RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "87078-131-54",
      "PackageDescription": "24 POUCH in 1 CARTON (87078-131-54)  / 5 mL in 1 POUCH (87078-131-05) ",
      "NDC11Code": "87078-0131-54",
      "ProductNDC": "87078-131",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Onessip Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250922",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "MEDWISE LIFESCIENCES INC.",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/5mL",
      "Status": "Active",
      "LastUpdate": "2025-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250922",
      "SamplePackage": "N",
      "IndicationAndUsage": ": 1 Temporarily reduces fever, 2 Temporarily relieves minor aches and pains due to: the common coldfluheadachesore throattoothache."
    },
    {
      "NDCCode": "87078-131-52",
      "PackageDescription": "12 POUCH in 1 CARTON (87078-131-52)  / 5 mL in 1 POUCH (87078-131-05) ",
      "NDC11Code": "87078-0131-52",
      "ProductNDC": "87078-131",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Onessip Acetaminophen",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250922",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "MEDWISE LIFESCIENCES INC.",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/5mL",
      "Status": "Active",
      "LastUpdate": "2025-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250922",
      "SamplePackage": "N",
      "IndicationAndUsage": ": 1 Temporarily reduces fever, 2 Temporarily relieves minor aches and pains due to: the common coldfluheadachesore throattoothache."
    },
    {
      "NDCCode": "52000-131-01",
      "PackageDescription": "54.7 mL in 1 BOTTLE, PLASTIC (52000-131-01) ",
      "NDC11Code": "52000-0131-01",
      "ProductNDC": "52000-131",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hand Sanitizer 1.85oz",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180101",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "UNIVERSAL DISTRIBUTION CENTER LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "62",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "hand sanitizer to help reduce bacteria on the skin."
    },
    {
      "NDCCode": "62207-131-54",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-131-54) ",
      "NDC11Code": "62207-0131-54",
      "ProductNDC": "62207-131",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoprolol Succinate",
      "NonProprietaryName": "Metoprolol Succinate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240816",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA216509",
      "LabelerName": "Granules India Ltd",
      "SubstanceName": "METOPROLOL SUCCINATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240816",
      "SamplePackage": "N",
      "IndicationAndUsage": "Metoprolol succinate is a beta-adrenergic blocker indicated for the treatment of. : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .",
      "Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in alcohol; slightly soluble in isopropyl alcohol. Inactive ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, d-mannitol, ethylcellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, titanium dioxide. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "68645-131-54",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (68645-131-54) ",
      "NDC11Code": "68645-0131-54",
      "ProductNDC": "68645-131",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluoxetine",
      "NonProprietaryName": "Fluoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110125",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076001",
      "LabelerName": "Legacy Pharmaceutical Packaging, LLC",
      "SubstanceName": "FLUOXETINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-03-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20110125",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]., 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]. , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)].",
      "Description": "Fluoxetine Capsules, are a selective serotonin reuptake inhibitor for oral administration. They are also marketed for the treatment of premenstrual dysphoric disorder (Sarafem ®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the following structural formula:. C 17H 18F 3NOHCl M.W. 345.79. Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride, USP equivalent to 10 mg (32.3 µmol) or 20 mg (64.7 µmol) of fluoxetine. In addition, the capsules also contain the following inactive ingredients: ammonium hydroxide, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, gelatin, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac, and titanium dioxide."
    },
    {
      "NDCCode": "10544-131-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (10544-131-30)",
      "NDC11Code": "10544-0131-30",
      "ProductNDC": "10544-131",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Furosemide",
      "NonProprietaryName": "Furosemide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130830",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078010",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "FUROSEMIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Furosemide tablets, USP is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.",
      "Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide tablets, USP for oral administration contain furosemide, USP as the active ingredient and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is available as white to off white round tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide, USP is a white to slightly yellow odorless crystalline powder. It is practically insoluble in water, soluble in 15 parts of acetone, freely soluble in dimethylformamide and in solution of alkali hydroxides; soluble in methanol; sparingly soluble in alcohol; very slightly soluble in chloroform. The CAS Registry Number is 54-31-9. It has a molecular formula of C12H11ClN2O5S and a molecular weight of 330.75. Tested by USP Dissolution Test 1. The molecular structure is as follows."
    },
    {
      "NDCCode": "10544-131-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (10544-131-90)",
      "NDC11Code": "10544-0131-90",
      "ProductNDC": "10544-131",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Furosemide",
      "NonProprietaryName": "Furosemide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130830",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078010",
      "LabelerName": "Blenheim Pharmacal, Inc.",
      "SubstanceName": "FUROSEMIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Furosemide tablets, USP is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.",
      "Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide tablets, USP for oral administration contain furosemide, USP as the active ingredient and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is available as white to off white round tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide, USP is a white to slightly yellow odorless crystalline powder. It is practically insoluble in water, soluble in 15 parts of acetone, freely soluble in dimethylformamide and in solution of alkali hydroxides; soluble in methanol; sparingly soluble in alcohol; very slightly soluble in chloroform. The CAS Registry Number is 54-31-9. It has a molecular formula of C12H11ClN2O5S and a molecular weight of 330.75. Tested by USP Dissolution Test 1. The molecular structure is as follows."
    },
    {
      "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": "49404-131-01",
      "PackageDescription": "27 g in 1 PATCH (49404-131-01)",
      "NDC11Code": "49404-0131-01",
      "ProductNDC": "49404-131",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dr.jart Dermask Micro Jet Clearing Solution",
      "NonProprietaryName": "Niacinamide, Salicylic Acid",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20161102",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Have & Be Co., Ltd.",
      "SubstanceName": "NIACINAMIDE; SALICYLIC ACID",
      "StrengthNumber": ".54; .00027",
      "StrengthUnit": "g/27g; g/27g",
      "Status": "Deprecated",
      "LastUpdate": "2020-11-06",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231"
    },
    {
      "NDCCode": "76413-131-03",
      "PackageDescription": "3 POUCH in 1 BOX (76413-131-03)  > 21 d in 1 POUCH",
      "NDC11Code": "76413-0131-03",
      "ProductNDC": "76413-131",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nuvaring",
      "NonProprietaryName": "Etonogestrel And Ethinyl Estradiol",
      "DosageFormName": "INSERT, EXTENDED RELEASE",
      "RouteName": "VAGINAL",
      "StartMarketingDate": "20011003",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021187",
      "LabelerName": "Central Texas Community Health Centers",
      "SubstanceName": "ETONOGESTREL; ETHINYL ESTRADIOL",
      "StrengthNumber": ".12; .015",
      "StrengthUnit": "mg/d; mg/d",
      "Pharm_Classes": "Progesterone Congeners [CS],Progestin [EPC],Estrogen Receptor Agonists [MoA],Estrogen [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "FOR VAGINAL USE ONLY. NuvaRing® is indicated for use by females of reproductive age to prevent pregnancy.",
      "Description": "NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. NuvaRing is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. NuvaRing is not made with natural rubber latex. NuvaRing has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows."
    },
    {
      "NDCCode": "78206-131-01",
      "PackageDescription": "1 KIT in 1 CARTON (78206-131-01)  / 1 CARTRIDGE in 1 KIT / 1.08 mL in 1 CARTRIDGE (78206-131-99) ",
      "NDC11Code": "78206-0131-01",
      "ProductNDC": "78206-131",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Follistim Aq",
      "NonProprietaryName": "Follitropin",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20230724",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA021211",
      "LabelerName": "Organon LLC",
      "SubstanceName": "FOLLITROPIN",
      "StrengthNumber": "900",
      "StrengthUnit": "[iU]/1.08mL",
      "Pharm_Classes": "Gonadotropin [EPC], Gonadotropins [CS]",
      "Status": "Active",
      "LastUpdate": "2026-05-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230724",
      "SamplePackage": "N",
      "IndicationAndUsage": "FOLLISTIM® AQ Cartridge (follitropin beta) injection, is indicated. In Women for.",
      "Description": "Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH. The molecular weight is approximately 40 kDa. FOLLISTIM AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the FOLLISTIM Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, FOLLISTIM AQ may contain up to 11% of oxidized follitropin beta."
    },
    {
      "NDCCode": "87078-121-52",
      "PackageDescription": "12 POUCH in 1 CARTON (87078-121-52)  / 5 mL in 1 POUCH",
      "NDC11Code": "87078-0121-52",
      "ProductNDC": "87078-121",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Onessip Acetaminophen Oral Suspension Bubble Gum 5 Ml",
      "NonProprietaryName": "Acetaminophen 160 Mg / 5 Ml",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251001",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M013",
      "LabelerName": "MEDWISE LIFESCIENCES INC.",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/5mL",
      "Status": "Active",
      "LastUpdate": "2025-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily reduces fever. Temporarily relieves minor aches and pains due to: the common coldfluheadachesore throattoothache."
    },
    {
      "NDCCode": "87078-331-16",
      "PackageDescription": "16 POUCH in 1 CARTON (87078-331-16)  / 10 mL in 1 POUCH (87078-331-01) ",
      "NDC11Code": "87078-0331-16",
      "ProductNDC": "87078-331",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Onessip Day Time Kids Cold And Cough Plus Fever",
      "NonProprietaryName": "Acetaminophen 325 Mg And Dextromethorphan Hbr 10 Mg Oral Liquid Day Time Kids",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260515",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "MEDWISE LIFESCIENCES INC.",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN",
      "StrengthNumber": "10; 325",
      "StrengthUnit": "mg/10mL; mg/10mL",
      "Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-05-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260515",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves common cold/flu symptoms: 1 cough due to minor throat & bronchial irritation, 2 sore throat, 3 headache, 4 minor aches & pains, 5 fever."
    },
    {
      "NDCCode": "87078-411-52",
      "PackageDescription": "12 POUCH in 1 CARTON (87078-411-52)  / 5 mL in 1 POUCH",
      "NDC11Code": "87078-0411-52",
      "ProductNDC": "87078-411",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Onessip Diphenhydramine Hcl 12.5 Mg/ 5 Ml Oral Solution",
      "NonProprietaryName": "Diphenhydramine Hcl",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251006",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "MEDWISE LIFESCIENCES INC.",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251006",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitching of the nose or throat."
    },
    {
      "NDCCode": "87078-421-52",
      "PackageDescription": "12 POUCH in 1 CARTON (87078-421-52)  / 5 mL in 1 POUCH",
      "NDC11Code": "87078-0421-52",
      "ProductNDC": "87078-421",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Onessip Diphenhydramine Hcl 12.5 Mg/ 5 Ml Oral Solution (cherry)",
      "NonProprietaryName": "Diphenhydramine Hcl",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251006",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "MEDWISE LIFESCIENCES INC.",
      "SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
      "StrengthNumber": "12.5",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-10-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251017",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitching of the nose or throat."
    },
    {
      "NDCCode": "87078-872-32",
      "PackageDescription": "12 POUCH in 1 CARTON (87078-872-32)  / 15 mL in 1 POUCH (87078-872-03) ",
      "NDC11Code": "87078-0872-32",
      "ProductNDC": "87078-872",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Onessip Adult Nighttime Severe Cold And Flu",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hci",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260128",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "MEDWISE LIFESCIENCES INC.",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE",
      "StrengthNumber": "10; 20; 650; 12.5",
      "StrengthUnit": "mg/15mL; mg/15mL; mg/15mL; mg/15mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260128",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 temporarily relieves common cold/flu symptoms: nasal congestionsinus congestion & pressurecough due to minor throat & bronchial irritationminor aches & painsheadachefeversore throatrunny nose & sneezingreduces swelling of nasal passagestemporarily restores freer breathing through the nosepromotes nasal and/or sinus drainage."
    },
    {
      "NDCCode": "87078-972-32",
      "PackageDescription": "12 POUCH in 1 CARTON (87078-972-32)  / 15 mL in 1 POUCH (87078-972-03) ",
      "NDC11Code": "87078-0972-32",
      "ProductNDC": "87078-972",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Onessip Adult Daytime Severe Cold And Flu",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20251215",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "MEDWISE LIFESCIENCES INC.",
      "SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN",
      "StrengthNumber": "10; 20; 650; 400",
      "StrengthUnit": "mg/15mL; mg/15mL; mg/15mL; mg/15mL",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251215",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses: 1 temporarily relieves common cold/flu symptoms: nasal congestionsinus congestion & pressurecough due to minor throat & bronchial irritationminor aches & painsheadachefeversore throatreduces swelling of nasal passagestemporarily restores freer breathing through the nosepromotes nasal and/or sinus drainagehelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
    },
    {
      "NDCCode": "0007-3261-01",
      "PackageDescription": "20 mL in 1 VIAL, SINGLE-USE (0007-3261-01)",
      "NDC11Code": "00007-3261-01",
      "ProductNDC": "0007-3261",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bexxar",
      "ProprietaryNameSuffix": "Dosimetric",
      "NonProprietaryName": "Tositumomab I-131",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20090715",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125011",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "TOSITUMOMAB I-131",
      "StrengthNumber": ".61",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "CD20-directed Antibody Interactions [MoA],CD20-directed Radiotherapeutic Antibody [EPC],Radiopharmaceutical Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2014-03-05"
    },
    {
      "NDCCode": "0007-3262-01",
      "PackageDescription": "20 mL in 1 VIAL, SINGLE-USE (0007-3262-01)",
      "NDC11Code": "00007-3262-01",
      "ProductNDC": "0007-3262",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Bexxar",
      "ProprietaryNameSuffix": "Therapeutic",
      "NonProprietaryName": "Tositumomab I-131",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20090715",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125011",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "TOSITUMOMAB I-131",
      "StrengthNumber": "5.6",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "CD20-directed Antibody Interactions [MoA],CD20-directed Radiotherapeutic Antibody [EPC],Radiopharmaceutical Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2014-03-05"
    },
    {
      "NDCCode": "0019-9450-01",
      "PackageDescription": "1 VIAL in 1 CAN (0019-9450-01)  > 1 mL in 1 VIAL",
      "NDC11Code": "00019-9450-01",
      "ProductNDC": "0019-9450",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Iodide I-131",
      "ProprietaryNameSuffix": "Therapeutic",
      "NonProprietaryName": "Sodium Iodide, I-131",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110822",
      "EndMarketingDate": "20170701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016515",
      "LabelerName": "Mallinckrodt Inc.",
      "SubstanceName": "SODIUM IODIDE I-131",
      "StrengthNumber": "5",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-03"
    },
    {
      "NDCCode": "0019-9450-02",
      "PackageDescription": "1 VIAL in 1 CAN (0019-9450-02)  > 2 mL in 1 VIAL",
      "NDC11Code": "00019-9450-02",
      "ProductNDC": "0019-9450",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Iodide I-131",
      "ProprietaryNameSuffix": "Therapeutic",
      "NonProprietaryName": "Sodium Iodide, I-131",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110822",
      "EndMarketingDate": "20170701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016515",
      "LabelerName": "Mallinckrodt Inc.",
      "SubstanceName": "SODIUM IODIDE I-131",
      "StrengthNumber": "5",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-03"
    },
    {
      "NDCCode": "0019-9450-03",
      "PackageDescription": "1 VIAL in 1 CAN (0019-9450-03)  > 3 mL in 1 VIAL",
      "NDC11Code": "00019-9450-03",
      "ProductNDC": "0019-9450",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Iodide I-131",
      "ProprietaryNameSuffix": "Therapeutic",
      "NonProprietaryName": "Sodium Iodide, I-131",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110822",
      "EndMarketingDate": "20170701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016515",
      "LabelerName": "Mallinckrodt Inc.",
      "SubstanceName": "SODIUM IODIDE I-131",
      "StrengthNumber": "5",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-03"
    },
    {
      "NDCCode": "0019-9450-04",
      "PackageDescription": "1 VIAL in 1 CAN (0019-9450-04)  > 4 mL in 1 VIAL",
      "NDC11Code": "00019-9450-04",
      "ProductNDC": "0019-9450",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Iodide I-131",
      "ProprietaryNameSuffix": "Therapeutic",
      "NonProprietaryName": "Sodium Iodide, I-131",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110822",
      "EndMarketingDate": "20170701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016515",
      "LabelerName": "Mallinckrodt Inc.",
      "SubstanceName": "SODIUM IODIDE I-131",
      "StrengthNumber": "5",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-03"
    },
    {
      "NDCCode": "0019-9450-05",
      "PackageDescription": "1 VIAL in 1 CAN (0019-9450-05)  > 5 mL in 1 VIAL",
      "NDC11Code": "00019-9450-05",
      "ProductNDC": "0019-9450",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Iodide I-131",
      "ProprietaryNameSuffix": "Therapeutic",
      "NonProprietaryName": "Sodium Iodide, I-131",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110822",
      "EndMarketingDate": "20170701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016515",
      "LabelerName": "Mallinckrodt Inc.",
      "SubstanceName": "SODIUM IODIDE I-131",
      "StrengthNumber": "5",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-03"
    },
    {
      "NDCCode": "0019-9450-07",
      "PackageDescription": "1 VIAL in 1 CAN (0019-9450-07)  > 7 mL in 1 VIAL",
      "NDC11Code": "00019-9450-07",
      "ProductNDC": "0019-9450",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Iodide I-131",
      "ProprietaryNameSuffix": "Therapeutic",
      "NonProprietaryName": "Sodium Iodide, I-131",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110822",
      "EndMarketingDate": "20170701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016515",
      "LabelerName": "Mallinckrodt Inc.",
      "SubstanceName": "SODIUM IODIDE I-131",
      "StrengthNumber": "5",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-03"
    },
    {
      "NDCCode": "0019-9451-02",
      "PackageDescription": "1 VIAL in 1 CAN (0019-9451-02)  > 2 mL in 1 VIAL",
      "NDC11Code": "00019-9451-02",
      "ProductNDC": "0019-9451",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Iodide I-131",
      "ProprietaryNameSuffix": "Therapeutic",
      "NonProprietaryName": "Sodium Iodide, I-131",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110822",
      "EndMarketingDate": "20170701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016515",
      "LabelerName": "Mallinckrodt Inc.",
      "SubstanceName": "SODIUM IODIDE I-131",
      "StrengthNumber": "25",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-03"
    },
    {
      "NDCCode": "0019-9451-03",
      "PackageDescription": "1 VIAL in 1 CAN (0019-9451-03)  > 3 mL in 1 VIAL",
      "NDC11Code": "00019-9451-03",
      "ProductNDC": "0019-9451",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Iodide I-131",
      "ProprietaryNameSuffix": "Therapeutic",
      "NonProprietaryName": "Sodium Iodide, I-131",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110822",
      "EndMarketingDate": "20170701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016515",
      "LabelerName": "Mallinckrodt Inc.",
      "SubstanceName": "SODIUM IODIDE I-131",
      "StrengthNumber": "25",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-03"
    },
    {
      "NDCCode": "0019-9451-04",
      "PackageDescription": "1 VIAL in 1 CAN (0019-9451-04)  > 4 mL in 1 VIAL",
      "NDC11Code": "00019-9451-04",
      "ProductNDC": "0019-9451",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sodium Iodide I-131",
      "ProprietaryNameSuffix": "Therapeutic",
      "NonProprietaryName": "Sodium Iodide, I-131",
      "DosageFormName": "SOLUTION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110822",
      "EndMarketingDate": "20170701",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA016515",
      "LabelerName": "Mallinckrodt Inc.",
      "SubstanceName": "SODIUM IODIDE I-131",
      "StrengthNumber": "25",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2017-07-03"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"87078-131-54","ProprietaryName":"Onessip Acetaminophen","NonProprietaryName":"Acetaminophen"},{"NDCCode":"87078-131-52","ProprietaryName":"Onessip Acetaminophen","NonProprietaryName":"Acetaminophen"},{"NDCCode":"52000-131-01","ProprietaryName":"Hand Sanitizer 1.85oz","NonProprietaryName":"Alcohol"},{"NDCCode":"62207-131-54","ProprietaryName":"Metoprolol Succinate","NonProprietaryName":"Metoprolol Succinate"},{"NDCCode":"68645-131-54","ProprietaryName":"Fluoxetine","NonProprietaryName":"Fluoxetine"},{"NDCCode":"10544-131-30","ProprietaryName":"Furosemide","NonProprietaryName":"Furosemide"},{"NDCCode":"10544-131-90","ProprietaryName":"Furosemide","NonProprietaryName":"Furosemide"},{"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":"49404-131-01","ProprietaryName":"Dr.jart Dermask Micro Jet Clearing Solution","NonProprietaryName":"Niacinamide, Salicylic Acid"},{"NDCCode":"76413-131-03","ProprietaryName":"Nuvaring","NonProprietaryName":"Etonogestrel And Ethinyl Estradiol"},{"NDCCode":"78206-131-01","ProprietaryName":"Follistim Aq","NonProprietaryName":"Follitropin"},{"NDCCode":"87078-121-52","ProprietaryName":"Onessip Acetaminophen Oral Suspension Bubble Gum 5 Ml","NonProprietaryName":"Acetaminophen 160 Mg / 5 Ml"},{"NDCCode":"87078-331-16","ProprietaryName":"Onessip Day Time Kids Cold And Cough Plus Fever","NonProprietaryName":"Acetaminophen 325 Mg And Dextromethorphan Hbr 10 Mg Oral Liquid Day Time Kids"},{"NDCCode":"87078-411-52","ProprietaryName":"Onessip Diphenhydramine Hcl 12.5 Mg/ 5 Ml Oral Solution","NonProprietaryName":"Diphenhydramine Hcl"},{"NDCCode":"87078-421-52","ProprietaryName":"Onessip Diphenhydramine Hcl 12.5 Mg/ 5 Ml Oral Solution (cherry)","NonProprietaryName":"Diphenhydramine Hcl"},{"NDCCode":"87078-872-32","ProprietaryName":"Onessip Adult Nighttime Severe Cold And Flu","NonProprietaryName":"Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hci"},{"NDCCode":"87078-972-32","ProprietaryName":"Onessip Adult Daytime Severe Cold And Flu","NonProprietaryName":"Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci"},{"NDCCode":"0007-3261-01","ProprietaryName":"Bexxar","NonProprietaryName":"Tositumomab I-131"},{"NDCCode":"0007-3262-01","ProprietaryName":"Bexxar","NonProprietaryName":"Tositumomab I-131"},{"NDCCode":"0019-9450-01","ProprietaryName":"Sodium Iodide I-131","NonProprietaryName":"Sodium Iodide, I-131"},{"NDCCode":"0019-9450-02","ProprietaryName":"Sodium Iodide I-131","NonProprietaryName":"Sodium Iodide, I-131"},{"NDCCode":"0019-9450-03","ProprietaryName":"Sodium Iodide I-131","NonProprietaryName":"Sodium Iodide, I-131"},{"NDCCode":"0019-9450-04","ProprietaryName":"Sodium Iodide I-131","NonProprietaryName":"Sodium Iodide, I-131"},{"NDCCode":"0019-9450-05","ProprietaryName":"Sodium Iodide I-131","NonProprietaryName":"Sodium Iodide, I-131"},{"NDCCode":"0019-9450-07","ProprietaryName":"Sodium Iodide I-131","NonProprietaryName":"Sodium Iodide, I-131"},{"NDCCode":"0019-9451-02","ProprietaryName":"Sodium Iodide I-131","NonProprietaryName":"Sodium Iodide, I-131"},{"NDCCode":"0019-9451-03","ProprietaryName":"Sodium Iodide I-131","NonProprietaryName":"Sodium Iodide, I-131"},{"NDCCode":"0019-9451-04","ProprietaryName":"Sodium Iodide I-131","NonProprietaryName":"Sodium Iodide, I-131"}]}
                    

<NDCList><NDC><NDCCode>87078-131-54</NDCCode><ProprietaryName>Onessip Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>87078-131-52</NDCCode><ProprietaryName>Onessip Acetaminophen</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>52000-131-01</NDCCode><ProprietaryName>Hand Sanitizer 1.85oz</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>62207-131-54</NDCCode><ProprietaryName>Metoprolol Succinate</ProprietaryName><NonProprietaryName>Metoprolol Succinate</NonProprietaryName></NDC><NDC><NDCCode>68645-131-54</NDCCode><ProprietaryName>Fluoxetine</ProprietaryName><NonProprietaryName>Fluoxetine</NonProprietaryName></NDC><NDC><NDCCode>10544-131-30</NDCCode><ProprietaryName>Furosemide</ProprietaryName><NonProprietaryName>Furosemide</NonProprietaryName></NDC><NDC><NDCCode>10544-131-90</NDCCode><ProprietaryName>Furosemide</ProprietaryName><NonProprietaryName>Furosemide</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>49404-131-01</NDCCode><ProprietaryName>Dr.jart Dermask Micro Jet Clearing Solution</ProprietaryName><NonProprietaryName>Niacinamide, Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>76413-131-03</NDCCode><ProprietaryName>Nuvaring</ProprietaryName><NonProprietaryName>Etonogestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>78206-131-01</NDCCode><ProprietaryName>Follistim Aq</ProprietaryName><NonProprietaryName>Follitropin</NonProprietaryName></NDC><NDC><NDCCode>87078-121-52</NDCCode><ProprietaryName>Onessip Acetaminophen Oral Suspension Bubble Gum 5 Ml</ProprietaryName><NonProprietaryName>Acetaminophen 160 Mg / 5 Ml</NonProprietaryName></NDC><NDC><NDCCode>87078-331-16</NDCCode><ProprietaryName>Onessip Day Time Kids Cold And Cough Plus Fever</ProprietaryName><NonProprietaryName>Acetaminophen 325 Mg And Dextromethorphan Hbr 10 Mg Oral Liquid Day Time Kids</NonProprietaryName></NDC><NDC><NDCCode>87078-411-52</NDCCode><ProprietaryName>Onessip Diphenhydramine Hcl 12.5 Mg/ 5 Ml Oral Solution</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>87078-421-52</NDCCode><ProprietaryName>Onessip Diphenhydramine Hcl 12.5 Mg/ 5 Ml Oral Solution (cherry)</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>87078-872-32</NDCCode><ProprietaryName>Onessip Adult Nighttime Severe Cold And Flu</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hci</NonProprietaryName></NDC><NDC><NDCCode>87078-972-32</NDCCode><ProprietaryName>Onessip Adult Daytime Severe Cold And Flu</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci</NonProprietaryName></NDC><NDC><NDCCode>0007-3261-01</NDCCode><ProprietaryName>Bexxar</ProprietaryName><NonProprietaryName>Tositumomab I-131</NonProprietaryName></NDC><NDC><NDCCode>0007-3262-01</NDCCode><ProprietaryName>Bexxar</ProprietaryName><NonProprietaryName>Tositumomab I-131</NonProprietaryName></NDC><NDC><NDCCode>0019-9450-01</NDCCode><ProprietaryName>Sodium Iodide I-131</ProprietaryName><NonProprietaryName>Sodium Iodide, I-131</NonProprietaryName></NDC><NDC><NDCCode>0019-9450-02</NDCCode><ProprietaryName>Sodium Iodide I-131</ProprietaryName><NonProprietaryName>Sodium Iodide, I-131</NonProprietaryName></NDC><NDC><NDCCode>0019-9450-03</NDCCode><ProprietaryName>Sodium Iodide I-131</ProprietaryName><NonProprietaryName>Sodium Iodide, I-131</NonProprietaryName></NDC><NDC><NDCCode>0019-9450-04</NDCCode><ProprietaryName>Sodium Iodide I-131</ProprietaryName><NonProprietaryName>Sodium Iodide, I-131</NonProprietaryName></NDC><NDC><NDCCode>0019-9450-05</NDCCode><ProprietaryName>Sodium Iodide I-131</ProprietaryName><NonProprietaryName>Sodium Iodide, I-131</NonProprietaryName></NDC><NDC><NDCCode>0019-9450-07</NDCCode><ProprietaryName>Sodium Iodide I-131</ProprietaryName><NonProprietaryName>Sodium Iodide, I-131</NonProprietaryName></NDC><NDC><NDCCode>0019-9451-02</NDCCode><ProprietaryName>Sodium Iodide I-131</ProprietaryName><NonProprietaryName>Sodium Iodide, I-131</NonProprietaryName></NDC><NDC><NDCCode>0019-9451-03</NDCCode><ProprietaryName>Sodium Iodide I-131</ProprietaryName><NonProprietaryName>Sodium Iodide, I-131</NonProprietaryName></NDC><NDC><NDCCode>0019-9451-04</NDCCode><ProprietaryName>Sodium Iodide I-131</ProprietaryName><NonProprietaryName>Sodium Iodide, I-131</NonProprietaryName></NDC></NDCList>