RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "76519-1033-8",
      "PackageDescription": "28 TABLET in 1 BOTTLE (76519-1033-8) ",
      "NDC11Code": "76519-1033-08",
      "ProductNDC": "76519-1033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Losartan Potassium",
      "NonProprietaryName": "Losartan Potassium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203835",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "LOSARTAN POTASSIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20160114",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.1 Hypertension. Losartan potassium tablets, USP are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Losartan Potassium tablets may be administered with other antihypertensive agents. 1.2 Hypertensive Patients with Left Ventricular Hypertrophy. Losartan Potassium tablets, USP are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. 1.3 Nephropathy in Type 2 Diabetic Patients. Losartan Potassium tablets, USP are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium tablets, USP reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.3)].",
      "Description": "Losartan potassium, USP is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan.  Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide.  Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.  The botanical source for pregelatinized starch is corn starch."
    },
    {
      "NDCCode": "58118-1033-8",
      "PackageDescription": "30 CAPSULE in 1 BLISTER PACK (58118-1033-8) ",
      "NDC11Code": "58118-1033-08",
      "ProductNDC": "58118-1033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Chlordiazepoxide Hydrochloride",
      "NonProprietaryName": "Chlordiazepoxide Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190219",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA083116",
      "LabelerName": "Clinical Solutions Wholesale, LLC",
      "SubstanceName": "CHLORDIAZEPOXIDE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
      "DEASchedule": "CIV",
      "Status": "Active",
      "LastUpdate": "2024-01-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190219",
      "SamplePackage": "N",
      "IndicationAndUsage": "Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide HCl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
      "Description": "Chlordiazepoxide hydrochloride is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochloride is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence. Chlordiazepoxide hydrochloride is 7-chloro-2- (methylamino)-5-phenyl-3 H-1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The structural formula is:. C 16H 14ClN 3O  HCl M.W. 336.22. Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride, USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no. 10, FD&C blue no. 1, FD&C blue no. 1 aluminum lake, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, and titanium dioxide. The 5 mg and 25 mg also contain D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol, and synthetic black iron oxide. In addition, the 5 mg contains D&C red no. 33 and the 10 mg also contains butyl paraben, edetate calcium disodium, dimethyl polysiloxane, ethylene glycol monoethyl ether, FD&C red no. 40, methyl paraben, propyl paraben, sodium, sodium lauryl sulfate, sodium propionate, and soya lecithin."
    },
    {
      "NDCCode": "70710-1033-8",
      "PackageDescription": "21 CAPSULE in 1 BOTTLE (70710-1033-8) ",
      "NDC11Code": "70710-1033-08",
      "ProductNDC": "70710-1033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lenalidomide",
      "NonProprietaryName": "Lenalidomide",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220912",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210154",
      "LabelerName": "Zydus Pharmaceuticals USA Inc.",
      "SubstanceName": "LENALIDOMIDE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Thalidomide Analog [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-02-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220912",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2).",
      "Description": "Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The molecular formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is white to off-white to pale-yellow solid powder. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide capsule is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: croscarmellose sodium, gelatin, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose and titanium dioxide. Each 2.5 mg capsule shell contains: FD& C Blue # 1, FD& C Red#40 and FD&C Yellow # 6. Each 10 mg capsule shell contains: D&C Red # 33, D&C Yellow# 10 and FD & C Blue # 1. Each 15 mg capsule shell contains: D&C Red # 28 and FD & C Blue # 1. Each 20 mg capsule shell contains: D&C Red # 28, D&C Red # 33, D&C Yellow # 10 and FD & C Blue # 1. Each 25 mg capsule shell contains: D&C Red # 28 and FD & C Blue # 1. Each capsule is imprinted with black pharmaceutical ink which contains following inactive ingredients: black iron oxide, potassium hydroxide and shellac."
    },
    {
      "NDCCode": "76519-1011-8",
      "PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (76519-1011-8) ",
      "NDC11Code": "76519-1011-08",
      "ProductNDC": "76519-1011",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartate And Acetaminophen",
      "NonProprietaryName": "Hydrocodone Bitartrate, Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120517",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040846",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
      "StrengthNumber": "2.5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "StartMarketingDatePackage": "20120517",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of moderate to moderately severe pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [seeWARNINGS], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]. Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula. Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available in a variety of strengths as described in the following table. Hydrocodone Strength Bitartrate Acetaminophen. 2.5 mg/325 mg 2.5 mg 325 mg 5 mg/325 mg 5 mg 325 mg. 7.5 mg/325 mg 7.5 mg 325 mg. 10 mg/325 mg 10 mg 325 mg. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium and magnesium stearate. Meets USP Dissolution Test 1."
    },
    {
      "NDCCode": "76519-1171-0",
      "PackageDescription": "8.5 g in 1 INHALER (76519-1171-0) ",
      "NDC11Code": "76519-1171-00",
      "ProductNDC": "76519-1171",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Albuterol Sulfate",
      "ProprietaryNameSuffix": "Hfa",
      "NonProprietaryName": "Albuterol Sulfate",
      "DosageFormName": "AEROSOL, METERED",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20190325",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021457",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "ALBUTEROL SULFATE",
      "StrengthNumber": "90",
      "StrengthUnit": "ug/g",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20190325",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.1 Bronchospasm. Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm. Albuterol Sulfate HFA Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.",
      "Description": "The active ingredient of Albuterol Sulfate HFA Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name α1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and has the following chemical structure. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C13H21NO3)2H2SO4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official generic name in the United States, and salbutamol sulfate is the World Health Organization recommended generic name. Albuterol Sulfate HFA Inhalation Aerosol is a pressurized metered-dose aerosol unit with a dose counter. Albuterol Sulfate HFA is for oral inhalation only. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1, 1, 1, 2-tetrafluoroethane) and ethanol. Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face. After priming, each actuation delivers 108 mcg albuterol sulfate, from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Each canister provides 200 actuations (inhalations). This product does not contain chlorofluorocarbons (CFCs) as the propellant."
    },
    {
      "NDCCode": "76519-1033-1",
      "PackageDescription": "118 TABLET in 1 BOTTLE (76519-1033-1) ",
      "NDC11Code": "76519-1033-01",
      "ProductNDC": "76519-1033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Losartan Potassium",
      "NonProprietaryName": "Losartan Potassium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203835",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "LOSARTAN POTASSIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20160114",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.1 Hypertension. Losartan potassium tablets, USP are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Losartan Potassium tablets may be administered with other antihypertensive agents. 1.2 Hypertensive Patients with Left Ventricular Hypertrophy. Losartan Potassium tablets, USP are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. 1.3 Nephropathy in Type 2 Diabetic Patients. Losartan Potassium tablets, USP are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium tablets, USP reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.3)].",
      "Description": "Losartan potassium, USP is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan.  Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide.  Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.  The botanical source for pregelatinized starch is corn starch."
    },
    {
      "NDCCode": "76519-1033-2",
      "PackageDescription": "29 TABLET in 1 BOTTLE (76519-1033-2) ",
      "NDC11Code": "76519-1033-02",
      "ProductNDC": "76519-1033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Losartan Potassium",
      "NonProprietaryName": "Losartan Potassium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203835",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "LOSARTAN POTASSIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20160114",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.1 Hypertension. Losartan potassium tablets, USP are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Losartan Potassium tablets may be administered with other antihypertensive agents. 1.2 Hypertensive Patients with Left Ventricular Hypertrophy. Losartan Potassium tablets, USP are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. 1.3 Nephropathy in Type 2 Diabetic Patients. Losartan Potassium tablets, USP are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium tablets, USP reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.3)].",
      "Description": "Losartan potassium, USP is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan.  Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide.  Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.  The botanical source for pregelatinized starch is corn starch."
    },
    {
      "NDCCode": "76519-1033-3",
      "PackageDescription": "30 TABLET in 1 BOTTLE (76519-1033-3) ",
      "NDC11Code": "76519-1033-03",
      "ProductNDC": "76519-1033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Losartan Potassium",
      "NonProprietaryName": "Losartan Potassium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203835",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "LOSARTAN POTASSIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20160114",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.1 Hypertension. Losartan potassium tablets, USP are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Losartan Potassium tablets may be administered with other antihypertensive agents. 1.2 Hypertensive Patients with Left Ventricular Hypertrophy. Losartan Potassium tablets, USP are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. 1.3 Nephropathy in Type 2 Diabetic Patients. Losartan Potassium tablets, USP are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium tablets, USP reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.3)].",
      "Description": "Losartan potassium, USP is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan.  Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide.  Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.  The botanical source for pregelatinized starch is corn starch."
    },
    {
      "NDCCode": "76519-1033-9",
      "PackageDescription": "90 TABLET in 1 BOTTLE (76519-1033-9) ",
      "NDC11Code": "76519-1033-09",
      "ProductNDC": "76519-1033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Losartan Potassium",
      "NonProprietaryName": "Losartan Potassium",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160114",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203835",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "LOSARTAN POTASSIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20160114",
      "SamplePackage": "N",
      "IndicationAndUsage": "1.1 Hypertension. Losartan potassium tablets, USP are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Losartan Potassium tablets may be administered with other antihypertensive agents. 1.2 Hypertensive Patients with Left Ventricular Hypertrophy. Losartan Potassium tablets, USP are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. 1.3 Nephropathy in Type 2 Diabetic Patients. Losartan Potassium tablets, USP are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium tablets, USP reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.3)].",
      "Description": "Losartan potassium, USP is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan.  Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide.  Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.  The botanical source for pregelatinized starch is corn starch."
    },
    {
      "NDCCode": "43742-1033-1",
      "PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-1033-1) ",
      "NDC11Code": "43742-1033-01",
      "ProductNDC": "43742-1033",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kidney/bladder Support",
      "NonProprietaryName": "Equisetum Hyemale, Solidago Virgaurea, Cantharis, Kidney (suis), Berberis Vulgaris, Calcarea Carbonica, Terebinthina, Apis Mellifica, Pulsatilla (vulgaris), Sepia, Staphysagria",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170620",
      "EndMarketingDate": "20230815",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Deseret Biologicals, Inc.",
      "SubstanceName": "APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; DELPHINIUM STAPHISAGRIA SEED; EQUISETUM HYEMALE; LYTTA VESICATORIA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK KIDNEY; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP; TURPENTINE OIL",
      "StrengthNumber": "30; 12; 30; 3; 6; 12; 8; 30; 30; 3; 12",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-08-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170620",
      "EndMarketingDatePackage": "20230815",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50090-1033-0",
      "PackageDescription": "10 CAPSULE in 1 BOTTLE (50090-1033-0) ",
      "NDC11Code": "50090-1033-00",
      "ProductNDC": "50090-1033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cefdinir",
      "NonProprietaryName": "Cefdinir",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060530",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065264",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "CEFDINIR",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-04-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191009",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir 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. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
      "Description": "Cefdinir capsules contains the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α,7β(Z)]]-7-[[(2-amino-4 thiazolyl) (hydroxyimino) acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The molecular formula is C14H13N5O5S2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below:. Cefdinir capsules contain 300 mg of cefdinir and the following inactive ingredients: carboxymethylcellulose calcium; colloidal silicon dioxide; and magnesium stearate. The capsule shells contain D&C Red #28; FD&C Blue #1; FD&C Red #40; gelatin and titanium dioxide."
    },
    {
      "NDCCode": "50090-1033-1",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE (50090-1033-1) ",
      "NDC11Code": "50090-1033-01",
      "ProductNDC": "50090-1033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cefdinir",
      "NonProprietaryName": "Cefdinir",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060530",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065264",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "CEFDINIR",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-04-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20141128",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir 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. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
      "Description": "Cefdinir capsules contains the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α,7β(Z)]]-7-[[(2-amino-4 thiazolyl) (hydroxyimino) acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The molecular formula is C14H13N5O5S2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below:. Cefdinir capsules contain 300 mg of cefdinir and the following inactive ingredients: carboxymethylcellulose calcium; colloidal silicon dioxide; and magnesium stearate. The capsule shells contain D&C Red #28; FD&C Blue #1; FD&C Red #40; gelatin and titanium dioxide."
    },
    {
      "NDCCode": "50090-1033-2",
      "PackageDescription": "14 CAPSULE in 1 BOTTLE (50090-1033-2) ",
      "NDC11Code": "50090-1033-02",
      "ProductNDC": "50090-1033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cefdinir",
      "NonProprietaryName": "Cefdinir",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060530",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065264",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "CEFDINIR",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Active",
      "LastUpdate": "2025-04-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191009",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir 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. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
      "Description": "Cefdinir capsules contains the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α,7β(Z)]]-7-[[(2-amino-4 thiazolyl) (hydroxyimino) acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The molecular formula is C14H13N5O5S2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below:. Cefdinir capsules contain 300 mg of cefdinir and the following inactive ingredients: carboxymethylcellulose calcium; colloidal silicon dioxide; and magnesium stearate. The capsule shells contain D&C Red #28; FD&C Blue #1; FD&C Red #40; gelatin and titanium dioxide."
    },
    {
      "NDCCode": "50090-1033-3",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (50090-1033-3) ",
      "NDC11Code": "50090-1033-03",
      "ProductNDC": "50090-1033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cefdinir",
      "NonProprietaryName": "Cefdinir",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20060530",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065264",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "CEFDINIR",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20191009",
      "SamplePackage": "N",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir 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. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.",
      "Description": "Cefdinir capsules contains the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α,7β(Z)]]-7-[[(2-amino-4 thiazolyl) (hydroxyimino) acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The molecular formula is C14H13N5O5S2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below:. Cefdinir capsules contain 300 mg of cefdinir and the following inactive ingredients: carboxymethylcellulose calcium; colloidal silicon dioxide; and magnesium stearate. The capsule shells contain D&C Red #28; FD&C Blue #1; FD&C Red #40; gelatin and titanium dioxide."
    },
    {
      "NDCCode": "60986-1033-7",
      "PackageDescription": "236 mL in 1 BOTTLE, GLASS (60986-1033-7) ",
      "NDC11Code": "60986-1033-07",
      "ProductNDC": "60986-1033",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Female Tonic",
      "NonProprietaryName": "Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Cimicifuga Racemosa, Convallaria Majalis, Crocus Sativus, Cyclamen Europaeum, Damiana, Hydrastis Canadensis, Caulophyllum Thalictroides, Lilium Tigrinum, Senecio Aureus, Staphysagria, Naja Tripudians",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "19920301",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Marco Pharma International LLC.",
      "SubstanceName": "ALCHEMILLA XANTHOCHLORA FLOWERING TOP; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; CYCLAMEN PURPURASCENS TUBER; DELPHINIUM STAPHISAGRIA SEED; GALIUM ODORATUM; GOLDENSEAL; LILIUM LANCIFOLIUM FLOWERING TOP; MATRICARIA RECUTITA; MENTHA PIPERITA; NAJA NAJA VENOM; PACKERA AUREA; ROSMARINUS OFFICINALIS FLOWERING TOP; SAFFRON; TURNERA DIFFUSA LEAFY TWIG; VALERIAN; VIOLA ODORATA",
      "StrengthNumber": "1; 3; 4; 2; 3; 2; 3; 3; 4; 1; 3; 4; 1; 1; 8; 4; 1; 3; 3; 1; 1",
      "StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20180228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Adults take 1 tablespoon two to three times daily. Children 12 to 18 years of age take 1 teaspoon two to three times daily. Not intended for children under 12 years of age."
    },
    {
      "NDCCode": "62795-1033-2",
      "PackageDescription": "1 BOTTLE in 1 CARTON (62795-1033-2)  / 100 TABLET in 1 BOTTLE",
      "NDC11Code": "62795-1033-02",
      "ProductNDC": "62795-1033",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "T Relief Arthritis",
      "NonProprietaryName": "Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160301",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "MediNatura Inc",
      "SubstanceName": "ARNICA MONTANA; BRYONIA ALBA ROOT; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF",
      "StrengthNumber": "3; 3; 7; 6; 8; 3; 2; 6; 4; 6; 6; 6; 4",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20160301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Relieves: 1 Arthritis pain, 2 Joint pain, 3 Joint stiffness."
    },
    {
      "NDCCode": "62795-1033-4",
      "PackageDescription": "100 TABLET in 1 BOTTLE (62795-1033-4) ",
      "NDC11Code": "62795-1033-04",
      "ProductNDC": "62795-1033",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "T Relief Arthritis",
      "NonProprietaryName": "Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160301",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "MediNatura Inc",
      "SubstanceName": "ARNICA MONTANA; BRYONIA ALBA ROOT; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF",
      "StrengthNumber": "3; 3; 7; 6; 8; 3; 2; 6; 4; 6; 6; 6; 4",
      "StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20221116",
      "SamplePackage": "N",
      "IndicationAndUsage": "Relieves: 1 Arthritis pain, 2 Joint pain, 3 Joint stiffness."
    },
    {
      "NDCCode": "63629-1033-1",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (63629-1033-1) ",
      "NDC11Code": "63629-1033-01",
      "ProductNDC": "63629-1033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenobarbital",
      "NonProprietaryName": "Phenobarbital",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20141124",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "PHENOBARBITAL",
      "StrengthNumber": "16.2",
      "StrengthUnit": "mg/1",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2026-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20141124",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
      "Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. Each phenobarbital tablet contains 16.2 mg (1/4 grain), 32.4 mg (1/2 grain), 64.8 mg (1 grain) or 97.2 mg (11/2 grain) of phenobarbital. In addition each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
    },
    {
      "NDCCode": "68745-1033-1",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (68745-1033-1)  > 30 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "68745-1033-01",
      "ProductNDC": "68745-1033",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mat Lumiere",
      "ProprietaryNameSuffix": "Long-lasting Soft Matte Sunscreen Makeup Broad Spectrum Spf 15, 41 Soft Bisque",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120701",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CHANEL PARFUMS BEAUTE",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "1.8",
      "StrengthUnit": "mL/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-05-05"
    },
    {
      "NDCCode": "68745-1033-2",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (68745-1033-2)  > 20 mL in 1 BOTTLE, PUMP",
      "NDC11Code": "68745-1033-02",
      "ProductNDC": "68745-1033",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mat Lumiere",
      "ProprietaryNameSuffix": "Long-lasting Soft Matte Sunscreen Makeup Broad Spectrum Spf 15, 41 Soft Bisque",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "EMULSION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120701",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "CHANEL PARFUMS BEAUTE",
      "SubstanceName": "TITANIUM DIOXIDE",
      "StrengthNumber": "1.8",
      "StrengthUnit": "mL/30mL",
      "Status": "Deprecated",
      "LastUpdate": "2014-05-05"
    },
    {
      "NDCCode": "76519-1000-1",
      "PackageDescription": "10 TABLET in 1 BOTTLE (76519-1000-1)",
      "NDC11Code": "76519-1000-01",
      "ProductNDC": "76519-1000",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hyrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110829",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078722",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP are should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pKa of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d ] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinised starch, talc and titanium dioxide."
    },
    {
      "NDCCode": "76519-1000-2",
      "PackageDescription": "20 TABLET in 1 BOTTLE (76519-1000-2)",
      "NDC11Code": "76519-1000-02",
      "ProductNDC": "76519-1000",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hyrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110829",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078722",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP are should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pKa of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d ] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinised starch, talc and titanium dioxide."
    },
    {
      "NDCCode": "76519-1000-3",
      "PackageDescription": "30 TABLET in 1 BOTTLE (76519-1000-3)",
      "NDC11Code": "76519-1000-03",
      "ProductNDC": "76519-1000",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hyrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110829",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078722",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP are should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pKa of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d ] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinised starch, talc and titanium dioxide."
    },
    {
      "NDCCode": "76519-1000-5",
      "PackageDescription": "15 TABLET in 1 BOTTLE (76519-1000-5)",
      "NDC11Code": "76519-1000-05",
      "ProductNDC": "76519-1000",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hyrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110829",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078722",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP are should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pKa of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d ] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinised starch, talc and titanium dioxide."
    },
    {
      "NDCCode": "76519-1000-6",
      "PackageDescription": "60 TABLET in 1 BOTTLE (76519-1000-6)",
      "NDC11Code": "76519-1000-06",
      "ProductNDC": "76519-1000",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hyrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110829",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078722",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP are should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pKa of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d ] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinised starch, talc and titanium dioxide."
    },
    {
      "NDCCode": "76519-1000-7",
      "PackageDescription": "120 TABLET in 1 BOTTLE (76519-1000-7)",
      "NDC11Code": "76519-1000-07",
      "ProductNDC": "76519-1000",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hyrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110829",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078722",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP are should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pKa of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d ] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinised starch, talc and titanium dioxide."
    },
    {
      "NDCCode": "76519-1000-9",
      "PackageDescription": "90 TABLET in 1 BOTTLE (76519-1000-9)",
      "NDC11Code": "76519-1000-09",
      "ProductNDC": "76519-1000",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hyrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110829",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078722",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "7.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP are should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
      "Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pKa of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d ] cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinised starch, talc and titanium dioxide."
    },
    {
      "NDCCode": "76519-1001-1",
      "PackageDescription": "1 TABLET, FILM COATED in 1 BOTTLE (76519-1001-1)",
      "NDC11Code": "76519-1001-01",
      "ProductNDC": "76519-1001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111122",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076361",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin 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. Levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Clinical Pharmacology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.",
      "Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. C18H20FN3O4½ H2O M.W. 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3 > Cu+2 > Zn+2 > Mg+2 > Ca+2. Excipients and Description of Dosage Form. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 2 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide."
    },
    {
      "NDCCode": "76519-1001-2",
      "PackageDescription": "2 TABLET, FILM COATED in 1 BOTTLE (76519-1001-2)",
      "NDC11Code": "76519-1001-02",
      "ProductNDC": "76519-1001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111122",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076361",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin 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. Levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Clinical Pharmacology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.",
      "Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. C18H20FN3O4½ H2O M.W. 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3 > Cu+2 > Zn+2 > Mg+2 > Ca+2. Excipients and Description of Dosage Form. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 2 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide."
    },
    {
      "NDCCode": "76519-1001-3",
      "PackageDescription": "3 TABLET, FILM COATED in 1 BOTTLE (76519-1001-3)",
      "NDC11Code": "76519-1001-03",
      "ProductNDC": "76519-1001",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levofloxacin",
      "NonProprietaryName": "Levofloxacin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20111122",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076361",
      "LabelerName": "H.J. Harkins Company, Inc.",
      "SubstanceName": "LEVOFLOXACIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin 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. Levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Clinical Pharmacology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.",
      "Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. C18H20FN3O4½ H2O M.W. 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3 > Cu+2 > Zn+2 > Mg+2 > Ca+2. Excipients and Description of Dosage Form. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 2 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"76519-1033-8","ProprietaryName":"Losartan Potassium","NonProprietaryName":"Losartan Potassium"},{"NDCCode":"58118-1033-8","ProprietaryName":"Chlordiazepoxide Hydrochloride","NonProprietaryName":"Chlordiazepoxide Hydrochloride"},{"NDCCode":"70710-1033-8","ProprietaryName":"Lenalidomide","NonProprietaryName":"Lenalidomide"},{"NDCCode":"76519-1011-8","ProprietaryName":"Hydrocodone Bitartate And Acetaminophen","NonProprietaryName":"Hydrocodone Bitartrate, Acetaminophen"},{"NDCCode":"76519-1171-0","ProprietaryName":"Albuterol Sulfate","NonProprietaryName":"Albuterol Sulfate"},{"NDCCode":"76519-1033-1","ProprietaryName":"Losartan Potassium","NonProprietaryName":"Losartan Potassium"},{"NDCCode":"76519-1033-2","ProprietaryName":"Losartan Potassium","NonProprietaryName":"Losartan Potassium"},{"NDCCode":"76519-1033-3","ProprietaryName":"Losartan Potassium","NonProprietaryName":"Losartan Potassium"},{"NDCCode":"76519-1033-9","ProprietaryName":"Losartan Potassium","NonProprietaryName":"Losartan Potassium"},{"NDCCode":"43742-1033-1","ProprietaryName":"Kidney/bladder Support","NonProprietaryName":"Equisetum Hyemale, Solidago Virgaurea, Cantharis, Kidney (suis), Berberis Vulgaris, Calcarea Carbonica, Terebinthina, Apis Mellifica, Pulsatilla (vulgaris), Sepia, Staphysagria"},{"NDCCode":"50090-1033-0","ProprietaryName":"Cefdinir","NonProprietaryName":"Cefdinir"},{"NDCCode":"50090-1033-1","ProprietaryName":"Cefdinir","NonProprietaryName":"Cefdinir"},{"NDCCode":"50090-1033-2","ProprietaryName":"Cefdinir","NonProprietaryName":"Cefdinir"},{"NDCCode":"50090-1033-3","ProprietaryName":"Cefdinir","NonProprietaryName":"Cefdinir"},{"NDCCode":"60986-1033-7","ProprietaryName":"Female Tonic","NonProprietaryName":"Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Cimicifuga Racemosa, Convallaria Majalis, Crocus Sativus, Cyclamen Europaeum, Damiana, Hydrastis Canadensis, Caulophyllum Thalictroides, Lilium Tigrinum, Senecio Aureus, Staphysagria, Naja Tripudians"},{"NDCCode":"62795-1033-2","ProprietaryName":"T Relief Arthritis","NonProprietaryName":"Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root"},{"NDCCode":"62795-1033-4","ProprietaryName":"T Relief Arthritis","NonProprietaryName":"Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root"},{"NDCCode":"63629-1033-1","ProprietaryName":"Phenobarbital","NonProprietaryName":"Phenobarbital"},{"NDCCode":"68745-1033-1","ProprietaryName":"Mat Lumiere","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"68745-1033-2","ProprietaryName":"Mat Lumiere","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"76519-1000-1","ProprietaryName":"Cyclobenzaprine Hyrochloride","NonProprietaryName":"Cyclobenzaprine Hydrochloride"},{"NDCCode":"76519-1000-2","ProprietaryName":"Cyclobenzaprine Hyrochloride","NonProprietaryName":"Cyclobenzaprine Hydrochloride"},{"NDCCode":"76519-1000-3","ProprietaryName":"Cyclobenzaprine Hyrochloride","NonProprietaryName":"Cyclobenzaprine Hydrochloride"},{"NDCCode":"76519-1000-5","ProprietaryName":"Cyclobenzaprine Hyrochloride","NonProprietaryName":"Cyclobenzaprine Hydrochloride"},{"NDCCode":"76519-1000-6","ProprietaryName":"Cyclobenzaprine Hyrochloride","NonProprietaryName":"Cyclobenzaprine Hydrochloride"},{"NDCCode":"76519-1000-7","ProprietaryName":"Cyclobenzaprine Hyrochloride","NonProprietaryName":"Cyclobenzaprine Hydrochloride"},{"NDCCode":"76519-1000-9","ProprietaryName":"Cyclobenzaprine Hyrochloride","NonProprietaryName":"Cyclobenzaprine Hydrochloride"},{"NDCCode":"76519-1001-1","ProprietaryName":"Levofloxacin","NonProprietaryName":"Levofloxacin"},{"NDCCode":"76519-1001-2","ProprietaryName":"Levofloxacin","NonProprietaryName":"Levofloxacin"},{"NDCCode":"76519-1001-3","ProprietaryName":"Levofloxacin","NonProprietaryName":"Levofloxacin"}]}
                    

<NDCList><NDC><NDCCode>76519-1033-8</NDCCode><ProprietaryName>Losartan Potassium</ProprietaryName><NonProprietaryName>Losartan Potassium</NonProprietaryName></NDC><NDC><NDCCode>58118-1033-8</NDCCode><ProprietaryName>Chlordiazepoxide Hydrochloride</ProprietaryName><NonProprietaryName>Chlordiazepoxide Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70710-1033-8</NDCCode><ProprietaryName>Lenalidomide</ProprietaryName><NonProprietaryName>Lenalidomide</NonProprietaryName></NDC><NDC><NDCCode>76519-1011-8</NDCCode><ProprietaryName>Hydrocodone Bitartate And Acetaminophen</ProprietaryName><NonProprietaryName>Hydrocodone Bitartrate, Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>76519-1171-0</NDCCode><ProprietaryName>Albuterol Sulfate</ProprietaryName><NonProprietaryName>Albuterol Sulfate</NonProprietaryName></NDC><NDC><NDCCode>76519-1033-1</NDCCode><ProprietaryName>Losartan Potassium</ProprietaryName><NonProprietaryName>Losartan Potassium</NonProprietaryName></NDC><NDC><NDCCode>76519-1033-2</NDCCode><ProprietaryName>Losartan Potassium</ProprietaryName><NonProprietaryName>Losartan Potassium</NonProprietaryName></NDC><NDC><NDCCode>76519-1033-3</NDCCode><ProprietaryName>Losartan Potassium</ProprietaryName><NonProprietaryName>Losartan Potassium</NonProprietaryName></NDC><NDC><NDCCode>76519-1033-9</NDCCode><ProprietaryName>Losartan Potassium</ProprietaryName><NonProprietaryName>Losartan Potassium</NonProprietaryName></NDC><NDC><NDCCode>43742-1033-1</NDCCode><ProprietaryName>Kidney/bladder Support</ProprietaryName><NonProprietaryName>Equisetum Hyemale, Solidago Virgaurea, Cantharis, Kidney (suis), Berberis Vulgaris, Calcarea Carbonica, Terebinthina, Apis Mellifica, Pulsatilla (vulgaris), Sepia, Staphysagria</NonProprietaryName></NDC><NDC><NDCCode>50090-1033-0</NDCCode><ProprietaryName>Cefdinir</ProprietaryName><NonProprietaryName>Cefdinir</NonProprietaryName></NDC><NDC><NDCCode>50090-1033-1</NDCCode><ProprietaryName>Cefdinir</ProprietaryName><NonProprietaryName>Cefdinir</NonProprietaryName></NDC><NDC><NDCCode>50090-1033-2</NDCCode><ProprietaryName>Cefdinir</ProprietaryName><NonProprietaryName>Cefdinir</NonProprietaryName></NDC><NDC><NDCCode>50090-1033-3</NDCCode><ProprietaryName>Cefdinir</ProprietaryName><NonProprietaryName>Cefdinir</NonProprietaryName></NDC><NDC><NDCCode>60986-1033-7</NDCCode><ProprietaryName>Female Tonic</ProprietaryName><NonProprietaryName>Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Cimicifuga Racemosa, Convallaria Majalis, Crocus Sativus, Cyclamen Europaeum, Damiana, Hydrastis Canadensis, Caulophyllum Thalictroides, Lilium Tigrinum, Senecio Aureus, Staphysagria, Naja Tripudians</NonProprietaryName></NDC><NDC><NDCCode>62795-1033-2</NDCCode><ProprietaryName>T Relief Arthritis</ProprietaryName><NonProprietaryName>Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root</NonProprietaryName></NDC><NDC><NDCCode>62795-1033-4</NDCCode><ProprietaryName>T Relief Arthritis</ProprietaryName><NonProprietaryName>Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root</NonProprietaryName></NDC><NDC><NDCCode>63629-1033-1</NDCCode><ProprietaryName>Phenobarbital</ProprietaryName><NonProprietaryName>Phenobarbital</NonProprietaryName></NDC><NDC><NDCCode>68745-1033-1</NDCCode><ProprietaryName>Mat Lumiere</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>68745-1033-2</NDCCode><ProprietaryName>Mat Lumiere</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>76519-1000-1</NDCCode><ProprietaryName>Cyclobenzaprine Hyrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76519-1000-2</NDCCode><ProprietaryName>Cyclobenzaprine Hyrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76519-1000-3</NDCCode><ProprietaryName>Cyclobenzaprine Hyrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76519-1000-5</NDCCode><ProprietaryName>Cyclobenzaprine Hyrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76519-1000-6</NDCCode><ProprietaryName>Cyclobenzaprine Hyrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76519-1000-7</NDCCode><ProprietaryName>Cyclobenzaprine Hyrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76519-1000-9</NDCCode><ProprietaryName>Cyclobenzaprine Hyrochloride</ProprietaryName><NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>76519-1001-1</NDCCode><ProprietaryName>Levofloxacin</ProprietaryName><NonProprietaryName>Levofloxacin</NonProprietaryName></NDC><NDC><NDCCode>76519-1001-2</NDCCode><ProprietaryName>Levofloxacin</ProprietaryName><NonProprietaryName>Levofloxacin</NonProprietaryName></NDC><NDC><NDCCode>76519-1001-3</NDCCode><ProprietaryName>Levofloxacin</ProprietaryName><NonProprietaryName>Levofloxacin</NonProprietaryName></NDC></NDCList>