RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "50742-463-16",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (50742-463-16)  / 16 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "50742-0463-16",
      "ProductNDC": "50742-463",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Docetaxel",
      "NonProprietaryName": "Docetaxel Anhydrous",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20170907",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA207563",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "DOCETAXEL ANHYDROUS",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2026-03-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170907",
      "SamplePackage": "N",
      "IndicationAndUsage": "Docetaxel  Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC):single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC):single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC):with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC):with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN):with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
      "Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous), and multiple-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
    },
    {
      "NDCCode": "10304-463-16",
      "PackageDescription": "360 L in 1 CYLINDER (10304-463-16) ",
      "NDC11Code": "10304-0463-16",
      "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": "43333-463-16",
      "PackageDescription": "500 mL in 1 BOTTLE, PUMP (43333-463-16)",
      "NDC11Code": "43333-0463-16",
      "ProductNDC": "43333-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Antibacterial Foaming Hand Wash Holiday Spice",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150824",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Tonic Bath and Body Products Shenzhen Ltd.",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/13mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-11-17",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "50742-665-16",
      "PackageDescription": "473 mL in 1 BOTTLE (50742-665-16) ",
      "NDC11Code": "50742-0665-16",
      "ProductNDC": "50742-665",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
      "NonProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
      "DosageFormName": "ELIXIR",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210801",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
      "StrengthNumber": "16.2; .1037; .0194; .0065",
      "StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
      "Pharm_Classes": "Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2023-01-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210801",
      "SamplePackage": "N",
      "Description": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir - Grape Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:  Phenobarbital, USP................................. 16.2 mg  Hyoscyamine Sulfate, USP................ 0.1037 mg  Atropine Sulfate, USP......................... 0.0194 mg  Scopolamine Hydrobromide, USP.... 0.0065 mgInactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1.Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir – Mint Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:  Phenobarbital, USP................................. 16.2 mg  Hyoscyamine Sulfate, USP................ 0.1037 mg  Atropine Sulfate, USP......................... 0.0194 mg  Scopolamine Hydrobromide, USP.... 0.0065 mgInactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Natural Mint Flavor, FD&C Yellow #5, and FD&C Blue #1."
    },
    {
      "NDCCode": "50742-666-16",
      "PackageDescription": "473 mL in 1 BOTTLE (50742-666-16) ",
      "NDC11Code": "50742-0666-16",
      "ProductNDC": "50742-666",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
      "NonProprietaryName": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide",
      "DosageFormName": "ELIXIR",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210801",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE",
      "StrengthNumber": "16.2; .1037; .0194; .0065",
      "StrengthUnit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
      "Pharm_Classes": "Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2023-01-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210801",
      "SamplePackage": "N",
      "Description": "Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir - Grape Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:  Phenobarbital, USP................................. 16.2 mg  Hyoscyamine Sulfate, USP................ 0.1037 mg  Atropine Sulfate, USP......................... 0.0194 mg  Scopolamine Hydrobromide, USP.... 0.0065 mgInactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1.Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir – Mint Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:  Phenobarbital, USP................................. 16.2 mg  Hyoscyamine Sulfate, USP................ 0.1037 mg  Atropine Sulfate, USP......................... 0.0194 mg  Scopolamine Hydrobromide, USP.... 0.0065 mgInactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Natural Mint Flavor, FD&C Yellow #5, and FD&C Blue #1."
    },
    {
      "NDCCode": "0173-0889-39",
      "PackageDescription": "2 TABLET, FILM COATED in 1 BOTTLE (0173-0889-39) ",
      "NDC11Code": "00173-0889-39",
      "ProductNDC": "0173-0889",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Krintafel",
      "NonProprietaryName": "Tafenoquine Succinate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190122",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210795",
      "LabelerName": "GlaxoSmithKline LLC",
      "SubstanceName": "TAFENOQUINE SUCCINATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Status": "Active",
      "LastUpdate": "2026-07-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190122",
      "SamplePackage": "N",
      "IndicationAndUsage": "KRINTAFEL is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving chloroquine therapy for acute P. vivax infection [see Dosage and Administration (2.2)]. Limitations of Use: 1 KRINTAFEL is NOT indicated for the treatment of acute P. vivax malaria., 2 Concomitant use of KRINTAFEL with antimalarials other than chloroquine is not recommended because of the risk of recurrence of P. vivax malaria [see Warnings and Precautions (5.6)].",
      "Description": "KRINTAFEL contains tafenoquine succinate, an antimalarial agent for oral administration. The chemical name of tafenoquine succinate is (±) 8-[(4-amino-1-methylbutyl)amino]-2,6-dimethoxy-4‑methyl-5-[3-(trifluoromethyl)phenoxy]quinoline succinate. The molecular formula of tafenoquine succinate is C24H28F3N3O3C4H6O4, and its molecular mass is 581.6 as the succinate salt (463.5 as free base). The structural formula is shown below. Each KRINTAFEL tablet contains 150 mg of tafenoquine (equivalent to 188.2 mg tafenoquine succinate). Inactive ingredients include magnesium stearate, mannitol, and microcrystalline cellulose. The tablet film-coating inactive ingredients include hydroxypropylmethylcellulose, polyethylene glycol, red iron oxide, and titanium dioxide."
    },
    {
      "NDCCode": "12784-463-27",
      "PackageDescription": "227 kg in 1 DRUM (12784-463-27) ",
      "NDC11Code": "12784-0463-27",
      "ProductNDC": "12784-463",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Magnesium Hydroxide",
      "DosageFormName": "PASTE",
      "StartMarketingDate": "20260313",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "SPI Pharma, Inc",
      "SubstanceName": "MAGNESIUM HYDROXIDE",
      "StrengthNumber": "31",
      "StrengthUnit": "kg/100kg",
      "Status": "Unfinished",
      "LastUpdate": "2026-03-16",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "13-MAR-26"
    },
    {
      "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": "33261-463-01",
      "PackageDescription": "100 mL in 1 BOTTLE, PLASTIC (33261-463-01)",
      "NDC11Code": "33261-0463-01",
      "ProductNDC": "33261-463",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Amoxicillin",
      "NonProprietaryName": "Amoxicillin",
      "DosageFormName": "POWDER, FOR SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20061228",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065334",
      "LabelerName": "Aidarex Pharmaceuticals LLC",
      "SubstanceName": "AMOXICILLIN",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/5mL",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension, USP and other antibacterial drugs, amoxicillin for oral suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin for oral suspension, USP is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below.",
      "Description": "Formulationof amoxicillin for oral suspension, USP contains amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each 5 mL of reconstituted suspension contains amoxicillin trihydrate equivalent to 200 mg or 400 mg anhydrous amoxicillin. Each 5 mL of the 200 mg and 400 mg reconstituted suspension contains 0.16 mEq (3.61 mg) of sodium; Inactive ingredients: sucrose, sodium citrate, sodium benzoate, edetate disodium, FD&C Red No. 3, xanthan gum, bubble-gum flavor, and colloidal silicon dioxide."
    },
    {
      "NDCCode": "47593-463-21",
      "PackageDescription": "208000 mL in 1 DRUM (47593-463-21) ",
      "NDC11Code": "47593-0463-21",
      "ProductNDC": "47593-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Scrub-stat",
      "NonProprietaryName": "Chlorhexidine Gluconate",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19860722",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019258",
      "LabelerName": "Ecolab Inc.",
      "SubstanceName": "CHLORHEXIDINE GLUCONATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151223",
      "EndMarketingDatePackage": "20241015",
      "SamplePackage": "N",
      "IndicationAndUsage": "surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care. healthcare personnel handwash: handwash to help reduce bacteria that potentially can cause disease."
    },
    {
      "NDCCode": "47593-463-44",
      "PackageDescription": "1134000 mL in 1 CONTAINER (47593-463-44) ",
      "NDC11Code": "47593-0463-44",
      "ProductNDC": "47593-463",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Scrub-stat",
      "NonProprietaryName": "Chlorhexidine Gluconate",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "19860722",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019258",
      "LabelerName": "Ecolab Inc.",
      "SubstanceName": "CHLORHEXIDINE GLUCONATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151223",
      "EndMarketingDatePackage": "20241015",
      "SamplePackage": "N",
      "IndicationAndUsage": "surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care. healthcare personnel handwash: handwash to help reduce bacteria that potentially can cause disease."
    },
    {
      "NDCCode": "63629-8320-1",
      "PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE (63629-8320-1) ",
      "NDC11Code": "63629-8320-01",
      "ProductNDC": "63629-8320",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eletriptan Hydrobromide",
      "NonProprietaryName": "Eletriptan Hydrobromide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180216",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210708",
      "LabelerName": "Bryant Ranch Prepack",
      "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": "2024-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200518",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use.",
      "Description": "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 molecular formula is C22H26N2O2S . HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is an off-white to brown color powder that is freely soluble in methanol and very slightly soluble in water. Each eletriptan hydrobromide tablet for oral administration contains 24.23 or 48.46 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 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "63629-8320-2",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (63629-8320-2) ",
      "NDC11Code": "63629-8320-02",
      "ProductNDC": "63629-8320",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Eletriptan Hydrobromide",
      "NonProprietaryName": "Eletriptan Hydrobromide",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20180216",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210708",
      "LabelerName": "Bryant Ranch Prepack",
      "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": "2024-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use.",
      "Description": "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 molecular formula is C22H26N2O2S . HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is an off-white to brown color powder that is freely soluble in methanol and very slightly soluble in water. Each eletriptan hydrobromide tablet for oral administration contains 24.23 or 48.46 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 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "50742-181-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE (50742-181-01) ",
      "NDC11Code": "50742-0181-01",
      "ProductNDC": "50742-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200730",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211132",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200730",
      "SamplePackage": "N",
      "Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg tablet contains 5 mg of leucovorin (equivalent to 5.4 mg of leucovorin calcium), each 10 mg tablet contains 10 mg of leucovorin (equivalent to 10.8 mg of leucovorin calcium), each 15 mg tablet contains 15 mg of leucovorin (equivalent to 16.2 mg of leucovorin calcium) and each 25 mg tablet contains 25 mg of leucovorin (equivalent to 27.01 mg of leucovorin calcium). The 5 mg, 10 mg, 15 mg and 25 mg tablets contain the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Additionally, the 15 mg and 25 mg tablets contains FD&C yellow #6."
    },
    {
      "NDCCode": "50742-181-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (50742-181-30) ",
      "NDC11Code": "50742-0181-30",
      "ProductNDC": "50742-181",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200730",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211132",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200730",
      "SamplePackage": "N",
      "Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg tablet contains 5 mg of leucovorin (equivalent to 5.4 mg of leucovorin calcium), each 10 mg tablet contains 10 mg of leucovorin (equivalent to 10.8 mg of leucovorin calcium), each 15 mg tablet contains 15 mg of leucovorin (equivalent to 16.2 mg of leucovorin calcium) and each 25 mg tablet contains 25 mg of leucovorin (equivalent to 27.01 mg of leucovorin calcium). The 5 mg, 10 mg, 15 mg and 25 mg tablets contain the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Additionally, the 15 mg and 25 mg tablets contains FD&C yellow #6."
    },
    {
      "NDCCode": "50742-182-12",
      "PackageDescription": "12 TABLET in 1 BOTTLE (50742-182-12) ",
      "NDC11Code": "50742-0182-12",
      "ProductNDC": "50742-182",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200730",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211132",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200730",
      "SamplePackage": "N",
      "Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg tablet contains 5 mg of leucovorin (equivalent to 5.4 mg of leucovorin calcium), each 10 mg tablet contains 10 mg of leucovorin (equivalent to 10.8 mg of leucovorin calcium), each 15 mg tablet contains 15 mg of leucovorin (equivalent to 16.2 mg of leucovorin calcium) and each 25 mg tablet contains 25 mg of leucovorin (equivalent to 27.01 mg of leucovorin calcium). The 5 mg, 10 mg, 15 mg and 25 mg tablets contain the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Additionally, the 15 mg and 25 mg tablets contains FD&C yellow #6."
    },
    {
      "NDCCode": "50742-182-24",
      "PackageDescription": "24 TABLET in 1 BOTTLE (50742-182-24) ",
      "NDC11Code": "50742-0182-24",
      "ProductNDC": "50742-182",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200730",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211132",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200730",
      "SamplePackage": "N",
      "Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg tablet contains 5 mg of leucovorin (equivalent to 5.4 mg of leucovorin calcium), each 10 mg tablet contains 10 mg of leucovorin (equivalent to 10.8 mg of leucovorin calcium), each 15 mg tablet contains 15 mg of leucovorin (equivalent to 16.2 mg of leucovorin calcium) and each 25 mg tablet contains 25 mg of leucovorin (equivalent to 27.01 mg of leucovorin calcium). The 5 mg, 10 mg, 15 mg and 25 mg tablets contain the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Additionally, the 15 mg and 25 mg tablets contains FD&C yellow #6."
    },
    {
      "NDCCode": "50742-183-24",
      "PackageDescription": "24 TABLET in 1 BOTTLE (50742-183-24) ",
      "NDC11Code": "50742-0183-24",
      "ProductNDC": "50742-183",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200730",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211132",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200730",
      "SamplePackage": "N",
      "Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg tablet contains 5 mg of leucovorin (equivalent to 5.4 mg of leucovorin calcium), each 10 mg tablet contains 10 mg of leucovorin (equivalent to 10.8 mg of leucovorin calcium), each 15 mg tablet contains 15 mg of leucovorin (equivalent to 16.2 mg of leucovorin calcium) and each 25 mg tablet contains 25 mg of leucovorin (equivalent to 27.01 mg of leucovorin calcium). The 5 mg, 10 mg, 15 mg and 25 mg tablets contain the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Additionally, the 15 mg and 25 mg tablets contains FD&C yellow #6."
    },
    {
      "NDCCode": "50742-184-25",
      "PackageDescription": "25 TABLET in 1 BOTTLE (50742-184-25) ",
      "NDC11Code": "50742-0184-25",
      "ProductNDC": "50742-184",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Leucovorin Calcium",
      "NonProprietaryName": "Leucovorin Calcium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20200730",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211132",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "LEUCOVORIN CALCIUM",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
      "Status": "Active",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200730",
      "SamplePackage": "N",
      "Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg tablet contains 5 mg of leucovorin (equivalent to 5.4 mg of leucovorin calcium), each 10 mg tablet contains 10 mg of leucovorin (equivalent to 10.8 mg of leucovorin calcium), each 15 mg tablet contains 15 mg of leucovorin (equivalent to 16.2 mg of leucovorin calcium) and each 25 mg tablet contains 25 mg of leucovorin (equivalent to 27.01 mg of leucovorin calcium). The 5 mg, 10 mg, 15 mg and 25 mg tablets contain the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Additionally, the 15 mg and 25 mg tablets contains FD&C yellow #6."
    },
    {
      "NDCCode": "50742-224-15",
      "PackageDescription": "150 CAPSULE in 1 BOTTLE, PLASTIC (50742-224-15) ",
      "NDC11Code": "50742-0224-15",
      "ProductNDC": "50742-224",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tizanidine Hydrochloride",
      "NonProprietaryName": "Tizanidine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190320",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210267",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "TIZANIDINE HYDROCHLORIDE",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190320",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tizanidine hydrochloride is indicated for the treatment of spasticity in adults.",
      "Description": "Tizanidine contains tizanidine hydrochloride, USP as the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3 benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride, USP is a white to slightly yellow crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol. Tizanidine hydrochloride capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride, respectively), and the inactive ingredients, microcrystalline cellulose, anhydrous lactose, colloidal silicon dioxide, stearic acid. In addition, each of the empty hard gelatin capsules contain the following: gelatin, titanium dioxide, sodium lauryl sulfate and FD&C blue #1. The imprinting ink contains the following: shellac, propylene glycol, potassium hydroxide, ammonia and black iron oxide."
    },
    {
      "NDCCode": "50742-225-15",
      "PackageDescription": "150 CAPSULE in 1 BOTTLE, PLASTIC (50742-225-15) ",
      "NDC11Code": "50742-0225-15",
      "ProductNDC": "50742-225",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tizanidine Hydrochloride",
      "NonProprietaryName": "Tizanidine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190320",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210267",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "TIZANIDINE HYDROCHLORIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190320",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tizanidine hydrochloride is indicated for the treatment of spasticity in adults.",
      "Description": "Tizanidine contains tizanidine hydrochloride, USP as the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3 benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride, USP is a white to slightly yellow crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol. Tizanidine hydrochloride capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride, respectively), and the inactive ingredients, microcrystalline cellulose, anhydrous lactose, colloidal silicon dioxide, stearic acid. In addition, each of the empty hard gelatin capsules contain the following: gelatin, titanium dioxide, sodium lauryl sulfate and FD&C blue #1. The imprinting ink contains the following: shellac, propylene glycol, potassium hydroxide, ammonia and black iron oxide."
    },
    {
      "NDCCode": "50742-226-15",
      "PackageDescription": "150 CAPSULE in 1 BOTTLE, PLASTIC (50742-226-15) ",
      "NDC11Code": "50742-0226-15",
      "ProductNDC": "50742-226",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tizanidine Hydrochloride",
      "NonProprietaryName": "Tizanidine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190320",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210267",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "TIZANIDINE HYDROCHLORIDE",
      "StrengthNumber": "6",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190320",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tizanidine hydrochloride is indicated for the treatment of spasticity in adults.",
      "Description": "Tizanidine contains tizanidine hydrochloride, USP as the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3 benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride, USP is a white to slightly yellow crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol. Tizanidine hydrochloride capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride, respectively), and the inactive ingredients, microcrystalline cellulose, anhydrous lactose, colloidal silicon dioxide, stearic acid. In addition, each of the empty hard gelatin capsules contain the following: gelatin, titanium dioxide, sodium lauryl sulfate and FD&C blue #1. The imprinting ink contains the following: shellac, propylene glycol, potassium hydroxide, ammonia and black iron oxide."
    },
    {
      "NDCCode": "50742-233-01",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-233-01) ",
      "NDC11Code": "50742-0233-01",
      "ProductNDC": "50742-233",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Acetazolamide",
      "NonProprietaryName": "Acetazolamide",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203434",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "ACETAZOLAMIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]",
      "Status": "Active",
      "LastUpdate": "2025-12-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20170731",
      "SamplePackage": "N",
      "IndicationAndUsage": "For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide is also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.",
      "Description": "Acetazolamide Extended-Release Capsules are an inhibitor of the enzyme carbonic anhydrase. Acetazolamide is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for Acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl) acetamide and has the following chemical structure. Each acetazolamide extended-release capsule, for oral administration, contains 500 mg of acetazolamide and the following inactive ingredients. Microcrystalline cellulose, hydroxypropyl cellulose, pregelatinized starch, talc. The capsule shell contains gelatin, sodium lauryl sulphate and titanium dioxide. The imprinting ink contains shellac, potassium hydroxide and black iron oxide."
    },
    {
      "NDCCode": "50742-234-01",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-234-01) ",
      "NDC11Code": "50742-0234-01",
      "ProductNDC": "50742-234",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Indomethacin",
      "NonProprietaryName": "Indomethacin",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170508",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204853",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "INDOMETHACIN",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20170508",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50742-234-10",
      "PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-234-10) ",
      "NDC11Code": "50742-0234-10",
      "ProductNDC": "50742-234",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Indomethacin",
      "NonProprietaryName": "Indomethacin",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170508",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204853",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "INDOMETHACIN",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20170508",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50742-234-60",
      "PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-234-60) ",
      "NDC11Code": "50742-0234-60",
      "ProductNDC": "50742-234",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Indomethacin",
      "NonProprietaryName": "Indomethacin",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170508",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204853",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "INDOMETHACIN",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20170508",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50742-234-90",
      "PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-234-90) ",
      "NDC11Code": "50742-0234-90",
      "ProductNDC": "50742-234",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Indomethacin",
      "NonProprietaryName": "Indomethacin",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170508",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204853",
      "LabelerName": "Ingenus Pharmaceuticals, LLC",
      "SubstanceName": "INDOMETHACIN",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20170508",
      "SamplePackage": "N"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"50742-463-16","ProprietaryName":"Docetaxel","NonProprietaryName":"Docetaxel Anhydrous"},{"NDCCode":"10304-463-16","ProprietaryName":"Oxygen","NonProprietaryName":"Oxygen"},{"NDCCode":"43333-463-16","ProprietaryName":"Antibacterial Foaming Hand Wash Holiday Spice","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"50742-665-16","ProprietaryName":"Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide","NonProprietaryName":"Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide"},{"NDCCode":"50742-666-16","ProprietaryName":"Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide","NonProprietaryName":"Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide"},{"NDCCode":"0173-0889-39","ProprietaryName":"Krintafel","NonProprietaryName":"Tafenoquine Succinate"},{"NDCCode":"12784-463-27","NonProprietaryName":"Magnesium Hydroxide"},{"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":"33261-463-01","ProprietaryName":"Amoxicillin","NonProprietaryName":"Amoxicillin"},{"NDCCode":"47593-463-21","ProprietaryName":"Scrub-stat","NonProprietaryName":"Chlorhexidine Gluconate"},{"NDCCode":"47593-463-44","ProprietaryName":"Scrub-stat","NonProprietaryName":"Chlorhexidine Gluconate"},{"NDCCode":"63629-8320-1","ProprietaryName":"Eletriptan Hydrobromide","NonProprietaryName":"Eletriptan Hydrobromide"},{"NDCCode":"63629-8320-2","ProprietaryName":"Eletriptan Hydrobromide","NonProprietaryName":"Eletriptan Hydrobromide"},{"NDCCode":"50742-181-01","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"},{"NDCCode":"50742-181-30","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"},{"NDCCode":"50742-182-12","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"},{"NDCCode":"50742-182-24","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"},{"NDCCode":"50742-183-24","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"},{"NDCCode":"50742-184-25","ProprietaryName":"Leucovorin Calcium","NonProprietaryName":"Leucovorin Calcium"},{"NDCCode":"50742-224-15","ProprietaryName":"Tizanidine Hydrochloride","NonProprietaryName":"Tizanidine Hydrochloride"},{"NDCCode":"50742-225-15","ProprietaryName":"Tizanidine Hydrochloride","NonProprietaryName":"Tizanidine Hydrochloride"},{"NDCCode":"50742-226-15","ProprietaryName":"Tizanidine Hydrochloride","NonProprietaryName":"Tizanidine Hydrochloride"},{"NDCCode":"50742-233-01","ProprietaryName":"Acetazolamide","NonProprietaryName":"Acetazolamide"},{"NDCCode":"50742-234-01","ProprietaryName":"Indomethacin","NonProprietaryName":"Indomethacin"},{"NDCCode":"50742-234-10","ProprietaryName":"Indomethacin","NonProprietaryName":"Indomethacin"},{"NDCCode":"50742-234-60","ProprietaryName":"Indomethacin","NonProprietaryName":"Indomethacin"},{"NDCCode":"50742-234-90","ProprietaryName":"Indomethacin","NonProprietaryName":"Indomethacin"}]}
                    

<NDCList><NDC><NDCCode>50742-463-16</NDCCode><ProprietaryName>Docetaxel</ProprietaryName><NonProprietaryName>Docetaxel Anhydrous</NonProprietaryName></NDC><NDC><NDCCode>10304-463-16</NDCCode><ProprietaryName>Oxygen</ProprietaryName><NonProprietaryName>Oxygen</NonProprietaryName></NDC><NDC><NDCCode>43333-463-16</NDCCode><ProprietaryName>Antibacterial Foaming Hand Wash Holiday Spice</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>50742-665-16</NDCCode><ProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</ProprietaryName><NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>50742-666-16</NDCCode><ProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</ProprietaryName><NonProprietaryName>Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>0173-0889-39</NDCCode><ProprietaryName>Krintafel</ProprietaryName><NonProprietaryName>Tafenoquine Succinate</NonProprietaryName></NDC><NDC><NDCCode>12784-463-27</NDCCode><NonProprietaryName>Magnesium Hydroxide</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>33261-463-01</NDCCode><ProprietaryName>Amoxicillin</ProprietaryName><NonProprietaryName>Amoxicillin</NonProprietaryName></NDC><NDC><NDCCode>47593-463-21</NDCCode><ProprietaryName>Scrub-stat</ProprietaryName><NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName></NDC><NDC><NDCCode>47593-463-44</NDCCode><ProprietaryName>Scrub-stat</ProprietaryName><NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName></NDC><NDC><NDCCode>63629-8320-1</NDCCode><ProprietaryName>Eletriptan Hydrobromide</ProprietaryName><NonProprietaryName>Eletriptan Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>63629-8320-2</NDCCode><ProprietaryName>Eletriptan Hydrobromide</ProprietaryName><NonProprietaryName>Eletriptan Hydrobromide</NonProprietaryName></NDC><NDC><NDCCode>50742-181-01</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC><NDC><NDCCode>50742-181-30</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC><NDC><NDCCode>50742-182-12</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC><NDC><NDCCode>50742-182-24</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC><NDC><NDCCode>50742-183-24</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC><NDC><NDCCode>50742-184-25</NDCCode><ProprietaryName>Leucovorin Calcium</ProprietaryName><NonProprietaryName>Leucovorin Calcium</NonProprietaryName></NDC><NDC><NDCCode>50742-224-15</NDCCode><ProprietaryName>Tizanidine Hydrochloride</ProprietaryName><NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50742-225-15</NDCCode><ProprietaryName>Tizanidine Hydrochloride</ProprietaryName><NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50742-226-15</NDCCode><ProprietaryName>Tizanidine Hydrochloride</ProprietaryName><NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50742-233-01</NDCCode><ProprietaryName>Acetazolamide</ProprietaryName><NonProprietaryName>Acetazolamide</NonProprietaryName></NDC><NDC><NDCCode>50742-234-01</NDCCode><ProprietaryName>Indomethacin</ProprietaryName><NonProprietaryName>Indomethacin</NonProprietaryName></NDC><NDC><NDCCode>50742-234-10</NDCCode><ProprietaryName>Indomethacin</ProprietaryName><NonProprietaryName>Indomethacin</NonProprietaryName></NDC><NDC><NDCCode>50742-234-60</NDCCode><ProprietaryName>Indomethacin</ProprietaryName><NonProprietaryName>Indomethacin</NonProprietaryName></NDC><NDC><NDCCode>50742-234-90</NDCCode><ProprietaryName>Indomethacin</ProprietaryName><NonProprietaryName>Indomethacin</NonProprietaryName></NDC></NDCList>