RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "54868-1380-3",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (54868-1380-3)",
      "NDC11Code": "54868-1380-03",
      "ProductNDC": "54868-1380",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dicloxacillin Sodium",
      "NonProprietaryName": "Dicloxacillin Sodium",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19921021",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061454",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DICLOXACILLIN SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "The penicillinase-resistant penicillins are indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drugs. Cultures and susceptibility tests should be performed initially to determine the causative organism and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility Testing). The penicillinase-resistant penicillins may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible 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.",
      "Description": "Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl penicillin series. It is a penicillinase-resistant, acid resistant semisynthetic penicillin suitable for oral administration. Dicloxacillin sodium is chemically designated as 4-Thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, 6-[[[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolyl]-carbonyl]-amino]-3,3-dimethyl-7-oxo-, monosodium salt, monohydrate, [2S-(2α5α,6β)] and has the following structural formula. Each capsule for oral administration contains dicloxacillin sodium equivalent to 250 or 500 mg of dicloxacillin. The inactive ingredients are gelatin, FD&C Blue #1, magnesium stearate, and titanium dioxide."
    },
    {
      "NDCCode": "54868-1380-0",
      "PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (54868-1380-0)",
      "NDC11Code": "54868-1380-00",
      "ProductNDC": "54868-1380",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dicloxacillin Sodium",
      "NonProprietaryName": "Dicloxacillin Sodium",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19921021",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061454",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DICLOXACILLIN SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "The penicillinase-resistant penicillins are indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drugs. Cultures and susceptibility tests should be performed initially to determine the causative organism and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility Testing). The penicillinase-resistant penicillins may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible 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.",
      "Description": "Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl penicillin series. It is a penicillinase-resistant, acid resistant semisynthetic penicillin suitable for oral administration. Dicloxacillin sodium is chemically designated as 4-Thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, 6-[[[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolyl]-carbonyl]-amino]-3,3-dimethyl-7-oxo-, monosodium salt, monohydrate, [2S-(2α5α,6β)] and has the following structural formula. Each capsule for oral administration contains dicloxacillin sodium equivalent to 250 or 500 mg of dicloxacillin. The inactive ingredients are gelatin, FD&C Blue #1, magnesium stearate, and titanium dioxide."
    },
    {
      "NDCCode": "54868-1380-1",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (54868-1380-1)",
      "NDC11Code": "54868-1380-01",
      "ProductNDC": "54868-1380",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dicloxacillin Sodium",
      "NonProprietaryName": "Dicloxacillin Sodium",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19921021",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061454",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DICLOXACILLIN SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "The penicillinase-resistant penicillins are indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drugs. Cultures and susceptibility tests should be performed initially to determine the causative organism and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility Testing). The penicillinase-resistant penicillins may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible 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.",
      "Description": "Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl penicillin series. It is a penicillinase-resistant, acid resistant semisynthetic penicillin suitable for oral administration. Dicloxacillin sodium is chemically designated as 4-Thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, 6-[[[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolyl]-carbonyl]-amino]-3,3-dimethyl-7-oxo-, monosodium salt, monohydrate, [2S-(2α5α,6β)] and has the following structural formula. Each capsule for oral administration contains dicloxacillin sodium equivalent to 250 or 500 mg of dicloxacillin. The inactive ingredients are gelatin, FD&C Blue #1, magnesium stearate, and titanium dioxide."
    },
    {
      "NDCCode": "54868-1380-2",
      "PackageDescription": "40 CAPSULE in 1 BOTTLE, PLASTIC (54868-1380-2)",
      "NDC11Code": "54868-1380-02",
      "ProductNDC": "54868-1380",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dicloxacillin Sodium",
      "NonProprietaryName": "Dicloxacillin Sodium",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19921021",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061454",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DICLOXACILLIN SODIUM",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "The penicillinase-resistant penicillins are indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drugs. Cultures and susceptibility tests should be performed initially to determine the causative organism and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility Testing). The penicillinase-resistant penicillins may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible 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.",
      "Description": "Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl penicillin series. It is a penicillinase-resistant, acid resistant semisynthetic penicillin suitable for oral administration. Dicloxacillin sodium is chemically designated as 4-Thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, 6-[[[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolyl]-carbonyl]-amino]-3,3-dimethyl-7-oxo-, monosodium salt, monohydrate, [2S-(2α5α,6β)] and has the following structural formula. Each capsule for oral administration contains dicloxacillin sodium equivalent to 250 or 500 mg of dicloxacillin. The inactive ingredients are gelatin, FD&C Blue #1, magnesium stearate, and titanium dioxide."
    },
    {
      "NDCCode": "36987-1380-3",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1380-3)",
      "NDC11Code": "36987-1380-03",
      "ProductNDC": "36987-1380",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Watermelon",
      "NonProprietaryName": "Watermelon",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "WATERMELON",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [CS],Dietary Proteins [CS],Fruit Proteins [EXT],Cell-mediated Immunity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "37662-1380-3",
      "PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (37662-1380-3) ",
      "NDC11Code": "37662-1380-03",
      "ProductNDC": "37662-1380",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Plumbum Metallicum",
      "NonProprietaryName": "Plumbum Metallicum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220818",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "LEAD",
      "StrengthNumber": "6",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-08-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220818",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "67296-1380-3",
      "PackageDescription": "30 TABLET in 1 BOTTLE (67296-1380-3) ",
      "NDC11Code": "67296-1380-03",
      "ProductNDC": "67296-1380",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propranolol Hydrochloride",
      "NonProprietaryName": "Propranolol Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081013",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078955",
      "LabelerName": "RedPharm Drug, Inc.",
      "SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20081013",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hypertension. Propranolol hydrochloride tablets are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol hydrochloride tablets are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol hydrochloride tablets are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol hydrochloride tablets are indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol hydrochloride tablets, USP causes a reduction in the tremor amplitude but not in the tremor frequency. Propranolol hydrochloride tablets are not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol hydrochloride tablets improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol hydrochloride tablets are indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.",
      "Description": "Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It's molecular and structural formulae are. [propranololhclusp]. C16H21NO2.HCl. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets, USP are: lactose monohydrate, corn starch, sodium starch glycolate, magnesium stearate, and povidone. In addition, propranolol hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain FD &C yellow No.6 Aluminium Lake and Color D&C Yellow No. 10; propranolol hydrochloride tablets, USP 20 mg and 40mg contain FD&C Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D&C Red No. 30 Lake."
    },
    {
      "NDCCode": "69238-1380-3",
      "PackageDescription": "1 BOTTLE in 1 CARTON (69238-1380-3)  / 5 mL in 1 BOTTLE",
      "NDC11Code": "69238-1380-03",
      "ProductNDC": "69238-1380",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Difluprednate",
      "NonProprietaryName": "Difluprednate Ophthalmic",
      "DosageFormName": "EMULSION",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20211118",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211526",
      "LabelerName": "Amneal Pharmaceuticals LLC",
      "SubstanceName": "DIFLUPREDNATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/mL",
      "Status": "Active",
      "LastUpdate": "2026-09-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20211118",
      "SamplePackage": "N",
      "Description": "Difluprednate ophthalmic emulsion, 0.05% is a sterile, topical anti-inflammatory corticosteroid for topical ophthalmic use. The chemical name is (6α,11β)-21-(Acetyloxy)-6,9-difluoro-11-hydroxy-17-(1-oxobutoxy)pregna-1,4-diene-3,20-dione. Difluprednate is represented by the following structural formula. Difluprednate has a molecular weight of 508.55 g/mol, and the molecular formula is C27H34F2O7. Difluprednate (micronized) is a white to creamy-white crystalline powder. It is freely soluble in acetonitrile and in chloroform, soluble in methanol, in ethanol and in dioxane; slightly soluble in ether; practically insoluble in water. Each mL contains:. Active: difluprednate 0.5 mg (0.05%). Inactives: boric acid, castor oil, glycerin, polysorbate 80, water for injection, sodium acetate, edetate disodium, sodium hydroxide (to adjust the pH to 5.2 to 5.8). The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsmol/kg. Preservative: sorbic acid 0.1%."
    },
    {
      "NDCCode": "70710-1380-3",
      "PackageDescription": "30 TABLET in 1 BOTTLE (70710-1380-3) ",
      "NDC11Code": "70710-1380-03",
      "ProductNDC": "70710-1380",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dapagliflozin",
      "NonProprietaryName": "Dapagliflozin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260406",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA211582",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "DAPAGLIFLOZIN",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260406",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dapagliflozin tablets are indicated: 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors., 2 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "Description": "Dapagliflozin, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-[4-chloro-3-(4-ethoxybenzyl) phenyl]-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The molecular formula is C21H25ClO6 and the molecular weight is 408.88. The structural formula is. Dapagliflozin is a white to off-white solid and soluble in methanol and ethanol. Dapagliflozin tablets, USP are available as a film-coated tablet for oral administration. Each tablet contains 5 mg or 10 mg dapagliflozin and contains following inactive ingredients: anhydrous lactose, crospovidone, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, poloxamer, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide."
    },
    {
      "NDCCode": "71335-1380-3",
      "PackageDescription": "60 TABLET in 1 BOTTLE (71335-1380-3) ",
      "NDC11Code": "71335-1380-03",
      "ProductNDC": "71335-1380",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lisinopril",
      "NonProprietaryName": "Lisinopril",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076059",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "LISINOPRIL",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2024-10-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191031",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lisinopril tablets are an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
      "Description": "Lisinopril, USP is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Each tablet for oral administration contains 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg of lisinopril. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, FD&C Blue #2 Aluminum Lake (10 mg only), FD&C Yellow #5 (tartrazine) Aluminum Lake (20 mg, 30 mg, and 40 mg, only), magnesium stearate, mannitol, pregelatinized starch."
    },
    {
      "NDCCode": "0440-1380-40",
      "PackageDescription": "40 CAPSULE in 1 BOTTLE, PLASTIC (0440-1380-40)",
      "NDC11Code": "00440-1380-40",
      "ProductNDC": "0440-1380",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dicloxacillin Sodium",
      "NonProprietaryName": "Dicloxacillin Sodium",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19710401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061454",
      "LabelerName": "Liberty Pharmaceuticals, Inc.",
      "SubstanceName": "DICLOXACILLIN SODIUM",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "The penicillinase-resistant penicillins are indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drugs. Cultures and susceptibility tests should be performed initially to determine the causative organism and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility Testing). The penicillinase-resistant penicillins may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible 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.",
      "Description": "Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl penicillin series. It is a penicillinase-resistant, acid resistant semisynthetic penicillin suitable for oral administration. Dicloxacillin sodium is chemically designated as 4-Thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, 6-[[[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolyl]-carbonyl]-amino]-3,3-dimethyl-7-oxo-, monosodium salt, monohydrate, [2S-(2α5α,6β)] and has the following structural formula. Each capsule for oral administration contains dicloxacillin sodium equivalent to 250 or 500 mg of dicloxacillin. The inactive ingredient is magnesium stearate. The capsule shells contain FD&C Blue 1, titanium dioxide, and gelatin."
    },
    {
      "NDCCode": "0527-1380-01",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0527-1380-01) ",
      "NDC11Code": "00527-1380-01",
      "ProductNDC": "0527-1380",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Unithroid",
      "NonProprietaryName": "Levothyroxine Sodium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20000821",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021210",
      "LabelerName": "Lannett Company, Inc.",
      "SubstanceName": "LEVOTHYROXINE SODIUM",
      "StrengthNumber": ".3",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-08-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20000821",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "48951-1380-2",
      "PackageDescription": "30 mL in 1 BOTTLE, SPRAY (48951-1380-2) ",
      "NDC11Code": "48951-1380-02",
      "ProductNDC": "48951-1380",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Arnica Nettle",
      "NonProprietaryName": "Arnica Nettle",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20090901",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Uriel Pharmacy Inc.",
      "SubstanceName": "ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; LYTTA VESICATORIA; THUJA OCCIDENTALIS WHOLE; URTICA URENS",
      "StrengthNumber": "1; 1; 1; 3; 1; 1",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20090901",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions: FOR TOPICAL USE ONLY."
    },
    {
      "NDCCode": "50090-1380-0",
      "PackageDescription": "1 KIT in 1 KIT (50090-1380-0)  *  21 TABLET, FILM COATED in 1 KIT *  7 TABLET, FILM COATED in 1 KIT",
      "NDC11Code": "50090-1380-00",
      "ProductNDC": "50090-1380",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Orsythia",
      "NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
      "DosageFormName": "KIT",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110511",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077099",
      "LabelerName": "A-S Medication Solutions",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "PackageNdcExcludeFlag": "Y",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "ORSYTHIA® (levonorgestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. TABLE II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and levonorgestrel implants, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5 Foams, creams, gels, vaginal suppositories, and vaginal film. 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7 With spermicidal cream or jelly. 8 Without spermicides. 9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were excluded from the calculation of the Pearl index due to the use of back-up contraception and/or missing 3 or more consecutive pills.",
      "Description": "21 pink active tablets each containing 0.1 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present are FD&C red #40 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch and vitamin E. 7 light-green inert tablets, each containing FD&C blue #2, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol and pregelatinized starch."
    },
    {
      "NDCCode": "51662-1380-1",
      "PackageDescription": "1 SYRINGE in 1 CARTON (51662-1380-1)  > 50 mL in 1 SYRINGE",
      "NDC11Code": "51662-1380-01",
      "ProductNDC": "51662-1380",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextrose",
      "NonProprietaryName": "Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "PARENTERAL",
      "StartMarketingDate": "20191029",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "DEXTROSE MONOHYDRATE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20191029",
      "SamplePackage": "N",
      "IndicationAndUsage": "50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels. The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to ensure proper utilization of dextrose and avoid production of hyperglycemia.",
      "Description": "50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection as a fluid and nutrient replenisher. Each mL of fluid contains 0.5 g dextrose, hydrous which delivers 3.4 kcal/gram. The solution has an osmolarity of 2.5 mOsmol/mL (calc.) and a pH of 3.2-6.5. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit. Dextrose, USP is chemically designated C6H12O6  H2O (D-glucose monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following formula. Water for Injection, USP is chemically designated H2O. The delivery device is composed of a 50 mL glass syringe barrel with rubber stopper, and custom molded IMS injector with Luer Connector."
    },
    {
      "NDCCode": "54868-0018-3",
      "PackageDescription": "20 TABLET in 1 BOTTLE (54868-0018-3)",
      "NDC11Code": "54868-0018-03",
      "ProductNDC": "54868-0018",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Erythromycin Ethylsuccinate",
      "NonProprietaryName": "Erythromycin Ethylsuccinate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA061904",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate tablets and other antibacterial drugs, erythromycin ethylsuccinate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible 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. Erythromycin ethylsuccinate tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae , or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.3 The therapeutic dose should be administered for 10 days. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).3.",
      "Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration are intended primarily for adults or older children. Each tablet contains erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity. The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Confectioner's sugar (contains corn starch), corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium and sodium citrate."
    },
    {
      "NDCCode": "54868-0021-3",
      "PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (54868-0021-3)",
      "NDC11Code": "54868-0021-03",
      "ProductNDC": "54868-0021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950811",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090624",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
      "StrengthNumber": "800; 160",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "54868-0023-3",
      "PackageDescription": "500 CAPSULE in 1 BOTTLE (54868-0023-3)",
      "NDC11Code": "54868-0023-03",
      "ProductNDC": "54868-0023",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline Hyclate",
      "NonProprietaryName": "Doxycycline Hyclate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930611",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062031",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DOXYCYCLINE HYCLATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-19"
    },
    {
      "NDCCode": "54868-0024-3",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (54868-0024-3)",
      "NDC11Code": "54868-0024-03",
      "ProductNDC": "54868-0024",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tetracycline Hydrochloride",
      "NonProprietaryName": "Tetracycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19880301",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA060704",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
      "Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide."
    },
    {
      "NDCCode": "54868-0025-3",
      "PackageDescription": "40 CAPSULE in 1 BOTTLE (54868-0025-3)",
      "NDC11Code": "54868-0025-03",
      "ProductNDC": "54868-0025",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tetracycline Hydrochloride",
      "NonProprietaryName": "Tetracycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961009",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA060704",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
      "Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide."
    },
    {
      "NDCCode": "54868-0032-3",
      "PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (54868-0032-3)",
      "NDC11Code": "54868-0032-03",
      "ProductNDC": "54868-0032",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
      "NonProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950127",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA085762",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE",
      "StrengthNumber": "2.5; .025",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
      "DEASchedule": "CV",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Diphenoxylate hydrochloride and atropine sulfate tablets are effective as adjunctive therapy in the management of diarrhea.",
      "Description": "Each tablet for oral administration contains. diphenoxylatehydrochloride, USP 2.5 mg(Warning – May be habit forming). atropinesulfate, USP 0.025 mg. Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3, 3-diphenylpropyl)-4-phenyl-isonipecotate monohydrochloride and has the following structure. Atropine sulfate, an anticholinergic, is endo-(±)-alpha-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicylo[3.2.1] oct-3-yl ester sulfate (2:1)] (salt) monohydrate and has the following structure. A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch and stearic acid."
    },
    {
      "NDCCode": "54868-0033-3",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (54868-0033-3)",
      "NDC11Code": "54868-0033-03",
      "ProductNDC": "54868-0033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dicyclomine Hydrochloride",
      "NonProprietaryName": "Dicyclomine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19951026",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA084285",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Dicyclomine hydrochloride tablets and capsules are indicated for the treatment of functional bowel/ irritable bowel syndrome.",
      "Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following forms. 1. Dicyclomine Hydrochloride Tablets USP, for oral administration, contain 20 mg dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: acacia, pregelatinized starch, anhydrous lactose, compressible sugar, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, stearic acid, and FD & C Blue #1 Aluminum Lake. 2. Dicyclomine Hydrochloride Capsules USP, for oral administration, contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate; and the capsules shells contain: gelatin, FD&C Blue # 1, and FD&C Red # 3. Chemically, dicyclomine hydrochloride is 2-(Diethylamino)ethyl [bicyclohexyl]-1-carboxylate hydrochloride with the structural formula. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether."
    },
    {
      "NDCCode": "54868-0034-3",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (54868-0034-3)",
      "NDC11Code": "54868-0034-03",
      "ProductNDC": "54868-0034",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoclopramide",
      "NonProprietaryName": "Metoclopramide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20030501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078807",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "The use of metoclopramide tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration. Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Metoclopramide tablets, are indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide tablets within different time intervals. Significant relief of nausea occurs early and continues to improve over a three-week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.",
      "Description": "For oral administration, Metoclopramide tablets, USP 10 mg are white to off white, capsule shaped, biconvex tablets with \"RF11\" embossed on one side and score line on the other side. Each tablet contains. 10 mg of metoclopramide base as metoclopramide hydrochloride USP."
    },
    {
      "NDCCode": "54868-0038-3",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE (54868-0038-3)",
      "NDC11Code": "54868-0038-03",
      "ProductNDC": "54868-0038",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Temazepam",
      "NonProprietaryName": "Temazepam",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080110",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070920",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "TEMAZEPAM",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
      "Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. Its structural formula may be represented as follows. C16H13ClN2O2               M.W. = 300.74. Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol. Temazepam capsules, 15 mg, 22.5 mg and 30 mg, are for oral administration. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, powdered cellulose and sodium lauryl sulfate."
    },
    {
      "NDCCode": "54868-0039-3",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE (54868-0039-3)",
      "NDC11Code": "54868-0039-03",
      "ProductNDC": "54868-0039",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Temazepam",
      "NonProprietaryName": "Temazepam",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070920",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "TEMAZEPAM",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
      "Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. Its structural formula may be represented as follows. C16H13ClN2O2               M.W. = 300.74. Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol. Temazepam capsules, 15 mg, 22.5 mg and 30 mg, are for oral administration. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, powdered cellulose and sodium lauryl sulfate."
    },
    {
      "NDCCode": "54868-0043-3",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (54868-0043-3)",
      "NDC11Code": "54868-0043-03",
      "ProductNDC": "54868-0043",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dipyridamole",
      "NonProprietaryName": "Dipyridamole",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080905",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089000",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DIPYRIDAMOLE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-19"
    },
    {
      "NDCCode": "54868-0048-3",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (54868-0048-3)",
      "NDC11Code": "54868-0048-03",
      "ProductNDC": "54868-0048",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clonidine Hydrochloride",
      "NonProprietaryName": "Clonidine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20011003",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070925",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "CLONIDINE HYDROCHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Clonidine hydrochloride USP tablets are indicated in the treatment of hypertension. Clonidine hydrochloride USP tablets may be employed alone or concomitantly with other antihypertensive agents.",
      "Description": "Clonidine hydrochloride USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. Clonidine hydrochloride tablets contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. The 0.1 mg also contains D&C yellow #10 aluminum lake, and the 0.3 mg contains D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
    },
    {
      "NDCCode": "54868-0050-3",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-0050-3)",
      "NDC11Code": "54868-0050-03",
      "ProductNDC": "54868-0050",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methyldopa",
      "NonProprietaryName": "Methyldopa",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950829",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070098",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "METHYLDOPA",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Hypertension.",
      "Description": "Methyldopa USP is an antihypertensive drug. Methyldopa USP is the L-isomer of alpha-methyldopa. Its chemical name is levo-3-(3,4-dihydroxyphenyl)- 2-methylalanine sesquihydrate. Its structural formula is. C 10H13NO4  1 1/2 H2O M.W. 238.24. Methyldopa USP is a white to yellowish white, odorless fine powder and is sparingly soluble in water. Each tablet, for oral administration, contains 250 mg or 500 mg of methyldopa USP. Potency is calculated in the anhydrous basis. Inactive ingredients: citric acid, colloidal silicon dioxide, edetate disodium, ethylcellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. In addition, the 250 mg tablet contains calcium sulfate, hydroxypropyl cellulose, and talc, and the 500 mg tablet contains polysorbate 80."
    },
    {
      "NDCCode": "54868-0053-3",
      "PackageDescription": "100 TABLET in 1 BOTTLE (54868-0053-3)",
      "NDC11Code": "54868-0053-03",
      "ProductNDC": "54868-0053",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propranolol Hydrochloride",
      "NonProprietaryName": "Propranolol Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078955",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Propranolol hydrochloride tablets are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Propranolol hydrochloride tablets are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Propranolol hydrochloride tablets are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Propranolol hydrochloride tablets are indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol hydrochloride tablets, USP causes a reduction in the tremor amplitude but not in the tremor frequency. Propranolol hydrochloride tablets are not indicated for the treatment of tremor associated with Parkinsonism. Propranolol hydrochloride tablets improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Propranolol hydrochloride tablets are indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.",
      "Description": "hydrochloride(Propranolol is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets, USP are: lactose monohydrate, corn starch, sodium starch glycolate, magnesium stearate, and povidone. In addition, propranolol hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain FD &C yellow No.6 Aluminium Lake and Color D&C Yellow No. 10; propranolol hydrochloride tablets, USP 20 mg and 40mg contain FD&C Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D&C Red No. 30 Lake."
    },
    {
      "NDCCode": "54868-0056-3",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (54868-0056-3)",
      "NDC11Code": "54868-0056-03",
      "ProductNDC": "54868-0056",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrochlorothiazide",
      "NonProprietaryName": "Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19920922",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA083177",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Hydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide USP have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets USP are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
      "Description": "Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. C7H8ClN3O4S2 M.W. 297.74. Hydrochlorothiazide USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, FD&C Yellow No. 6 Lake, lactose monohydrate and magnesium stearate."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"54868-1380-3","ProprietaryName":"Dicloxacillin Sodium","NonProprietaryName":"Dicloxacillin Sodium"},{"NDCCode":"54868-1380-0","ProprietaryName":"Dicloxacillin Sodium","NonProprietaryName":"Dicloxacillin Sodium"},{"NDCCode":"54868-1380-1","ProprietaryName":"Dicloxacillin Sodium","NonProprietaryName":"Dicloxacillin Sodium"},{"NDCCode":"54868-1380-2","ProprietaryName":"Dicloxacillin Sodium","NonProprietaryName":"Dicloxacillin Sodium"},{"NDCCode":"36987-1380-3","ProprietaryName":"Watermelon","NonProprietaryName":"Watermelon"},{"NDCCode":"37662-1380-3","ProprietaryName":"Plumbum Metallicum","NonProprietaryName":"Plumbum Metallicum"},{"NDCCode":"67296-1380-3","ProprietaryName":"Propranolol Hydrochloride","NonProprietaryName":"Propranolol Hydrochloride"},{"NDCCode":"69238-1380-3","ProprietaryName":"Difluprednate","NonProprietaryName":"Difluprednate Ophthalmic"},{"NDCCode":"70710-1380-3","ProprietaryName":"Dapagliflozin","NonProprietaryName":"Dapagliflozin"},{"NDCCode":"71335-1380-3","ProprietaryName":"Lisinopril","NonProprietaryName":"Lisinopril"},{"NDCCode":"0440-1380-40","ProprietaryName":"Dicloxacillin Sodium","NonProprietaryName":"Dicloxacillin Sodium"},{"NDCCode":"0527-1380-01","ProprietaryName":"Unithroid","NonProprietaryName":"Levothyroxine Sodium"},{"NDCCode":"48951-1380-2","ProprietaryName":"Arnica Nettle","NonProprietaryName":"Arnica Nettle"},{"NDCCode":"50090-1380-0","ProprietaryName":"Orsythia","NonProprietaryName":"Levonorgestrel And Ethinyl Estradiol"},{"NDCCode":"51662-1380-1","ProprietaryName":"Dextrose","NonProprietaryName":"Dextrose"},{"NDCCode":"54868-0018-3","ProprietaryName":"Erythromycin Ethylsuccinate","NonProprietaryName":"Erythromycin Ethylsuccinate"},{"NDCCode":"54868-0021-3","ProprietaryName":"Sulfamethoxazole And Trimethoprim","NonProprietaryName":"Sulfamethoxazole And Trimethoprim"},{"NDCCode":"54868-0023-3","ProprietaryName":"Doxycycline Hyclate","NonProprietaryName":"Doxycycline Hyclate"},{"NDCCode":"54868-0024-3","ProprietaryName":"Tetracycline Hydrochloride","NonProprietaryName":"Tetracycline Hydrochloride"},{"NDCCode":"54868-0025-3","ProprietaryName":"Tetracycline Hydrochloride","NonProprietaryName":"Tetracycline Hydrochloride"},{"NDCCode":"54868-0032-3","ProprietaryName":"Diphenoxylate Hydrochloride And Atropine Sulfate","NonProprietaryName":"Diphenoxylate Hydrochloride And Atropine Sulfate"},{"NDCCode":"54868-0033-3","ProprietaryName":"Dicyclomine Hydrochloride","NonProprietaryName":"Dicyclomine Hydrochloride"},{"NDCCode":"54868-0034-3","ProprietaryName":"Metoclopramide","NonProprietaryName":"Metoclopramide"},{"NDCCode":"54868-0038-3","ProprietaryName":"Temazepam","NonProprietaryName":"Temazepam"},{"NDCCode":"54868-0039-3","ProprietaryName":"Temazepam","NonProprietaryName":"Temazepam"},{"NDCCode":"54868-0043-3","ProprietaryName":"Dipyridamole","NonProprietaryName":"Dipyridamole"},{"NDCCode":"54868-0048-3","ProprietaryName":"Clonidine Hydrochloride","NonProprietaryName":"Clonidine Hydrochloride"},{"NDCCode":"54868-0050-3","ProprietaryName":"Methyldopa","NonProprietaryName":"Methyldopa"},{"NDCCode":"54868-0053-3","ProprietaryName":"Propranolol Hydrochloride","NonProprietaryName":"Propranolol Hydrochloride"},{"NDCCode":"54868-0056-3","ProprietaryName":"Hydrochlorothiazide","NonProprietaryName":"Hydrochlorothiazide"}]}
                    

<NDCList><NDC><NDCCode>54868-1380-3</NDCCode><ProprietaryName>Dicloxacillin Sodium</ProprietaryName><NonProprietaryName>Dicloxacillin Sodium</NonProprietaryName></NDC><NDC><NDCCode>54868-1380-0</NDCCode><ProprietaryName>Dicloxacillin Sodium</ProprietaryName><NonProprietaryName>Dicloxacillin Sodium</NonProprietaryName></NDC><NDC><NDCCode>54868-1380-1</NDCCode><ProprietaryName>Dicloxacillin Sodium</ProprietaryName><NonProprietaryName>Dicloxacillin Sodium</NonProprietaryName></NDC><NDC><NDCCode>54868-1380-2</NDCCode><ProprietaryName>Dicloxacillin Sodium</ProprietaryName><NonProprietaryName>Dicloxacillin Sodium</NonProprietaryName></NDC><NDC><NDCCode>36987-1380-3</NDCCode><ProprietaryName>Watermelon</ProprietaryName><NonProprietaryName>Watermelon</NonProprietaryName></NDC><NDC><NDCCode>37662-1380-3</NDCCode><ProprietaryName>Plumbum Metallicum</ProprietaryName><NonProprietaryName>Plumbum Metallicum</NonProprietaryName></NDC><NDC><NDCCode>67296-1380-3</NDCCode><ProprietaryName>Propranolol Hydrochloride</ProprietaryName><NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>69238-1380-3</NDCCode><ProprietaryName>Difluprednate</ProprietaryName><NonProprietaryName>Difluprednate Ophthalmic</NonProprietaryName></NDC><NDC><NDCCode>70710-1380-3</NDCCode><ProprietaryName>Dapagliflozin</ProprietaryName><NonProprietaryName>Dapagliflozin</NonProprietaryName></NDC><NDC><NDCCode>71335-1380-3</NDCCode><ProprietaryName>Lisinopril</ProprietaryName><NonProprietaryName>Lisinopril</NonProprietaryName></NDC><NDC><NDCCode>0440-1380-40</NDCCode><ProprietaryName>Dicloxacillin Sodium</ProprietaryName><NonProprietaryName>Dicloxacillin Sodium</NonProprietaryName></NDC><NDC><NDCCode>0527-1380-01</NDCCode><ProprietaryName>Unithroid</ProprietaryName><NonProprietaryName>Levothyroxine Sodium</NonProprietaryName></NDC><NDC><NDCCode>48951-1380-2</NDCCode><ProprietaryName>Arnica Nettle</ProprietaryName><NonProprietaryName>Arnica Nettle</NonProprietaryName></NDC><NDC><NDCCode>50090-1380-0</NDCCode><ProprietaryName>Orsythia</ProprietaryName><NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>51662-1380-1</NDCCode><ProprietaryName>Dextrose</ProprietaryName><NonProprietaryName>Dextrose</NonProprietaryName></NDC><NDC><NDCCode>54868-0018-3</NDCCode><ProprietaryName>Erythromycin Ethylsuccinate</ProprietaryName><NonProprietaryName>Erythromycin Ethylsuccinate</NonProprietaryName></NDC><NDC><NDCCode>54868-0021-3</NDCCode><ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName><NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName></NDC><NDC><NDCCode>54868-0023-3</NDCCode><ProprietaryName>Doxycycline Hyclate</ProprietaryName><NonProprietaryName>Doxycycline Hyclate</NonProprietaryName></NDC><NDC><NDCCode>54868-0024-3</NDCCode><ProprietaryName>Tetracycline Hydrochloride</ProprietaryName><NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-0025-3</NDCCode><ProprietaryName>Tetracycline Hydrochloride</ProprietaryName><NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-0032-3</NDCCode><ProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</ProprietaryName><NonProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>54868-0033-3</NDCCode><ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName><NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-0034-3</NDCCode><ProprietaryName>Metoclopramide</ProprietaryName><NonProprietaryName>Metoclopramide</NonProprietaryName></NDC><NDC><NDCCode>54868-0038-3</NDCCode><ProprietaryName>Temazepam</ProprietaryName><NonProprietaryName>Temazepam</NonProprietaryName></NDC><NDC><NDCCode>54868-0039-3</NDCCode><ProprietaryName>Temazepam</ProprietaryName><NonProprietaryName>Temazepam</NonProprietaryName></NDC><NDC><NDCCode>54868-0043-3</NDCCode><ProprietaryName>Dipyridamole</ProprietaryName><NonProprietaryName>Dipyridamole</NonProprietaryName></NDC><NDC><NDCCode>54868-0048-3</NDCCode><ProprietaryName>Clonidine Hydrochloride</ProprietaryName><NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-0050-3</NDCCode><ProprietaryName>Methyldopa</ProprietaryName><NonProprietaryName>Methyldopa</NonProprietaryName></NDC><NDC><NDCCode>54868-0053-3</NDCCode><ProprietaryName>Propranolol Hydrochloride</ProprietaryName><NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-0056-3</NDCCode><ProprietaryName>Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Hydrochlorothiazide</NonProprietaryName></NDC></NDCList>