RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "16590-843-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (16590-843-90)",
      "NDC11Code": "16590-0843-90",
      "ProductNDC": "16590-843",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prozac",
      "NonProprietaryName": "Fluoxetine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19871229",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018936",
      "LabelerName": "Stat Rx USA",
      "SubstanceName": "FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Prozac is indicated for the treatment of major depressive disorder. Adult — The efficacy of Prozac was established in 5– and 6–week trials with depressed adult and geriatric outpatients (≥18 years of age) whose diagnoses corresponded most closely to the DSM–III (currently DSM–IV) category of major depressive disorder (see CLINICAL TRIALS). A major depressive episode (DSM–IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effects of Prozac in hospitalized depressed patients have not been adequately studied. The efficacy of Prozac 20 mg once daily in maintaining a response in major depressive disorder for up to 38 weeks following 12 weeks of open–label acute treatment (50 weeks total) was demonstrated in a placebo–controlled trial. The efficacy of Prozac Weekly once weekly in maintaining a response in major depressive disorder has been demonstrated in a placebo–controlled trial for up to 25 weeks following open–label acute treatment of 13 weeks with Prozac 20 mg daily for a total treatment of 38 weeks. However, it is unknown whether or not Prozac Weekly given on a once–weekly basis provides the same level of protection from relapse as that provided by Prozac 20 mg daily (see  CLINICAL TRIALS). Pediatric (children and adolescents) — The efficacy of Prozac in children and adolescents was established in two 8– to 9–week placebo–controlled clinical trials in depressed outpatients whose diagnoses corresponded most closely to the DSM–III–R or DSM–IV category of major depressive disorder (see CLINICAL TRIALS). The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should be reevaluated periodically. Adult — Prozac is indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in the DSM–III–R; i.e., the obsessions or compulsions cause marked distress, are time–consuming, or significantly interfere with social or occupational functioning. The efficacy of Prozac was established in 13–week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the DSM–III–R category of OCD (see CLINICAL TRIALS). OCD is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego–dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The effectiveness of Prozac in long–term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo–controlled trials. Therefore, the physician who elects to use Prozac for extended periods should periodically reevaluate the long–term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Pediatric (children and adolescents) — The efficacy of Prozac in children and adolescents was established in a 13–week, dose titration, clinical trial in patients with OCD, as defined in DSM–IV (see CLINICAL TRIALS). Prozac is indicated for the treatment of binge–eating and vomiting behaviors in patients with moderate to severe bulimia nervosa. The efficacy of Prozac was established in 8– to 16–week trials for adult outpatients with moderate to severe bulimia nervosa, i.e., at least 3 bulimic episodes per week for 6 months (see CLINICAL TRIALS). The efficacy of Prozac 60 mg/day in maintaining a response, in patients with bulimia who responded during an 8–week acute treatment phase while taking Prozac 60 mg/day and were then observed for relapse during a period of up to 52 weeks, was demonstrated in a placebo–controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use Prozac for extended periods should periodically reevaluate the long–term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Prozac is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM–IV. Panic disorder is characterized by the occurrence of unexpected panic attacks, and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Prozac was established in two 12–week clinical trials in patients whose diagnoses corresponded to the DSM–IV category of panic disorder (see CLINICAL TRIALS). Panic disorder (DSM–IV) is characterized by recurrent, unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which 4 or more of the following symptoms develop abruptly and reach a peak within 10 minutes: 1) palpitations, pounding heart, or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5) feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded, or faint; 9) fear of losing control; 10) fear of dying; 11) paresthesias (numbness or tingling sensations); 12) chills or hot flashes. The effectiveness of Prozac in long–term use, i.e., for more than 12 weeks, has not been established in placebo–controlled trials. Therefore, the physician who elects to use Prozac for extended periods should periodically reevaluate the long–term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
      "Description": "Prozac® (fluoxetine capsules, USP and fluoxetine oral solution, USP) is a psychotropic drug for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off–white crystalline solid with a solubility of 14 mg/mL in water. Each Pulvule® contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The Pulvules also contain starch, gelatin, silicone, titanium dioxide, iron oxide, and other inactive ingredients. The 10– and 20–mg Pulvules also contain FDandC Blue No. 1, and the 40–mg Pulvule also contains FDnadC Blue No. 1 and FDandC Yellow No. 6. The oral solution contains fluoxetine hydrochloride equivalent to 20 mg/5 mL (64.7 μmol) of fluoxetine. It also contains alcohol 0.23%, benzoic acid, flavoring agent, glycerin, purified water, and sucrose. Prozac Weekly capsules, a delayed–release formulation, contain enteric–coated pellets of fluoxetine hydrochloride equivalent to 90 mg (291 μmol) of fluoxetine. The capsules also contain DandC Yellow No. 10, FDandC Blue No. 2, gelatin, hypromellose, hypromellose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, triethyl citrate, and other inactive ingredients."
    },
    {
      "NDCCode": "43353-843-60",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (43353-843-60) ",
      "NDC11Code": "43353-0843-60",
      "ProductNDC": "43353-843",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atorvastatin Calcium",
      "NonProprietaryName": "Atorvastatin Calcium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180217",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076477",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20180628",
      "SamplePackage": "N",
      "IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
      "Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*,R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium, USP is a white to off-white crystalline powder. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble to insoluble in water and pH 7.4 phosphate buffer; insoluble in acetonitrile; slightly soluble to very slightly soluble in ethanol; and freely soluble to slightly soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate; candelilla wax, FCC; croscarmellose sodium; hydroxypropyl cellulose; hypromellose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polysorbate 80; simethicone emulsion; talc, and titanium dioxide."
    },
    {
      "NDCCode": "55700-843-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (55700-843-90) ",
      "NDC11Code": "55700-0843-90",
      "ProductNDC": "55700-843",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrochlorothiazide",
      "NonProprietaryName": "Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200221",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040412",
      "LabelerName": "Quality Care Products, LLC",
      "SubstanceName": "HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20200313",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
      "Description": "Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is supplied as 25 mg and 50 mg tablets for oral use. Each tablet contains the following inactive ingredients: FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch."
    },
    {
      "NDCCode": "60429-843-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (60429-843-90)",
      "NDC11Code": "60429-0843-90",
      "ProductNDC": "60429-843",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rosuvastatin",
      "NonProprietaryName": "Rosuvastatin Calcium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160912",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079145",
      "LabelerName": "Golden State Medical Supply, Inc.",
      "SubstanceName": "ROSUVASTATIN CALCIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-02-07"
    },
    {
      "NDCCode": "61919-843-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (61919-843-90) ",
      "NDC11Code": "61919-0843-90",
      "ProductNDC": "61919-843",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151125",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202764",
      "LabelerName": "DirectRX",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "800",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20151125",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gabapentin Tablets, USP are indicated for. Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
      "Description": "The active ingredient in gabapentin tablets USP is gabapentin USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. The inactive ingredients are mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium stearate and aquarius® BP18114 Cool Vanilla."
    },
    {
      "NDCCode": "63187-843-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (63187-843-90) ",
      "NDC11Code": "63187-0843-90",
      "ProductNDC": "63187-843",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eszopiclone",
      "NonProprietaryName": "Eszopiclone",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140425",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202929",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "ESZOPICLONE",
      "StrengthNumber": "3",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2023-07-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).",
      "Description": "Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1carboxylate. Its molecular weight is 388.81, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2."
    },
    {
      "NDCCode": "69097-843-05",
      "PackageDescription": "90 TABLET in 1 BOTTLE (69097-843-05) ",
      "NDC11Code": "69097-0843-05",
      "ProductNDC": "69097-843",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Quinapril",
      "NonProprietaryName": "Quinapril",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160722",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078457",
      "LabelerName": "Cipla USA Inc.",
      "SubstanceName": "QUINAPRIL HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2023-01-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160722",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypertension. Quinapril is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Quinapril may be used alone or in combination with thiazide diuretics. Heart Failure. Quinapril is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril does not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.",
      "Description": "Quinapril hydrochloride, USP is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride, USP is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 HCl and its structural formula is. Quinapril hydrochloride, USP is a white to off-white amorphous powder that is freely soluble in aqueous solvents. Quinapril tablets, USP contain quinapril hydrochloride equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of quinapril for oral administration. Each tablet also contains lactose monohydrate, magnesium carbonate, magnesium stearate, crospovidone, povidone and opadry brown (hypromellose, titanium dioxide, iron oxide and macrogol)."
    },
    {
      "NDCCode": "70934-843-90",
      "PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-843-90) ",
      "NDC11Code": "70934-0843-90",
      "ProductNDC": "70934-843",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Glipizide",
      "NonProprietaryName": "Glipizide",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210316",
      "EndMarketingDate": "20230630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206928",
      "LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
      "SubstanceName": "GLIPIZIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20210504",
      "EndMarketingDatePackage": "20230630",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71205-843-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71205-843-90) ",
      "NDC11Code": "71205-0843-90",
      "ProductNDC": "71205-843",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Perphenazine",
      "NonProprietaryName": "Perphenazine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205056",
      "LabelerName": "Proficient Rx LP",
      "SubstanceName": "PERPHENAZINE",
      "StrengthNumber": "8",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
      "Status": "Active",
      "LastUpdate": "2023-02-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230210",
      "SamplePackage": "N",
      "IndicationAndUsage": "Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.",
      "Description": "Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol),  a piperazinyl phenothiazine, having the chemical formula, C21H26CIN3OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg and 16 mg of perphenazine. Inactive ingredients: microcrystalline cellulose, hypromellose, lactose monohydrate, corn starch, purified water, magnesium stearate, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide and polysorbate 80. Its structural formula is."
    },
    {
      "NDCCode": "71610-843-60",
      "PackageDescription": "90 TABLET in 1 BOTTLE (71610-843-60) ",
      "NDC11Code": "71610-0843-60",
      "ProductNDC": "71610-843",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Furosemide",
      "NonProprietaryName": "Furosemide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077293",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "FUROSEMIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-07-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240626",
      "SamplePackage": "N",
      "IndicationAndUsage": "Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide tablets are particularly useful when an agent with greater diuretic potential is desired.",
      "Description": "Furosemide tablets are a diuretic which is an anthranilic acid derivative. Furosemide tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch, lactose anhydrous, magnesium stearate, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and colloidal silicon dioxide. Chemically, it is 4-chloro-N-furfuryl- 5-sulfamoylanthranilic acid. Furosemide tablets are available as white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows."
    },
    {
      "NDCCode": "76420-843-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (76420-843-90) ",
      "NDC11Code": "76420-0843-90",
      "ProductNDC": "76420-843",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celecoxib",
      "NonProprietaryName": "Celecoxib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201203",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205129",
      "LabelerName": "Asclemed USA, Inc.",
      "SubstanceName": "CELECOXIB",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240817",
      "SamplePackage": "N",
      "IndicationAndUsage": "Celecoxib is indicated.",
      "Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red #40 aluminum lake. 100 mg capsule contains shellac, propylene glycol, ammonia and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol, ammonia and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, ammonia, yellow iron oxide, and FD & C Blue No. # 1 aluminum lake."
    },
    {
      "NDCCode": "16590-005-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (16590-005-90)",
      "NDC11Code": "16590-0005-90",
      "ProductNDC": "16590-005",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alprazolam",
      "NonProprietaryName": "Alprazolam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110325",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074112",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "ALPRAZOLAM",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or ‘lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or ‘mind going blank’ because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam.",
      "Description": "Alprazolam is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, for oral administration, contains 0.25, 0.5, or 1 mg of alprazolam. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD & C Yellow #6 Aluminum Lake, and the 1 mg also contains FD & C Blue #2 Aluminum Lake."
    },
    {
      "NDCCode": "16590-006-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (16590-006-90)",
      "NDC11Code": "16590-0006-90",
      "ProductNDC": "16590-006",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alprazolam",
      "NonProprietaryName": "Alprazolam",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110325",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074112",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "ALPRAZOLAM",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or ‘lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or ‘mind going blank’ because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam.",
      "Description": "Alprazolam is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, for oral administration, contains 0.25, 0.5, or 1 mg of alprazolam. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD & C Yellow #6 Aluminum Lake, and the 1 mg also contains FD & C Blue #2 Aluminum Lake."
    },
    {
      "NDCCode": "16590-008-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (16590-008-90)",
      "NDC11Code": "16590-0008-90",
      "ProductNDC": "16590-008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amantadine Hydrochloride",
      "NonProprietaryName": "Amantadine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19870218",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA071293",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "AMANTADINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.",
      "Description": "Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H18NCl. It has the following structural formula. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride is available as 100 mg capsules for oral administration. Inactive ingredients: corn starch, croscarmellose sodium, ethylcellulose, FD&C Blue #1, FD&C Red #40, gelatin, magnesium stearate, methylparaben, microcrystalline cellulose, pregelatinized starch, propylparaben, sodium lauryl sulfate and titanium dioxide."
    },
    {
      "NDCCode": "16590-009-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (16590-009-90)",
      "NDC11Code": "16590-0009-90",
      "ProductNDC": "16590-009",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ambien",
      "NonProprietaryName": "Zolpidem Tartrate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930401",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019908",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "ZOLPIDEM TARTRATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Ambien (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Ambien has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
      "Description": "Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Ambien tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80."
    },
    {
      "NDCCode": "16590-011-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-011-90)",
      "NDC11Code": "16590-0011-90",
      "ProductNDC": "16590-011",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amitriptyline Hydrochloride",
      "NonProprietaryName": "Amitriptyline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19970911",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040218",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
      "Description": "Amitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride. Its empirical formula is C20H23NHCl, and its structural formula is. Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Amitriptyline HCl is supplied as 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg tablets. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, sodium starch glycolate and titanium dioxide. The 10 mg tablets also contain FD&C blue #1 lake. The 25 mg tablets also contain D&C yellow #10 lake and FD&C blue #2 lake. The 50 mg tablets also contain synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide. The 75 mg tablets also contain FD&C yellow #6 lake. The 100 mg tablets also contain D&C red #33 lake and FD&C red #40 lake. The 150 mg tablets also contain FD&C blue #2 lake and FD&C yellow #6 lake."
    },
    {
      "NDCCode": "16590-012-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-012-90)",
      "NDC11Code": "16590-0012-90",
      "ProductNDC": "16590-012",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amitriptyline Hydrochloride",
      "NonProprietaryName": "Amitriptyline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19970911",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040218",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
      "Description": "Amitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride. Its empirical formula is C20H23NHCl, and its structural formula is. Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Amitriptyline HCl is supplied as 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg tablets. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, sodium starch glycolate and titanium dioxide. The 10 mg tablets also contain FD&C blue #1 lake. The 25 mg tablets also contain D&C yellow #10 lake and FD&C blue #2 lake. The 50 mg tablets also contain synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide. The 75 mg tablets also contain FD&C yellow #6 lake. The 100 mg tablets also contain D&C red #33 lake and FD&C red #40 lake. The 150 mg tablets also contain FD&C blue #2 lake and FD&C yellow #6 lake."
    },
    {
      "NDCCode": "16590-013-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-013-90)",
      "NDC11Code": "16590-0013-90",
      "ProductNDC": "16590-013",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amitriptyline Hydrochloride",
      "NonProprietaryName": "Amitriptyline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19970911",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040218",
      "LabelerName": "STAT Rx USA LLC",
      "SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tricyclic Antidepressant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
      "Description": "Amitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride. Its empirical formula is C20H23NHCl, and its structural formula is. Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Amitriptyline HCl is supplied as 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg tablets. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, sodium starch glycolate and titanium dioxide. The 10 mg tablets also contain FD&C blue #1 lake. The 25 mg tablets also contain D&C yellow #10 lake and FD&C blue #2 lake. The 50 mg tablets also contain synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide. The 75 mg tablets also contain FD&C yellow #6 lake. The 100 mg tablets also contain D&C red #33 lake and FD&C red #40 lake. The 150 mg tablets also contain FD&C blue #2 lake and FD&C yellow #6 lake."
    },
    {
      "NDCCode": "16590-019-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (16590-019-90)",
      "NDC11Code": "16590-0019-90",
      "ProductNDC": "16590-019",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110125",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065101",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
      "StrengthNumber": "500; 125",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Amoxicillin and clavulanate potassium tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below.",
      "Description": "Amoxicillin and clavulanate potassium tablets are an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin is ( 2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and has the following structural formula. C 16H19N3O5S·3H2O M.W. 419.46. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and has the following structural formula. C 8H8KNO5 M.W. 237.25. Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. Each amoxicillin and clavulanate potassium tablet contains 0.63 mEq potassium."
    },
    {
      "NDCCode": "16590-022-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (16590-022-90)",
      "NDC11Code": "16590-0022-90",
      "ProductNDC": "16590-022",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetaminophen, Butalbital And Caffeine",
      "NonProprietaryName": "Acetaminophen, Butalbital And Caffeine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19880216",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089536",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "ACETAMINOPHEN; BUTALBITAL; CAFFEINE",
      "StrengthNumber": "325; 50; 40",
      "StrengthUnit": "mg/1; mg/1; mg/1",
      "Pharm_Classes": "Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.",
      "Description": "Each tablet, for oral administration, contains. Butalbital, USP..................50 mg. Acetaminophen.................325 mg. Caffeine, USP...................40 mg. In addition, each tablet contains the following inactive ingredients: FD and C Lake Blue #1, Magnesium Stearate, Microcrystalline Cellulose, Colloidal Silicon Dioxide, and Sodium Starch Glycolate. Butalbital (5-allyl-5-isobutylbarbituric acid), a white, odorless, crystalline powder having a slightly bitter taste, is a short to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula."
    },
    {
      "NDCCode": "16590-023-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (16590-023-90)",
      "NDC11Code": "16590-0023-90",
      "ProductNDC": "16590-023",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetaminophen And Codeine",
      "NonProprietaryName": "Acetaminophen And Codeine Phosphate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19880930",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089805",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
      "StrengthNumber": "300; 30",
      "StrengthUnit": "mg/1; mg/1",
      "DEASchedule": "CIII",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.",
      "Description": "Acetaminophen and codeine is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. Each 300 mg/30 mg Acetaminophen and Codeine Phosphate Tablet contains:          Acetaminophen ......................................................................................................300 mg          Codeine Phosphate ..................................................................................................30 mg. Each 300 mg/60 mg Acetaminophen and Codeine Phosphate Tablet contains:          Acetaminophen ......................................................................................................300 mg          Codeine Phosphate ..................................................................................................60 mg."
    },
    {
      "NDCCode": "16590-026-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (16590-026-90)",
      "NDC11Code": "16590-0026-90",
      "ProductNDC": "16590-026",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Baclofen",
      "NonProprietaryName": "Baclofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19910918",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072824",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "BACLOFEN",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
      "Description": "Baclofen USP is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The structural formula is represented below.      BACLOFEN STRUCTURE IIMAGE. Baclofen Tablets USP 10 mg and 20 mg contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and starch (corn)."
    },
    {
      "NDCCode": "16590-027-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (16590-027-90)",
      "NDC11Code": "16590-0027-90",
      "ProductNDC": "16590-027",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Baclofen",
      "NonProprietaryName": "Baclofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19910918",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA072828",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "BACLOFEN",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
      "Description": "Baclofen USP is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The structural formula is represented below.      BACLOFEN STRUCTURE IIMAGE. Baclofen Tablets USP 10 mg and 20 mg contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and starch (corn)."
    },
    {
      "NDCCode": "16590-036-90",
      "PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-036-90)",
      "NDC11Code": "16590-0036-90",
      "ProductNDC": "16590-036",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupropion Hydrochloride",
      "NonProprietaryName": "Bupropion Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090702",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079095",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "BUPROPION HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (SR) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
      "Description": "Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1- dimethylethyl)amino]-1 -propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100 mg, 150 mg, and 200 mg white to off-white, film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the following inactive ingredients:  hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate, and diluted hydrochloric acid. The film coating contains lactose monohydrate, hydroxypropyl cellulose, titanium dioxide, and polyethylene glycol."
    },
    {
      "NDCCode": "16590-037-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (16590-037-90)",
      "NDC11Code": "16590-0037-90",
      "ProductNDC": "16590-037",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupropion Hydrochloride",
      "NonProprietaryName": "Bupropion Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100201",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075491",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "BUPROPION HYDROCHLORIDE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder. A physician considering bupropion for the management of a patient’s first episode of depression should be aware that the drug may cause generalized seizures in a dose dependent manner with an approximate incidence of 0.4% (4/1,000). This incidence of seizures may exceed that of other marketed antidepressants by as much as 4-fold. This relative risk is only an approximate estimate because no direct comparative studies have been conducted (see WARNINGS). The efficacy of bupropion has been established in three placebo-controlled trials, including two of approximately 3 weeks’ duration in depressed inpatients and one of approximately 6 weeks’ duration in depressed outpatients. The depressive disorder of the patients studied corresponds most closely to the Major Depression category of the APA Diagnostic and Statistical Manual III. Major depression implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts. Effectiveness of bupropion in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use bupropion for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
      "Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white or almost white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride tablets, USP for oral administration, are available containing 75 mg or 100 mg of bupropion hydrochloride, USP. Each tablet also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, hydrochloric acid, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide and triacetin. In addition, the 75 mg tablets contain synthetic red iron oxide and synthetic yellow iron oxide and the 100 mg tablets contain FD and C Blue No. 2 Aluminum Lake and FD and C Yellow No. 6 Aluminum Lake."
    },
    {
      "NDCCode": "16590-038-90",
      "PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16590-038-90)",
      "NDC11Code": "16590-0038-90",
      "ProductNDC": "16590-038",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bupropion Hydrochloride",
      "NonProprietaryName": "Bupropion Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090702",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079095",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "BUPROPION HYDROCHLORIDE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (SR) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.",
      "Description": "Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1- dimethylethyl)amino]-1 -propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100 mg, 150 mg, and 200 mg white to off-white, film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the following inactive ingredients:  hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate, and diluted hydrochloric acid. The film coating contains lactose monohydrate, hydroxypropyl cellulose, titanium dioxide, and polyethylene glycol."
    },
    {
      "NDCCode": "16590-039-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (16590-039-90)",
      "NDC11Code": "16590-0039-90",
      "ProductNDC": "16590-039",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carisoprodol",
      "NonProprietaryName": "Carisoprodol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960124",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040124",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "CARISOPRODOL",
      "StrengthNumber": "350",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskietal conditions in adults.  Carisprodol Tablets should only be used for short periods (up to two or three weeks) brcause adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculosketal conditions are generally of short duration [see Dosage and Administration (2)].",
      "Description": "Carisoprodol Tablets are available as 350 mg round, white tablets for oral administration.  Carisoprodol is a white, crystalline powder, having a mide, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol in chloroform, and in acetone; its solubility is practically independent of pH.  Carisoprodol is present as a racemic mixture.  Chemically, carisioprodol is N-isopropyl-2-methyl-2-propyl-1,3- propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other Ingredients:  colloidal silicon dioxide, latose monohydrate, magnesium stearate, microcrystalline cellulose, methylcellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid."
    },
    {
      "NDCCode": "16590-046-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE (16590-046-90)",
      "NDC11Code": "16590-0046-90",
      "ProductNDC": "16590-046",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Celebrex",
      "NonProprietaryName": "Celecoxib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19981002",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020998",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "CELECOXIB",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].",
      "Description": "CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. CELEBREX oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
    },
    {
      "NDCCode": "16590-048-90",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16590-048-90)",
      "NDC11Code": "16590-0048-90",
      "ProductNDC": "16590-048",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cimetidine",
      "NonProprietaryName": "Cimetidine",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19940517",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074246",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "CIMETIDINE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Cimetidine tablets are indicated in. (1) Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine. (2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg h.s. for periods of up to five years. (3) Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks. (4) Erosive gastroesophageal reflux (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine beyond 12 weeks has not been established (see DOSAGE AND ADMINISTRATION: GERD). (5) The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).",
      "Description": "Cimetidine is a histamine H2-receptor antagonist. Chemically it is N\"-cyano-N-methyl-N'-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]-ethyl]guanidine. Its structural formula is. Cimetidine contains an imidazole ring, and is chemically related to histamine. Cimetidine has a bitter taste and characteristic odor."
    },
    {
      "NDCCode": "16590-050-90",
      "PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (16590-050-90)",
      "NDC11Code": "16590-0050-90",
      "ProductNDC": "16590-050",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20051116",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065253",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"16590-843-90","ProprietaryName":"Prozac","NonProprietaryName":"Fluoxetine Hydrochloride"},{"NDCCode":"43353-843-60","ProprietaryName":"Atorvastatin Calcium","NonProprietaryName":"Atorvastatin Calcium"},{"NDCCode":"55700-843-90","ProprietaryName":"Hydrochlorothiazide","NonProprietaryName":"Hydrochlorothiazide"},{"NDCCode":"60429-843-90","ProprietaryName":"Rosuvastatin","NonProprietaryName":"Rosuvastatin Calcium"},{"NDCCode":"61919-843-90","ProprietaryName":"Gabapentin","NonProprietaryName":"Gabapentin"},{"NDCCode":"63187-843-90","ProprietaryName":"Eszopiclone","NonProprietaryName":"Eszopiclone"},{"NDCCode":"69097-843-05","ProprietaryName":"Quinapril","NonProprietaryName":"Quinapril"},{"NDCCode":"70934-843-90","ProprietaryName":"Glipizide","NonProprietaryName":"Glipizide"},{"NDCCode":"71205-843-90","ProprietaryName":"Perphenazine","NonProprietaryName":"Perphenazine"},{"NDCCode":"71610-843-60","ProprietaryName":"Furosemide","NonProprietaryName":"Furosemide"},{"NDCCode":"76420-843-90","ProprietaryName":"Celecoxib","NonProprietaryName":"Celecoxib"},{"NDCCode":"16590-005-90","ProprietaryName":"Alprazolam","NonProprietaryName":"Alprazolam"},{"NDCCode":"16590-006-90","ProprietaryName":"Alprazolam","NonProprietaryName":"Alprazolam"},{"NDCCode":"16590-008-90","ProprietaryName":"Amantadine Hydrochloride","NonProprietaryName":"Amantadine Hydrochloride"},{"NDCCode":"16590-009-90","ProprietaryName":"Ambien","NonProprietaryName":"Zolpidem Tartrate"},{"NDCCode":"16590-011-90","ProprietaryName":"Amitriptyline Hydrochloride","NonProprietaryName":"Amitriptyline Hydrochloride"},{"NDCCode":"16590-012-90","ProprietaryName":"Amitriptyline Hydrochloride","NonProprietaryName":"Amitriptyline Hydrochloride"},{"NDCCode":"16590-013-90","ProprietaryName":"Amitriptyline Hydrochloride","NonProprietaryName":"Amitriptyline Hydrochloride"},{"NDCCode":"16590-019-90","ProprietaryName":"Amoxicillin And Clavulanate Potassium","NonProprietaryName":"Amoxicillin And Clavulanate Potassium"},{"NDCCode":"16590-022-90","ProprietaryName":"Acetaminophen, Butalbital And Caffeine","NonProprietaryName":"Acetaminophen, Butalbital And Caffeine"},{"NDCCode":"16590-023-90","ProprietaryName":"Acetaminophen And Codeine","NonProprietaryName":"Acetaminophen And Codeine Phosphate"},{"NDCCode":"16590-026-90","ProprietaryName":"Baclofen","NonProprietaryName":"Baclofen"},{"NDCCode":"16590-027-90","ProprietaryName":"Baclofen","NonProprietaryName":"Baclofen"},{"NDCCode":"16590-036-90","ProprietaryName":"Bupropion Hydrochloride","NonProprietaryName":"Bupropion Hydrochloride"},{"NDCCode":"16590-037-90","ProprietaryName":"Bupropion Hydrochloride","NonProprietaryName":"Bupropion Hydrochloride"},{"NDCCode":"16590-038-90","ProprietaryName":"Bupropion Hydrochloride","NonProprietaryName":"Bupropion Hydrochloride"},{"NDCCode":"16590-039-90","ProprietaryName":"Carisoprodol","NonProprietaryName":"Carisoprodol"},{"NDCCode":"16590-046-90","ProprietaryName":"Celebrex","NonProprietaryName":"Celecoxib"},{"NDCCode":"16590-048-90","ProprietaryName":"Cimetidine","NonProprietaryName":"Cimetidine"},{"NDCCode":"16590-050-90","ProprietaryName":"Cephalexin","NonProprietaryName":"Cephalexin"}]}
                    

<NDCList><NDC><NDCCode>16590-843-90</NDCCode><ProprietaryName>Prozac</ProprietaryName><NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>43353-843-60</NDCCode><ProprietaryName>Atorvastatin Calcium</ProprietaryName><NonProprietaryName>Atorvastatin Calcium</NonProprietaryName></NDC><NDC><NDCCode>55700-843-90</NDCCode><ProprietaryName>Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>60429-843-90</NDCCode><ProprietaryName>Rosuvastatin</ProprietaryName><NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName></NDC><NDC><NDCCode>61919-843-90</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>63187-843-90</NDCCode><ProprietaryName>Eszopiclone</ProprietaryName><NonProprietaryName>Eszopiclone</NonProprietaryName></NDC><NDC><NDCCode>69097-843-05</NDCCode><ProprietaryName>Quinapril</ProprietaryName><NonProprietaryName>Quinapril</NonProprietaryName></NDC><NDC><NDCCode>70934-843-90</NDCCode><ProprietaryName>Glipizide</ProprietaryName><NonProprietaryName>Glipizide</NonProprietaryName></NDC><NDC><NDCCode>71205-843-90</NDCCode><ProprietaryName>Perphenazine</ProprietaryName><NonProprietaryName>Perphenazine</NonProprietaryName></NDC><NDC><NDCCode>71610-843-60</NDCCode><ProprietaryName>Furosemide</ProprietaryName><NonProprietaryName>Furosemide</NonProprietaryName></NDC><NDC><NDCCode>76420-843-90</NDCCode><ProprietaryName>Celecoxib</ProprietaryName><NonProprietaryName>Celecoxib</NonProprietaryName></NDC><NDC><NDCCode>16590-005-90</NDCCode><ProprietaryName>Alprazolam</ProprietaryName><NonProprietaryName>Alprazolam</NonProprietaryName></NDC><NDC><NDCCode>16590-006-90</NDCCode><ProprietaryName>Alprazolam</ProprietaryName><NonProprietaryName>Alprazolam</NonProprietaryName></NDC><NDC><NDCCode>16590-008-90</NDCCode><ProprietaryName>Amantadine Hydrochloride</ProprietaryName><NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16590-009-90</NDCCode><ProprietaryName>Ambien</ProprietaryName><NonProprietaryName>Zolpidem Tartrate</NonProprietaryName></NDC><NDC><NDCCode>16590-011-90</NDCCode><ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName><NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16590-012-90</NDCCode><ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName><NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16590-013-90</NDCCode><ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName><NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16590-019-90</NDCCode><ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName><NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName></NDC><NDC><NDCCode>16590-022-90</NDCCode><ProprietaryName>Acetaminophen, Butalbital And Caffeine</ProprietaryName><NonProprietaryName>Acetaminophen, Butalbital And Caffeine</NonProprietaryName></NDC><NDC><NDCCode>16590-023-90</NDCCode><ProprietaryName>Acetaminophen And Codeine</ProprietaryName><NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName></NDC><NDC><NDCCode>16590-026-90</NDCCode><ProprietaryName>Baclofen</ProprietaryName><NonProprietaryName>Baclofen</NonProprietaryName></NDC><NDC><NDCCode>16590-027-90</NDCCode><ProprietaryName>Baclofen</ProprietaryName><NonProprietaryName>Baclofen</NonProprietaryName></NDC><NDC><NDCCode>16590-036-90</NDCCode><ProprietaryName>Bupropion Hydrochloride</ProprietaryName><NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16590-037-90</NDCCode><ProprietaryName>Bupropion Hydrochloride</ProprietaryName><NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16590-038-90</NDCCode><ProprietaryName>Bupropion Hydrochloride</ProprietaryName><NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>16590-039-90</NDCCode><ProprietaryName>Carisoprodol</ProprietaryName><NonProprietaryName>Carisoprodol</NonProprietaryName></NDC><NDC><NDCCode>16590-046-90</NDCCode><ProprietaryName>Celebrex</ProprietaryName><NonProprietaryName>Celecoxib</NonProprietaryName></NDC><NDC><NDCCode>16590-048-90</NDCCode><ProprietaryName>Cimetidine</ProprietaryName><NonProprietaryName>Cimetidine</NonProprietaryName></NDC><NDC><NDCCode>16590-050-90</NDCCode><ProprietaryName>Cephalexin</ProprietaryName><NonProprietaryName>Cephalexin</NonProprietaryName></NDC></NDCList>