{
"NDC": [
{
"NDCCode": "54868-0218-0",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (54868-0218-0)",
"NDC11Code": "54868-0218-00",
"ProductNDC": "54868-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084612",
"LabelerName": "Physicians Total Care, Inc",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is."
},
{
"NDCCode": "54868-0218-1",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (54868-0218-1)",
"NDC11Code": "54868-0218-01",
"ProductNDC": "54868-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084612",
"LabelerName": "Physicians Total Care, Inc",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is."
},
{
"NDCCode": "54868-0218-2",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (54868-0218-2)",
"NDC11Code": "54868-0218-02",
"ProductNDC": "54868-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084612",
"LabelerName": "Physicians Total Care, Inc",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is."
},
{
"NDCCode": "54868-0218-3",
"PackageDescription": "3 TABLET in 1 BOTTLE, PLASTIC (54868-0218-3)",
"NDC11Code": "54868-0218-03",
"ProductNDC": "54868-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084612",
"LabelerName": "Physicians Total Care, Inc",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is."
},
{
"NDCCode": "54868-0218-4",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (54868-0218-4)",
"NDC11Code": "54868-0218-04",
"ProductNDC": "54868-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084612",
"LabelerName": "Physicians Total Care, Inc",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is."
},
{
"NDCCode": "54868-0218-5",
"PackageDescription": "16 TABLET in 1 BOTTLE, PLASTIC (54868-0218-5)",
"NDC11Code": "54868-0218-05",
"ProductNDC": "54868-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
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"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084612",
"LabelerName": "Physicians Total Care, Inc",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is."
},
{
"NDCCode": "54868-0218-6",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (54868-0218-6)",
"NDC11Code": "54868-0218-06",
"ProductNDC": "54868-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084612",
"LabelerName": "Physicians Total Care, Inc",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is."
},
{
"NDCCode": "54868-0218-7",
"PackageDescription": "40 TABLET in 1 BOTTLE, PLASTIC (54868-0218-7)",
"NDC11Code": "54868-0218-07",
"ProductNDC": "54868-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084612",
"LabelerName": "Physicians Total Care, Inc",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is."
},
{
"NDCCode": "54868-0218-8",
"PackageDescription": "50 TABLET in 1 BOTTLE, PLASTIC (54868-0218-8)",
"NDC11Code": "54868-0218-08",
"ProductNDC": "54868-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084612",
"LabelerName": "Physicians Total Care, Inc",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is."
},
{
"NDCCode": "54868-0218-9",
"PackageDescription": "5 TABLET in 1 BOTTLE, PLASTIC (54868-0218-9)",
"NDC11Code": "54868-0218-09",
"ProductNDC": "54868-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19940119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084612",
"LabelerName": "Physicians Total Care, Inc",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is."
},
{
"NDCCode": "12860-0218-0",
"PackageDescription": "1 BAG in 1 DRUM (12860-0218-0) > 50000 g in 1 BAG",
"NDC11Code": "12860-0218-00",
"ProductNDC": "12860-0218",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Estradiol",
"DosageFormName": "POWDER",
"StartMarketingDate": "19800425",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "N.V. Organon",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "15631-0218-0",
"PackageDescription": "100 PELLET in 1 PACKAGE (15631-0218-0) ",
"NDC11Code": "15631-0218-00",
"ProductNDC": "15631-0218",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hekla Lava",
"NonProprietaryName": "Hekla Lava",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "HEKLA LAVA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "49706-0218-0",
"PackageDescription": "50 kg in 1 DRUM (49706-0218-0)",
"NDC11Code": "49706-0218-00",
"ProductNDC": "49706-0218",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Atenolol",
"DosageFormName": "POWDER",
"StartMarketingDate": "20100108",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Erregierre SpA",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50090-0218-0",
"PackageDescription": "200 mL in 1 BOTTLE (50090-0218-0)",
"NDC11Code": "50090-0218-00",
"ProductNDC": "50090-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062703",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "125",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "51927-0218-0",
"PackageDescription": "1 kg in 1 BOTTLE (51927-0218-0) ",
"NDC11Code": "51927-0218-00",
"ProductNDC": "51927-0218",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aspirin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20211026",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Professional Compounding Centers of America",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-01-13",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "26-OCT-21"
},
{
"NDCCode": "55984-0218-0",
"PackageDescription": "25 kg in 1 CARTON (55984-0218-0) ",
"NDC11Code": "55984-0218-00",
"ProductNDC": "55984-0218",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Amoxicillin Trihydrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20220412",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Sandoz Industrial Products S.A",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "25",
"StrengthUnit": "kg/25kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "12-APR-22"
},
{
"NDCCode": "60870-0218-0",
"PackageDescription": "1 BAG in 1 DRUM (60870-0218-0) > 50000 g in 1 BAG",
"NDC11Code": "60870-0218-00",
"ProductNDC": "60870-0218",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Estradiol",
"DosageFormName": "POWDER",
"StartMarketingDate": "19800425",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Aspen Oss B.V.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2023-01-11",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "25-APR-80"
},
{
"NDCCode": "62147-0218-0",
"PackageDescription": "25 kg in 1 DRUM (62147-0218-0) ",
"NDC11Code": "62147-0218-00",
"ProductNDC": "62147-0218",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Palonosetron Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140411",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "USV Private Limited",
"SubstanceName": "PALONOSETRON HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-12-21",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "11-APR-14"
},
{
"NDCCode": "70518-0218-0",
"PackageDescription": "6 TABLET in 1 BOTTLE, PLASTIC (70518-0218-0) ",
"NDC11Code": "70518-0218-00",
"ProductNDC": "70518-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenazopyridine Hydrochloride",
"NonProprietaryName": "Phenazopyridine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170214",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170214",
"SamplePackage": "N",
"IndicationAndUsage": "Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATIONsection.).",
"Description": "Phenazopyridine Hydrochloride is dark brown fine granular powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. Phenazopyridine HCl tablets contain the following inactive ingredients: hypromellose, polyethylene glycol, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, maize(corn) starch, silicone dioxide, polyvinylpyrrolidone."
},
{
"NDCCode": "71335-0218-0",
"PackageDescription": "7 TABLET in 1 BOTTLE (71335-0218-0) ",
"NDC11Code": "71335-0218-00",
"ProductNDC": "71335-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077073",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220923",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablet, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension (1.1). o Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Coronary Artery Disease (1.2). o Chronic Stable Angina. o Vasospastic Angina (Prinzmetal's or Variant Angina). o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25CIN2O5C6H6O3S, and its structural formula is."
},
{
"NDCCode": "0378-0218-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0218-01) ",
"NDC11Code": "00378-0218-01",
"ProductNDC": "0378-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073457",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990617",
"SamplePackage": "N",
"IndicationAndUsage": "Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. 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. Atenolol tablets may be administered with other antihypertensive agents.",
"Description": "Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato)."
},
{
"NDCCode": "0378-0218-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0218-10) ",
"NDC11Code": "00378-0218-10",
"ProductNDC": "0378-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073457",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990617",
"SamplePackage": "N",
"IndicationAndUsage": "Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. 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. Atenolol tablets may be administered with other antihypertensive agents.",
"Description": "Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato)."
},
{
"NDCCode": "22840-0218-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-0218-2) ",
"NDC11Code": "22840-0218-02",
"ProductNDC": "22840-0218",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "K-o-r-t Standardized Grass Pollen Mix",
"NonProprietaryName": "Poa Pratensis, Dactylis Glomerata, Agrostis Alba And Phleum Pratense",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19680915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101837",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN; POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN",
"StrengthNumber": "2500; 2500; 2500; 2500",
"StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19680915",
"SamplePackage": "N",
"IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
"Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "22840-0218-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0218-4) ",
"NDC11Code": "22840-0218-04",
"ProductNDC": "22840-0218",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "K-o-r-t Standardized Grass Pollen Mix",
"NonProprietaryName": "Poa Pratensis, Dactylis Glomerata, Agrostis Alba And Phleum Pratense",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19680915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101837",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN; POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN",
"StrengthNumber": "2500; 2500; 2500; 2500",
"StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19680915",
"SamplePackage": "N",
"IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
"Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "22840-0218-5",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (22840-0218-5) ",
"NDC11Code": "22840-0218-05",
"ProductNDC": "22840-0218",
"ProductTypeName": "STANDARDIZED ALLERGENIC",
"ProprietaryName": "K-o-r-t Standardized Grass Pollen Mix",
"NonProprietaryName": "Poa Pratensis, Dactylis Glomerata, Agrostis Alba And Phleum Pratense",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19680915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101837",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN; POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN",
"StrengthNumber": "2500; 2500; 2500; 2500",
"StrengthUnit": "[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19680915",
"SamplePackage": "N",
"IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
"Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
},
{
"NDCCode": "31722-218-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (31722-218-01)",
"NDC11Code": "31722-0218-01",
"ProductNDC": "31722-218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090294",
"LabelerName": "Camber Pharmaceutical, Inc.",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine Mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate USP. Each tab let contains the fo llowing inactive ingredients: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "31722-218-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (31722-218-10)",
"NDC11Code": "31722-0218-10",
"ProductNDC": "31722-218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090294",
"LabelerName": "Camber Pharmaceutical, Inc.",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine Mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate USP. Each tab let contains the fo llowing inactive ingredients: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "31722-218-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (31722-218-30)",
"NDC11Code": "31722-0218-30",
"ProductNDC": "31722-218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090294",
"LabelerName": "Camber Pharmaceutical, Inc.",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine Mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate USP. Each tab let contains the fo llowing inactive ingredients: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "43598-218-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (43598-218-30)",
"NDC11Code": "43598-0218-30",
"ProductNDC": "43598-218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19901022",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050564",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "250; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"Description": "Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients: : 1 Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium."
},
{
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"Description": "Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients: : 1 Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium."
}
]
}
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<Description>Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is.</Description>
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<Description>Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is.</Description>
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<Description>Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is.</Description>
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<Description>Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is.</Description>
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<IndicationAndUsage>Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is.</Description>
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<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is.</Description>
</NDC>
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<LabelerName>Physicians Total Care, Inc</LabelerName>
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<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
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<IndicationAndUsage>Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is.</Description>
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<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
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<IndicationAndUsage>Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is.</Description>
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<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is.</Description>
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<IndicationAndUsage>Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Dexamethasone Tablets 0.5, 0.75, 1, 1.5, 2, 4 and 6 mg USP, Dexamethasone Oral Solution, 0.5 mg per 5 mL and Dexamethasone Intensol Oral Solution (Concentrate), 1 mg per mL are for oral administration. Each tablet contains. Dexamethasone 0.5, 0.75, 1, 1.5, 2, 4, or 6 mg. Each 5 mL of Oral Solution contains. Dexamethasone....................................................... 0.5 mg. Each mL of Intensol Oral Solution (Concentrate) contains. Dexamethasone....................................................... 1 mg. Alcohol 30%. The tablets contain lactose monohydrate, magnesium stearate, starch, sucrose, cosmetic ochre (1 mg), D&C Yellow No. 10 (0.5, 4 mg), FD&C Blue No. 1 (0.75, 1.5 mg), FD&C Green No. 3 (4, 6 mg), FD&C Red No. 3 (1.5 mg), FD&C Red No. 40 (1.5 mg), and FD&C Yellow No. 6 (0.5, 4 mg). The oral solution contains citric acid, disodium edetate, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, sorbitol and water. The Intensol oral solution contains alcohol, benzoic acid, citric acid, disodium edetate, propylene glycol, and water. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular formula is C22H29FO5. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene,3,20-dione and the structural formula is.</Description>
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<SamplePackage>N</SamplePackage>
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<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20220412</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Sandoz Industrial Products S.A</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>kg/25kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-APR-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>60870-0218-0</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (60870-0218-0) > 50000 g in 1 BAG</PackageDescription>
<NDC11Code>60870-0218-00</NDC11Code>
<ProductNDC>60870-0218</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19800425</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Aspen Oss B.V.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-01-11</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-APR-80</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>62147-0218-0</NDCCode>
<PackageDescription>25 kg in 1 DRUM (62147-0218-0) </PackageDescription>
<NDC11Code>62147-0218-00</NDC11Code>
<ProductNDC>62147-0218</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Palonosetron Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140411</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>USV Private Limited</LabelerName>
<SubstanceName>PALONOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-21</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-APR-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>70518-0218-0</NDCCode>
<PackageDescription>6 TABLET in 1 BOTTLE, PLASTIC (70518-0218-0) </PackageDescription>
<NDC11Code>70518-0218-00</NDC11Code>
<ProductNDC>70518-0218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenazopyridine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170214</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATIONsection.).</IndicationAndUsage>
<Description>Phenazopyridine Hydrochloride is dark brown fine granular powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. Phenazopyridine HCl tablets contain the following inactive ingredients: hypromellose, polyethylene glycol, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, maize(corn) starch, silicone dioxide, polyvinylpyrrolidone.</Description>
</NDC>
<NDC>
<NDCCode>71335-0218-0</NDCCode>
<PackageDescription>7 TABLET in 1 BOTTLE (71335-0218-0) </PackageDescription>
<NDC11Code>71335-0218-00</NDC11Code>
<ProductNDC>71335-0218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077073</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablet, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension (1.1). o Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Coronary Artery Disease (1.2). o Chronic Stable Angina. o Vasospastic Angina (Prinzmetal's or Variant Angina). o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-1, 4-dihydro-6-methyl-3, 5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25CIN2O5C6H6O3S, and its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0378-0218-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0218-01) </PackageDescription>
<NDC11Code>00378-0218-01</NDC11Code>
<ProductNDC>0378-0218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073457</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. 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. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato).</Description>
</NDC>
<NDC>
<NDCCode>0378-0218-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0218-10) </PackageDescription>
<NDC11Code>00378-0218-10</NDC11Code>
<ProductNDC>0378-0218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073457</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. 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. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato).</Description>
</NDC>
<NDC>
<NDCCode>22840-0218-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-0218-2) </PackageDescription>
<NDC11Code>22840-0218-02</NDC11Code>
<ProductNDC>22840-0218</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>K-o-r-t Standardized Grass Pollen Mix</ProprietaryName>
<NonProprietaryName>Poa Pratensis, Dactylis Glomerata, Agrostis Alba And Phleum Pratense</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19680915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101837</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN; POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN</SubstanceName>
<StrengthNumber>2500; 2500; 2500; 2500</StrengthNumber>
<StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19680915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
<Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>22840-0218-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0218-4) </PackageDescription>
<NDC11Code>22840-0218-04</NDC11Code>
<ProductNDC>22840-0218</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>K-o-r-t Standardized Grass Pollen Mix</ProprietaryName>
<NonProprietaryName>Poa Pratensis, Dactylis Glomerata, Agrostis Alba And Phleum Pratense</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19680915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101837</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN; POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN</SubstanceName>
<StrengthNumber>2500; 2500; 2500; 2500</StrengthNumber>
<StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19680915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
<Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>22840-0218-5</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (22840-0218-5) </PackageDescription>
<NDC11Code>22840-0218-05</NDC11Code>
<ProductNDC>22840-0218</ProductNDC>
<ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>K-o-r-t Standardized Grass Pollen Mix</ProprietaryName>
<NonProprietaryName>Poa Pratensis, Dactylis Glomerata, Agrostis Alba And Phleum Pratense</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19680915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101837</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN; POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN</SubstanceName>
<StrengthNumber>2500; 2500; 2500; 2500</StrengthNumber>
<StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19680915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
<Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
</NDC>
<NDC>
<NDCCode>31722-218-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (31722-218-01)</PackageDescription>
<NDC11Code>31722-0218-01</NDC11Code>
<ProductNDC>31722-218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090294</ApplicationNumber>
<LabelerName>Camber Pharmaceutical, Inc.</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
<Description>Benztropine Mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate USP. Each tab let contains the fo llowing inactive ingredients: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>31722-218-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (31722-218-10)</PackageDescription>
<NDC11Code>31722-0218-10</NDC11Code>
<ProductNDC>31722-218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090294</ApplicationNumber>
<LabelerName>Camber Pharmaceutical, Inc.</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
<Description>Benztropine Mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate USP. Each tab let contains the fo llowing inactive ingredients: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>31722-218-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (31722-218-30)</PackageDescription>
<NDC11Code>31722-0218-30</NDC11Code>
<ProductNDC>31722-218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090294</ApplicationNumber>
<LabelerName>Camber Pharmaceutical, Inc.</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
<Description>Benztropine Mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each tablet, for oral administration, contains 0.5 mg, 1 mg or 2 mg of benztropine mesylate USP. Each tab let contains the fo llowing inactive ingredients: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>43598-218-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (43598-218-30)</PackageDescription>
<NDC11Code>43598-0218-30</NDC11Code>
<ProductNDC>43598-218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19901022</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050564</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>250; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<Description>Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients: : 1 Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium.</Description>
</NDC>
<NDC>
<NDCCode>43598-218-78</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (43598-218-78)</PackageDescription>
<NDC11Code>43598-0218-78</NDC11Code>
<ProductNDC>43598-218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19901022</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050564</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>250; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<Description>Amoxicillin and Clavulanate Potassium is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6‑aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta‑lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients: : 1 Tablets- Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium.</Description>
</NDC>
</NDCList>