PAROXETINE- paroxetine hydrochloride hemihydrate tablet, film coated, extended release

PAROXETINE by

Drug Labeling and Warnings

PAROXETINE by is a Prescription medication manufactured, distributed, or labeled by Rhodes Pharmaceuticals L.P., Quotient Sciences-Philadelphia, LLC, Beijing Sciecure Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Postmarketing Reports

Voluntary reports of adverse events in patients taking immediate-release paroxetine hydrochloride that have been received since market introduction and not listed above that may have no causal relationship with the drug include acute pancreatitis, elevated liver function tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction), Guillain-Barré syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, priapism, syndrome of inappropriate ADH secretion, symptoms suggestive of prolactinemia and galactorrhea; extrapyramidal symptoms which have included akathisia, bradykinesia, cogwheel rigidity, dystonia, hypertonia, oculogyric crisis which has been associated with concomitant use of pimozide; tremor and trismus; status epilepticus, acute renal failure, pulmonary hypertension, allergic alveolitis, anaphylaxis, eclampsia, laryngismus, optic neuritis, porphyria, restless legs syndrome (RLS), ventricular fibrillation, ventricular tachycardia (including torsade de pointes), thrombocytopenia, hemolytic anemia, events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, and agranulocytosis), vasculitic syndromes (such as Henoch-Schönlein purpura), and premature births in pregnant women. There has been a case report of an elevated phenytoin level after 4 weeks of immediate-release paroxetine and phenytoin coadministration. There has been a case report of severe hypotension when immediate-release paroxetine was added to chronic metoprolol treatment.

  • DRUG ABUSE AND DEPENDENCE

    Controlled Substance Class

    Paroxetine extended-release tablets are not a controlled substance.

    Physical and Psychologic Dependence

    Paroxetine extended-release tablets have not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of paroxetine extended-release tablets (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

  • OVERDOSAGE

    Human Experience

    Since the introduction of immediate-release paroxetine hydrochloride in the United States, 342 spontaneous cases of deliberate or accidental overdosage during paroxetine treatment have been reported worldwide (circa 1999). These include overdoses with paroxetine alone and in combination with other substances. Of these, 48 cases were fatal and of the fatalities, 17 appeared to involve paroxetine alone. Eight fatal cases that documented the amount of paroxetine ingested were generally confounded by the ingestion of other drugs or alcohol or the presence of significant comorbid conditions. Of 145 non-fatal cases with known outcome, most recovered without sequelae. The largest known ingestion involved 2,000 mg of paroxetine (33 times the maximum recommended daily dose) in a patient who recovered.

    Commonly reported adverse events associated with paroxetine overdosage include somnolence, coma, nausea, tremor, tachycardia, confusion, vomiting, and dizziness. Other notable signs and symptoms observed with overdoses involving paroxetine (alone or with other substances) include mydriasis, convulsions (including status epilepticus), ventricular dysrhythmias (including torsade de pointes), hypertension, aggressive reactions, syncope, hypotension, stupor, bradycardia, dystonia, rhabdomyolysis, symptoms of hepatic dysfunction (including hepatic failure, hepatic necrosis, jaundice, hepatitis, and hepatic steatosis), serotonin syndrome, manic reactions, myoclonus, acute renal failure, and urinary retention.

    Overdosage Management

    No specific antidotes for paroxetine are known. Treatment should consist of those general measures employed in the management of overdosage with any drugs effective in the treatment of major depressive disorder.

    Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, or exchange perfusion are unlikely to be of benefit.

    A specific caution involves patients taking or recently having taken paroxetine who might ingest excessive quantities of a tricyclic antidepressant. In such a case, accumulation of the parent tricyclic and an active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for close medical observation (see PRECAUTIONS: Drugs Metabolized by Cytochrome CYP2D6).

    In managing overdosage, consider the possibility of multiple-drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the Physicians' Desk Reference (PDR).

  • DOSAGE AND ADMINISTRATION

    Major Depressive Disorder

    Usual Initial Dosage

    Paroxetine extended-release tablets should be administered as a single daily dose, usually in the morning, with or without food. The recommended initial dose is 25 mg/day. Patients were dosed in a range of 25 mg to 62.5 mg/day in the clinical trials demonstrating the effectiveness of paroxetine extended-release tablets in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 25 mg dose may benefit from dose increases, in 12.5 mg/day increments, up to a maximum of 62.5 mg/day. Dose changes should occur at intervals of at least 1 week.

    Patients should be cautioned that paroxetine extended-release tablets should not be chewed or crushed, and should be swallowed whole.

    Maintenance Therapy

    There is no body of evidence available to answer the question of how long the patient treated with paroxetine extended-release tablets should remain on it. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose of an antidepressant needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.

    Systematic evaluation of the efficacy of immediate-release paroxetine hydrochloride has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg, which corresponds to a 37.5 mg dose of paroxetine extended-release tablets, based on relative bioavailability considerations (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

    Panic Disorder

    Usual Initial Dosage

    Paroxetine extended-release tablets should be administered as a single daily dose, usually in the morning. Patients should be started on 12.5 mg/day. Dose changes should occur in 12.5 mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 12.5 mg to 75 mg/day in the clinical trials demonstrating the effectiveness of paroxetine extended-release tablets. The maximum dosage should not exceed 75 mg/day.

    Patients should be cautioned that paroxetine extended-release tablets should not be chewed or crushed, and should be swallowed whole.

    Maintenance Therapy

    Long-term maintenance of efficacy with the immediate-release formulation of paroxetine was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to immediate-release paroxetine demonstrated a lower relapse rate compared to patients on placebo. Panic disorder is a chronic condition and it is reasonable to consider continuation for a responding patient.

    Dosage adjustments should be made to maintain the patient on the lowest effective dosage and patients should be periodically reassessed to determine the need for continued treatment.

    Social Anxiety Disorder

    Usual Initial Dosage

    Paroxetine extended-release tablets should be administered as a single daily dose, usually in the morning, with or without food. The recommended initial dose is 12.5 mg/day. Patients were dosed in a range of 12.5 mg to 37.5 mg/day in the clinical trial demonstrating the effectiveness of paroxetine extended-release tablets in the treatment of social anxiety disorder. If the dose is increased, this should occur at intervals of at least 1 week, in increments of 12.5 mg/day, up to a maximum of 37.5 mg/day.

    Patients should be cautioned that paroxetine extended-release tablets should not be chewed or crushed, and should be swallowed whole.

    Maintenance Therapy

    There is no body of evidence available to answer the question of how long the patient treated with paroxetine extended-release tablets should remain on it. Although the efficacy of paroxetine extended-release tablets beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage and patients should be periodically reassessed to determine the need for continued treatment.

    Premenstrual Dysphoric Disorder

    Usual Initial Dosage

    Paroxetine extended-release tablets should be administered as a single daily dose, usually in the morning, with or without food. Paroxetine extended-release tablets may be administered either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment. The recommended initial dose is 12.5 mg/day. In clinical trials, both 12.5 mg/day and 25 mg/day were shown to be effective. Dose changes should occur at intervals of at least 1 week.

    Patients should be cautioned that paroxetine extended-release tablets should not be chewed or crushed, and should be swallowed whole.

    Maintenance/Continuation Therapy

    The effectiveness of paroxetine extended-release tablets for a period exceeding 3 menstrual cycles has not been systematically evaluated in controlled trials. However, women commonly report that symptoms worsen with age until relieved by the onset of menopause. Therefore, it is reasonable to consider continuation of a responding patient. Patients should be periodically reassessed to determine the need for continued treatment.

    Special Populations

    Treatment of Pregnant Women during the Third Trimester

    Neonates exposed to paroxetine extended-release tablets and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see WARNINGS: Usage in Pregnancy). When treating pregnant women with paroxetine during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.

    Dosage for Elderly or Debilitated Patients, and Patients with Severe Renal or Hepatic Impairment

    The recommended initial dose of paroxetine extended-release tablets is 12.5 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 50 mg/day.

    Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

    At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with paroxetine extended-release tablets. Conversely, at least 14 days should be allowed after stopping paroxetine extended-release tablets before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

    Use of Paroxetine Extended-Release Tablets with Other MAOIs, Such as Linezolid or Methylene Blue

    Do not start paroxetine extended-release tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

    In some cases, a patient already receiving therapy with paroxetine extended-release tablets may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, paroxetine extended-release tablets should be stopped promptly and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with paroxetine extended-release tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

    The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with paroxetine extended-release tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

    Discontinuation of Treatment with Paroxetine Extended-Release Tablets

    Symptoms associated with discontinuation of immediate-release paroxetine hydrochloride or paroxetine extended-release tablets have been reported (see PRECAUTIONS: Discontinuation of Treatment with Paroxetine Extended-Release Tablets). Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which paroxetine extended-release tablets are being prescribed. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

  • HOW SUPPLIED

    Paroxetine Extended-Release Tablets, USP are supplied as follows:

    12.5 mg White enteric coated, round, bi-convex tablets, with one side debossed 2271 and the other side blank:

    NDC: 42858-703-03Bottles of 30
    NDC: 42858-703-50Bottles of 500

    25 mg Brown enteric coated, round, bi-convex tablets, with one side debossed 2272 and the other side blank:

    NDC: 42858-705-03Bottles of 30
    NDC: 42858-705-50Bottles of 500

    37.5 mg Orange enteric coated, round, bi-convex tablets, with one side debossed 2273 and the other side blank.:

    NDC: 42858-707-03Bottles of 30
    NDC: 42858-707-50Bottles of 500

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

  • SPL UNCLASSIFIED SECTION

    Manufactured by Quotient Sciences-Philadelphia, LLC
    Boothwyn, PA 19061

    Manufactured for Sciecure Pharma Inc.
    Monmouth Junction, NJ 08852

    Marketed by Rhodes Pharmaceuticals
    Coventry, RI 02816

    Rev.06/2019

    306001-0A

  • MEDICATION GUIDEPAROXETINE (par ox' e teen) EXTENDED-RELEASE TABLETS, USP

    Read the Medication Guide that comes with Paroxetine Extended-Release Tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.

    What is the most important information I should know about Paroxetine Extended-Release Tablets?

    Paroxetine Extended-Release Tablets and other antidepressant medicines may cause serious side effects, including:

    Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

    Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

    Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Paroxetine Extended-Release Tablets may be associated with these serious side effects:

    Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

    Do not stop Paroxetine Extended-Release Tablets without first talking to your healthcare provider. Stopping Paroxetine Extended-Release Tablets too quickly may cause serious symptoms including:

    What are Paroxetine Extended-Release Tablets?

    Paroxetine Extended-Release Tablets are a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. Paroxetine Extended-Release Tablets are also used to treat:

    Talk to your healthcare provider if you do not think that your condition is getting better with treatment using Paroxetine Extended-Release Tablets.

    Who should not take Paroxetine Extended-Release Tablets?

    Do not take Paroxetine Extended-Release Tablets if you:

    What should I tell my healthcare provider before taking Paroxetine Extended-Release Tablets? Ask if you are not sure.

    Before starting Paroxetine Extended-Release Tablets, tell your healthcare provider if you:

    Tell your healthcare provider about all the medicines you take, including prescription and non- prescription medicines, vitamins, and herbal supplements. Paroxetine Extended-Release Tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects.

    Your healthcare provider or pharmacist can tell you if it is safe to take Paroxetine Extended-Release Tablets with your other medicines. Do not start or stop any medicine while taking Paroxetine Extended-Release Tablets without talking to your healthcare provider first.

    If you take Paroxetine Extended-Release tablets, you should not take any other medicines that contain paroxetine, including PAXIL® and PEXEVA® (paroxetine mesylate).

    How should I take Paroxetine Extended-Release Tablets?

    What should I avoid while taking Paroxetine Extended-Release Tablets?

    Paroxetine Extended-Release Tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Paroxetine Extended-Release Tablets affects you. Do not drink alcohol while using Paroxetine Extended-Release Tablets.

    What are possible side effects of Paroxetine Extended-Release Tablets?

    Paroxetine Extended-Release Tablets may cause serious side effects, including all of those described in the section entitled "What is the most important information I should know about Paroxetine Extended-Release Tablets?"

    Common possible side effects in people who take Paroxetine Extended-Release Tablets include:

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Paroxetine Extended-Release Tablets. For more information, ask your healthcare provider or pharmacist.

    CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 or 1-800-332-1088.

    How should I store Paroxetine Extended-Release Tablets?

    Keep Paroxetine Extended-Release Tablets and all medicines out of the reach of children.

    General information about Paroxetine Extended-Release Tablets

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Paroxetine Extended-Release Tablets for a condition for which it was not prescribed. Do not give Paroxetine Extended-Release Tablets to other people, even if they have the same condition. It may harm them.

    This Medication Guide summarizes the most important information about Paroxetine Extended-Release Tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about Paroxetine Extended-Release Tablets that is written for healthcare professionals.

    For more information about Paroxetine Extended-Release Tablets call 1-888-827-0616.

    What are the ingredients in Paroxetine Extended-Release Tablets?

    Active ingredient: paroxetine hydrochloride

    Inactive ingredients in tablets: carboxymethylcellulose sodium, copovidone, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid – ethyl acrylate copolymer (1:1), polysorbate 80, silicon dioxide, sodium lauryl sulfate, talcum, titanium dioxide and triethyl citrate. In addition, the 25 mg tablets also contain the following coloring agents: iron oxide black and iron oxide red and the 37.5 mg tablets contain iron oxide red and iron oxide yellow.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Manufactured by:
    Quotient Sciences-Philadelphia, LLC
    Boothwyn, PA 19061

    Manufactured for:
    Sciecure Pharma Inc.
    Monmouth Junction, NJ 08852

    Marketed by:
    Rhodes Pharmaceuticals L.P.
    Coventry, RI 02816
    Revised: 06/2019

    Brands listed are the trademarks of their respective owners.
    306001-0A

  • PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Bottle Label

    NDC 42858-703-03

    Paroxetine
    Extended-Release
    Tablets, USP

    12.5 mg
    Rx Only

    PHARMACIST: Dispense the
    accompanying Medication
    Guide to each patient

    Rhodes

    30 Tablets

    PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label

    NDC 42858-705-03

    Paroxetine
    Extended-Release
    Tablets, USP

    25 mg
    Rx Only

    PHARMACIST: Dispense the
    accompanying Medication
    Guide to each patient

    Rhodes

    30 Tablets

    PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 37.5 mg Tablet Bottle Label

    NDC 42858-707-03

    Paroxetine
    Extended-Release
    Tablets, USP

    37.5 mg
    Rx Only

    PHARMACIST: Dispense the
    accompanying Medication
    Guide to each patient

    Rhodes

    30 Tablets

    PRINCIPAL DISPLAY PANEL - 37.5 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    PAROXETINE 
    paroxetine hydrochloride hemihydrate tablet, film coated, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 42858-703
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAROXETINE HYDROCHLORIDE HEMIHYDRATE (UNII: X2ELS050D8) (PAROXETINE - UNII:41VRH5220H) PAROXETINE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Hypromellose, unspecified (UNII: 3NXW29V3WO)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Silicon dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Triethyl Citrate (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 2271
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 42858-703-0330 in 1 BOTTLE; Type 0: Not a Combination Product09/14/2018
    2NDC: 42858-703-50500 in 1 BOTTLE; Type 0: Not a Combination Product09/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20929309/14/2018
    PAROXETINE 
    paroxetine hydrochloride hemihydrate tablet, film coated, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 42858-705
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAROXETINE HYDROCHLORIDE HEMIHYDRATE (UNII: X2ELS050D8) (PAROXETINE - UNII:41VRH5220H) PAROXETINE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Hypromellose, unspecified (UNII: 3NXW29V3WO)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Silicon dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Triethyl Citrate (UNII: 8Z96QXD6UM)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 2272
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 42858-705-0330 in 1 BOTTLE; Type 0: Not a Combination Product09/14/2018
    2NDC: 42858-705-50500 in 1 BOTTLE; Type 0: Not a Combination Product09/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20929309/14/2018
    PAROXETINE 
    paroxetine hydrochloride hemihydrate tablet, film coated, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 42858-707
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAROXETINE HYDROCHLORIDE HEMIHYDRATE (UNII: X2ELS050D8) (PAROXETINE - UNII:41VRH5220H) PAROXETINE37.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Hypromellose, unspecified (UNII: 3NXW29V3WO)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Silicon dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Triethyl Citrate (UNII: 8Z96QXD6UM)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 2273
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 42858-707-0330 in 1 BOTTLE; Type 0: Not a Combination Product09/14/2018
    2NDC: 42858-707-50500 in 1 BOTTLE; Type 0: Not a Combination Product09/14/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20929309/14/2018
    Labeler - Rhodes Pharmaceuticals L.P. (831928986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sciecure Pharma Inc.078463813ANALYSIS(42858-703, 42858-705, 42858-707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Quotient Sciences-Philadelphia, LLC126874135MANUFACTURE(42858-703, 42858-705, 42858-707)

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