RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "54868-5656-1",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (54868-5656-1)  > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "54868-5656-01",
      "ProductNDC": "54868-5656",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Loratadine And Pseudoephedrine",
      "NonProprietaryName": "Loratadine And Pseudoephedrine",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080527",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076557",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
      "StrengthNumber": "10; 240",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:sneezingitchy, watery eyesrunny noseitching of the nose or throat. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
    },
    {
      "NDCCode": "54868-5656-2",
      "PackageDescription": "3 BLISTER PACK in 1 CARTON (54868-5656-2)  > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
      "NDC11Code": "54868-5656-02",
      "ProductNDC": "54868-5656",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Loratadine And Pseudoephedrine",
      "NonProprietaryName": "Loratadine And Pseudoephedrine",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080527",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076557",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
      "StrengthNumber": "10; 240",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:sneezingitchy, watery eyesrunny noseitching of the nose or throat. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
    },
    {
      "NDCCode": "50090-5656-2",
      "PackageDescription": "21 TABLET in 1 BOTTLE (50090-5656-2) ",
      "NDC11Code": "50090-5656-02",
      "ProductNDC": "50090-5656",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210525",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210914",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 1. Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis. 2. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions. 6. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis. 12. Nervous SystemAcute exacerbations of multiple sclerosis. 13. MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
      "Description": "Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione,17,21-dihydroxy- and its molecular weight is 358.43. The structural formula is represented below. Prednisone tablets are available in 3 strengths:10 mg, 20 mg and 50 mg. Inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Cellulose Powder, Magnesium Stearate, and Croscarmellose Sodium."
    },
    {
      "NDCCode": "54868-5656-0",
      "PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (54868-5656-0)",
      "NDC11Code": "54868-5656-00",
      "ProductNDC": "54868-5656",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Loratadine And Pseudoephedrine",
      "NonProprietaryName": "Loratadine And Pseudoephedrine",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080527",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076557",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
      "StrengthNumber": "10; 240",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:sneezingitchy, watery eyesrunny noseitching of the nose or throat. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
    },
    {
      "NDCCode": "0703-5656-01",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0703-5656-01)  / 25 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "00703-5656-01",
      "ProductNDC": "0703-5656",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Toposar",
      "NonProprietaryName": "Etoposide",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19960801",
      "EndMarketingDate": "20240131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA074529",
      "LabelerName": "Teva Parenteral Medicines, Inc.",
      "SubstanceName": "ETOPOSIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2024-02-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19960801",
      "EndMarketingDatePackage": "20240131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Toposar (etoposide injection) is indicated in the management of the following neoplasms.",
      "Description": "Toposar® (etoposide injection USP) (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4'-demethylepipodophyllotoxin 9-[4,6-0-(R)-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether. It is made more miscible with water by means of organic solvents. Toposar (etoposide injection USP) is available for intravenous use as a sterile 20 mg/mL solution in 100 mg (5 mL), 500 mg (25 mL), or 1 g (50 mL) sterile, multiple dose vials. The pH of the clear, yellow liquid is 3.0 to 4.0. Each mL contains: 20 mg etoposide, USP, 2 mg citric acid anhydrous, 80 mg polysorbate 80, 650 mg polyethylene glycol 300 (57.5% v/v and 65.0% w/v), and 262 mg dehydrated alcohol (33.2% v/v and 26.2% w/v). The structural formula is. C29H32O13 M.W. 588.56."
    },
    {
      "NDCCode": "0904-5656-61",
      "PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-5656-61)  > 1 TABLET in 1 BLISTER PACK",
      "NDC11Code": "00904-5656-61",
      "ProductNDC": "0904-5656",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clonidine Hydrochloride",
      "NonProprietaryName": "Clonidine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20061120",
      "EndMarketingDate": "20210331",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070974",
      "LabelerName": "Major Pharmaceuticals",
      "SubstanceName": "CLONIDINE HYDROCHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20061120",
      "EndMarketingDatePackage": "20210331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50090-5656-0",
      "PackageDescription": "10 TABLET in 1 BOTTLE (50090-5656-0) ",
      "NDC11Code": "50090-5656-00",
      "ProductNDC": "50090-5656",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210525",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210914",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 1. Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis. 2. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions. 6. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis. 12. Nervous SystemAcute exacerbations of multiple sclerosis. 13. MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
      "Description": "Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione,17,21-dihydroxy- and its molecular weight is 358.43. The structural formula is represented below. Prednisone tablets are available in 3 strengths:10 mg, 20 mg and 50 mg. Inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Cellulose Powder, Magnesium Stearate, and Croscarmellose Sodium."
    },
    {
      "NDCCode": "50090-5656-1",
      "PackageDescription": "15 TABLET in 1 BOTTLE (50090-5656-1) ",
      "NDC11Code": "50090-5656-01",
      "ProductNDC": "50090-5656",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210525",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210914",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 1. Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis. 2. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions. 6. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis. 12. Nervous SystemAcute exacerbations of multiple sclerosis. 13. MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
      "Description": "Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione,17,21-dihydroxy- and its molecular weight is 358.43. The structural formula is represented below. Prednisone tablets are available in 3 strengths:10 mg, 20 mg and 50 mg. Inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Cellulose Powder, Magnesium Stearate, and Croscarmellose Sodium."
    },
    {
      "NDCCode": "50090-5656-4",
      "PackageDescription": "50 TABLET in 1 BOTTLE (50090-5656-4) ",
      "NDC11Code": "50090-5656-04",
      "ProductNDC": "50090-5656",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210525",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210914",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 1. Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis. 2. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions. 6. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis. 12. Nervous SystemAcute exacerbations of multiple sclerosis. 13. MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
      "Description": "Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione,17,21-dihydroxy- and its molecular weight is 358.43. The structural formula is represented below. Prednisone tablets are available in 3 strengths:10 mg, 20 mg and 50 mg. Inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Cellulose Powder, Magnesium Stearate, and Croscarmellose Sodium."
    },
    {
      "NDCCode": "50090-5656-5",
      "PackageDescription": "30 TABLET in 1 BOTTLE (50090-5656-5) ",
      "NDC11Code": "50090-5656-05",
      "ProductNDC": "50090-5656",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210525",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210914",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 1. Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis. 2. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions. 6. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis. 12. Nervous SystemAcute exacerbations of multiple sclerosis. 13. MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
      "Description": "Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione,17,21-dihydroxy- and its molecular weight is 358.43. The structural formula is represented below. Prednisone tablets are available in 3 strengths:10 mg, 20 mg and 50 mg. Inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Cellulose Powder, Magnesium Stearate, and Croscarmellose Sodium."
    },
    {
      "NDCCode": "50090-5656-7",
      "PackageDescription": "100 TABLET in 1 BOTTLE (50090-5656-7) ",
      "NDC11Code": "50090-5656-07",
      "ProductNDC": "50090-5656",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210525",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210914",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 1. Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis. 2. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions. 6. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis. 12. Nervous SystemAcute exacerbations of multiple sclerosis. 13. MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
      "Description": "Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione,17,21-dihydroxy- and its molecular weight is 358.43. The structural formula is represented below. Prednisone tablets are available in 3 strengths:10 mg, 20 mg and 50 mg. Inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Cellulose Powder, Magnesium Stearate, and Croscarmellose Sodium."
    },
    {
      "NDCCode": "50090-5656-8",
      "PackageDescription": "40 TABLET in 1 BOTTLE (50090-5656-8) ",
      "NDC11Code": "50090-5656-08",
      "ProductNDC": "50090-5656",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Prednisone",
      "NonProprietaryName": "Prednisone",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20181204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA210525",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "PREDNISONE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20210914",
      "SamplePackage": "N",
      "IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. 1. Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis. 2. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis. 3. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions. 6. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis. 12. Nervous SystemAcute exacerbations of multiple sclerosis. 13. MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.",
      "Description": "Prednisone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione,17,21-dihydroxy- and its molecular weight is 358.43. The structural formula is represented below. Prednisone tablets are available in 3 strengths:10 mg, 20 mg and 50 mg. Inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Cellulose Powder, Magnesium Stearate, and Croscarmellose Sodium."
    },
    {
      "NDCCode": "54868-0017-2",
      "PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-0017-2)",
      "NDC11Code": "54868-0017-02",
      "ProductNDC": "54868-0017",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Niaspan",
      "NonProprietaryName": "Niacin",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090512",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020381",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "NIACIN",
      "StrengthNumber": "1000",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Limitations of Use. No incremental benefit of NIASPAN coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established.",
      "Description": "NIASPAN (niacin tablet, film-coated extended-release), contains niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula. NIASPAN is an unscored, medium-orange, film-coated tablet for oral administration and is available in three tablet strengths containing 500, 750, and 1000 mg niacin. NIASPAN tablets also contain the inactive ingredients hypromellose, povidone, stearic acid, and polyethylene glycol, and the following coloring agents: FD&C yellow #6/sunset yellow FCF Aluminum Lake, synthetic red and yellow iron oxides, and titanium dioxide."
    },
    {
      "NDCCode": "54868-0021-2",
      "PackageDescription": "14 TABLET in 1 BOTTLE (54868-0021-2)",
      "NDC11Code": "54868-0021-02",
      "ProductNDC": "54868-0021",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950811",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090624",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
      "StrengthNumber": "800; 160",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "54868-0023-2",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE (54868-0023-2)",
      "NDC11Code": "54868-0023-02",
      "ProductNDC": "54868-0023",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Doxycycline Hyclate",
      "NonProprietaryName": "Doxycycline Hyclate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19930611",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062031",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DOXYCYCLINE HYCLATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder which is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule, for oral administration, contains Doxycycline Hyclate, equivalent to 50 mg or 100 mg of Doxycycline. Each tablet, for oral administration, contains Doxycycline Hyclate, equivalent to 100 mg of Doxycycline. Doxycycline Hyclate Capsules USP 50 mg and 100 mg contain the following inactive ingredients: magnesium stearate and microcrystalline cellulose. The capsule shells contain: FD&C Blue No. 1, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide. Doxycycline Hyclate Tablets USP 100 mg contain the following inactive ingredients: croscarmellose sodium, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate and titanium dioxide."
    },
    {
      "NDCCode": "54868-0028-2",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54868-0028-2)",
      "NDC11Code": "54868-0028-02",
      "ProductNDC": "54868-0028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Theophylline",
      "NonProprietaryName": "Theophylline",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961219",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089808",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "THEOPHYLLINE ANHYDROUS",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.",
      "Description": "Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine-2,6-dione,3,7-dihydro-1,3-dimethyl-, and is represented by the following structural formula. C7H8N4O2 M.W. 180.17. This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations). Each extended-release tablet for oral administration contains either 100 mg, 200 mg, 300 mg or 450 mg of anhydrous theophylline. Tablets also contain as inactive ingredients: hypromellose, anhydrous lactose, magnesium stearate and povidone."
    },
    {
      "NDCCode": "54868-0029-2",
      "PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54868-0029-2)",
      "NDC11Code": "54868-0029-02",
      "ProductNDC": "54868-0029",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Theophylline",
      "NonProprietaryName": "Theophylline",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070917",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089763",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "THEOPHYLLINE ANHYDROUS",
      "StrengthNumber": "300",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Theophylline extended-release tablets are indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.",
      "Description": "Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine-2,6-dione,3,7-dihydro-1,3-dimethyl-, and is represented by the following structural formula. C7H8N4O2 M.W. 180.17. This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations). Each extended-release tablet for oral administration contains either 100 mg, 200 mg, 300 mg or 450 mg of anhydrous theophylline. Tablets also contain as inactive ingredients: hypromellose, anhydrous lactose, magnesium stearate and povidone."
    },
    {
      "NDCCode": "54868-0033-2",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (54868-0033-2)",
      "NDC11Code": "54868-0033-02",
      "ProductNDC": "54868-0033",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dicyclomine Hydrochloride",
      "NonProprietaryName": "Dicyclomine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "19951026",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA084285",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Dicyclomine hydrochloride tablets and capsules are indicated for the treatment of functional bowel/ irritable bowel syndrome.",
      "Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following forms. 1. Dicyclomine Hydrochloride Tablets USP, for oral administration, contain 20 mg dicyclomine hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: acacia, pregelatinized starch, anhydrous lactose, compressible sugar, dicalcium phosphate, colloidal silicon dioxide, magnesium stearate, stearic acid, and FD & C Blue #1 Aluminum Lake. 2. Dicyclomine Hydrochloride Capsules USP, for oral administration, contain 10 mg of dicyclomine hydrochloride, USP. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, calcium sulfate, magnesium stearate; and the capsules shells contain: gelatin, FD&C Blue # 1, and FD&C Red # 3. Chemically, dicyclomine hydrochloride is 2-(Diethylamino)ethyl [bicyclohexyl]-1-carboxylate hydrochloride with the structural formula. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether."
    },
    {
      "NDCCode": "54868-0034-2",
      "PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (54868-0034-2)",
      "NDC11Code": "54868-0034-02",
      "ProductNDC": "54868-0034",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Metoclopramide",
      "NonProprietaryName": "Metoclopramide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20030501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078807",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "The use of metoclopramide tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration. Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. Metoclopramide tablets, are indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide tablets within different time intervals. Significant relief of nausea occurs early and continues to improve over a three-week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.",
      "Description": "For oral administration, Metoclopramide tablets, USP 10 mg are white to off white, capsule shaped, biconvex tablets with \"RF11\" embossed on one side and score line on the other side. Each tablet contains. 10 mg of metoclopramide base as metoclopramide hydrochloride USP."
    },
    {
      "NDCCode": "54868-0038-2",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (54868-0038-2)",
      "NDC11Code": "54868-0038-02",
      "ProductNDC": "54868-0038",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Temazepam",
      "NonProprietaryName": "Temazepam",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080110",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070920",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "TEMAZEPAM",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
      "Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. Its structural formula may be represented as follows. C16H13ClN2O2               M.W. = 300.74. Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol. Temazepam capsules, 15 mg, 22.5 mg and 30 mg, are for oral administration. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, powdered cellulose and sodium lauryl sulfate."
    },
    {
      "NDCCode": "54868-0039-2",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (54868-0039-2)",
      "NDC11Code": "54868-0039-02",
      "ProductNDC": "54868-0039",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Temazepam",
      "NonProprietaryName": "Temazepam",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20050111",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070920",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "TEMAZEPAM",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
      "Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. Its structural formula may be represented as follows. C16H13ClN2O2               M.W. = 300.74. Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol. Temazepam capsules, 15 mg, 22.5 mg and 30 mg, are for oral administration. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, powdered cellulose and sodium lauryl sulfate."
    },
    {
      "NDCCode": "54868-0042-2",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (54868-0042-2)",
      "NDC11Code": "54868-0042-02",
      "ProductNDC": "54868-0042",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dipyridamole",
      "NonProprietaryName": "Dipyridamole",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090807",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088999",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DIPYRIDAMOLE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-19"
    },
    {
      "NDCCode": "54868-0043-2",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (54868-0043-2)",
      "NDC11Code": "54868-0043-02",
      "ProductNDC": "54868-0043",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dipyridamole",
      "NonProprietaryName": "Dipyridamole",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080905",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089000",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DIPYRIDAMOLE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-19"
    },
    {
      "NDCCode": "54868-0044-2",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (54868-0044-2)",
      "NDC11Code": "54868-0044-02",
      "ProductNDC": "54868-0044",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dipyridamole",
      "NonProprietaryName": "Dipyridamole",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090608",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089001",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DIPYRIDAMOLE",
      "StrengthNumber": "75",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-19"
    },
    {
      "NDCCode": "54868-0048-2",
      "PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (54868-0048-2)",
      "NDC11Code": "54868-0048-02",
      "ProductNDC": "54868-0048",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clonidine Hydrochloride",
      "NonProprietaryName": "Clonidine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20011003",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070925",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "CLONIDINE HYDROCHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Clonidine hydrochloride USP tablets are indicated in the treatment of hypertension. Clonidine hydrochloride USP tablets may be employed alone or concomitantly with other antihypertensive agents.",
      "Description": "Clonidine hydrochloride USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. Clonidine hydrochloride tablets contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. The 0.1 mg also contains D&C yellow #10 aluminum lake, and the 0.3 mg contains D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
    },
    {
      "NDCCode": "54868-0049-2",
      "PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (54868-0049-2)",
      "NDC11Code": "54868-0049-02",
      "ProductNDC": "54868-0049",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clonidine Hydrochloride",
      "NonProprietaryName": "Clonidine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950109",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070924",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "CLONIDINE HYDROCHLORIDE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Clonidine hydrochloride USP tablets are indicated in the treatment of hypertension. Clonidine hydrochloride USP tablets may be employed alone or concomitantly with other antihypertensive agents.",
      "Description": "Clonidine hydrochloride USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. Clonidine hydrochloride tablets contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. The 0.1 mg also contains D&C yellow #10 aluminum lake, and the 0.3 mg contains D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
    },
    {
      "NDCCode": "54868-0050-2",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-0050-2)",
      "NDC11Code": "54868-0050-02",
      "ProductNDC": "54868-0050",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Methyldopa",
      "NonProprietaryName": "Methyldopa",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19950829",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070098",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "METHYLDOPA",
      "StrengthNumber": "250",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Hypertension.",
      "Description": "Methyldopa USP is an antihypertensive drug. Methyldopa USP is the L-isomer of alpha-methyldopa. Its chemical name is levo-3-(3,4-dihydroxyphenyl)- 2-methylalanine sesquihydrate. Its structural formula is. C 10H13NO4  1 1/2 H2O M.W. 238.24. Methyldopa USP is a white to yellowish white, odorless fine powder and is sparingly soluble in water. Each tablet, for oral administration, contains 250 mg or 500 mg of methyldopa USP. Potency is calculated in the anhydrous basis. Inactive ingredients: citric acid, colloidal silicon dioxide, edetate disodium, ethylcellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. In addition, the 250 mg tablet contains calcium sulfate, hydroxypropyl cellulose, and talc, and the 500 mg tablet contains polysorbate 80."
    },
    {
      "NDCCode": "54868-0052-2",
      "PackageDescription": "100 TABLET in 1 BOTTLE (54868-0052-2)",
      "NDC11Code": "54868-0052-02",
      "ProductNDC": "54868-0052",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propranolol Hydrochloride",
      "NonProprietaryName": "Propranolol Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20030227",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078955",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Propranolol hydrochloride tablets are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Propranolol hydrochloride tablets are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Propranolol hydrochloride tablets are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Propranolol hydrochloride tablets are indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol hydrochloride tablets, USP causes a reduction in the tremor amplitude but not in the tremor frequency. Propranolol hydrochloride tablets are not indicated for the treatment of tremor associated with Parkinsonism. Propranolol hydrochloride tablets improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Propranolol hydrochloride tablets are indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.",
      "Description": "hydrochloride(Propranolol is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets, USP are: lactose monohydrate, corn starch, sodium starch glycolate, magnesium stearate, and povidone. In addition, propranolol hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain FD &C yellow No.6 Aluminium Lake and Color D&C Yellow No. 10; propranolol hydrochloride tablets, USP 20 mg and 40mg contain FD&C Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D&C Red No. 30 Lake."
    },
    {
      "NDCCode": "54868-0053-2",
      "PackageDescription": "60 TABLET in 1 BOTTLE (54868-0053-2)",
      "NDC11Code": "54868-0053-02",
      "ProductNDC": "54868-0053",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Propranolol Hydrochloride",
      "NonProprietaryName": "Propranolol Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961209",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078955",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Propranolol hydrochloride tablets are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets are not indicated in the management of hypertensive emergencies. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Propranolol hydrochloride tablets are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Propranolol hydrochloride tablets are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Propranolol hydrochloride tablets are indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol hydrochloride tablets, USP causes a reduction in the tremor amplitude but not in the tremor frequency. Propranolol hydrochloride tablets are not indicated for the treatment of tremor associated with Parkinsonism. Propranolol hydrochloride tablets improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Propranolol hydrochloride tablets are indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.",
      "Description": "hydrochloride(Propranolol is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. It’s molecular and structural formulae are. Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and in ethanol. Its molecular weight is 295.80. Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets, USP are: lactose monohydrate, corn starch, sodium starch glycolate, magnesium stearate, and povidone. In addition, propranolol hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain FD &C yellow No.6 Aluminium Lake and Color D&C Yellow No. 10; propranolol hydrochloride tablets, USP 20 mg and 40mg contain FD&C Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D&C Red No. 30 Lake."
    },
    {
      "NDCCode": "54868-0055-2",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (54868-0055-2)",
      "NDC11Code": "54868-0055-02",
      "ProductNDC": "54868-0055",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Digoxin",
      "NonProprietaryName": "Digoxin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20000821",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077002",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "DIGOXIN",
      "StrengthNumber": "250",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Digoxin Tablets are indicated for the treatment of mild to moderate heart failure. Digoxin Tablets increase left ventricular ejection fraction and improve heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, Digoxin Tablets should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified.",
      "Description": "Digoxin Tablets, USP are one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of two portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. lts molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin Tablets, USP are supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients. 125 mcg (0.125 mg): anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate and starch 1500. 250 mcg (0.25 mg): anhydrous lactose, colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate and starch 1500."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"54868-5656-1","ProprietaryName":"Loratadine And Pseudoephedrine","NonProprietaryName":"Loratadine And Pseudoephedrine"},{"NDCCode":"54868-5656-2","ProprietaryName":"Loratadine And Pseudoephedrine","NonProprietaryName":"Loratadine And Pseudoephedrine"},{"NDCCode":"50090-5656-2","ProprietaryName":"Prednisone","NonProprietaryName":"Prednisone"},{"NDCCode":"54868-5656-0","ProprietaryName":"Loratadine And Pseudoephedrine","NonProprietaryName":"Loratadine And Pseudoephedrine"},{"NDCCode":"0703-5656-01","ProprietaryName":"Toposar","NonProprietaryName":"Etoposide"},{"NDCCode":"0904-5656-61","ProprietaryName":"Clonidine Hydrochloride","NonProprietaryName":"Clonidine Hydrochloride"},{"NDCCode":"50090-5656-0","ProprietaryName":"Prednisone","NonProprietaryName":"Prednisone"},{"NDCCode":"50090-5656-1","ProprietaryName":"Prednisone","NonProprietaryName":"Prednisone"},{"NDCCode":"50090-5656-4","ProprietaryName":"Prednisone","NonProprietaryName":"Prednisone"},{"NDCCode":"50090-5656-5","ProprietaryName":"Prednisone","NonProprietaryName":"Prednisone"},{"NDCCode":"50090-5656-7","ProprietaryName":"Prednisone","NonProprietaryName":"Prednisone"},{"NDCCode":"50090-5656-8","ProprietaryName":"Prednisone","NonProprietaryName":"Prednisone"},{"NDCCode":"54868-0017-2","ProprietaryName":"Niaspan","NonProprietaryName":"Niacin"},{"NDCCode":"54868-0021-2","ProprietaryName":"Sulfamethoxazole And Trimethoprim","NonProprietaryName":"Sulfamethoxazole And Trimethoprim"},{"NDCCode":"54868-0023-2","ProprietaryName":"Doxycycline Hyclate","NonProprietaryName":"Doxycycline Hyclate"},{"NDCCode":"54868-0028-2","ProprietaryName":"Theophylline","NonProprietaryName":"Theophylline"},{"NDCCode":"54868-0029-2","ProprietaryName":"Theophylline","NonProprietaryName":"Theophylline"},{"NDCCode":"54868-0033-2","ProprietaryName":"Dicyclomine Hydrochloride","NonProprietaryName":"Dicyclomine Hydrochloride"},{"NDCCode":"54868-0034-2","ProprietaryName":"Metoclopramide","NonProprietaryName":"Metoclopramide"},{"NDCCode":"54868-0038-2","ProprietaryName":"Temazepam","NonProprietaryName":"Temazepam"},{"NDCCode":"54868-0039-2","ProprietaryName":"Temazepam","NonProprietaryName":"Temazepam"},{"NDCCode":"54868-0042-2","ProprietaryName":"Dipyridamole","NonProprietaryName":"Dipyridamole"},{"NDCCode":"54868-0043-2","ProprietaryName":"Dipyridamole","NonProprietaryName":"Dipyridamole"},{"NDCCode":"54868-0044-2","ProprietaryName":"Dipyridamole","NonProprietaryName":"Dipyridamole"},{"NDCCode":"54868-0048-2","ProprietaryName":"Clonidine Hydrochloride","NonProprietaryName":"Clonidine Hydrochloride"},{"NDCCode":"54868-0049-2","ProprietaryName":"Clonidine Hydrochloride","NonProprietaryName":"Clonidine Hydrochloride"},{"NDCCode":"54868-0050-2","ProprietaryName":"Methyldopa","NonProprietaryName":"Methyldopa"},{"NDCCode":"54868-0052-2","ProprietaryName":"Propranolol Hydrochloride","NonProprietaryName":"Propranolol Hydrochloride"},{"NDCCode":"54868-0053-2","ProprietaryName":"Propranolol Hydrochloride","NonProprietaryName":"Propranolol Hydrochloride"},{"NDCCode":"54868-0055-2","ProprietaryName":"Digoxin","NonProprietaryName":"Digoxin"}]}
                    

<NDCList><NDC><NDCCode>54868-5656-1</NDCCode><ProprietaryName>Loratadine And Pseudoephedrine</ProprietaryName><NonProprietaryName>Loratadine And Pseudoephedrine</NonProprietaryName></NDC><NDC><NDCCode>54868-5656-2</NDCCode><ProprietaryName>Loratadine And Pseudoephedrine</ProprietaryName><NonProprietaryName>Loratadine And Pseudoephedrine</NonProprietaryName></NDC><NDC><NDCCode>50090-5656-2</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>54868-5656-0</NDCCode><ProprietaryName>Loratadine And Pseudoephedrine</ProprietaryName><NonProprietaryName>Loratadine And Pseudoephedrine</NonProprietaryName></NDC><NDC><NDCCode>0703-5656-01</NDCCode><ProprietaryName>Toposar</ProprietaryName><NonProprietaryName>Etoposide</NonProprietaryName></NDC><NDC><NDCCode>0904-5656-61</NDCCode><ProprietaryName>Clonidine Hydrochloride</ProprietaryName><NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50090-5656-0</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>50090-5656-1</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>50090-5656-4</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>50090-5656-5</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>50090-5656-7</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>50090-5656-8</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>54868-0017-2</NDCCode><ProprietaryName>Niaspan</ProprietaryName><NonProprietaryName>Niacin</NonProprietaryName></NDC><NDC><NDCCode>54868-0021-2</NDCCode><ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName><NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName></NDC><NDC><NDCCode>54868-0023-2</NDCCode><ProprietaryName>Doxycycline Hyclate</ProprietaryName><NonProprietaryName>Doxycycline Hyclate</NonProprietaryName></NDC><NDC><NDCCode>54868-0028-2</NDCCode><ProprietaryName>Theophylline</ProprietaryName><NonProprietaryName>Theophylline</NonProprietaryName></NDC><NDC><NDCCode>54868-0029-2</NDCCode><ProprietaryName>Theophylline</ProprietaryName><NonProprietaryName>Theophylline</NonProprietaryName></NDC><NDC><NDCCode>54868-0033-2</NDCCode><ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName><NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-0034-2</NDCCode><ProprietaryName>Metoclopramide</ProprietaryName><NonProprietaryName>Metoclopramide</NonProprietaryName></NDC><NDC><NDCCode>54868-0038-2</NDCCode><ProprietaryName>Temazepam</ProprietaryName><NonProprietaryName>Temazepam</NonProprietaryName></NDC><NDC><NDCCode>54868-0039-2</NDCCode><ProprietaryName>Temazepam</ProprietaryName><NonProprietaryName>Temazepam</NonProprietaryName></NDC><NDC><NDCCode>54868-0042-2</NDCCode><ProprietaryName>Dipyridamole</ProprietaryName><NonProprietaryName>Dipyridamole</NonProprietaryName></NDC><NDC><NDCCode>54868-0043-2</NDCCode><ProprietaryName>Dipyridamole</ProprietaryName><NonProprietaryName>Dipyridamole</NonProprietaryName></NDC><NDC><NDCCode>54868-0044-2</NDCCode><ProprietaryName>Dipyridamole</ProprietaryName><NonProprietaryName>Dipyridamole</NonProprietaryName></NDC><NDC><NDCCode>54868-0048-2</NDCCode><ProprietaryName>Clonidine Hydrochloride</ProprietaryName><NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-0049-2</NDCCode><ProprietaryName>Clonidine Hydrochloride</ProprietaryName><NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-0050-2</NDCCode><ProprietaryName>Methyldopa</ProprietaryName><NonProprietaryName>Methyldopa</NonProprietaryName></NDC><NDC><NDCCode>54868-0052-2</NDCCode><ProprietaryName>Propranolol Hydrochloride</ProprietaryName><NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-0053-2</NDCCode><ProprietaryName>Propranolol Hydrochloride</ProprietaryName><NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>54868-0055-2</NDCCode><ProprietaryName>Digoxin</ProprietaryName><NonProprietaryName>Digoxin</NonProprietaryName></NDC></NDCList>