRS total score, the BPRS psychosis cluster, the CGI severity score and the PANSS total and negative subscale scores. Although 80 mg twice daily had a numerically greater effect than 40 mg twice daily, the difference was not statistically significant.
  • In a 6-week, placebo-controlled trial (n = 419) comparing three fixed doses of ziprasidone (20 mg, 60 mg, and 100 mg twice daily) with placebo, all three dose groups were superior to placebo on the PANSS total score, the BPRS total score, the BPRS psychosis cluster, and the CGI severity score. Only the 100 mg twice daily dose group was superior to placebo on the PANSS negative subscale score. There was no clear evidence for a dose-response relationship within the 20 mg twice daily to 100 mg twice daily dose range.
  • In a 4-week, placebo-controlled trial (n = 200) comparing three fixed doses of ziprasidone (5 mg, 20 mg and 40 mg twice daily), none of the dose groups was statistically superior to placebo on any outcome of interest.
  • A study was conducted in stable chronic or subchronic (CGI-S ≤ 5 at baseline) schizophrenic inpatients (n = 294) who had been hospitalized for not less than 2 months. After a 3-day single-blind placebo run-in, subjects were randomized to one of three fixed doses of ziprasidone (20 mg, 40 mg, or 80 mg twice daily) or placebo and observed for relapse. Patients were observed for “impending psychotic relapse,” defined as CGI-improvement score of ≥ 6 (much worse or very much worse) and/or scores ≥ 6 (moderately severe) on the hostility or uncooperativeness items of the PANSS on 2 consecutive days. Ziprasidone was significantly superior to placebo in time to relapse, with no significant difference between the different dose groups. There were insufficient data to examine population subsets based on age and race. Examination of population subsets based on gender did not reveal any differential responsiveness.

16 HOW SUPPLIED/STORAGE AND HANDLING

Ziprasidone Hydrochloride Capsules are available containing ziprasidone hydrochloride monohydrate, USP equivalent to 20 mg, 40 mg, 60 mg or 80 mg of ziprasidone.

The 20 mg capsule is a hard-shell gelatin capsule with a blue opaque cap and white opaque body axially printed with MYLAN over ZE 20 in black ink on both the cap and the body. It is filled with slightly pink colored powder. They are available as follows:

NDC 51079-351-16 – Unit dose blister packages of 60 (10 cards of 6 capsules each).

The 40 mg capsule is a hard-shell gelatin capsule with a blue opaque cap and blue opaque body axially printed with MYLAN over ZE 40 in black ink on both the cap and the body. It is filled with slightly pink colored powder. They are available as follows:

NDC 51079-352-16 – Unit dose blister packages of 60 (10 cards of 6 capsules each).

The 60 mg capsule is a hard-shell gelatin capsule with a white opaque cap and white opaque body axially printed with MYLAN over ZE 60 in black ink on both the cap and the body. It is filled with slightly pink colored powder. They are available as follows:

NDC 51079-353-16 – Unit dose blister packages of 60 (10 cards of 6 capsules each).

The 80 mg capsule is a hard-shell gelatin capsule with a blue opaque cap and white opaque body axially printed with MYLAN over ZE 80 in black ink on both the cap and the body. It is filled with slightly pink colored powder. They are available as follows:

NDC 51079-354-16 – Unit dose blister packages of 60 (10 cards of 6 capsules each).

Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]

PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

17 PATIENT COUNSELING INFORMATION

See FDA Approved Patient Labeling (17.4).

Please refer to the patient package insert. To assure safe and effective use of ziprasidone hydrochloride capsules, the information and instructions provided in the patient information should be discussed with patients.

17.1 Administration with Food

Patients should be instructed to take ziprasidone hydrochloride capsules with food for optimal absorption. The absorption of ziprasidone is increased up to 2-fold in the presence of food [see Drug Interactions (7.8) and Clinical Pharmacology (12.3)].

17.2 QTc Prolongation

Patients should be advised to inform their health care providers of the following: History of QT prolongation; recent acute myocardial infarction; uncompensated heart failure; prescription of other drugs that have demonstrated QT prolongation; risk for significant electrolyte abnormalities; and history of cardiac arrhythmia [see Contraindications (4.1) and Warnings and Precautions (5.2)].

Patients should be instructed to report the onset of any conditions that put them at risk for significant electrolyte disturbances, hypokalemia in particular, including but not limited to the initiation of diuretic therapy or prolonged diarrhea. In addition, patients should be instructed to report symptoms such as dizziness, palpitations, or syncope to the prescriber [see Warnings and Precautions (5.2)].

17.3 Severe Cutaneous Adverse Reactions

Patients should be instructed to report to their health care provider at the earliest onset any signs or symptoms that may be associated with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or with severe cutaneous adverse reactions, such as Stevens-Johnson syndrome [see Warnings and Precautions (5.4)] .

The brands listed are trademarks of their respective owners.

17.4 FDA Approved Patient Labeling

PATIENT INFORMATION
ZIPRASIDONE HYDROCHLORIDE CAPSULES
(zi pras′ i done hye″ droe klor′ ide)
20 mg, 40 mg, 60 mg and 80 mg

Information for patients taking ziprasidone hydrochloride capsules or their caregivers

This summary contains important information about ziprasidone hydrochloride capsules. It is not meant to take the place of your doctor’s instructions. Read this information carefully before you take ziprasidone hydrochloride capsules. Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about ziprasidone hydrochloride capsules.

What Are Ziprasidone Hydrochloride Capsules?

Ziprasidone hydrochloride capsules are a type of prescription medicine called a psychotropic, also known as an atypical antipsychotic. Ziprasidone hydrochloride capsules can be used to treat symptoms of schizophrenia.

Who Should Take Ziprasidone Hydrochloride Capsules?

Only your doctor can know if ziprasidone hydrochloride capsules are right for you. Ziprasidone hydrochloride capsules may be prescribed for you if you have schizophrenia.

Symptoms of schizophrenia may include:

  • hearing voices, seeing things, or sensing things that are not there (hallucinations)
  • beliefs that are not true (delusions)
  • unusual suspiciousness (paranoia)
  • becoming withdrawn from family and friends

If you show a response to ziprasidone hydrochloride capsules, your symptoms may improve. If you continue to take ziprasidone hydrochloride capsules there is less chance of your symptoms returning. Do not stop taking the capsules even when you feel better without first discussing it with your doctor.

It is also important to remember that ziprasidone hydrochloride capsules should be taken with food.

What Is The Most Important Safety Information I Should Know About Ziprasidone Hydrochloride Capsules?

Ziprasidone hydrochloride capsules are not approved for the treatment of patients with dementia-related psychosis. Elderly patients with a diagnosis of psychosis related to dementia treated with antipsychotics are at an increased risk of death when compared to patients who are treated with placebo (a sugar pill).

Ziprasidone hydrochloride capsules are an effective drug to treat the symptoms of schizophrenia. However, one potential side effect is that it may change the way the electrical current in your heart works more than some other drugs. The change is small and it is not known whether this will be harmful, but some other drugs that cause this kind of change have in rare cases caused dangerous heart rhythm abnormalities. Because of this, ziprasidone hydrochloride capsules should be used only after your doctor has considered this risk for ziprasidone hydrochloride capsules against the risks and benefits of other medications available for treating schizophrenia.

Your risk of dangerous changes in heart rhythm can be increased if you are taking certain other medicines and if you already have certain abnormal heart conditions. Therefore, it is important to tell your doctor about any other medicines that you take, including non-prescription medicines, supplements, and herbal medicines. You must also tell your doctor about any heart problems you have or have had.

Who Should NOT Take Ziprasidone Hydrochloride Capsules?

Elderly patients with a diagnosis of psychosis related to dementia. Ziprasidone hydrochloride capsules are not approved for the treatment of these patients.

Anything that can increase the chance of a heart rhythm abnormality should be avoided. Therefore, do not take ziprasidone hydrochloride capsules if:

  • You have certain heart diseases, for example, long QT syndrome, a recent heart attack, severe heart failure or certain irregularities of heart rhythm (discuss the specifics with your doctor)
  • You are currently taking medications that should not be taken in combination with ziprasidone, for example, dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol or tacrolimus.

What To Tell Your Doctor Before You Start Ziprasidone Hydrochloride Capsules

Only your doctor can decide if ziprasidone hydrochloride capsules are right for you. Before you start ziprasidone hydrochloride capsules, be sure to tell your doctor if you:

  • have had any problem with the way your heart beats or any heart related illness or disease
  • any family history of heart disease, including recent heart attack
  • have had any problem with fainting or dizziness
  • are taking or have recently taken any prescription medicines
  • are taking any over-the-counter medicines you can buy without a prescription, including natural/herbal remedies
  • have had any problems with your liver
  • are pregnant, might be pregnant, or plan to get pregnant
  • are breast feeding
  • are allergic to any medicines
  • have ever had an allergic reaction to ziprasidone or any of the other ingredients of ziprasidone hydrochloride capsules. Ask your doctor or pharmacist for a list of these ingredients
  • have low levels of potassium or magnesium in your blood

Your doctor may want you to get additional laboratory tests to see if ziprasidone hydrochloride capsules are an appropriate treatment for you.

Ziprasidone Hydrochloride Capsules And Other Medicines

There are some medications that may be unsafe to use when taking ziprasidone hydrochloride capsules and there are some medicines that can affect how well ziprasidone hydrochloride capsules work. While you are on ziprasidone, check with your doctor before starting any new prescription or over-the-counter medications, including natural/herbal remedies.

How To Take Ziprasidone Hydrochloride Capsules

  • Take ziprasidone hydrochloride capsules only as directed by your doctor.
  • Swallow the capsules whole.
  • Take ziprasidone hydrochloride capsules with food.
  • It is best to take ziprasidone hydrochloride capsules at the same time each day.
  • Ziprasidone hydrochloride capsules may take a few weeks to work. It is important to be patient.
  • Do not change your dose or stop taking your medicine without your doctor’s approval.
  • Remember to keep taking your capsules, even when you feel better.

Possible Side Effects

Because these problems could mean you’re having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you:

  • Faint or lose consciousness
  • Feel a change in the way that your heart beats (palpitations)

Common side effects of ziprasidone hydrochloride capsules include the following and should also be discussed with your doctor if they occur:

  • Feeling unusually tired or sleepy
  • Nausea or upset stomach
  • Constipation
  • Dizziness
  • Restlessness
  • Abnormal muscle movements, including tremor, shuffling and uncontrolled involuntary movements
  • Diarrhea
  • Rash
  • Increased cough / runny nose

If you develop any side effects that concern you, talk with your doctor. It is particularly important to tell your doctor if you have diarrhea, vomiting, or another illness that can cause you to lose fluids. Your doctor may want to check your blood to make sure that you have the right amount of important salts after such illnesses.

For a list of all side effects that have been reported, ask your doctor or pharmacist for the Ziprasidone Hydrochloride Capsules Professional Package Insert.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What To Do For An Overdose

In case of an overdose, call your doctor or poison control center right away or go to the nearest emergency room.

Other Important Safety Information

A serious condition called neuroleptic malignant syndrome (NMS) can occur with all antipsychotic medications including ziprasidone hydrochloride capsules. Signs of NMS include very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. NMS is a rare but serious side effect that could be fatal. Therefore, tell your doctor if you experience any of these signs.

Delayed-onset drug reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with ziprasidone. Signs of DRESS may include rash, fever, and swollen lymph nodes. Other severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome can occur with ziprasidone. Signs of Stevens-Johnson syndrome may include rash with blisters which could include ulcers in mouth, skin shedding, fever and target-like spots in the skin. DRESS and other SCAR are sometimes fatal; therefore, tell your doctor immediately if you experience any of these signs.

Adverse reactions related to high blood sugar (hyperglycemia), sometimes serious, have been reported in patients treated with atypical antipsychotics. There have been few reports of hyperglycemia or diabetes in patients treated with ziprasidone hydrochloride capsules, and it is not known if ziprasidone hydrochloride capsules are associated with these reactions. Patients treated with an atypical antipsychotic should be monitored for symptoms of hyperglycemia.

Dizziness caused by a drop in your blood pressure may occur with ziprasidone hydrochloride capsules, especially when you first start taking this medication or when the dose is increased. If this happens, be careful not to stand up too quickly, and talk to your doctor about the problem.

Before taking ziprasidone hydrochloride capsules, tell your doctor if you are pregnant or plan on becoming pregnant. It is advised that you don’t breast feed an infant if you are taking ziprasidone hydrochloride capsules.

Because ziprasidone hydrochloride capsules can cause sleepiness, be careful when operating machinery or driving a motor vehicle.

Since medications of the same drug class as ziprasidone hydrochloride capsules may interfere with the ability of the body to adjust to heat, it is best to avoid situations involving high temperature or humidity.

It is best to avoid consuming alcoholic beverages while taking ziprasidone hydrochloride capsules.

Call your doctor immediately if you take more than the amount of ziprasidone hydrochloride capsules prescribed by your doctor.

Ziprasidone hydrochloride capsules have not been shown to be safe or effective in the treatment of children and teenagers under the age of 18 years old.

Keep ziprasidone hydrochloride capsules and all medicines out of the reach of children.

How To Store Ziprasidone Hydrochloride Capsules

Store ziprasidone hydrochloride capsules at 20º to 25ºC (68º to 77ºF).

For More Information About Ziprasidone Hydrochloride Capsules

This sheet is only a summary. Ziprasidone hydrochloride capsules are a prescription medicine and only your doctor can decide if it is right for you. If you have any questions or want more information about ziprasidone hydrochloride capsules, talk with your doctor or pharmacist.

For more information, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured in India by:
Mylan Laboratories Limited
Hyderabad — 500 034, India
Code No. MH/DRUGS/25/NKD/89

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-11296 R2
5/16

PRINCIPAL DISPLAY PANEL — 20 mg

NDC 51079-351-16

Ziprasidone HCl
Capsules
20 mg*

60 Capsules (10 x 6)

*Each capsule contains ziprasidone
hydrochloride monohydrate, USP
equivalent to 20 mg of ziprasidone.

Usual Dosage: See accompanying
prescribing information and Patient
Information Leaflet.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Code No.: MH/DRUGS/25/NKD/89

Manufactured for:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Made in India

Rx only

S-11297

Code No.: MH/DRUGS/25/NKD/89

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Ziprasidone HCl 20 mg Capsules Unit Carton Label
(click image for full-size original)
Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg

NDC 51079-352-16

Ziprasidone HCl
Capsules
40 mg*

60 Capsules (10 x 6)

*Each capsule contains ziprasidone
hydrochloride monohydrate, USP
equivalent to 40 mg of ziprasidone.

Usual Dosage: See accompanying
prescribing information and Patient
Information Leaflet.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Code No.: MH/DRUGS/25/NKD/89

Manufactured for:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Made in India

Rx only

S-11298

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Ziprasidone HCl 40 mg Capsules Unit Carton Label
(click image for full-size original)
Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 mg

NDC 51079-353-16

Ziprasidone HCl
Capsules
60 mg*

60 Capsules (10 x 6)

*Each capsule contains ziprasidone
hydrochloride monohydrate, USP
equivalent to 60 mg of ziprasidone.

Usual Dosage: See accompanying
prescribing information and Patient
Information Leaflet.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Code No.: MH/DRUGS/25/NKD/89

Manufactured for:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Made in India

Rx only

S-11299

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Ziprasidone HCl 60 Capsules Unit Carton Label
(click image for full-size original)
Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 80 mg

NDC 51079-354-16

Ziprasidone HCl
Capsules
80 mg*

60 Capsules (10 x 6)

*Each capsule contains ziprasidone
hydrochloride monohydrate, USP
equivalent to 80 mg of ziprasidone.

Usual Dosage: See accompanying
prescribing information and Patient
Information Leaflet.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Code No.: MH/DRUGS/25/NKD/89

Manufactured for:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Made in India

Rx only

S-11300

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Ziprasidone HCl 80 mg Capsules Unit Carton Label
(click image for full-size original)
Unit Carton
(click image for full-size original)
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-351(NDC:0378-7350)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE) ZIPRASIDONE 20 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLACRILIN POTASSIUM
POTASSIUM HYDROXIDE
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color blue (blue opaque) , white (white opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code MYLAN;ZE;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-351-16 60 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-351-01)
1 NDC:51079-351-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (51079-351-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202395 09/30/2014 07/31/2017
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-352(NDC:0378-7351)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE) ZIPRASIDONE 40 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLACRILIN POTASSIUM
POTASSIUM HYDROXIDE
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color blue (blue opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code MYLAN;ZE;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-352-16 60 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-352-01)
1 NDC:51079-352-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (51079-352-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202395 09/30/2014 01/31/2018
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-353(NDC:0378-7352)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE) ZIPRASIDONE 60 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
GELATIN, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLACRILIN POTASSIUM
POTASSIUM HYDROXIDE
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color white (white opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code MYLAN;ZE;60
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-353-16 60 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-353-01)
1 NDC:51079-353-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (51079-353-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202395 09/30/2014 02/28/2018
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-354(NDC:0378-7353)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE) ZIPRASIDONE 80 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLACRILIN POTASSIUM
POTASSIUM HYDROXIDE
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color blue (blue opaque) , white (white opaque) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code MYLAN;ZE;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-354-16 60 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-354-01)
1 NDC:51079-354-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (51079-354-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202395 09/30/2014 02/28/2018
Labeler — Mylan Institutional Inc. (039615992)

Revised: 11/2017 Mylan Institutional Inc.

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