RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "68428-463-12",
      "PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-463-12) ",
      "NDC11Code": "68428-0463-12",
      "ProductNDC": "68428-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lac Defloratum",
      "NonProprietaryName": "Skim Milk",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101202",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "SKIM MILK",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20101202",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68428-463-03",
      "PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-463-03) ",
      "NDC11Code": "68428-0463-03",
      "ProductNDC": "68428-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lac Defloratum",
      "NonProprietaryName": "Skim Milk",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101202",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "SKIM MILK",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20101202",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68428-463-05",
      "PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-463-05) ",
      "NDC11Code": "68428-0463-05",
      "ProductNDC": "68428-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lac Defloratum",
      "NonProprietaryName": "Skim Milk",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101202",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "SKIM MILK",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20101202",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68428-463-06",
      "PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-463-06) ",
      "NDC11Code": "68428-0463-06",
      "ProductNDC": "68428-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lac Defloratum",
      "NonProprietaryName": "Skim Milk",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101202",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "SKIM MILK",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20101202",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "68428-463-11",
      "PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-463-11) ",
      "NDC11Code": "68428-0463-11",
      "ProductNDC": "68428-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lac Defloratum",
      "NonProprietaryName": "Skim Milk",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101202",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "SKIM MILK",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-04-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20101202",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "10304-463-12",
      "PackageDescription": "4250 L in 1 CYLINDER (10304-463-12) ",
      "NDC11Code": "10304-0463-12",
      "ProductNDC": "10304-463",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Oxygen",
      "NonProprietaryName": "Oxygen",
      "DosageFormName": "GAS",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20000612",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205865",
      "LabelerName": "Delille Oxygen Company",
      "SubstanceName": "OXYGEN",
      "StrengthNumber": "995",
      "StrengthUnit": "mL/L",
      "Status": "Active",
      "LastUpdate": "2025-11-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20000612",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "11673-463-12",
      "PackageDescription": "1 KIT in 1 KIT (11673-463-12)  *  177 mL in 1 BOTTLE, PLASTIC *  177 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "11673-0463-12",
      "ProductNDC": "11673-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Daytime Mucus Relief Severe Cold And Nighttime Cold And Flu",
      "ProprietaryNameSuffix": "Maximum Strength",
      "NonProprietaryName": "Daytime Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci, Nighttime Acetaminophen, Diphenhydramine Hci, Phenylephrine Hci",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20180111",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M012",
      "LabelerName": "TARGET Corporation",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20180111",
      "SamplePackage": "N",
      "IndicationAndUsage": "Nighttime: 1 temporarily relieves these common cold and flu symptoms , 2 cough , 3 nasal congestion , 4 minor aches and pains , 5 sore throat , 6 headache , 7 runny nose , 8 sneezing , 9 temporarily reduces fever , 10 controls cough to help you get to sleep."
    },
    {
      "NDCCode": "63868-463-24",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (63868-463-24)  > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
      "NDC11Code": "63868-0463-24",
      "ProductNDC": "63868-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Daytime Sinus",
      "NonProprietaryName": "Acetaminophen, Phenylephrine Hydrochloride",
      "DosageFormName": "CAPSULE, LIQUID FILLED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170412",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Chain Drug Marketing Association Inc.",
      "SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "325; 5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20170412",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves symptoms due to the common cold. minor aches and pains. headache. fever. nasal congestion. sinus congestion & pressure. temporarily relieves symptoms due to hay fever or other upper respiratory allergies. minor aches and pains. headache. nasal congestion. sinus congestion & pressure."
    },
    {
      "NDCCode": "67209-463-30",
      "PackageDescription": "12 BOTTLE in 1 BOX (67209-463-30)  > 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE",
      "NDC11Code": "67209-0463-30",
      "ProductNDC": "67209-463",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "StartMarketingDate": "20090723",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "WellSpring Pharma Services Inc.",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "65",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "99207-463-12",
      "PackageDescription": "46000 TABLET, FILM COATED, EXTENDED RELEASE in 1 DRUM (99207-463-12)",
      "NDC11Code": "99207-0463-12",
      "ProductNDC": "99207-463",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "StartMarketingDate": "20090723",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Medicis Pharmaceutical Corp",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "65",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "0049-2340-05",
      "PackageDescription": "12 BLISTER PACK in 1 CARTON (0049-2340-05)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (0049-2340-79) ",
      "NDC11Code": "00049-2340-05",
      "ProductNDC": "0049-2340",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Relpax",
      "NonProprietaryName": "Eletriptan Hydrobromide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20021226",
      "EndMarketingDate": "20260430",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021016",
      "LabelerName": "ROERIG",
      "SubstanceName": "ELETRIPTAN HYDROBROMIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-04-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20021226",
      "EndMarketingDatePackage": "20260430",
      "SamplePackage": "N",
      "IndicationAndUsage": "RELPAX is indicated for the acute treatment of migraine with or without aura in adults.",
      "Description": "RELPAX (eletriptan hydrobromide) tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The empirical formula is C22H26N2O2S . HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is a white to light pale colored powder that is readily soluble in water. Each RELPAX Tablet for oral administration contains 24.2 or 48.5 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients microcrystalline cellulose NF, lactose monohydrate NF, croscarmellose sodium NF, magnesium stearate NF, titanium dioxide USP, hypromellose, triacetin USP and FD&C Yellow No. 6 aluminum lake."
    },
    {
      "NDCCode": "14141-463-01",
      "PackageDescription": "1 TUBE in 1 BOX (14141-463-01)  / 2 g in 1 TUBE",
      "NDC11Code": "14141-0463-01",
      "ProductNDC": "14141-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lbel Solutions Pro Hialuron Balm Balsamo Labial Hidratante 72h Fps 20 Hydrating Lip Balm 72h Spf 20 Cherry Glaze",
      "NonProprietaryName": "Octinoxate, Zinc Oxide",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251211",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "BEL STAR S A",
      "SubstanceName": "ZINC OXIDE; OCTINOXATE",
      "StrengthNumber": "49; 75",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251211",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburn."
    },
    {
      "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": "16714-463-01",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (16714-463-01)  > 1 TABLET in 1 BLISTER PACK",
      "NDC11Code": "16714-0463-01",
      "ProductNDC": "16714-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Her Style",
      "NonProprietaryName": "Levonorgestrel",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20161101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207976",
      "LabelerName": "Northstar Rx LLC",
      "SubstanceName": "LEVONORGESTREL",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-11",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "21695-871-40",
      "PackageDescription": "12 TABLET, FILM COATED in 1 BLISTER PACK (21695-871-40)",
      "NDC11Code": "21695-0871-40",
      "ProductNDC": "21695-871",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Relpax",
      "NonProprietaryName": "Eletriptan Hydrobromide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20021226",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021016",
      "LabelerName": "Rebel Distributors Corp",
      "SubstanceName": "ELETRIPTAN HYDROBROMIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "RELPAX is indicated for the acute treatment of migraine with or without aura in adults. RELPAX is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of RELPAX Tablets have not been established for cluster headache, which is present in an older, predominantly male population.",
      "Description": "RELPAX® (eletriptan) Tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The empirical formula is C22H26N2O2S . HBr, representing a molecular weight of 463.40. Eletriptan hydrobromide is a white to light pale colored powder that is readily soluble in water. Each RELPAX Tablet for oral administration contains 24.2 or 48.5 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients microcrystalline cellulose NF, lactose NF, croscarmellose sodium NF, magnesium stearate NF, titanium dioxide USP, hypromellose, triacetin USP and FD&C Yellow No. 6 aluminum lake."
    },
    {
      "NDCCode": "24201-463-01",
      "PackageDescription": "1 VIAL in 1 KIT (24201-463-01)  / 1 mL in 1 VIAL",
      "NDC11Code": "24201-0463-01",
      "ProductNDC": "24201-463",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dihydroergotamine Mesylate",
      "NonProprietaryName": "Dihydroergotamine Mesylate",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20200414",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211393",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "DIHYDROERGOTAMINE MESYLATE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Ergotamine Derivative [EPC], Ergotamines [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20200414",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dihydroergotamine mesylate nasal spray is indicated for the acute treatment of migraine headaches with or without aura. Dihydroergotamine mesylate nasal spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.",
      "Description": "Dihydroergotamine mesylate is ergotamine hydrogenated in the 9,10 position as the mesylate salt. Dihydroergotamine mesylate is known chemically as ergotaman-3', 6', 18-trione, 9,10-dihydro-12'-hydroxy-2'-methyl-5'- (phenylmethyl)-, (5'α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C33H37N5O5CH4O3S. The chemical structure is. Dihydroergotamine mesylate nasal spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: 1  dihydroergotamine mesylate, USP 4 mg, 2  caffeine, anhydrous, USP 10 mg, 3  dextrose, anhydrous, USP 50 mg, 4  carbon dioxide, USP qs, 5  purified water, USP qs 1 mL."
    },
    {
      "NDCCode": "24201-463-08",
      "PackageDescription": "8 VIAL in 1 CARTON (24201-463-08)  / 1 mL in 1 VIAL",
      "NDC11Code": "24201-0463-08",
      "ProductNDC": "24201-463",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dihydroergotamine Mesylate",
      "NonProprietaryName": "Dihydroergotamine Mesylate",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20200414",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211393",
      "LabelerName": "Hikma Pharmaceuticals USA Inc.",
      "SubstanceName": "DIHYDROERGOTAMINE MESYLATE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Ergotamine Derivative [EPC], Ergotamines [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200414",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dihydroergotamine mesylate nasal spray is indicated for the acute treatment of migraine headaches with or without aura. Dihydroergotamine mesylate nasal spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.",
      "Description": "Dihydroergotamine mesylate is ergotamine hydrogenated in the 9,10 position as the mesylate salt. Dihydroergotamine mesylate is known chemically as ergotaman-3', 6', 18-trione, 9,10-dihydro-12'-hydroxy-2'-methyl-5'- (phenylmethyl)-, (5'α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C33H37N5O5CH4O3S. The chemical structure is. Dihydroergotamine mesylate nasal spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: 1  dihydroergotamine mesylate, USP 4 mg, 2  caffeine, anhydrous, USP 10 mg, 3  dextrose, anhydrous, USP 50 mg, 4  carbon dioxide, USP qs, 5  purified water, USP qs 1 mL."
    },
    {
      "NDCCode": "30142-463-62",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (30142-463-62)  > 24 TABLET in 1 BLISTER PACK",
      "NDC11Code": "30142-0463-62",
      "ProductNDC": "30142-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy",
      "NonProprietaryName": "Chlorpheniramine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19870715",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Kroger Company",
      "SubstanceName": "CHLORPHENIRAMINE MALEATE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "35573-463-30",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (35573-463-30) ",
      "NDC11Code": "35573-0463-30",
      "ProductNDC": "35573-463",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tadalafil",
      "NonProprietaryName": "Tadalafil",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA215556",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "TADALAFIL",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-01-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20230401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3) .",
      "Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablet, USP is available as yellow colored, oval-shaped, film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, copovidone, sodium lauryl sulfate, magnesium stearate, hypromellose, titanium dioxide, iron oxide yellow and triacetin."
    },
    {
      "NDCCode": "37808-463-78",
      "PackageDescription": "1 BOTTLE in 1 CARTON (37808-463-78)  > 100 TABLET in 1 BOTTLE",
      "NDC11Code": "37808-0463-78",
      "ProductNDC": "37808-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Allergy",
      "NonProprietaryName": "Chlorpheniramine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19941012",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "H E B",
      "SubstanceName": "CHLORPHENIRAMINE MALEATE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "41163-463-62",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (41163-463-62)  > 24 TABLET in 1 BLISTER PACK",
      "NDC11Code": "41163-0463-62",
      "ProductNDC": "41163-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Equaline Allergy",
      "NonProprietaryName": "Chlorpheniramine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040830",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Supervalu Inc",
      "SubstanceName": "CHLORPHENIRAMINE MALEATE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-13",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "41163-463-78",
      "PackageDescription": "1 BOTTLE in 1 CARTON (41163-463-78)  > 100 TABLET in 1 BOTTLE",
      "NDC11Code": "41163-0463-78",
      "ProductNDC": "41163-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Equaline Allergy",
      "NonProprietaryName": "Chlorpheniramine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20040830",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Supervalu Inc",
      "SubstanceName": "CHLORPHENIRAMINE MALEATE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-13",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "42291-463-30",
      "PackageDescription": "3 BLISTER PACK in 1 BOX (42291-463-30)  / 10 TABLET in 1 BLISTER PACK (42291-463-11) ",
      "NDC11Code": "42291-0463-30",
      "ProductNDC": "42291-463",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Telmisartan And Hydrochlorothiazide",
      "NonProprietaryName": "Telmisartan And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240618",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202544",
      "LabelerName": "AvKARE",
      "SubstanceName": "TELMISARTAN; HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "80; 12.5",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Active",
      "LastUpdate": "2026-09-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240618",
      "SamplePackage": "N",
      "IndicationAndUsage": "Telmisartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy [see Clinical Studies (14)]. Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy for the treatment of hypertension [see Dosage and Administration (2.1)]. Telmisartan and hydrochlorothiazide tablets may be used alone or in combination with other antihypertensive agents.",
      "Description": "Telmisartan and Hydrochlorothiazide Tablets, USP are a combination of telmisartan, USP an orally active angiotensin II antagonist acting on the AT 1receptor subtype, and hydrochlorothiazide, USP a thiazide diuretic. Telmisartan, USP a non-peptide molecule, is chemically described as 4’-[[4-methyl- 6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl] methyl]-2-biphenylcarboxylic acid. Its empirical formula is C 33H 30N 4O 2, its molecular weight is 514.62, and its structural formula is:. Telmisartan, USP is a white or slightly yellowish crystalline powder. It is practically insoluble in water, slightly soluble in methanol, sparingly soluble in methylene chloride and it dissolves in 1M sodium hydroxide. Hydrochlorothiazide, USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is very slightly soluble in water, and freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide, sparingly soluble in methanol; insoluble in ether, in chloroform and dilute mineral acids. Hydrochlorothiazide, USP is chemically described as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2, and its structural formula is:. Telmisartan and Hydrochlorothiazide Tablets, USP are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan, USP and hydrochlorothiazide, USP respectively. The tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, povidone K-25, sodium hydroxide, sodium stearyl fumarate and talc. As coloring agents, the 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg tablets contain ferric oxide red, the 80 mg/25 mg tablets also contain ferric oxide yellow. Telmisartan and Hydrochlorothiazide Tablets, USP are hygroscopic and require protection from moisture. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "43063-463-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43063-463-30) ",
      "NDC11Code": "43063-0463-30",
      "ProductNDC": "43063-463",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Isoniazid",
      "NonProprietaryName": "Isoniazid",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19720901",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA080937",
      "LabelerName": "PD-Rx Pharmaceuticals, Inc.",
      "SubstanceName": "ISONIAZID",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Antimycobacterial [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20160127",
      "SamplePackage": "N",
      "IndicationAndUsage": "Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. Isoniazid tablets, USP are recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis): 1 Persons with human immunodeficiency virus (HIV) infection (greater than or equal to 5 mm) and persons with risk factors for HIV infection whose HIV infection status is unknown but who are suspected of having HIV infection. Preventive therapy may be considered for HIV infected persons who are tuberculin-negative but belong to groups in which the prevalence of tuberculosis infection is high. Candidates for preventive therapy who have HIV infection should have a minimum of 12 months of therapy., 2 Close contacts of persons with newly diagnosed infectious tuberculosis (greater than or equal to 5 mm). In addition, tuberculin-negative (less than 5 mm) children and adolescents who have been close contacts of infectious persons within the past 3 months are candidates for preventive therapy until a repeat tuberculin skin test is done 12 weeks after contact with the infectious source. If the repeat skin test is positive (greater than 5 mm), therapy should be continued., 3 Recent converters, as indicated by a tuberculin skin test (greater than or equal to 10 mm increase within a 2-year period for those less than 35 years old; greater than or equal to 15 mm increase for those greater than or equal to 35 years of age). All infants and children younger than 4 years of age with a greater than 10 mm skin test are included in this category., 4 Persons with abnormal chest radiographs that show fibrotic lesions likely to represent old healed tuberculosis (greater than or equal to 5 mm). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly., 5 Intravenous drug users known to be HIV-seronegative (greater than 10 mm)., 6 Persons with the following medical conditions that have been reported to increase the risk of tuberculosis (greater than or equal to 10 mm): silicosis; diabetes mellitus; prolonged therapy with adrenocorticosteroids; immunosuppressive therapy; some hematologic and reticuloendothelial diseases, such as leukemia or Hodgkin’s disease; end-stage renal disease; clinical situations associated with substantial rapid weight loss or chronic undernutrition (including: intestinal bypass surgery for obesity, the postgastrectomy state [with or without weight loss], chronic peptic ulcer disease, chronic malabsorption syndromes and carcinomas of the oropharynx and upper gastrointestinal tract that prevent adequate nutritional intake). Candidates for preventive therapy who have fibrotic pulmonary lesions consistent with healed tuberculosis or who have pulmonary silicosis should have 12 months of isoniazid or 4 months of isoniazid and rifampin, concomitantly.",
      "Description": "Isoniazid, USP is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil, microcrystalline cellulose, pregelatinized corn starch and talc. Isoniazid, USP is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has the following structural formula. C 6H 7N 3O M.W. 137.14. Isoniazid, USP is odorless, and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Isoniazid, USP is slowly affected by exposure to air and light."
    },
    {
      "NDCCode": "49884-463-55",
      "PackageDescription": "30 BLISTER PACK in 1 CARTON (49884-463-55)  > 1 LOZENGE in 1 BLISTER PACK (49884-463-52)",
      "NDC11Code": "49884-0463-55",
      "ProductNDC": "49884-463",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fentanyl Citrate",
      "NonProprietaryName": "Fentanyl Citrate",
      "DosageFormName": "LOZENGE",
      "RouteName": "ORAL; TRANSMUCOSAL",
      "StartMarketingDate": "20111017",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077312",
      "LabelerName": "Par Pharmaceutical Inc.",
      "SubstanceName": "FENTANYL CITRATE",
      "StrengthNumber": "1200",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2018-12-07",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "52125-463-02",
      "PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-463-02)",
      "NDC11Code": "52125-0463-02",
      "ProductNDC": "52125-463",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130522",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076317",
      "LabelerName": "REMEDYREPACK INC.",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "55312-463-78",
      "PackageDescription": "1 BOTTLE in 1 CARTON (55312-463-78)  > 100 TABLET in 1 BOTTLE",
      "NDC11Code": "55312-0463-78",
      "ProductNDC": "55312-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Chlortab",
      "NonProprietaryName": "Chlorpheniramine Maleate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070522",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Western Family Foods Inc",
      "SubstanceName": "CHLORPHENIRAMINE MALEATE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-07"
    },
    {
      "NDCCode": "58151-368-96",
      "PackageDescription": "12 BLISTER PACK in 1 CARTON (58151-368-96)  / 1 TABLET in 1 BLISTER PACK",
      "NDC11Code": "58151-0368-96",
      "ProductNDC": "58151-368",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Relpax",
      "NonProprietaryName": "Eletriptan Hydrobromide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20240821",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021016",
      "LabelerName": "Viatris Specialty LLC",
      "SubstanceName": "ELETRIPTAN HYDROBROMIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-05-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250123",
      "SamplePackage": "N",
      "IndicationAndUsage": "RELPAX is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with RELPAX, reconsider the diagnosis of migraine before RELPAX is administered to treat any subsequent attacks., 2 RELPAX is not intended for the prevention of migraine attacks., 3 Safety and effectiveness of RELPAX have not been established for cluster headache.",
      "Description": "RELPAX (eletriptan hydrobromide) tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The empirical formula is C22H26N2O2S . HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is a white to light pale colored powder that is readily soluble in water. Each RELPAX Tablet for oral administration contains 24.2 or 48.5 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin USP."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"68428-463-12","ProprietaryName":"Lac Defloratum","NonProprietaryName":"Skim Milk"},{"NDCCode":"68428-463-03","ProprietaryName":"Lac Defloratum","NonProprietaryName":"Skim Milk"},{"NDCCode":"68428-463-05","ProprietaryName":"Lac Defloratum","NonProprietaryName":"Skim Milk"},{"NDCCode":"68428-463-06","ProprietaryName":"Lac Defloratum","NonProprietaryName":"Skim Milk"},{"NDCCode":"68428-463-11","ProprietaryName":"Lac Defloratum","NonProprietaryName":"Skim Milk"},{"NDCCode":"10304-463-12","ProprietaryName":"Oxygen","NonProprietaryName":"Oxygen"},{"NDCCode":"11673-463-12","ProprietaryName":"Daytime Mucus Relief Severe Cold And Nighttime Cold And Flu","NonProprietaryName":"Daytime Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci, Nighttime Acetaminophen, Diphenhydramine Hci, Phenylephrine Hci"},{"NDCCode":"63868-463-24","ProprietaryName":"Daytime Sinus","NonProprietaryName":"Acetaminophen, Phenylephrine Hydrochloride"},{"NDCCode":"67209-463-30","NonProprietaryName":"Minocycline Hydrochloride"},{"NDCCode":"99207-463-12","NonProprietaryName":"Minocycline Hydrochloride"},{"NDCCode":"0049-2340-05","ProprietaryName":"Relpax","NonProprietaryName":"Eletriptan Hydrobromide"},{"NDCCode":"14141-463-01","ProprietaryName":"Lbel Solutions Pro Hialuron Balm Balsamo Labial Hidratante 72h Fps 20 Hydrating Lip Balm 72h Spf 20 Cherry Glaze","NonProprietaryName":"Octinoxate, Zinc Oxide"},{"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":"16714-463-01","ProprietaryName":"Her Style","NonProprietaryName":"Levonorgestrel"},{"NDCCode":"21695-871-40","ProprietaryName":"Relpax","NonProprietaryName":"Eletriptan Hydrobromide"},{"NDCCode":"24201-463-01","ProprietaryName":"Dihydroergotamine Mesylate","NonProprietaryName":"Dihydroergotamine Mesylate"},{"NDCCode":"24201-463-08","ProprietaryName":"Dihydroergotamine Mesylate","NonProprietaryName":"Dihydroergotamine Mesylate"},{"NDCCode":"30142-463-62","ProprietaryName":"Allergy","NonProprietaryName":"Chlorpheniramine Maleate"},{"NDCCode":"35573-463-30","ProprietaryName":"Tadalafil","NonProprietaryName":"Tadalafil"},{"NDCCode":"37808-463-78","ProprietaryName":"Allergy","NonProprietaryName":"Chlorpheniramine Maleate"},{"NDCCode":"41163-463-62","ProprietaryName":"Equaline Allergy","NonProprietaryName":"Chlorpheniramine Maleate"},{"NDCCode":"41163-463-78","ProprietaryName":"Equaline Allergy","NonProprietaryName":"Chlorpheniramine Maleate"},{"NDCCode":"42291-463-30","ProprietaryName":"Telmisartan And Hydrochlorothiazide","NonProprietaryName":"Telmisartan And Hydrochlorothiazide"},{"NDCCode":"43063-463-30","ProprietaryName":"Isoniazid","NonProprietaryName":"Isoniazid"},{"NDCCode":"49884-463-55","ProprietaryName":"Fentanyl Citrate","NonProprietaryName":"Fentanyl Citrate"},{"NDCCode":"52125-463-02","ProprietaryName":"Topiramate","NonProprietaryName":"Topiramate"},{"NDCCode":"55312-463-78","ProprietaryName":"Chlortab","NonProprietaryName":"Chlorpheniramine Maleate"},{"NDCCode":"58151-368-96","ProprietaryName":"Relpax","NonProprietaryName":"Eletriptan Hydrobromide"}]}
                    

<NDCList><NDC><NDCCode>68428-463-12</NDCCode><ProprietaryName>Lac Defloratum</ProprietaryName><NonProprietaryName>Skim Milk</NonProprietaryName></NDC><NDC><NDCCode>68428-463-03</NDCCode><ProprietaryName>Lac Defloratum</ProprietaryName><NonProprietaryName>Skim Milk</NonProprietaryName></NDC><NDC><NDCCode>68428-463-05</NDCCode><ProprietaryName>Lac Defloratum</ProprietaryName><NonProprietaryName>Skim Milk</NonProprietaryName></NDC><NDC><NDCCode>68428-463-06</NDCCode><ProprietaryName>Lac Defloratum</ProprietaryName><NonProprietaryName>Skim Milk</NonProprietaryName></NDC><NDC><NDCCode>68428-463-11</NDCCode><ProprietaryName>Lac Defloratum</ProprietaryName><NonProprietaryName>Skim Milk</NonProprietaryName></NDC><NDC><NDCCode>10304-463-12</NDCCode><ProprietaryName>Oxygen</ProprietaryName><NonProprietaryName>Oxygen</NonProprietaryName></NDC><NDC><NDCCode>11673-463-12</NDCCode><ProprietaryName>Daytime Mucus Relief Severe Cold And Nighttime Cold And Flu</ProprietaryName><NonProprietaryName>Daytime Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci, Nighttime Acetaminophen, Diphenhydramine Hci, Phenylephrine Hci</NonProprietaryName></NDC><NDC><NDCCode>63868-463-24</NDCCode><ProprietaryName>Daytime Sinus</ProprietaryName><NonProprietaryName>Acetaminophen, Phenylephrine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>67209-463-30</NDCCode><NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>99207-463-12</NDCCode><NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0049-2340-05</NDCCode><ProprietaryName>Relpax</ProprietaryName><NonProprietaryName>Eletriptan Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>14141-463-01</NDCCode><ProprietaryName>Lbel Solutions Pro Hialuron Balm Balsamo Labial Hidratante 72h Fps 20 Hydrating Lip Balm 72h Spf 20 Cherry Glaze</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide</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>16714-463-01</NDCCode><ProprietaryName>Her Style</ProprietaryName><NonProprietaryName>Levonorgestrel</NonProprietaryName></NDC><NDC><NDCCode>21695-871-40</NDCCode><ProprietaryName>Relpax</ProprietaryName><NonProprietaryName>Eletriptan Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>24201-463-01</NDCCode><ProprietaryName>Dihydroergotamine Mesylate</ProprietaryName><NonProprietaryName>Dihydroergotamine Mesylate</NonProprietaryName></NDC><NDC><NDCCode>24201-463-08</NDCCode><ProprietaryName>Dihydroergotamine Mesylate</ProprietaryName><NonProprietaryName>Dihydroergotamine Mesylate</NonProprietaryName></NDC><NDC><NDCCode>30142-463-62</NDCCode><ProprietaryName>Allergy</ProprietaryName><NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName></NDC><NDC><NDCCode>35573-463-30</NDCCode><ProprietaryName>Tadalafil</ProprietaryName><NonProprietaryName>Tadalafil</NonProprietaryName></NDC><NDC><NDCCode>37808-463-78</NDCCode><ProprietaryName>Allergy</ProprietaryName><NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName></NDC><NDC><NDCCode>41163-463-62</NDCCode><ProprietaryName>Equaline Allergy</ProprietaryName><NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName></NDC><NDC><NDCCode>41163-463-78</NDCCode><ProprietaryName>Equaline Allergy</ProprietaryName><NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName></NDC><NDC><NDCCode>42291-463-30</NDCCode><ProprietaryName>Telmisartan And Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Telmisartan And Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>43063-463-30</NDCCode><ProprietaryName>Isoniazid</ProprietaryName><NonProprietaryName>Isoniazid</NonProprietaryName></NDC><NDC><NDCCode>49884-463-55</NDCCode><ProprietaryName>Fentanyl Citrate</ProprietaryName><NonProprietaryName>Fentanyl Citrate</NonProprietaryName></NDC><NDC><NDCCode>52125-463-02</NDCCode><ProprietaryName>Topiramate</ProprietaryName><NonProprietaryName>Topiramate</NonProprietaryName></NDC><NDC><NDCCode>55312-463-78</NDCCode><ProprietaryName>Chlortab</ProprietaryName><NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName></NDC><NDC><NDCCode>58151-368-96</NDCCode><ProprietaryName>Relpax</ProprietaryName><NonProprietaryName>Eletriptan Hydrobromide</NonProprietaryName></NDC></NDCList>