RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "59088-131-73",
      "PackageDescription": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (59088-131-73) ",
      "NDC11Code": "59088-0131-73",
      "ProductNDC": "59088-131",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diclofenac Potassium",
      "NonProprietaryName": "Diclofenac Potassium 25 Mg",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260410",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210078",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "DICLOFENAC POTASSIUM",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-04-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260410",
      "SamplePackage": "N",
      "IndicationAndUsage": "Diclofenac Potassium Capsules are indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. ( 1).",
      "Description": "Diclofenac Potassium Capsules is a nonsteroidal anti-inflammatory drug, available as liquid-filled capsules of 25 mg base, equivalent to 28.3 mg potassium salt for oral administration. Diclofenac potassium is a white to slight yellowish crystalline powder. It is sparingly soluble in water at 25°C. The chemical name is benzeneacetic acid, 2-[(2,6dichlorophenyl) amino]-, monopotassium salt. The molecular weight is 334.24. Its molecular formula is C 14H 10Cl 2NKO 2, and it has the following chemical structure. The inactive ingredients in Diclofenac Potassium Capsules include: polyethylene glycol 400, glycerin, sorbitol, povidone, polysorbate 80, hydrochloric acid, purified water. The capsule shell contains gelatin, glycerin, lecithin, medium chain triglyceride, purified water, sorbitol, and opacode black ink (Shellac*Glaze, Isopropyl Alcohol, Ferrosoferric oxide, n-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide 28 %)."
    },
    {
      "NDCCode": "69423-131-01",
      "PackageDescription": "2 CYLINDER in 1 CELLO PACK (69423-131-01)  > 73 g in 1 CYLINDER",
      "NDC11Code": "69423-0131-01",
      "ProductNDC": "69423-131",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Secret Luxe Lavender Clear",
      "NonProprietaryName": "Aluminum Zirconium Octachlorohydrex Gly",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161108",
      "EndMarketingDate": "20211231",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY",
      "StrengthNumber": "16",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-08-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170711",
      "EndMarketingDatePackage": "20200825",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69423-131-73",
      "PackageDescription": "73 g in 1 CYLINDER (69423-131-73) ",
      "NDC11Code": "69423-0131-73",
      "ProductNDC": "69423-131",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Secret Luxe Lavender Clear",
      "NonProprietaryName": "Aluminum Zirconium Octachlorohydrex Gly",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161108",
      "EndMarketingDate": "20211231",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "The Procter & Gamble Manufacturing Company",
      "SubstanceName": "ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY",
      "StrengthNumber": "16",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20161108",
      "EndMarketingDatePackage": "20211231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59088-104-73",
      "PackageDescription": "120 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-104-73) ",
      "NDC11Code": "59088-0104-73",
      "ProductNDC": "59088-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluoride",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110601",
      "EndMarketingDate": "20260228",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20110601",
      "EndMarketingDatePackage": "20260228",
      "SamplePackage": "N",
      "IndicationAndUsage": "For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F*) during the period of tooth development results in a significant decrease in the incidence of dental caries. Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F*.",
      "Description": "Each Fluoride Chewable Tablet 0.25 mgis erythrosine (FD&C Red Dye No.3) free. Each tablet contains 0.25 mg F* from 55 mg sodium fluoride (NaF). Each tablet for oral administration contains sodium fluoride equivalent to fluoride 0.25 mg and the following inactive ingredients: cherry flavor, croscarmellose sodium, D&C Red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sucrose."
    },
    {
      "NDCCode": "59088-105-73",
      "PackageDescription": "120 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-105-73) ",
      "NDC11Code": "59088-0105-73",
      "ProductNDC": "59088-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluoride",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110601",
      "EndMarketingDate": "20260228",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20110601",
      "EndMarketingDatePackage": "20260228",
      "SamplePackage": "N",
      "IndicationAndUsage": "For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F*) during the period of tooth development results in a significant decrease in the incidence of dental caries. Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F*.",
      "Description": "Each Fluoride Chewable Tablet 0.5 mgis erythrosine (FD&C Red Dye No. 3) free. Each tablet contains 0.5 mg F* from 1.1 mg sodium fluoride (NaF). Each tablet for oral administration contains sodium fluoride equivalent to fluoride 0.5 mg and the following inactive ingredients: croscarmellose sodium, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, grape flavor, magnesium stearate, mannitol, microcrystalline cellulose, sucrose."
    },
    {
      "NDCCode": "59088-106-73",
      "PackageDescription": "120 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-106-73) ",
      "NDC11Code": "59088-0106-73",
      "ProductNDC": "59088-106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluoride",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110601",
      "EndMarketingDate": "20251231",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20110601",
      "EndMarketingDatePackage": "20251231",
      "SamplePackage": "N",
      "IndicationAndUsage": "For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F*) during the period of tooth development results in a significant decrease in the incidence of dental caries. Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F*.",
      "Description": "Each Fluoride Chewable Tablet 1.0 mgis erythrosine (FD&C Red Dye No. 3) free. Each tablet contains 1.0 mg F* from 2.2 mg sodium fluoride (NaF). Each tablet for oral administration contains sodium fluoride equivalent to fluoride 1.0 mg and the following inactive ingredients: croscarmellose sodium, FD&C Yellow No. 6 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, orange flavor, sucrose."
    },
    {
      "NDCCode": "0409-4346-73",
      "PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4346-73)  / 20 mL in 1 VIAL, SINGLE-DOSE (0409-4346-16) ",
      "NDC11Code": "00409-4346-73",
      "ProductNDC": "0409-4346",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aminocaproic Acid",
      "NonProprietaryName": "Aminocaproic Acid",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20100512",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070010",
      "LabelerName": "Hospira, Inc.",
      "SubstanceName": "AMINOCAPROIC ACID",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
      "Status": "Active",
      "LastUpdate": "2026-05-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20100512",
      "SamplePackage": "N",
      "IndicationAndUsage": "Aminocaproic Acid Injection, is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures), and portacaval shunt; hematological disorders such as aplastic anemia; acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may frequently be associated with life-threatening complications following severe trauma, anoxia, and shock. Symptomatic of such complications is surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.).",
      "Description": "Aminocaproic Acid Injection, USP is a 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Aminocaproic Acid is soluble in water, acid and alkaline solutions; it is sparingly soluble in methanol and practically insoluble in chloroform. Aminocaproic Acid Injection, USP, for intravenous administration, is a sterile pyrogen-free solution containing 250 mg/mL of aminocaproic acid and Water for Injection. The solution contains no bacteriostat or antimicrobial agent and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Hydrochloric acid may be added to adjust pH to approximately 6.8 during manufacture. Its chemical structure is. NH2 - CH2 - CH2 - CH2 - CH2 - CH2 - COOH. Molecular Weight: 131.17. The semi-rigid vial is fabricated from a specifically formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration."
    },
    {
      "NDCCode": "16590-781-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (16590-781-30)",
      "NDC11Code": "16590-0781-30",
      "ProductNDC": "16590-781",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lithium Carbonate",
      "NonProprietaryName": "Lithium Carbonate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19820129",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018558",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "LITHIUM CARBONATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Mood Stabilizer [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "Description": "Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy (see DOSAGE AND ADMINISTRATION). Each tablet for oral administration contains. Lithium Carbonate . . . . . . . . . . 300 mg. Each capsule for oral administration contains:. Lithium Carbonate . . . . . . . . . . 150 mg, 300 mg or 600 mg. Each 5 mL of solution for oral administration contains. Lithium ion (Li+) . . . . . . . . . . 8 mEq. (equivalent to amount of lithium in 300 mg of lithium carbonate), alcohol 0.3% v/v. The capsules contain talc, gelatin, FD and C Red No. 40, titanium dioxide, and the imprinting ink contains FD and C Blue No. 2, FD and C Yellow No. 6, FD and C Red No. 40, synthetic black iron oxide, and pharmaceutical glaze. The tablets contain calcium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and sodium starch glycolate. The solution contains alcohol, sorbitol, flavoring, water, and other ingredients. Lithium Oral Solution is a palatable oral dosage form of lithium ion. It is prepared in solution from lithium hydroxide and citric acid in a ratio approximately di-lithium citrate. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. The empirical formula for Lithium Citrate is C6H 5Li3O7; molecular weight 209.92. Lithium acts as an antimanic. Lithium Carbonate is a white, light, alkaline powder with molecular formula Li2CO3 and molecular weight 73.89. Preclinical studies have shown that lithium alters sodium transport in nerve and muscle cells and effects a shift toward intraneuronal metabolism of catecholamines, but the specific biochemical mechanism of lithium action in mania is unknown. Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks. Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, since the risk of lithium toxicity is very high in such patients. If the psychiatric indication is life-threatening, and if such a patient fails to respond to other measures, lithium treatment may be undertaken with extreme caution, including daily serum lithium determinations and adjustment to the usually low doses ordinarily tolerated by these individuals. In such instances, hospitalization is a necessity. Lithium may cause fetal harm when administered to a pregnant woman. There have been reports of lithium having adverse effects on nidations in rats, embryo viability in mice, and metabolism in-vitro of rat testis and human spermatozoa have been attributed to lithium, as have teratogenicity in submammalian species and cleft palates in mice. Studies in rats, rabbits and monkeys have shown no evidence of lithium-induced teratology. Data from lithium birth registries suggest an increase in cardiac and other anomalies, especially Ebstein’s anomaly. If the patient becomes pregnant while taking lithium, she should be apprised of the potential risk to the fetus. If possible, lithium should be withdrawn for at least the first trimester unless it is determined that this would seriously endanger the mother. Chronic lithium therapy may be associated with diminution of renal concentrating ability, occasionally presenting as nephrogenic diabetes insipidus, with polyuria and polydipsia. Such patients should be carefully managed to avoid dehydration with resulting lithium retention and toxicity. This condition is usually reversible when lithium is discontinued. Morphologic changes with glomerular and interstitial fibrosis and nephron-atrophy have been reported in patients on chronic lithium therapy. Morphologic changes have also been seen in bipolar patients never exposed to lithium. The relationship between renal functional and morphologic changes and their association with lithium therapy has not been established. When kidney function is assessed, for baseline data prior to starting lithium therapy or thereafter, routine urinalysis and other tests may be used to evaluate tubular function (e.g., urine specific gravity or osmolality following a period of water deprivation, or 24-hour urine volume) and glomerular function (e.g., serum creatinine or creatinine clearance). During lithium therapy, progressive or sudden changes in renal function, even within the normal range, indicate the need for reevaluation of treatment. Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels (see DOSAGE AND ADMINISTRATION). The ability to tolerate lithium is greater during the acute manic phase and decreases when manic symptoms subside (see DOSAGE AND ADMINISTRATION). The distribution space of lithium approximates that of total body water. Lithium is primarily excreted in urine with insignificant excretion in feces. Renal excretion of lithium is proportional to its plasma concentration. The half-life of elimination of lithium is approximately 24 hours. Lithium decreases sodium reabsorption by the renal tubules which could lead to sodium depletion. Therefore, it is essential for the patient to maintain a normal diet, including salt, and an adequate fluid intake (2500-3000 mL) at least during the initial stabilization period. Decreased tolerance to lithium has been reported to ensue from protracted sweating or diarrhea and, if such occur, supplemental fluid and salt should be administered. In addition to sweating and diarrhea, concomitant infection with elevated temperatures may also necessitate a temporary reduction or cessation of medication. Previously existing underlying thyroid disorders do not necessarily constitute a contraindication to lithium treatment; where hypothyroidism exists, careful monitoring of thyroid function during lithium stabilization and maintenance allows for correction of changing thyroid parameters, if any. Where hypothyroidism occurs during lithium stabilization and maintenance, supplemental thyroid treatment may be used. Outpatients and their families should be warned that the patient must discontinue lithium therapy and contact his physician if such clinical signs of lithium toxicity as diarrhea, vomiting, tremor, mild ataxia, drowsiness, or muscular weakness occur. Lithium may impair mental and/or physical abilities. Caution patients about activities requiring alertness (e.g., operating vehicles or machinery). An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leucocytosis, elevated serum enzymes, BUN and FBS) followed by irreversible brain damage has occurred in a few patients treated with lithium plus haloperidol. A causal relationship between these events and the concomitant administration of lithium and haloperidol has not been established; however, patients receiving such combined therapy should be monitored closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs appear. The possibility of similar adverse interactions with other antipsychotic medication exists. Lithium may prolong the effects of neuromuscular blocking agents. Therefore, neuromuscular blocking agents should be given with caution to patients receiving lithium. Caution should be used when lithium and diuretics or angiotensin converting enzyme (ACE) inhibitors are used concomitantly because sodium loss may reduce the renal clearance of lithium and increase serum lithium levels with risk of lithium toxicity. When such combinations are used, the lithium dosage may need to be decreased, and more frequent monitoring of lithium plasma levels is recommended. Lithium levels should be closely monitored when patients initiate or discontinue NSAID use. In some cases, lithium toxicity has resulted from interactions between an NSAID and lithium. Indomethacin and piroxicam have been reported to increase significantly steady-state plasma lithium concentrations. There is also evidence that other nonsteroidal anti-inflammatory agents, including the selective cyclooxygenase-2 (COX-2) inhibitors, have the same effect. In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg BID with celecoxib 200 mg BID as compared to subjects receiving lithium alone. See WARNINGS section. Lithium is excreted in human milk. Nursing should not be undertaken during lithium therapy except in rare and unusual circumstances where, in the view of the physician, the potential benefits to the mother outweigh possible hazards to the child. Since information regarding the safety and effectiveness of lithium in children under 12 years of age is not available, its use in such patients is not recommended at this time. There has been a report of a transient syndrome of acute dystonia and hyperreflexia occurring in a 15 kg child who ingested 300 mg of lithium carbonate. The likelihood of toxicity increases with increasing serum lithium levels. Serum lithium levels greater than 1.5 mEq/l carry a greater risk than lower levels. However, patients sensitive to lithium may exhibit toxic signs at serum levels below 1.5 mEq/l. Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of lithium toxicity, and can occur at lithium levels below 2.0 mEq/l. At higher levels, giddiness, ataxia, blurred vision, tinnitus and a large output of dilute urine may be seen. Serum lithium levels above 3.0 mEq/l may produce a complex clinical picture involving multiple organs and organ systems. Serum lithium levels should not be permitted to exceed 2.0 mEq/l during the acute treatment phase. Fine hand tremor, polyuria and mild thirst may occur during initial therapy for the acute manic phase, and may persist throughout treatment. Transient and mild nausea and general discomfort may also appear during the first few days of lithium administration. These side effects are an inconvenience rather than a disabling condition, and usually subside with continued treatment or a temporary reduction or cessation of dosage. If persistent, a cessation of dosage is indicated. The following adverse reactions have been reported and do not appear to be directly related to serum lithium levels. Tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), ataxia, choreo-athetotic movements, hyperactive deep tendon reflexes. Blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, incontinence of urine or feces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma, acute dystonia, downbeat nystagmus. Cardiac arrhythmia, hypotension, peripheral circulatory collapse, sinus node dysfunction with severe bradycardia (which may result in syncope). Cases of pseudotumor cerebri (increased intracranial pressure and papilledema) have been reported with lithium use. If undetected, this condition may result in enlargement of the blind spot, constriction of visual fields and eventual blindness due to optic atrophy. Lithium should be discontinued, if clinically possible, if this syndrome occurs. Anorexia, nausea, vomiting, diarrhea. Albuminuria, oliguria, polyuria, glycosuria. Drying and thinning of hair, anesthesia of skin, chronic folliculitis, xerosis cutis, alopecia and exacerbation of psoriasis. Blurred vision, dry mouth. Euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T3 and T4. Iodine 131 uptake may be elevated. (See PRECAUTIONS). Paradoxically, rare cases of hyperthyroidism have been reported. Diffuse slowing, widening of frequency spectrum, potentiation and disorganization of background rhythm. Reversible flattening, isoelectricity or inversion of T-waves. Fatigue, lethargy, transient scotomata, dehydration, weight loss, tendency to sleep. Transient electroencephalographic and electrocardiographic changes, leucocytosis, headache, diffuse non-toxic goiter with or without hypothyroidism, transient hyperglycemia, generalized pruritis with or without rash, cutaneous ulcers, albuminuria, worsening of organic brain syndromes, excessive weight gain, edematous swelling of ankles or wrists, and thirst or polyuria, sometimes resembling diabetes insipidus, and metallic taste. A single report has been received of the development of painful discoloration of fingers and toes and coldness of the extremities within one day of the starting of treatment of lithium. The mechanism through which these symptoms (resembling Raynaud’s Syndrome) developed is not known. Recovery followed discontinuance. The toxic levels for lithium are close to the therapeutic levels. It is therefore important that patients and their families be cautioned to watch for early symptoms and to discontinue the drug and inform the physician should they occur. Toxic symptoms are listed in detail under ADVERSE REACTIONS. No specific antidote for lithium poisoning is known. Early symptoms of lithium toxicity can usually be treated by reduction of cessation of dosage of the drug and resumption of the treatment at a lower dose after 24 to 48 hours. In severe cases of lithium poisoning, the first and foremost goal of treatment consists of elimination of this ion from the patient. Treatment is essentially the same as that used in barbiturate poisoning: 1) gastric lavage, 2) correction of fluid and electrolyte imbalance and 3) regulation of kidney functioning. Urea, mannitol, and aminophylline all produce significant increases in lithium excretion. Hemodialysis is an effective and rapid means of removing the ion from the severely toxic patient. Infection prophylaxis, regular chest X-rays, and preservation of adequate respiration are essential. Optimal patient response to Lithium Carbonate usually can be established and maintained with 600 mg t.i.d. Optimal patient response to Lithium Oral Solution usually can be established and maintained with 10 mL (2 full teaspoons) (16 mEq of lithium) t.i.d. Such doses will normally produce an effective serum lithium level ranging between 1.0 and 1.5 mEq/l. Dosage must be individualized according to serum levels and clinical response. Regular monitoring of the patient’s clinical state and of serum lithium levels is necessary. Serum levels should be determined twice per week during the acute phase, and until the serum level and clinical condition of the patient have been stabilized. The desirable serum lithium levels are 0.6 to 1.2 mEq/l. Dosage will vary from one individual to another, but usually 300 mg of Lithium Carbonate t.i.d. or q.i.d., or 5 mL (1 full teaspoon) (8 mEq of Lithium) of Lithium Oral Solution t.i.d. or q.i.d. will maintain this level. Serum lithium levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months. Patients abnormally sensitive to lithium may exhibit toxic signs at serum levels of 1.0 to 1.5 mEq/l. Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels ordinarily tolerated by other patients. Blood samples for serum lithium determination should be drawn immediately prior to the next dose when lithium concentrations are relatively stable (i.e., 8-12 hours after the previous dose). Total reliance must not be placed on serum levels alone. Accurate patient evaluation requires both clinical and laboratory analysis. NDC 0054-8528-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-4527-25: Bottles of 100 tablets. NDC 0054-4527-31: Bottles of 1000 tablets. (Identified 54 213). NDC 0054-8526-25: Unit dose, 10 capsules per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-2526-25: Bottles of 100 capsules. (Identified 54 463). NDC 0054-8527-25: Unit dose, 10 capsules per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-2527-25: Bottles of 100 capsules. NDC 0054-2527-31: Bottles of 1000 capsules. (size 0) (Identified 54 702). NDC 0054-8531-25: Unit dose, 10 capsules per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-2531-25: Bottles of 100 capsules. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container as defined in the USP/NF. NDC 0054-8529-04: Unit dose Patient Cup filled to deliver 5 mL, ten 5 mL Patient Cup per shelf pack, ten shelf packs per shipper. (For Institutional Use Only). NDC 0054-3527-63: Bottles of 500 mL. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP/NF. 4055501//05. Rev March 2005. © RLI, 2005."
    },
    {
      "NDCCode": "16590-781-60",
      "PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (16590-781-60)",
      "NDC11Code": "16590-0781-60",
      "ProductNDC": "16590-781",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lithium Carbonate",
      "NonProprietaryName": "Lithium Carbonate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19820129",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018558",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "LITHIUM CARBONATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Mood Stabilizer [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "Description": "Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy (see DOSAGE AND ADMINISTRATION). Each tablet for oral administration contains. Lithium Carbonate . . . . . . . . . . 300 mg. Each capsule for oral administration contains:. Lithium Carbonate . . . . . . . . . . 150 mg, 300 mg or 600 mg. Each 5 mL of solution for oral administration contains. Lithium ion (Li+) . . . . . . . . . . 8 mEq. (equivalent to amount of lithium in 300 mg of lithium carbonate), alcohol 0.3% v/v. The capsules contain talc, gelatin, FD and C Red No. 40, titanium dioxide, and the imprinting ink contains FD and C Blue No. 2, FD and C Yellow No. 6, FD and C Red No. 40, synthetic black iron oxide, and pharmaceutical glaze. The tablets contain calcium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and sodium starch glycolate. The solution contains alcohol, sorbitol, flavoring, water, and other ingredients. Lithium Oral Solution is a palatable oral dosage form of lithium ion. It is prepared in solution from lithium hydroxide and citric acid in a ratio approximately di-lithium citrate. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. The empirical formula for Lithium Citrate is C6H 5Li3O7; molecular weight 209.92. Lithium acts as an antimanic. Lithium Carbonate is a white, light, alkaline powder with molecular formula Li2CO3 and molecular weight 73.89. Preclinical studies have shown that lithium alters sodium transport in nerve and muscle cells and effects a shift toward intraneuronal metabolism of catecholamines, but the specific biochemical mechanism of lithium action in mania is unknown. Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks. Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, since the risk of lithium toxicity is very high in such patients. If the psychiatric indication is life-threatening, and if such a patient fails to respond to other measures, lithium treatment may be undertaken with extreme caution, including daily serum lithium determinations and adjustment to the usually low doses ordinarily tolerated by these individuals. In such instances, hospitalization is a necessity. Lithium may cause fetal harm when administered to a pregnant woman. There have been reports of lithium having adverse effects on nidations in rats, embryo viability in mice, and metabolism in-vitro of rat testis and human spermatozoa have been attributed to lithium, as have teratogenicity in submammalian species and cleft palates in mice. Studies in rats, rabbits and monkeys have shown no evidence of lithium-induced teratology. Data from lithium birth registries suggest an increase in cardiac and other anomalies, especially Ebstein’s anomaly. If the patient becomes pregnant while taking lithium, she should be apprised of the potential risk to the fetus. If possible, lithium should be withdrawn for at least the first trimester unless it is determined that this would seriously endanger the mother. Chronic lithium therapy may be associated with diminution of renal concentrating ability, occasionally presenting as nephrogenic diabetes insipidus, with polyuria and polydipsia. Such patients should be carefully managed to avoid dehydration with resulting lithium retention and toxicity. This condition is usually reversible when lithium is discontinued. Morphologic changes with glomerular and interstitial fibrosis and nephron-atrophy have been reported in patients on chronic lithium therapy. Morphologic changes have also been seen in bipolar patients never exposed to lithium. The relationship between renal functional and morphologic changes and their association with lithium therapy has not been established. When kidney function is assessed, for baseline data prior to starting lithium therapy or thereafter, routine urinalysis and other tests may be used to evaluate tubular function (e.g., urine specific gravity or osmolality following a period of water deprivation, or 24-hour urine volume) and glomerular function (e.g., serum creatinine or creatinine clearance). During lithium therapy, progressive or sudden changes in renal function, even within the normal range, indicate the need for reevaluation of treatment. Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels (see DOSAGE AND ADMINISTRATION). The ability to tolerate lithium is greater during the acute manic phase and decreases when manic symptoms subside (see DOSAGE AND ADMINISTRATION). The distribution space of lithium approximates that of total body water. Lithium is primarily excreted in urine with insignificant excretion in feces. Renal excretion of lithium is proportional to its plasma concentration. The half-life of elimination of lithium is approximately 24 hours. Lithium decreases sodium reabsorption by the renal tubules which could lead to sodium depletion. Therefore, it is essential for the patient to maintain a normal diet, including salt, and an adequate fluid intake (2500-3000 mL) at least during the initial stabilization period. Decreased tolerance to lithium has been reported to ensue from protracted sweating or diarrhea and, if such occur, supplemental fluid and salt should be administered. In addition to sweating and diarrhea, concomitant infection with elevated temperatures may also necessitate a temporary reduction or cessation of medication. Previously existing underlying thyroid disorders do not necessarily constitute a contraindication to lithium treatment; where hypothyroidism exists, careful monitoring of thyroid function during lithium stabilization and maintenance allows for correction of changing thyroid parameters, if any. Where hypothyroidism occurs during lithium stabilization and maintenance, supplemental thyroid treatment may be used. Outpatients and their families should be warned that the patient must discontinue lithium therapy and contact his physician if such clinical signs of lithium toxicity as diarrhea, vomiting, tremor, mild ataxia, drowsiness, or muscular weakness occur. Lithium may impair mental and/or physical abilities. Caution patients about activities requiring alertness (e.g., operating vehicles or machinery). An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leucocytosis, elevated serum enzymes, BUN and FBS) followed by irreversible brain damage has occurred in a few patients treated with lithium plus haloperidol. A causal relationship between these events and the concomitant administration of lithium and haloperidol has not been established; however, patients receiving such combined therapy should be monitored closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs appear. The possibility of similar adverse interactions with other antipsychotic medication exists. Lithium may prolong the effects of neuromuscular blocking agents. Therefore, neuromuscular blocking agents should be given with caution to patients receiving lithium. Caution should be used when lithium and diuretics or angiotensin converting enzyme (ACE) inhibitors are used concomitantly because sodium loss may reduce the renal clearance of lithium and increase serum lithium levels with risk of lithium toxicity. When such combinations are used, the lithium dosage may need to be decreased, and more frequent monitoring of lithium plasma levels is recommended. Lithium levels should be closely monitored when patients initiate or discontinue NSAID use. In some cases, lithium toxicity has resulted from interactions between an NSAID and lithium. Indomethacin and piroxicam have been reported to increase significantly steady-state plasma lithium concentrations. There is also evidence that other nonsteroidal anti-inflammatory agents, including the selective cyclooxygenase-2 (COX-2) inhibitors, have the same effect. In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg BID with celecoxib 200 mg BID as compared to subjects receiving lithium alone. See WARNINGS section. Lithium is excreted in human milk. Nursing should not be undertaken during lithium therapy except in rare and unusual circumstances where, in the view of the physician, the potential benefits to the mother outweigh possible hazards to the child. Since information regarding the safety and effectiveness of lithium in children under 12 years of age is not available, its use in such patients is not recommended at this time. There has been a report of a transient syndrome of acute dystonia and hyperreflexia occurring in a 15 kg child who ingested 300 mg of lithium carbonate. The likelihood of toxicity increases with increasing serum lithium levels. Serum lithium levels greater than 1.5 mEq/l carry a greater risk than lower levels. However, patients sensitive to lithium may exhibit toxic signs at serum levels below 1.5 mEq/l. Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of lithium toxicity, and can occur at lithium levels below 2.0 mEq/l. At higher levels, giddiness, ataxia, blurred vision, tinnitus and a large output of dilute urine may be seen. Serum lithium levels above 3.0 mEq/l may produce a complex clinical picture involving multiple organs and organ systems. Serum lithium levels should not be permitted to exceed 2.0 mEq/l during the acute treatment phase. Fine hand tremor, polyuria and mild thirst may occur during initial therapy for the acute manic phase, and may persist throughout treatment. Transient and mild nausea and general discomfort may also appear during the first few days of lithium administration. These side effects are an inconvenience rather than a disabling condition, and usually subside with continued treatment or a temporary reduction or cessation of dosage. If persistent, a cessation of dosage is indicated. The following adverse reactions have been reported and do not appear to be directly related to serum lithium levels. Tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), ataxia, choreo-athetotic movements, hyperactive deep tendon reflexes. Blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, incontinence of urine or feces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma, acute dystonia, downbeat nystagmus. Cardiac arrhythmia, hypotension, peripheral circulatory collapse, sinus node dysfunction with severe bradycardia (which may result in syncope). Cases of pseudotumor cerebri (increased intracranial pressure and papilledema) have been reported with lithium use. If undetected, this condition may result in enlargement of the blind spot, constriction of visual fields and eventual blindness due to optic atrophy. Lithium should be discontinued, if clinically possible, if this syndrome occurs. Anorexia, nausea, vomiting, diarrhea. Albuminuria, oliguria, polyuria, glycosuria. Drying and thinning of hair, anesthesia of skin, chronic folliculitis, xerosis cutis, alopecia and exacerbation of psoriasis. Blurred vision, dry mouth. Euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T3 and T4. Iodine 131 uptake may be elevated. (See PRECAUTIONS). Paradoxically, rare cases of hyperthyroidism have been reported. Diffuse slowing, widening of frequency spectrum, potentiation and disorganization of background rhythm. Reversible flattening, isoelectricity or inversion of T-waves. Fatigue, lethargy, transient scotomata, dehydration, weight loss, tendency to sleep. Transient electroencephalographic and electrocardiographic changes, leucocytosis, headache, diffuse non-toxic goiter with or without hypothyroidism, transient hyperglycemia, generalized pruritis with or without rash, cutaneous ulcers, albuminuria, worsening of organic brain syndromes, excessive weight gain, edematous swelling of ankles or wrists, and thirst or polyuria, sometimes resembling diabetes insipidus, and metallic taste. A single report has been received of the development of painful discoloration of fingers and toes and coldness of the extremities within one day of the starting of treatment of lithium. The mechanism through which these symptoms (resembling Raynaud’s Syndrome) developed is not known. Recovery followed discontinuance. The toxic levels for lithium are close to the therapeutic levels. It is therefore important that patients and their families be cautioned to watch for early symptoms and to discontinue the drug and inform the physician should they occur. Toxic symptoms are listed in detail under ADVERSE REACTIONS. No specific antidote for lithium poisoning is known. Early symptoms of lithium toxicity can usually be treated by reduction of cessation of dosage of the drug and resumption of the treatment at a lower dose after 24 to 48 hours. In severe cases of lithium poisoning, the first and foremost goal of treatment consists of elimination of this ion from the patient. Treatment is essentially the same as that used in barbiturate poisoning: 1) gastric lavage, 2) correction of fluid and electrolyte imbalance and 3) regulation of kidney functioning. Urea, mannitol, and aminophylline all produce significant increases in lithium excretion. Hemodialysis is an effective and rapid means of removing the ion from the severely toxic patient. Infection prophylaxis, regular chest X-rays, and preservation of adequate respiration are essential. Optimal patient response to Lithium Carbonate usually can be established and maintained with 600 mg t.i.d. Optimal patient response to Lithium Oral Solution usually can be established and maintained with 10 mL (2 full teaspoons) (16 mEq of lithium) t.i.d. Such doses will normally produce an effective serum lithium level ranging between 1.0 and 1.5 mEq/l. Dosage must be individualized according to serum levels and clinical response. Regular monitoring of the patient’s clinical state and of serum lithium levels is necessary. Serum levels should be determined twice per week during the acute phase, and until the serum level and clinical condition of the patient have been stabilized. The desirable serum lithium levels are 0.6 to 1.2 mEq/l. Dosage will vary from one individual to another, but usually 300 mg of Lithium Carbonate t.i.d. or q.i.d., or 5 mL (1 full teaspoon) (8 mEq of Lithium) of Lithium Oral Solution t.i.d. or q.i.d. will maintain this level. Serum lithium levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months. Patients abnormally sensitive to lithium may exhibit toxic signs at serum levels of 1.0 to 1.5 mEq/l. Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels ordinarily tolerated by other patients. Blood samples for serum lithium determination should be drawn immediately prior to the next dose when lithium concentrations are relatively stable (i.e., 8-12 hours after the previous dose). Total reliance must not be placed on serum levels alone. Accurate patient evaluation requires both clinical and laboratory analysis. NDC 0054-8528-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-4527-25: Bottles of 100 tablets. NDC 0054-4527-31: Bottles of 1000 tablets. (Identified 54 213). NDC 0054-8526-25: Unit dose, 10 capsules per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-2526-25: Bottles of 100 capsules. (Identified 54 463). NDC 0054-8527-25: Unit dose, 10 capsules per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-2527-25: Bottles of 100 capsules. NDC 0054-2527-31: Bottles of 1000 capsules. (size 0) (Identified 54 702). NDC 0054-8531-25: Unit dose, 10 capsules per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-2531-25: Bottles of 100 capsules. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container as defined in the USP/NF. NDC 0054-8529-04: Unit dose Patient Cup filled to deliver 5 mL, ten 5 mL Patient Cup per shelf pack, ten shelf packs per shipper. (For Institutional Use Only). NDC 0054-3527-63: Bottles of 500 mL. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP/NF. 4055501//05. Rev March 2005. © RLI, 2005."
    },
    {
      "NDCCode": "16590-781-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (16590-781-90)",
      "NDC11Code": "16590-0781-90",
      "ProductNDC": "16590-781",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lithium Carbonate",
      "NonProprietaryName": "Lithium Carbonate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19820129",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018558",
      "LabelerName": "STAT RX USA LLC",
      "SubstanceName": "LITHIUM CARBONATE",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Mood Stabilizer [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "Description": "Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy (see DOSAGE AND ADMINISTRATION). Each tablet for oral administration contains. Lithium Carbonate . . . . . . . . . . 300 mg. Each capsule for oral administration contains:. Lithium Carbonate . . . . . . . . . . 150 mg, 300 mg or 600 mg. Each 5 mL of solution for oral administration contains. Lithium ion (Li+) . . . . . . . . . . 8 mEq. (equivalent to amount of lithium in 300 mg of lithium carbonate), alcohol 0.3% v/v. The capsules contain talc, gelatin, FD and C Red No. 40, titanium dioxide, and the imprinting ink contains FD and C Blue No. 2, FD and C Yellow No. 6, FD and C Red No. 40, synthetic black iron oxide, and pharmaceutical glaze. The tablets contain calcium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and sodium starch glycolate. The solution contains alcohol, sorbitol, flavoring, water, and other ingredients. Lithium Oral Solution is a palatable oral dosage form of lithium ion. It is prepared in solution from lithium hydroxide and citric acid in a ratio approximately di-lithium citrate. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. The empirical formula for Lithium Citrate is C6H 5Li3O7; molecular weight 209.92. Lithium acts as an antimanic. Lithium Carbonate is a white, light, alkaline powder with molecular formula Li2CO3 and molecular weight 73.89. Preclinical studies have shown that lithium alters sodium transport in nerve and muscle cells and effects a shift toward intraneuronal metabolism of catecholamines, but the specific biochemical mechanism of lithium action in mania is unknown. Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks. Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, since the risk of lithium toxicity is very high in such patients. If the psychiatric indication is life-threatening, and if such a patient fails to respond to other measures, lithium treatment may be undertaken with extreme caution, including daily serum lithium determinations and adjustment to the usually low doses ordinarily tolerated by these individuals. In such instances, hospitalization is a necessity. Lithium may cause fetal harm when administered to a pregnant woman. There have been reports of lithium having adverse effects on nidations in rats, embryo viability in mice, and metabolism in-vitro of rat testis and human spermatozoa have been attributed to lithium, as have teratogenicity in submammalian species and cleft palates in mice. Studies in rats, rabbits and monkeys have shown no evidence of lithium-induced teratology. Data from lithium birth registries suggest an increase in cardiac and other anomalies, especially Ebstein’s anomaly. If the patient becomes pregnant while taking lithium, she should be apprised of the potential risk to the fetus. If possible, lithium should be withdrawn for at least the first trimester unless it is determined that this would seriously endanger the mother. Chronic lithium therapy may be associated with diminution of renal concentrating ability, occasionally presenting as nephrogenic diabetes insipidus, with polyuria and polydipsia. Such patients should be carefully managed to avoid dehydration with resulting lithium retention and toxicity. This condition is usually reversible when lithium is discontinued. Morphologic changes with glomerular and interstitial fibrosis and nephron-atrophy have been reported in patients on chronic lithium therapy. Morphologic changes have also been seen in bipolar patients never exposed to lithium. The relationship between renal functional and morphologic changes and their association with lithium therapy has not been established. When kidney function is assessed, for baseline data prior to starting lithium therapy or thereafter, routine urinalysis and other tests may be used to evaluate tubular function (e.g., urine specific gravity or osmolality following a period of water deprivation, or 24-hour urine volume) and glomerular function (e.g., serum creatinine or creatinine clearance). During lithium therapy, progressive or sudden changes in renal function, even within the normal range, indicate the need for reevaluation of treatment. Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels (see DOSAGE AND ADMINISTRATION). The ability to tolerate lithium is greater during the acute manic phase and decreases when manic symptoms subside (see DOSAGE AND ADMINISTRATION). The distribution space of lithium approximates that of total body water. Lithium is primarily excreted in urine with insignificant excretion in feces. Renal excretion of lithium is proportional to its plasma concentration. The half-life of elimination of lithium is approximately 24 hours. Lithium decreases sodium reabsorption by the renal tubules which could lead to sodium depletion. Therefore, it is essential for the patient to maintain a normal diet, including salt, and an adequate fluid intake (2500-3000 mL) at least during the initial stabilization period. Decreased tolerance to lithium has been reported to ensue from protracted sweating or diarrhea and, if such occur, supplemental fluid and salt should be administered. In addition to sweating and diarrhea, concomitant infection with elevated temperatures may also necessitate a temporary reduction or cessation of medication. Previously existing underlying thyroid disorders do not necessarily constitute a contraindication to lithium treatment; where hypothyroidism exists, careful monitoring of thyroid function during lithium stabilization and maintenance allows for correction of changing thyroid parameters, if any. Where hypothyroidism occurs during lithium stabilization and maintenance, supplemental thyroid treatment may be used. Outpatients and their families should be warned that the patient must discontinue lithium therapy and contact his physician if such clinical signs of lithium toxicity as diarrhea, vomiting, tremor, mild ataxia, drowsiness, or muscular weakness occur. Lithium may impair mental and/or physical abilities. Caution patients about activities requiring alertness (e.g., operating vehicles or machinery). An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leucocytosis, elevated serum enzymes, BUN and FBS) followed by irreversible brain damage has occurred in a few patients treated with lithium plus haloperidol. A causal relationship between these events and the concomitant administration of lithium and haloperidol has not been established; however, patients receiving such combined therapy should be monitored closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs appear. The possibility of similar adverse interactions with other antipsychotic medication exists. Lithium may prolong the effects of neuromuscular blocking agents. Therefore, neuromuscular blocking agents should be given with caution to patients receiving lithium. Caution should be used when lithium and diuretics or angiotensin converting enzyme (ACE) inhibitors are used concomitantly because sodium loss may reduce the renal clearance of lithium and increase serum lithium levels with risk of lithium toxicity. When such combinations are used, the lithium dosage may need to be decreased, and more frequent monitoring of lithium plasma levels is recommended. Lithium levels should be closely monitored when patients initiate or discontinue NSAID use. In some cases, lithium toxicity has resulted from interactions between an NSAID and lithium. Indomethacin and piroxicam have been reported to increase significantly steady-state plasma lithium concentrations. There is also evidence that other nonsteroidal anti-inflammatory agents, including the selective cyclooxygenase-2 (COX-2) inhibitors, have the same effect. In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg BID with celecoxib 200 mg BID as compared to subjects receiving lithium alone. See WARNINGS section. Lithium is excreted in human milk. Nursing should not be undertaken during lithium therapy except in rare and unusual circumstances where, in the view of the physician, the potential benefits to the mother outweigh possible hazards to the child. Since information regarding the safety and effectiveness of lithium in children under 12 years of age is not available, its use in such patients is not recommended at this time. There has been a report of a transient syndrome of acute dystonia and hyperreflexia occurring in a 15 kg child who ingested 300 mg of lithium carbonate. The likelihood of toxicity increases with increasing serum lithium levels. Serum lithium levels greater than 1.5 mEq/l carry a greater risk than lower levels. However, patients sensitive to lithium may exhibit toxic signs at serum levels below 1.5 mEq/l. Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of lithium toxicity, and can occur at lithium levels below 2.0 mEq/l. At higher levels, giddiness, ataxia, blurred vision, tinnitus and a large output of dilute urine may be seen. Serum lithium levels above 3.0 mEq/l may produce a complex clinical picture involving multiple organs and organ systems. Serum lithium levels should not be permitted to exceed 2.0 mEq/l during the acute treatment phase. Fine hand tremor, polyuria and mild thirst may occur during initial therapy for the acute manic phase, and may persist throughout treatment. Transient and mild nausea and general discomfort may also appear during the first few days of lithium administration. These side effects are an inconvenience rather than a disabling condition, and usually subside with continued treatment or a temporary reduction or cessation of dosage. If persistent, a cessation of dosage is indicated. The following adverse reactions have been reported and do not appear to be directly related to serum lithium levels. Tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), ataxia, choreo-athetotic movements, hyperactive deep tendon reflexes. Blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, incontinence of urine or feces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma, acute dystonia, downbeat nystagmus. Cardiac arrhythmia, hypotension, peripheral circulatory collapse, sinus node dysfunction with severe bradycardia (which may result in syncope). Cases of pseudotumor cerebri (increased intracranial pressure and papilledema) have been reported with lithium use. If undetected, this condition may result in enlargement of the blind spot, constriction of visual fields and eventual blindness due to optic atrophy. Lithium should be discontinued, if clinically possible, if this syndrome occurs. Anorexia, nausea, vomiting, diarrhea. Albuminuria, oliguria, polyuria, glycosuria. Drying and thinning of hair, anesthesia of skin, chronic folliculitis, xerosis cutis, alopecia and exacerbation of psoriasis. Blurred vision, dry mouth. Euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T3 and T4. Iodine 131 uptake may be elevated. (See PRECAUTIONS). Paradoxically, rare cases of hyperthyroidism have been reported. Diffuse slowing, widening of frequency spectrum, potentiation and disorganization of background rhythm. Reversible flattening, isoelectricity or inversion of T-waves. Fatigue, lethargy, transient scotomata, dehydration, weight loss, tendency to sleep. Transient electroencephalographic and electrocardiographic changes, leucocytosis, headache, diffuse non-toxic goiter with or without hypothyroidism, transient hyperglycemia, generalized pruritis with or without rash, cutaneous ulcers, albuminuria, worsening of organic brain syndromes, excessive weight gain, edematous swelling of ankles or wrists, and thirst or polyuria, sometimes resembling diabetes insipidus, and metallic taste. A single report has been received of the development of painful discoloration of fingers and toes and coldness of the extremities within one day of the starting of treatment of lithium. The mechanism through which these symptoms (resembling Raynaud’s Syndrome) developed is not known. Recovery followed discontinuance. The toxic levels for lithium are close to the therapeutic levels. It is therefore important that patients and their families be cautioned to watch for early symptoms and to discontinue the drug and inform the physician should they occur. Toxic symptoms are listed in detail under ADVERSE REACTIONS. No specific antidote for lithium poisoning is known. Early symptoms of lithium toxicity can usually be treated by reduction of cessation of dosage of the drug and resumption of the treatment at a lower dose after 24 to 48 hours. In severe cases of lithium poisoning, the first and foremost goal of treatment consists of elimination of this ion from the patient. Treatment is essentially the same as that used in barbiturate poisoning: 1) gastric lavage, 2) correction of fluid and electrolyte imbalance and 3) regulation of kidney functioning. Urea, mannitol, and aminophylline all produce significant increases in lithium excretion. Hemodialysis is an effective and rapid means of removing the ion from the severely toxic patient. Infection prophylaxis, regular chest X-rays, and preservation of adequate respiration are essential. Optimal patient response to Lithium Carbonate usually can be established and maintained with 600 mg t.i.d. Optimal patient response to Lithium Oral Solution usually can be established and maintained with 10 mL (2 full teaspoons) (16 mEq of lithium) t.i.d. Such doses will normally produce an effective serum lithium level ranging between 1.0 and 1.5 mEq/l. Dosage must be individualized according to serum levels and clinical response. Regular monitoring of the patient’s clinical state and of serum lithium levels is necessary. Serum levels should be determined twice per week during the acute phase, and until the serum level and clinical condition of the patient have been stabilized. The desirable serum lithium levels are 0.6 to 1.2 mEq/l. Dosage will vary from one individual to another, but usually 300 mg of Lithium Carbonate t.i.d. or q.i.d., or 5 mL (1 full teaspoon) (8 mEq of Lithium) of Lithium Oral Solution t.i.d. or q.i.d. will maintain this level. Serum lithium levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months. Patients abnormally sensitive to lithium may exhibit toxic signs at serum levels of 1.0 to 1.5 mEq/l. Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels ordinarily tolerated by other patients. Blood samples for serum lithium determination should be drawn immediately prior to the next dose when lithium concentrations are relatively stable (i.e., 8-12 hours after the previous dose). Total reliance must not be placed on serum levels alone. Accurate patient evaluation requires both clinical and laboratory analysis. NDC 0054-8528-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-4527-25: Bottles of 100 tablets. NDC 0054-4527-31: Bottles of 1000 tablets. (Identified 54 213). NDC 0054-8526-25: Unit dose, 10 capsules per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-2526-25: Bottles of 100 capsules. (Identified 54 463). NDC 0054-8527-25: Unit dose, 10 capsules per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-2527-25: Bottles of 100 capsules. NDC 0054-2527-31: Bottles of 1000 capsules. (size 0) (Identified 54 702). NDC 0054-8531-25: Unit dose, 10 capsules per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-2531-25: Bottles of 100 capsules. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container as defined in the USP/NF. NDC 0054-8529-04: Unit dose Patient Cup filled to deliver 5 mL, ten 5 mL Patient Cup per shelf pack, ten shelf packs per shipper. (For Institutional Use Only). NDC 0054-3527-63: Bottles of 500 mL. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP/NF. 4055501//05. Rev March 2005. © RLI, 2005."
    },
    {
      "NDCCode": "78794-131-00",
      "PackageDescription": "7.4 mL in 1 BOTTLE, PLASTIC (78794-131-00) ",
      "NDC11Code": "78794-0131-00",
      "ProductNDC": "78794-131",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kentkwik Hand Sanitizer Summertime",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200709",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Hand 2 Hand Industries, LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "73",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200709",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "59088-003-81",
      "PackageDescription": "14 TABLET in 1 BOTTLE, PLASTIC (59088-003-81) ",
      "NDC11Code": "59088-0003-81",
      "ProductNDC": "59088-003",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bruselix Bruising",
      "NonProprietaryName": "Vitamin C, Zinc, Arnica Montana Extract, Bromelain, Diosmin, Rutin, Citrus Bioflavonoids, Hesperidin Methyl Chalcone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241011",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Puretek Corporation",
      "SubstanceName": "ARNICA MONTANA FLOWER; STEM BROMELAIN; SODIUM ASCORBATE; HESPERIDIN METHYLCHALCONE; RUTIN; DIOSMIN; HESPERIDIN; ZINC PICOLINATE",
      "StrengthNumber": "50; 400; 120; 25; 50; 200; 25; 10",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Vitamin C [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-10-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241011",
      "SamplePackage": "N",
      "IndicationAndUsage": "Bruselix Bruising Tablets are formulated to provide nutritional support during the body’s natural recovery process. They may be helpful for individuals experiencing bruising due to minor injuries, surgical procedures, or sensitive skin. The formula contains antioxidants, enzymes, and natural extracts that are traditionally used to support overall skin health and recovery.",
      "Description": "Active Ingredients Each tablet contains: Vitamin C (as Sodium Ascorbate) ...............................................................120 mg Zinc (as Zinc Picolinate) ...............................................................................10 mg Arnica Montana Extract 10:1 (equivalent to 500 mg Arnica Montana Powder) ...50 mg Bromelain 2400 GDU/g (from Pineapple) ...................................................400 mg Diosmin (Citrus Aurantium) Fruit Extract.....................................................200 mg Rutin (Sophora Japonica) Flower Extract......................................................50 mg Citrus Bioflavonoids (from pulp and peel of lemon, orange, quince) ............25 mg Hesperidin Methyl Chalcone..........................................................................25 mg. Other Ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (Vegetable Source), Coating (Hydroxypropyl Methylcellulose, PEG-8)."
    },
    {
      "NDCCode": "59088-005-54",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-005-54) ",
      "NDC11Code": "59088-0005-54",
      "ProductNDC": "59088-005",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Multitol-m",
      "NonProprietaryName": "Multivitamin, Folate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240417",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE",
      "StrengthNumber": "13.5; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 2040; 8; 200; 1500; 3; 25; 2.3",
      "StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-04-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240417",
      "SamplePackage": "N",
      "IndicationAndUsage": "Multitol-M is indicated to provide vitamins and minerals supplement to men and women. Folate is effective in the treatment of megaloblastic anemias due to a deficiency of folate (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
      "Description": "Each caplet contains. Vitamin A (as Retinyl Acetate)………………........ 1500 mcg RAE Vitamin C (as Ascorbic Acid) .………………..………...… 120 mg Vitamin D3 (As Cholecalciferol) ..……………….. 20 mcg (800 IU) Vitamin E (DL-alpha Tocopheryl Acetate) .……………….. 13.5 mg Thiamin (As Thiamine Mononitrate) …….………………..… 3 mg Riboflavin …………………………….….…..………….... 3.4 mg Niacin (as Niacinamide)…………………………………… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride)…………………. 20 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)………………………….. 8 mcg Calcium (as Calcium Carbonate)…………………………. 200 mg Magnesium (as Magnesium Oxide)……………………… 200 mg Zinc (as Zinc Oxide)……………………………………….. 25 mg Selenium (as Selenium Amino Acid Chelate)……………. 55 mcg Manganese (as Manganese Sulfate)……………………… 2.3 mg Chromium (as Chromium Polynicotinate)……………….. 35 mcg Molybdenum (as Molybdenum Amino Acid Chelate).……. 45 mcg Other Ingredients: Organic Cocoa Powder, Croscarmellose Sodium, Crospovidone, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid. Coating: (Hydroxypropyl Methylcellulose [HPMC], PEG-8)."
    },
    {
      "NDCCode": "59088-008-54",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-008-54) ",
      "NDC11Code": "59088-0008-54",
      "ProductNDC": "59088-008",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Finazol",
      "NonProprietaryName": "Ferrous Fumarate, Folate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241011",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC CITRATE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON",
      "StrengthNumber": "1500; 200; 10; 45; 3.25; 3.35; 22.5; 6; 1000; 26; 100; 15; 100; 18; 25; 50; 30; 30; 1; .75; 37.5; 25; 24.5; 25",
      "StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1",
      "Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-11-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20241011",
      "SamplePackage": "N",
      "IndicationAndUsage": "Finazol is indicated for iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also, for conditions in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.",
      "Description": "Full Prescribing Information: DESCRIPTION: Active Ingredients: Each caplet contains: Vitamin A (as Retinyl Acetate) ……………………………….....1500 mcg RAE Vitamin C (as Ascorbic Acid) ….…..….…………………….……….....200 mg Vitamin D3 (as Cholecalciferol) ….…………………………....10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) ………………………….....45 mg Thiamin (as Thiamine Mononitrate) …..…..…………………………...3.25 mg Riboflavin (as Vitamin B2) …..…..…..…..………………………….…3.35 mg Niacin (as Niacinamide)……………………………………………..…22.5 mg Vitamin B6 (as Pyridoxine HCl)……………………………………………6 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …………………1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)……………………………………..26 mcg Biotin………………………………………………………………….100 mcg Pantothenic Acid (as Calcium Pantothenate)………………………….....15 mg Calcium (as Calcium Carbonate)………………………………………..100 mg Iron (as Ferrous Fumarate)……………………………………………....18 mg Iodine (as Potassium Iodide)…………………………………………...25 mcg Magnesium (as Magnesium Oxide)……………………………………...50 mg Zinc (as Zinc Citrate)……………………………………………………..30 mg Selenium (as Selenomethionine)….…………………………………….30 mcg Copper (as Copper Oxide)………………………………………………....1 mg Manganese (as Manganese Sulfate)…………………………………...0.75 mg Chromium (as Chromium Polynicotinate)…………………………….37.5 mcg Molybdenum (as Sodium Molybdate)…………………………………..25 mcg Potassium (as Potassium Chloride) ……………………………….…..24.5 mg Boron (as Boron Citrate)……………………………………..…………25 mcg. Other Ingredients: Crospovidone, Dextrin, Dextrose Monohydrate, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Purified Stearic Acid, Silicon Dioxide, Sodium Carboxymethylcellulose, Titanium Dioxide."
    },
    {
      "NDCCode": "59088-009-54",
      "PackageDescription": "30 TABLET in 1 BOTTLE (59088-009-54) ",
      "NDC11Code": "59088-0009-54",
      "ProductNDC": "59088-009",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prenatol-m",
      "NonProprietaryName": "Multivitamin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240506",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "CHOLECALCIFEROL; FERROUS FUMARATE; MOLYBDENUM; ASCORBIC ACID; ZINC OXIDE; CHOLINE BITARTRATE; RIBOFLAVIN; MAGNESIUM OXIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; VITAMIN A ACETATE; SELENIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CALCIUM CARBONATE; CHROMIUM NICOTINATE; MANGANESE SULFATE; POTASSIUM IODIDE; METHYLCOBALAMIN; LEVOMEFOLATE CALCIUM; THIAMINE MONONITRATE",
      "StrengthNumber": "20; 27; 50; 120; 25; 55; 3.4; 200; 13.5; 1500; 70; 20; 50; 200; 45; 2.6; 150; 10; 2040; 3",
      "StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1",
      "Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-05-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240506",
      "SamplePackage": "N",
      "IndicationAndUsage": "Indications and Usage: Prenatol-M is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prenatol-M may be beneficial in improving the nutritional status of women prior to conception.",
      "Description": "Each caplet contains: Vitamin A (as Retinyl Acetate) ………………....… 1500 mcg RAE Vitamin C (as Ascorbic Acid) ………………….………… 120 mg Vitamin D3 (as Cholecalciferol).……………....... 20 mcg (800 IU) Vitamin E (as Dl-Alpha Tocopheryl Acetate) ….......….…. 13.5 mg Thiamin (as Thiamine Mononitrate) …………...…………… 3 mg Riboflavin ……………………….…………………….…. 3.4 mg Niacin (as Niacinamide) ………………..……………….… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride) …....…………... 50 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) ….... 2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin) ……….……………... 10 mcg Choline (as Choline Bitartrate) …….……………………… 55 mg Calcium (as Calcium Carbonate) ……...…………………. 200 mg Iron (as Ferrous Fumarate) ………..……………………… 27 mg Iodine (as Potassium Iodine) …...……………………….150 mcg Magnesium (as Magnesium Oxide) …...………………… 200 mg Zinc (as Zinc Oxide) ………………...…………………….. 25 mg Selenium (as Selenium Amino Acid Chelate) ……………. 70 mcg Manganese (as Manganese Sulfate) ……………………… 2.6 mg Chromium (as Chromium Polynicotinate) ……………….. 45 mcg Molybdenum (as Molybdenum Amino Acid Chelate)…...… 50 mcg."
    },
    {
      "NDCCode": "59088-013-06",
      "PackageDescription": "60 g in 1 JAR (59088-013-06) ",
      "NDC11Code": "59088-0013-06",
      "ProductNDC": "59088-013",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Methylten",
      "NonProprietaryName": "Methyl Salicylate 10%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250113",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Puretek Corporation",
      "SubstanceName": "METHYL SALICYLATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2025-01-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250113",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints."
    },
    {
      "NDCCode": "59088-014-06",
      "PackageDescription": "60 g in 1 JAR (59088-014-06) ",
      "NDC11Code": "59088-0014-06",
      "ProductNDC": "59088-014",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Methyl Salicylate 25%",
      "ProprietaryNameSuffix": "Pain Relieving",
      "NonProprietaryName": "Methyl Salicylate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250612",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "Puretek Corporation",
      "SubstanceName": "METHYL SALICYLATE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250612",
      "SamplePackage": "N",
      "IndicationAndUsage": "■ For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains."
    },
    {
      "NDCCode": "59088-015-54",
      "PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-015-54) ",
      "NDC11Code": "59088-0015-54",
      "ProductNDC": "59088-015",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Flotrex",
      "NonProprietaryName": "Multivitamins, Sodium Fluoride 0.5 Mg",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250221",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
      "StrengthNumber": ".5; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5",
      "StrengthUnit": "mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
      "Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250221",
      "SamplePackage": "N",
      "IndicationAndUsage": "This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.",
      "Description": "Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid)....................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................................... 0.5 mg. Flotrex Multivitamin Chewable plus 0.5 mg Fluoride Tablets. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 0.5 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid (Vegetable), Sucrose, CI 42090 (FD&C Blue No. 1 Aluminum Lake), CI 45410 (Red 27 Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet."
    },
    {
      "NDCCode": "59088-017-54",
      "PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-017-54) ",
      "NDC11Code": "59088-0017-54",
      "ProductNDC": "59088-017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Flotrex",
      "NonProprietaryName": "Multivitamins, Sodium Fluoride 0.25 Mg",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250319",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
      "StrengthNumber": ".25; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5",
      "StrengthUnit": "mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
      "Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250319",
      "SamplePackage": "N",
      "IndicationAndUsage": "This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.",
      "Description": "Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid) ...................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ................................................................... 0.25 mg. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Stearic Acid (vegetable source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&C Blue No. 1 Aluminum Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet."
    },
    {
      "NDCCode": "59088-018-54",
      "PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-018-54) ",
      "NDC11Code": "59088-0018-54",
      "ProductNDC": "59088-018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Multivitamin",
      "NonProprietaryName": "Multivitamin",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250515",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN",
      "StrengthNumber": "750; 24; 36; 10; 10; 1.05; 1.05; 1.2; 13.5; 1000; 4.5",
      "StrengthUnit": "ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
      "Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250515",
      "SamplePackage": "N",
      "IndicationAndUsage": "Multivitamin Chewable Tablets is indicated to provide significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.",
      "Description": "Vitamin A (as Retinyl Acetate).................................... 750 mcg RAE. Vitamin C (as Sodium Ascorbate and Ascorbic Acid).............. 60 mg. Vitamin D3 (as Cholecalciferol)............................................ 10 mcg. Vitamin E (as DL-Alpha Tocopheryl Acetate)........................ 10 mg. Thiamin (as Thiamine Mononitrate).................................... 1.05 mg. Riboflavin............................................................................... 1.2 mg. Niacin (as Niacinamide)....................................................... 13.5 mg. Vitamin B6 (as Pyridoxine Hydrochloride).......................... 1.05 mg. Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE. (1000 mcg as L-5-Methylfolate). Vitamin B12 (as Methylcobalamin)..................................... 4.5 mcg."
    },
    {
      "NDCCode": "59088-020-54",
      "PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-020-54) ",
      "NDC11Code": "59088-0020-54",
      "ProductNDC": "59088-020",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Flotrex",
      "NonProprietaryName": "Multivitamins, Sodium Fluoride 1 Mg",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250710",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN",
      "StrengthNumber": "1; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5",
      "StrengthUnit": "mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1",
      "Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-07-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250710",
      "SamplePackage": "N",
      "IndicationAndUsage": "This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.",
      "Description": "Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid)....................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................................... 1 mg. Flotrex Multivitamin Chewable plus 1 mg Fluoride Tablets Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 1 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid (Vegetable), Sucrose, CI 42090 (FD&C Blue No. 1 Aluminum Lake), CI 45410 (Red 27 Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet."
    },
    {
      "NDCCode": "59088-022-54",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-022-54) ",
      "NDC11Code": "59088-0022-54",
      "ProductNDC": "59088-022",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Boostervite",
      "NonProprietaryName": "Multivitamin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260619",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "FERROUS FUMARATE; PANTOTHENIC ACID; ORANGE JUICE; BIOTIN; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; THIAMINE MONONITRATE; PYRIDOXINE HYDROCHLORIDE; CHOLECALCIFEROL; BROCCOLI SPROUT; PRUNUS CERASUS (BITTER CHERRY) FRUIT EXTRACT; KALE; WITHANIA SOMNIFERA ROOT",
      "StrengthNumber": "18; 50; 2.5; 300; 10; 10; 100; 1000; 100; 10; 10; 10; 2.5; 2.5; 2.5; 60",
      "StrengthUnit": "mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Folate Analog [EPC], Folic Acid [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-06-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260619",
      "SamplePackage": "N",
      "IndicationAndUsage": "Boostervite contains a combination of vitamins, minerals, and botanical extracts intended to supplement nutritional intake in patients with low energy associated with nutritional needs, under the supervision of a healthcare provider.",
      "Description": "Each Tablet Contains. Vitamin C (as ascorbic acid)……………….……………… 100 mg Vitamin D3 (as cholecalciferol)…………….……. 10 mcg (400 IU) Thiamin (as thiamine mononitrate)…………...……………. 10 mg Riboflavin ...................…………………………...………….. 10 mg Niacin (as niacinamide)…………………………....…………10 mg Vitamin B6 (as pyridoxine hydrochloride)………….……….10 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate) Vitamin B12 (as methylcobalamin)………………….….... 100 mcg Biotin (as d-Biotin)……………………...…….................... 300 mcg Pantothenic Acid (as d-Calcium Pantothenate)………....… 50 mg Iron (as Ferrous Fumarate)……………………………......... 18 mg Withania somnifera (Ashwagandha) Root Powder….....…. 60 mg Brassica oleracea acephala (Kale) Powder……….…...…. 2.5 mg Brassica oleracea italica (Broccoli) Sprout Powder..…...... 2.5 mg Citrus sinensis (Orange) Juice Powder……....................... 2.5 mg Prunus cerasus (Tart Cherry) Extract................................. 2.5 mg. Other Ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (vegetable source), Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol 400, Organic Maltodextrin, Organic Sunflower Lecithin, Organic Sunflower Oil, Organic Guar Gum)."
    },
    {
      "NDCCode": "59088-062-00",
      "PackageDescription": "1 KIT in 1 PACKAGE (59088-062-00)  *  1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET in 1 BOTTLE, PLASTIC (53746-253-60)  *  1 BOTTLE, PUMP in 1 KIT > 237 mL in 1 BOTTLE, PUMP (59088-310-16)  *  1 BOTTLE, PLASTIC in 1 KIT > 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16571-201-06)",
      "NDC11Code": "59088-0062-00",
      "ProductNDC": "59088-062",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dermacinrx Inflammatral Pak",
      "NonProprietaryName": "Diclofenac Sodium Delayed Release Tablets, Ranitidine Tablets, Capsaicin Cream",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20150612",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077863",
      "LabelerName": "PureTek Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2019-03-07",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "59088-078-54",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-078-54) ",
      "NDC11Code": "59088-0078-54",
      "ProductNDC": "59088-078",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pnv Prenatol",
      "NonProprietaryName": "Multivitamin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260821",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; CYANOCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE; .ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; CHOLINE BITARTRATE; FERROUS FUMARATE; POTASSIUM IODIDE",
      "StrengthNumber": "3.4; 20; 120; 1000; 10; 200; 1500; 3; 25; 2.6; 30; 200; 45; 50; 50; 70; 20; 55; 27; 150",
      "StrengthUnit": "mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1",
      "Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260821",
      "SamplePackage": "N",
      "IndicationAndUsage": "PNV Prenatol TM is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. PNV Prenatol TM may be beneficial in improving the nutritional status of women prior to conception.",
      "Description": "Each tablet contains. Vitamin A (as retinyl acetate)…………...1500 mcg RAE (5000 IU) Vitamin C (as ascorbic acid)……………….………………. 120 mg Vitamin D3 (as cholecalciferol)…………….……. 20 mcg (800 IU) dl-Alpha-Tocopheryl Acetate (as Vitamin E)……….....……. 30 mg Thiamin (as thiamine mononitrate)…………...……………….3 mg Riboflavin.....................…………………………...…...……. 3.4 mg Niacin (as niacinamide)…………………………....………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)………….………..50 mg Folate (as l-5-methyltetrahydrofolate calcium salt)……….. 1700 mcg DFE (1000 mcg L-5-Methylfolate) Vitamin B12 (as cyanocobalamin)………………….……….10 mcg. Choline (as choline bitartrate)..............................................55 mg Calcium (as calcium carbonate)……………………...……. 200 mg. Iron (as ferrous fumarate)...................................................27 mg. Iodine (as potassium iodide)............................................150 mcg Magnesium (as magnesium oxide)……………………...….200 mg Zinc (as zinc oxide)………………………………………....... 25 mg Selenium (as selenium amino acid chelate)……………….70 mcg Manganese (as manganese sulfate)………………………. 2.6 mg Chromium (as chromium polynicotinate)………………..... 45 mcg Molybdenum (as molybdenum amino acid chelate)……... 50 mcg. Other Ingredients:Croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, clear coating (hydroxypropyl methylcellulose, polyethylene glycol 400)."
    },
    {
      "NDCCode": "59088-083-00",
      "PackageDescription": "1 KIT in 1 PACKAGE (59088-083-00)  *  9 BLISTER PACK in 1 CARTON (55111-292-09)  / 9 TABLET in 1 BLISTER PACK *  85 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07) ",
      "NDC11Code": "59088-0083-00",
      "ProductNDC": "59088-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Migranow",
      "NonProprietaryName": "Sumatriptan Succinate, Camphor, Menthol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160418",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "Status": "Active",
      "LastUpdate": "2024-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160418",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sumatriptan tablets are indicated for the acute treatment of migraine attacks with or without aura in adults. Sumatriptan tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of sumatriptan tablets have not been established for cluster headache, which is present in an older, predominantly male population.",
      "Description": "Sumatriptan tablets USP contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine 1 receptor subtype agonist. Sumatriptan succinate USP is chemically designated as 3-[2- (dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:. The molecular formula is C 14H 21N 3O 2SC 4H 6O 4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "59088-090-54",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-090-54) ",
      "NDC11Code": "59088-0090-54",
      "ProductNDC": "59088-090",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dermacinrx Purefolix",
      "NonProprietaryName": "Folic Acid, Vitamin D3",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151103",
      "EndMarketingDate": "20211231",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "FOLIC ACID; VITAMIN D",
      "StrengthNumber": "1; 125",
      "StrengthUnit": "mg/1; ug/1",
      "Pharm_Classes": "Vitamin D [CS],Vitamin D [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20151103",
      "EndMarketingDatePackage": "20211231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59088-091-00",
      "PackageDescription": "1 KIT in 1 PACKAGE (59088-091-00)  *  30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0228-2892-03)  *  237 mL in 1 BOTTLE, PUMP (59088-389-16)",
      "NDC11Code": "59088-0091-00",
      "ProductNDC": "59088-091",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dermacinrx Dpn Pak",
      "NonProprietaryName": "Duloxetine, Lidocaine And Menthol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160526",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090776",
      "LabelerName": "PureTek Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2017-08-23"
    },
    {
      "NDCCode": "59088-093-00",
      "PackageDescription": "1 KIT in 1 PACKAGE (59088-093-00)  *  237 mL in 1 BOTTLE, PUMP (59088-310-16)  *  60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-60) ",
      "NDC11Code": "59088-0093-00",
      "ProductNDC": "59088-093",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Inflammacin",
      "NonProprietaryName": "Diclofenac Sodium, Capsaicin",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160111",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "Status": "Active",
      "LastUpdate": "2024-12-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160111",
      "SamplePackage": "N",
      "Description": "Diclofenac, as the sodium salt, is a benzene-acetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C 14H 10Cl 2NNaO 2, and it has the following structural formula:. Each enteric-coated tablet for oral administration contains 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients; black iron oxide, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, pharmaceutical glaze, polyethylene glycol, povidone, sodium starch glycolate, talc, titanium dioxide, triethyl citrate."
    },
    {
      "NDCCode": "59088-096-58",
      "PackageDescription": "6 BLISTER PACK in 1 CARTON (59088-096-58)  > 1 KIT in 1 BLISTER PACK *  1 TABLET in 1 BLISTER PACK",
      "NDC11Code": "59088-0096-58",
      "ProductNDC": "59088-096",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prenatal, Dha",
      "NonProprietaryName": "Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Ascorbic Acid, Niacin, Folic Acid, Ferrous Fumarate, Calcium Carbonate, Cholecalciferol, Vitamin E Acetate, Potassium Iodide, Zinc Oxide, Choline Bitartrate, And Doconexent",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20170810",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2020-05-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20170810",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "59088-105-64",
      "PackageDescription": "1000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-105-64)",
      "NDC11Code": "59088-0105-64",
      "ProductNDC": "59088-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluoride",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "TABLET, CHEWABLE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110601",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-07",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"59088-131-73","ProprietaryName":"Diclofenac Potassium","NonProprietaryName":"Diclofenac Potassium 25 Mg"},{"NDCCode":"69423-131-01","ProprietaryName":"Secret Luxe Lavender Clear","NonProprietaryName":"Aluminum Zirconium Octachlorohydrex Gly"},{"NDCCode":"69423-131-73","ProprietaryName":"Secret Luxe Lavender Clear","NonProprietaryName":"Aluminum Zirconium Octachlorohydrex Gly"},{"NDCCode":"59088-104-73","ProprietaryName":"Fluoride","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"59088-105-73","ProprietaryName":"Fluoride","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"59088-106-73","ProprietaryName":"Fluoride","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"0409-4346-73","ProprietaryName":"Aminocaproic Acid","NonProprietaryName":"Aminocaproic Acid"},{"NDCCode":"16590-781-30","ProprietaryName":"Lithium Carbonate","NonProprietaryName":"Lithium Carbonate"},{"NDCCode":"16590-781-60","ProprietaryName":"Lithium Carbonate","NonProprietaryName":"Lithium Carbonate"},{"NDCCode":"16590-781-90","ProprietaryName":"Lithium Carbonate","NonProprietaryName":"Lithium Carbonate"},{"NDCCode":"78794-131-00","ProprietaryName":"Kentkwik Hand Sanitizer Summertime","NonProprietaryName":"Alcohol"},{"NDCCode":"59088-003-81","ProprietaryName":"Bruselix Bruising","NonProprietaryName":"Vitamin C, Zinc, Arnica Montana Extract, Bromelain, Diosmin, Rutin, Citrus Bioflavonoids, Hesperidin Methyl Chalcone"},{"NDCCode":"59088-005-54","ProprietaryName":"Multitol-m","NonProprietaryName":"Multivitamin, Folate"},{"NDCCode":"59088-008-54","ProprietaryName":"Finazol","NonProprietaryName":"Ferrous Fumarate, Folate"},{"NDCCode":"59088-009-54","ProprietaryName":"Prenatol-m","NonProprietaryName":"Multivitamin"},{"NDCCode":"59088-013-06","ProprietaryName":"Methylten","NonProprietaryName":"Methyl Salicylate 10%"},{"NDCCode":"59088-014-06","ProprietaryName":"Methyl Salicylate 25%","NonProprietaryName":"Methyl Salicylate"},{"NDCCode":"59088-015-54","ProprietaryName":"Flotrex","NonProprietaryName":"Multivitamins, Sodium Fluoride 0.5 Mg"},{"NDCCode":"59088-017-54","ProprietaryName":"Flotrex","NonProprietaryName":"Multivitamins, Sodium Fluoride 0.25 Mg"},{"NDCCode":"59088-018-54","ProprietaryName":"Multivitamin","NonProprietaryName":"Multivitamin"},{"NDCCode":"59088-020-54","ProprietaryName":"Flotrex","NonProprietaryName":"Multivitamins, Sodium Fluoride 1 Mg"},{"NDCCode":"59088-022-54","ProprietaryName":"Boostervite","NonProprietaryName":"Multivitamin"},{"NDCCode":"59088-062-00","ProprietaryName":"Dermacinrx Inflammatral Pak","NonProprietaryName":"Diclofenac Sodium Delayed Release Tablets, Ranitidine Tablets, Capsaicin Cream"},{"NDCCode":"59088-078-54","ProprietaryName":"Pnv Prenatol","NonProprietaryName":"Multivitamin"},{"NDCCode":"59088-083-00","ProprietaryName":"Migranow","NonProprietaryName":"Sumatriptan Succinate, Camphor, Menthol"},{"NDCCode":"59088-090-54","ProprietaryName":"Dermacinrx Purefolix","NonProprietaryName":"Folic Acid, Vitamin D3"},{"NDCCode":"59088-091-00","ProprietaryName":"Dermacinrx Dpn Pak","NonProprietaryName":"Duloxetine, Lidocaine And Menthol"},{"NDCCode":"59088-093-00","ProprietaryName":"Inflammacin","NonProprietaryName":"Diclofenac Sodium, Capsaicin"},{"NDCCode":"59088-096-58","ProprietaryName":"Prenatal, Dha","NonProprietaryName":"Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Ascorbic Acid, Niacin, Folic Acid, Ferrous Fumarate, Calcium Carbonate, Cholecalciferol, Vitamin E Acetate, Potassium Iodide, Zinc Oxide, Choline Bitartrate, And Doconexent"},{"NDCCode":"59088-105-64","ProprietaryName":"Fluoride","NonProprietaryName":"Sodium Fluoride"}]}
                    

<NDCList><NDC><NDCCode>59088-131-73</NDCCode><ProprietaryName>Diclofenac Potassium</ProprietaryName><NonProprietaryName>Diclofenac Potassium 25 Mg</NonProprietaryName></NDC><NDC><NDCCode>69423-131-01</NDCCode><ProprietaryName>Secret Luxe Lavender Clear</ProprietaryName><NonProprietaryName>Aluminum Zirconium Octachlorohydrex Gly</NonProprietaryName></NDC><NDC><NDCCode>69423-131-73</NDCCode><ProprietaryName>Secret Luxe Lavender Clear</ProprietaryName><NonProprietaryName>Aluminum Zirconium Octachlorohydrex Gly</NonProprietaryName></NDC><NDC><NDCCode>59088-104-73</NDCCode><ProprietaryName>Fluoride</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>59088-105-73</NDCCode><ProprietaryName>Fluoride</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>59088-106-73</NDCCode><ProprietaryName>Fluoride</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>0409-4346-73</NDCCode><ProprietaryName>Aminocaproic Acid</ProprietaryName><NonProprietaryName>Aminocaproic Acid</NonProprietaryName></NDC><NDC><NDCCode>16590-781-30</NDCCode><ProprietaryName>Lithium Carbonate</ProprietaryName><NonProprietaryName>Lithium Carbonate</NonProprietaryName></NDC><NDC><NDCCode>16590-781-60</NDCCode><ProprietaryName>Lithium Carbonate</ProprietaryName><NonProprietaryName>Lithium Carbonate</NonProprietaryName></NDC><NDC><NDCCode>16590-781-90</NDCCode><ProprietaryName>Lithium Carbonate</ProprietaryName><NonProprietaryName>Lithium Carbonate</NonProprietaryName></NDC><NDC><NDCCode>78794-131-00</NDCCode><ProprietaryName>Kentkwik Hand Sanitizer Summertime</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>59088-003-81</NDCCode><ProprietaryName>Bruselix Bruising</ProprietaryName><NonProprietaryName>Vitamin C, Zinc, Arnica Montana Extract, Bromelain, Diosmin, Rutin, Citrus Bioflavonoids, Hesperidin Methyl Chalcone</NonProprietaryName></NDC><NDC><NDCCode>59088-005-54</NDCCode><ProprietaryName>Multitol-m</ProprietaryName><NonProprietaryName>Multivitamin, Folate</NonProprietaryName></NDC><NDC><NDCCode>59088-008-54</NDCCode><ProprietaryName>Finazol</ProprietaryName><NonProprietaryName>Ferrous Fumarate, Folate</NonProprietaryName></NDC><NDC><NDCCode>59088-009-54</NDCCode><ProprietaryName>Prenatol-m</ProprietaryName><NonProprietaryName>Multivitamin</NonProprietaryName></NDC><NDC><NDCCode>59088-013-06</NDCCode><ProprietaryName>Methylten</ProprietaryName><NonProprietaryName>Methyl Salicylate 10%</NonProprietaryName></NDC><NDC><NDCCode>59088-014-06</NDCCode><ProprietaryName>Methyl Salicylate 25%</ProprietaryName><NonProprietaryName>Methyl Salicylate</NonProprietaryName></NDC><NDC><NDCCode>59088-015-54</NDCCode><ProprietaryName>Flotrex</ProprietaryName><NonProprietaryName>Multivitamins, Sodium Fluoride 0.5 Mg</NonProprietaryName></NDC><NDC><NDCCode>59088-017-54</NDCCode><ProprietaryName>Flotrex</ProprietaryName><NonProprietaryName>Multivitamins, Sodium Fluoride 0.25 Mg</NonProprietaryName></NDC><NDC><NDCCode>59088-018-54</NDCCode><ProprietaryName>Multivitamin</ProprietaryName><NonProprietaryName>Multivitamin</NonProprietaryName></NDC><NDC><NDCCode>59088-020-54</NDCCode><ProprietaryName>Flotrex</ProprietaryName><NonProprietaryName>Multivitamins, Sodium Fluoride 1 Mg</NonProprietaryName></NDC><NDC><NDCCode>59088-022-54</NDCCode><ProprietaryName>Boostervite</ProprietaryName><NonProprietaryName>Multivitamin</NonProprietaryName></NDC><NDC><NDCCode>59088-062-00</NDCCode><ProprietaryName>Dermacinrx Inflammatral Pak</ProprietaryName><NonProprietaryName>Diclofenac Sodium Delayed Release Tablets, Ranitidine Tablets, Capsaicin Cream</NonProprietaryName></NDC><NDC><NDCCode>59088-078-54</NDCCode><ProprietaryName>Pnv Prenatol</ProprietaryName><NonProprietaryName>Multivitamin</NonProprietaryName></NDC><NDC><NDCCode>59088-083-00</NDCCode><ProprietaryName>Migranow</ProprietaryName><NonProprietaryName>Sumatriptan Succinate, Camphor, Menthol</NonProprietaryName></NDC><NDC><NDCCode>59088-090-54</NDCCode><ProprietaryName>Dermacinrx Purefolix</ProprietaryName><NonProprietaryName>Folic Acid, Vitamin D3</NonProprietaryName></NDC><NDC><NDCCode>59088-091-00</NDCCode><ProprietaryName>Dermacinrx Dpn Pak</ProprietaryName><NonProprietaryName>Duloxetine, Lidocaine And Menthol</NonProprietaryName></NDC><NDC><NDCCode>59088-093-00</NDCCode><ProprietaryName>Inflammacin</ProprietaryName><NonProprietaryName>Diclofenac Sodium, Capsaicin</NonProprietaryName></NDC><NDC><NDCCode>59088-096-58</NDCCode><ProprietaryName>Prenatal, Dha</ProprietaryName><NonProprietaryName>Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Ascorbic Acid, Niacin, Folic Acid, Ferrous Fumarate, Calcium Carbonate, Cholecalciferol, Vitamin E Acetate, Potassium Iodide, Zinc Oxide, Choline Bitartrate, And Doconexent</NonProprietaryName></NDC><NDC><NDCCode>59088-105-64</NDCCode><ProprietaryName>Fluoride</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC></NDCList>