{
"NDC": [
{
"NDCCode": "65862-290-84",
"PackageDescription": "84 CAPSULE in 1 BOTTLE (65862-290-84) ",
"NDC11Code": "65862-0290-84",
"ProductNDC": "65862-290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribavirin",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079117",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2024-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090917",
"SamplePackage": "N",
"IndicationAndUsage": "Ribavirin capsules are a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. (1.1). Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.",
"Description": "Ribavirin, is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see Figure 1). Figure 1: Structural FormulaRibavirin USP is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21. Ribavirin capsules USP consist of a white to off-white granular powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone-K 30, and magnesium stearate. The capsule shell consists of titanium dioxide, sodium lauryl sulfate, and gelatin. The capsule is printed with edible ink containing black iron oxide. Meets USP dissolution test 2."
},
{
"NDCCode": "65862-290-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (65862-290-05) ",
"NDC11Code": "65862-0290-05",
"ProductNDC": "65862-290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribavirin",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079117",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2024-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090917",
"SamplePackage": "N",
"IndicationAndUsage": "Ribavirin capsules are a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. (1.1). Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.",
"Description": "Ribavirin, is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see Figure 1). Figure 1: Structural FormulaRibavirin USP is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21. Ribavirin capsules USP consist of a white to off-white granular powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone-K 30, and magnesium stearate. The capsule shell consists of titanium dioxide, sodium lauryl sulfate, and gelatin. The capsule is printed with edible ink containing black iron oxide. Meets USP dissolution test 2."
},
{
"NDCCode": "65862-290-18",
"PackageDescription": "180 CAPSULE in 1 BOTTLE (65862-290-18) ",
"NDC11Code": "65862-0290-18",
"ProductNDC": "65862-290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribavirin",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079117",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2024-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090917",
"SamplePackage": "N",
"IndicationAndUsage": "Ribavirin capsules are a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. (1.1). Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.",
"Description": "Ribavirin, is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see Figure 1). Figure 1: Structural FormulaRibavirin USP is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21. Ribavirin capsules USP consist of a white to off-white granular powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone-K 30, and magnesium stearate. The capsule shell consists of titanium dioxide, sodium lauryl sulfate, and gelatin. The capsule is printed with edible ink containing black iron oxide. Meets USP dissolution test 2."
},
{
"NDCCode": "65862-290-39",
"PackageDescription": "3000 CAPSULE in 1 BAG (65862-290-39) ",
"NDC11Code": "65862-0290-39",
"ProductNDC": "65862-290",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-02-08",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "17-SEP-09"
},
{
"NDCCode": "65862-290-42",
"PackageDescription": "42 CAPSULE in 1 BOTTLE (65862-290-42) ",
"NDC11Code": "65862-0290-42",
"ProductNDC": "65862-290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribavirin",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079117",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2024-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090917",
"SamplePackage": "N",
"IndicationAndUsage": "Ribavirin capsules are a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. (1.1). Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.",
"Description": "Ribavirin, is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see Figure 1). Figure 1: Structural FormulaRibavirin USP is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21. Ribavirin capsules USP consist of a white to off-white granular powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone-K 30, and magnesium stearate. The capsule shell consists of titanium dioxide, sodium lauryl sulfate, and gelatin. The capsule is printed with edible ink containing black iron oxide. Meets USP dissolution test 2."
},
{
"NDCCode": "65862-290-56",
"PackageDescription": "56 CAPSULE in 1 BOTTLE (65862-290-56) ",
"NDC11Code": "65862-0290-56",
"ProductNDC": "65862-290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribavirin",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079117",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2024-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090917",
"SamplePackage": "N",
"IndicationAndUsage": "Ribavirin capsules are a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. (1.1). Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.",
"Description": "Ribavirin, is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see Figure 1). Figure 1: Structural FormulaRibavirin USP is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21. Ribavirin capsules USP consist of a white to off-white granular powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone-K 30, and magnesium stearate. The capsule shell consists of titanium dioxide, sodium lauryl sulfate, and gelatin. The capsule is printed with edible ink containing black iron oxide. Meets USP dissolution test 2."
},
{
"NDCCode": "65862-290-70",
"PackageDescription": "70 CAPSULE in 1 BOTTLE (65862-290-70) ",
"NDC11Code": "65862-0290-70",
"ProductNDC": "65862-290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribavirin",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079117",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2024-02-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090917",
"SamplePackage": "N",
"IndicationAndUsage": "Ribavirin capsules are a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. (1.1). Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.",
"Description": "Ribavirin, is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see Figure 1). Figure 1: Structural FormulaRibavirin USP is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21. Ribavirin capsules USP consist of a white to off-white granular powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone-K 30, and magnesium stearate. The capsule shell consists of titanium dioxide, sodium lauryl sulfate, and gelatin. The capsule is printed with edible ink containing black iron oxide. Meets USP dissolution test 2."
},
{
"NDCCode": "65862-419-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (65862-419-01) ",
"NDC11Code": "65862-0419-01",
"ProductNDC": "65862-419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "400; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100216",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "65862-419-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (65862-419-05) ",
"NDC11Code": "65862-0419-05",
"ProductNDC": "65862-419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "400; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100216",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "65862-419-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (65862-419-20) ",
"NDC11Code": "65862-0419-20",
"ProductNDC": "65862-419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "400; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100216",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "65862-419-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (65862-419-99) ",
"NDC11Code": "65862-0419-99",
"ProductNDC": "65862-419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "400; 80",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100216",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "65862-420-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (65862-420-01) ",
"NDC11Code": "65862-0420-01",
"ProductNDC": "65862-420",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100216",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "65862-420-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (65862-420-05) ",
"NDC11Code": "65862-0420-05",
"ProductNDC": "65862-420",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100216",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "65862-420-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (65862-420-20) ",
"NDC11Code": "65862-0420-20",
"ProductNDC": "65862-420",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100216",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "65862-420-99",
"PackageDescription": "1000 TABLET in 1 BOTTLE (65862-420-99) ",
"NDC11Code": "65862-0420-99",
"ProductNDC": "65862-420",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100216",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "65862-496-01",
"PackageDescription": "100 mL in 1 BOTTLE (65862-496-01) ",
"NDC11Code": "65862-0496-01",
"ProductNDC": "65862-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20100608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091348",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "200; 40",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100608",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim oral suspension in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim oral suspension is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim oral suspension could offer some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia. For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler’s Diarrhea in Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim oral suspension, USP is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim in each teaspoonful (5 mL).Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Each teaspoonful (5 mL) of the oral suspension contains 200 mg sulfamethoxazole and 40 mg trimethoprim as well as the following inactive ingredients: alcohol 0.04% (v/v), carboxymethylcellulose sodium, citric acid anhydrous, colloidal silicon dioxide, FD&C Red #40, flavour cherry #557, glycerin, methyl paraben, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, saccharin sodium, sodium benzoate, and sorbitol solution."
},
{
"NDCCode": "65862-496-47",
"PackageDescription": "473 mL in 1 BOTTLE (65862-496-47) ",
"NDC11Code": "65862-0496-47",
"ProductNDC": "65862-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20100608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091348",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "200; 40",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100608",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim oral suspension in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim oral suspension is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim oral suspension could offer some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia. For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler’s Diarrhea in Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim oral suspension, USP is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim in each teaspoonful (5 mL).Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Each teaspoonful (5 mL) of the oral suspension contains 200 mg sulfamethoxazole and 40 mg trimethoprim as well as the following inactive ingredients: alcohol 0.04% (v/v), carboxymethylcellulose sodium, citric acid anhydrous, colloidal silicon dioxide, FD&C Red #40, flavour cherry #557, glycerin, methyl paraben, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, saccharin sodium, sodium benzoate, and sorbitol solution."
},
{
"NDCCode": "65862-496-50",
"PackageDescription": "50 mL in 1 BOTTLE (65862-496-50) ",
"NDC11Code": "65862-0496-50",
"ProductNDC": "65862-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20100608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091348",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "200; 40",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100608",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim oral suspension in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim oral suspension is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim oral suspension could offer some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia. For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler’s Diarrhea in Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim oral suspension, USP is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim in each teaspoonful (5 mL).Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Each teaspoonful (5 mL) of the oral suspension contains 200 mg sulfamethoxazole and 40 mg trimethoprim as well as the following inactive ingredients: alcohol 0.04% (v/v), carboxymethylcellulose sodium, citric acid anhydrous, colloidal silicon dioxide, FD&C Red #40, flavour cherry #557, glycerin, methyl paraben, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, saccharin sodium, sodium benzoate, and sorbitol solution."
},
{
"NDCCode": "65862-770-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (65862-770-05) / 5 mL in 1 BOTTLE",
"NDC11Code": "65862-0770-05",
"ProductNDC": "65862-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20201203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205190",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201203",
"SamplePackage": "N",
"IndicationAndUsage": "Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.",
"Description": "Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for topical ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure: Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution contains a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution contains: Active: ketorolac tromethamine USP 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; water for injection; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust pH."
},
{
"NDCCode": "65862-802-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (65862-802-05) / 5 mL in 1 BOTTLE",
"NDC11Code": "65862-0802-05",
"ProductNDC": "65862-802",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimatoprost",
"NonProprietaryName": "Bimatoprost",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20221006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205537",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "BIMATOPROST",
"StrengthNumber": ".3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2023-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221006",
"SamplePackage": "N",
"IndicationAndUsage": "Bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.",
"Description": "Bimatoprost ophthalmic solution 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is:. Bimatoprost is a white to off-white color powder, which is freely soluble in methanol and slightly soluble in water. Bimatoprost ophthalmic solution 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost ophthalmic solution 0.03% contains Active: bimatoprost 0.3 mg/mL; Inactives: benzalkonium chloride 0.05 mg/mL, citric acid monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8."
},
{
"NDCCode": "65862-802-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (65862-802-10) / 7.5 mL in 1 BOTTLE",
"NDC11Code": "65862-0802-10",
"ProductNDC": "65862-802",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimatoprost",
"NonProprietaryName": "Bimatoprost",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20221006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205537",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "BIMATOPROST",
"StrengthNumber": ".3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2023-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221006",
"SamplePackage": "N",
"IndicationAndUsage": "Bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.",
"Description": "Bimatoprost ophthalmic solution 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is:. Bimatoprost is a white to off-white color powder, which is freely soluble in methanol and slightly soluble in water. Bimatoprost ophthalmic solution 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost ophthalmic solution 0.03% contains Active: bimatoprost 0.3 mg/mL; Inactives: benzalkonium chloride 0.05 mg/mL, citric acid monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8."
},
{
"NDCCode": "65862-802-44",
"PackageDescription": "1 BOTTLE in 1 CARTON (65862-802-44) / 2.5 mL in 1 BOTTLE",
"NDC11Code": "65862-0802-44",
"ProductNDC": "65862-802",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bimatoprost",
"NonProprietaryName": "Bimatoprost",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20221006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205537",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "BIMATOPROST",
"StrengthNumber": ".3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Active",
"LastUpdate": "2023-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221006",
"SamplePackage": "N",
"IndicationAndUsage": "Bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.",
"Description": "Bimatoprost ophthalmic solution 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is:. Bimatoprost is a white to off-white color powder, which is freely soluble in methanol and slightly soluble in water. Bimatoprost ophthalmic solution 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost ophthalmic solution 0.03% contains Active: bimatoprost 0.3 mg/mL; Inactives: benzalkonium chloride 0.05 mg/mL, citric acid monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8."
},
{
"NDCCode": "65862-840-03",
"PackageDescription": "1 BOTTLE in 1 CARTON (65862-840-03) / 3 mL in 1 BOTTLE",
"NDC11Code": "65862-0840-03",
"ProductNDC": "65862-840",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moxifloxacin",
"NonProprietaryName": "Moxifloxacin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20171004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206242",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171004",
"SamplePackage": "N",
"IndicationAndUsage": "Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:Corynebacterium species*Micrococcus luteus*Staphylococcus aureusStaphylococcus epidermidisStaphylococcus haemolyticusStaphylococcus hominisStaphylococcus warneri*Streptococcus pneumoniaeStreptococcus viridans groupAcinetobacter lwoffii*Haemophilus influenzaHaemophilus parainfluenzae*Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections.",
"Description": "Moxifloxacin ophthalmic solution USP, 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride USP is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. The chemical name for moxifloxacin hydrochloride is 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro- 6H-pyrrolol[3,4b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. The molecular formula for moxifloxacin hydrochloride is C21H24FN3O4HCl and its molecular weight is 437.9 g/mol. The chemical structure is presented below: Moxifloxacin hydrochloride USP is a slightly yellow to yellow powder or crystals, slightly hygroscopic. Each mL of moxifloxacin ophthalmic solution, USP contains 5.45 mg moxifloxacin hydrochloride USP, equivalent to 5 mg moxifloxacin base. Moxifloxacin ophthalmic solution, USP contains Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and water for injection. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8. Moxifloxacin ophthalmic solution, USP is an isotonic solution with an osmolality of approximately 290 mOsm/kg."
},
{
"NDCCode": "0173-0675-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0173-0675-01) ",
"NDC11Code": "00173-0675-01",
"ProductNDC": "0173-0675",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Malarone",
"NonProprietaryName": "Atovaquone And Proguanil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000726",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021078",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "ATOVAQUONE; PROGUANIL HYDROCHLORIDE",
"StrengthNumber": "250; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20000726",
"SamplePackage": "N",
"IndicationAndUsage": "MALARONE is an antimalarial indicated for: 1 prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. (1.1), 2 treatment of acute, uncomplicated P. falciparum malaria. (1.2).",
"Description": "MALARONE (atovaquone and proguanil hydrochloride) tablets (adult strength) and MALARONE (atovaquone and proguanil hydrochloride) pediatric tablets, for oral administration, contain a fixed‑dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is trans‑2‑[4‑(4‑chlorophenyl) cyclohexyl]‑3‑hydroxy‑1,4‑naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. The chemical name of proguanil hydrochloride is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride is a white crystalline solid that is sparingly soluble in water. It has a molecular weight of 290.22 and the molecular formula C11H16ClN5HCl. The compound has the following structural formula. Each MALARONE tablet (adult strength) contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride (equivalent to 87.4 mg of proguanil). Each MALARONE pediatric tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride (equivalent to 21.9 mg of proguanil). The inactive ingredients in both tablets are low‑substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone K30, and sodium starch glycolate. The tablet coating contains hypromellose, polyethylene glycol 400, polyethylene glycol 8000, red iron oxide, and titanium dioxide."
},
{
"NDCCode": "0173-0675-02",
"PackageDescription": "24 TABLET, FILM COATED in 1 DOSE PACK (0173-0675-02) ",
"NDC11Code": "00173-0675-02",
"ProductNDC": "0173-0675",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Malarone",
"NonProprietaryName": "Atovaquone And Proguanil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000726",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021078",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "ATOVAQUONE; PROGUANIL HYDROCHLORIDE",
"StrengthNumber": "250; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20000726",
"SamplePackage": "N",
"IndicationAndUsage": "MALARONE is an antimalarial indicated for: 1 prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. (1.1), 2 treatment of acute, uncomplicated P. falciparum malaria. (1.2).",
"Description": "MALARONE (atovaquone and proguanil hydrochloride) tablets (adult strength) and MALARONE (atovaquone and proguanil hydrochloride) pediatric tablets, for oral administration, contain a fixed‑dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is trans‑2‑[4‑(4‑chlorophenyl) cyclohexyl]‑3‑hydroxy‑1,4‑naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. The chemical name of proguanil hydrochloride is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride is a white crystalline solid that is sparingly soluble in water. It has a molecular weight of 290.22 and the molecular formula C11H16ClN5HCl. The compound has the following structural formula. Each MALARONE tablet (adult strength) contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride (equivalent to 87.4 mg of proguanil). Each MALARONE pediatric tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride (equivalent to 21.9 mg of proguanil). The inactive ingredients in both tablets are low‑substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone K30, and sodium starch glycolate. The tablet coating contains hypromellose, polyethylene glycol 400, polyethylene glycol 8000, red iron oxide, and titanium dioxide."
},
{
"NDCCode": "0173-0676-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0173-0676-01) ",
"NDC11Code": "00173-0676-01",
"ProductNDC": "0173-0676",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Malarone",
"NonProprietaryName": "Atovaquone And Proguanil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000726",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021078",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "ATOVAQUONE; PROGUANIL HYDROCHLORIDE",
"StrengthNumber": "62.5; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20000726",
"SamplePackage": "N",
"IndicationAndUsage": "MALARONE is an antimalarial indicated for: 1 prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. (1.1), 2 treatment of acute, uncomplicated P. falciparum malaria. (1.2).",
"Description": "MALARONE (atovaquone and proguanil hydrochloride) tablets (adult strength) and MALARONE (atovaquone and proguanil hydrochloride) pediatric tablets, for oral administration, contain a fixed‑dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is trans‑2‑[4‑(4‑chlorophenyl) cyclohexyl]‑3‑hydroxy‑1,4‑naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. The chemical name of proguanil hydrochloride is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride is a white crystalline solid that is sparingly soluble in water. It has a molecular weight of 290.22 and the molecular formula C11H16ClN5HCl. The compound has the following structural formula. Each MALARONE tablet (adult strength) contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride (equivalent to 87.4 mg of proguanil). Each MALARONE pediatric tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride (equivalent to 21.9 mg of proguanil). The inactive ingredients in both tablets are low‑substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone K30, and sodium starch glycolate. The tablet coating contains hypromellose, polyethylene glycol 400, polyethylene glycol 8000, red iron oxide, and titanium dioxide."
},
{
"NDCCode": "0378-4160-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4160-01) ",
"NDC11Code": "00378-4160-01",
"ProductNDC": "0378-4160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atovaquone And Proguanil Hydrochloride",
"NonProprietaryName": "Atovaquone And Proguanil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202362",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ATOVAQUONE; PROGUANIL HYDROCHLORIDE",
"StrengthNumber": "62.5; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140528",
"SamplePackage": "N",
"IndicationAndUsage": "Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for: 1 prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. (1.1), 2 treatment of acute, uncomplicated P. falciparum malaria. (1.2).",
"Description": "Atovaquone and proguanil hydrochloride tablets (adult strength) and atovaquone and proguanil hydrochloride pediatric tablets, for oral administration, contain a fixed-dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is 2-[trans-4-(p-Chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthoquinone. Atovaquone, USP is a yellow powder that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. The chemical name of proguanil hydrochloride is 1-(4-chlorophenyl)-5-(1-methylethyl)biguanide hydrochloride. Proguanil hydrochloride, USP is a white crystalline powder that is sparingly soluble in water. It has a molecular weight of 290.19 and the molecular formula C11H16ClN5HCl. The compound has the following structural formula. Each atovaquone and proguanil hydrochloride tablet (adult strength) contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride (equivalent to 87.4 mg of proguanil). Each atovaquone and proguanil hydrochloride pediatric tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride (equivalent to 21.9 mg of proguanil). The inactive ingredients in both tablets are black iron oxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, povidone, red iron oxide, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "0378-4162-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4162-01) ",
"NDC11Code": "00378-4162-01",
"ProductNDC": "0378-4162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atovaquone And Proguanil Hydrochloride",
"NonProprietaryName": "Atovaquone And Proguanil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202362",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ATOVAQUONE; PROGUANIL HYDROCHLORIDE",
"StrengthNumber": "250; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140528",
"SamplePackage": "N",
"IndicationAndUsage": "Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for: 1 prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. (1.1), 2 treatment of acute, uncomplicated P. falciparum malaria. (1.2).",
"Description": "Atovaquone and proguanil hydrochloride tablets (adult strength) and atovaquone and proguanil hydrochloride pediatric tablets, for oral administration, contain a fixed-dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is 2-[trans-4-(p-Chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthoquinone. Atovaquone, USP is a yellow powder that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. The chemical name of proguanil hydrochloride is 1-(4-chlorophenyl)-5-(1-methylethyl)biguanide hydrochloride. Proguanil hydrochloride, USP is a white crystalline powder that is sparingly soluble in water. It has a molecular weight of 290.19 and the molecular formula C11H16ClN5HCl. The compound has the following structural formula. Each atovaquone and proguanil hydrochloride tablet (adult strength) contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride (equivalent to 87.4 mg of proguanil). Each atovaquone and proguanil hydrochloride pediatric tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride (equivalent to 21.9 mg of proguanil). The inactive ingredients in both tablets are black iron oxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, povidone, red iron oxide, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "10544-576-84",
"PackageDescription": "84 TABLET in 1 BOTTLE (10544-576-84)",
"NDC11Code": "10544-0576-84",
"ProductNDC": "10544-576",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076533",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].",
"Description": "Tizanidine hydrochloride is a central alpha2-adrenergic agonist. Tizanidine HCl (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole hydrochloride. Tizanidine’s molecular formula is C9H8ClN5S-HCl, its molecular weight is 290.2 and its structural formula is. Tizanidine Tablets, USP are supplied as 2, and 4 mg tablets for oral administration. Tizanidine Tablets, USP are composed of the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base, and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose and stearic acid. Dissolution Test 2."
},
{
"NDCCode": "10544-863-84",
"PackageDescription": "84 TABLET in 1 BOTTLE (10544-863-84)",
"NDC11Code": "10544-0863-84",
"ProductNDC": "10544-863",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076533",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].",
"Description": "Tizanidine hydrochloride is a central alpha 2-adrenergic agonist. Tizanidine HCl (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole hydrochloride. Tizanidine’s molecular formula is C 9H 8ClN 5S-HCl, its molecular weight is 290.2 and its structural formula is:. Tizanidine Tablets, USP are supplied as 2, and 4 mg tablets for oral administration. Tizanidine Tablets, USP are composed of the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base, and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose and stearic acid. Dissolution Test 2."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>65862-290-84</NDCCode>
<PackageDescription>84 CAPSULE in 1 BOTTLE (65862-290-84) </PackageDescription>
<NDC11Code>65862-0290-84</NDC11Code>
<ProductNDC>65862-290</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ribavirin</ProprietaryName>
<NonProprietaryName>Ribavirin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079117</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>RIBAVIRIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
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<LastUpdate>2024-02-08</LastUpdate>
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<IndicationAndUsage>Ribavirin capsules are a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. (1.1). Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.</IndicationAndUsage>
<Description>Ribavirin, is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see Figure 1). Figure 1: Structural FormulaRibavirin USP is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21. Ribavirin capsules USP consist of a white to off-white granular powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone-K 30, and magnesium stearate. The capsule shell consists of titanium dioxide, sodium lauryl sulfate, and gelatin. The capsule is printed with edible ink containing black iron oxide. Meets USP dissolution test 2.</Description>
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<IndicationAndUsage>Ribavirin capsules are a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. (1.1). Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.</IndicationAndUsage>
<Description>Ribavirin, is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see Figure 1). Figure 1: Structural FormulaRibavirin USP is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21. Ribavirin capsules USP consist of a white to off-white granular powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone-K 30, and magnesium stearate. The capsule shell consists of titanium dioxide, sodium lauryl sulfate, and gelatin. The capsule is printed with edible ink containing black iron oxide. Meets USP dissolution test 2.</Description>
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<IndicationAndUsage>Ribavirin capsules are a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. (1.1). Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.</IndicationAndUsage>
<Description>Ribavirin, is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see Figure 1). Figure 1: Structural FormulaRibavirin USP is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21. Ribavirin capsules USP consist of a white to off-white granular powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone-K 30, and magnesium stearate. The capsule shell consists of titanium dioxide, sodium lauryl sulfate, and gelatin. The capsule is printed with edible ink containing black iron oxide. Meets USP dissolution test 2.</Description>
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<StartMarketingDatePackage>17-SEP-09</StartMarketingDatePackage>
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<IndicationAndUsage>Ribavirin capsules are a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. (1.1). Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.</IndicationAndUsage>
<Description>Ribavirin, is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see Figure 1). Figure 1: Structural FormulaRibavirin USP is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21. Ribavirin capsules USP consist of a white to off-white granular powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone-K 30, and magnesium stearate. The capsule shell consists of titanium dioxide, sodium lauryl sulfate, and gelatin. The capsule is printed with edible ink containing black iron oxide. Meets USP dissolution test 2.</Description>
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<IndicationAndUsage>Ribavirin capsules are a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. (1.1). Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.</IndicationAndUsage>
<Description>Ribavirin, is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see Figure 1). Figure 1: Structural FormulaRibavirin USP is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21. Ribavirin capsules USP consist of a white to off-white granular powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone-K 30, and magnesium stearate. The capsule shell consists of titanium dioxide, sodium lauryl sulfate, and gelatin. The capsule is printed with edible ink containing black iron oxide. Meets USP dissolution test 2.</Description>
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<IndicationAndUsage>Ribavirin capsules are a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. (1.1). Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection.</IndicationAndUsage>
<Description>Ribavirin, is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see Figure 1). Figure 1: Structural FormulaRibavirin USP is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The molecular formula is C8H12N4O5 and the molecular weight is 244.21. Ribavirin capsules USP consist of a white to off-white granular powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, povidone-K 30, and magnesium stearate. The capsule shell consists of titanium dioxide, sodium lauryl sulfate, and gelatin. The capsule is printed with edible ink containing black iron oxide. Meets USP dissolution test 2.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate.</Description>
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate.</Description>
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<StrengthUnit>mg/1; mg/1</StrengthUnit>
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<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate.</Description>
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<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate.</Description>
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<Description>Sulfamethoxazole and trimethoprim oral suspension, USP is a synthetic antibacterial combination product containing 200 mg sulfamethoxazole and 40 mg trimethoprim in each teaspoonful (5 mL).Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Each teaspoonful (5 mL) of the oral suspension contains 200 mg sulfamethoxazole and 40 mg trimethoprim as well as the following inactive ingredients: alcohol 0.04% (v/v), carboxymethylcellulose sodium, citric acid anhydrous, colloidal silicon dioxide, FD&C Red #40, flavour cherry #557, glycerin, methyl paraben, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, saccharin sodium, sodium benzoate, and sorbitol solution.</Description>
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<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20201203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205190</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.</IndicationAndUsage>
<Description>Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for topical ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure: Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution contains a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution contains: Active: ketorolac tromethamine USP 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; water for injection; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>65862-802-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65862-802-05) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>65862-0802-05</NDC11Code>
<ProductNDC>65862-802</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimatoprost</ProprietaryName>
<NonProprietaryName>Bimatoprost</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20221006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205537</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>BIMATOPROST</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.</IndicationAndUsage>
<Description>Bimatoprost ophthalmic solution 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is:. Bimatoprost is a white to off-white color powder, which is freely soluble in methanol and slightly soluble in water. Bimatoprost ophthalmic solution 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost ophthalmic solution 0.03% contains Active: bimatoprost 0.3 mg/mL; Inactives: benzalkonium chloride 0.05 mg/mL, citric acid monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>65862-802-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65862-802-10) / 7.5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>65862-0802-10</NDC11Code>
<ProductNDC>65862-802</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimatoprost</ProprietaryName>
<NonProprietaryName>Bimatoprost</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20221006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205537</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>BIMATOPROST</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.</IndicationAndUsage>
<Description>Bimatoprost ophthalmic solution 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is:. Bimatoprost is a white to off-white color powder, which is freely soluble in methanol and slightly soluble in water. Bimatoprost ophthalmic solution 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost ophthalmic solution 0.03% contains Active: bimatoprost 0.3 mg/mL; Inactives: benzalkonium chloride 0.05 mg/mL, citric acid monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>65862-802-44</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65862-802-44) / 2.5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>65862-0802-44</NDC11Code>
<ProductNDC>65862-802</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bimatoprost</ProprietaryName>
<NonProprietaryName>Bimatoprost</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20221006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205537</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>BIMATOPROST</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.</IndicationAndUsage>
<Description>Bimatoprost ophthalmic solution 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is:. Bimatoprost is a white to off-white color powder, which is freely soluble in methanol and slightly soluble in water. Bimatoprost ophthalmic solution 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost ophthalmic solution 0.03% contains Active: bimatoprost 0.3 mg/mL; Inactives: benzalkonium chloride 0.05 mg/mL, citric acid monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>65862-840-03</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65862-840-03) / 3 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>65862-0840-03</NDC11Code>
<ProductNDC>65862-840</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moxifloxacin</ProprietaryName>
<NonProprietaryName>Moxifloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20171004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206242</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:Corynebacterium species*Micrococcus luteus*Staphylococcus aureusStaphylococcus epidermidisStaphylococcus haemolyticusStaphylococcus hominisStaphylococcus warneri*Streptococcus pneumoniaeStreptococcus viridans groupAcinetobacter lwoffii*Haemophilus influenzaHaemophilus parainfluenzae*Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections.</IndicationAndUsage>
<Description>Moxifloxacin ophthalmic solution USP, 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride USP is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. The chemical name for moxifloxacin hydrochloride is 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro- 6H-pyrrolol[3,4b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. The molecular formula for moxifloxacin hydrochloride is C21H24FN3O4HCl and its molecular weight is 437.9 g/mol. The chemical structure is presented below: Moxifloxacin hydrochloride USP is a slightly yellow to yellow powder or crystals, slightly hygroscopic. Each mL of moxifloxacin ophthalmic solution, USP contains 5.45 mg moxifloxacin hydrochloride USP, equivalent to 5 mg moxifloxacin base. Moxifloxacin ophthalmic solution, USP contains Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and water for injection. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8. Moxifloxacin ophthalmic solution, USP is an isotonic solution with an osmolality of approximately 290 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>0173-0675-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0173-0675-01) </PackageDescription>
<NDC11Code>00173-0675-01</NDC11Code>
<ProductNDC>0173-0675</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Malarone</ProprietaryName>
<NonProprietaryName>Atovaquone And Proguanil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000726</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021078</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>ATOVAQUONE; PROGUANIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MALARONE is an antimalarial indicated for: 1 prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. (1.1), 2 treatment of acute, uncomplicated P. falciparum malaria. (1.2).</IndicationAndUsage>
<Description>MALARONE (atovaquone and proguanil hydrochloride) tablets (adult strength) and MALARONE (atovaquone and proguanil hydrochloride) pediatric tablets, for oral administration, contain a fixed‑dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is trans‑2‑[4‑(4‑chlorophenyl) cyclohexyl]‑3‑hydroxy‑1,4‑naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. The chemical name of proguanil hydrochloride is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride is a white crystalline solid that is sparingly soluble in water. It has a molecular weight of 290.22 and the molecular formula C11H16ClN5HCl. The compound has the following structural formula. Each MALARONE tablet (adult strength) contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride (equivalent to 87.4 mg of proguanil). Each MALARONE pediatric tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride (equivalent to 21.9 mg of proguanil). The inactive ingredients in both tablets are low‑substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone K30, and sodium starch glycolate. The tablet coating contains hypromellose, polyethylene glycol 400, polyethylene glycol 8000, red iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0173-0675-02</NDCCode>
<PackageDescription>24 TABLET, FILM COATED in 1 DOSE PACK (0173-0675-02) </PackageDescription>
<NDC11Code>00173-0675-02</NDC11Code>
<ProductNDC>0173-0675</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Malarone</ProprietaryName>
<NonProprietaryName>Atovaquone And Proguanil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000726</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021078</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>ATOVAQUONE; PROGUANIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MALARONE is an antimalarial indicated for: 1 prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. (1.1), 2 treatment of acute, uncomplicated P. falciparum malaria. (1.2).</IndicationAndUsage>
<Description>MALARONE (atovaquone and proguanil hydrochloride) tablets (adult strength) and MALARONE (atovaquone and proguanil hydrochloride) pediatric tablets, for oral administration, contain a fixed‑dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is trans‑2‑[4‑(4‑chlorophenyl) cyclohexyl]‑3‑hydroxy‑1,4‑naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. The chemical name of proguanil hydrochloride is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride is a white crystalline solid that is sparingly soluble in water. It has a molecular weight of 290.22 and the molecular formula C11H16ClN5HCl. The compound has the following structural formula. Each MALARONE tablet (adult strength) contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride (equivalent to 87.4 mg of proguanil). Each MALARONE pediatric tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride (equivalent to 21.9 mg of proguanil). The inactive ingredients in both tablets are low‑substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone K30, and sodium starch glycolate. The tablet coating contains hypromellose, polyethylene glycol 400, polyethylene glycol 8000, red iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0173-0676-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0173-0676-01) </PackageDescription>
<NDC11Code>00173-0676-01</NDC11Code>
<ProductNDC>0173-0676</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Malarone</ProprietaryName>
<NonProprietaryName>Atovaquone And Proguanil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000726</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021078</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>ATOVAQUONE; PROGUANIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>62.5; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MALARONE is an antimalarial indicated for: 1 prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. (1.1), 2 treatment of acute, uncomplicated P. falciparum malaria. (1.2).</IndicationAndUsage>
<Description>MALARONE (atovaquone and proguanil hydrochloride) tablets (adult strength) and MALARONE (atovaquone and proguanil hydrochloride) pediatric tablets, for oral administration, contain a fixed‑dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is trans‑2‑[4‑(4‑chlorophenyl) cyclohexyl]‑3‑hydroxy‑1,4‑naphthalenedione. Atovaquone is a yellow crystalline solid that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. The chemical name of proguanil hydrochloride is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride is a white crystalline solid that is sparingly soluble in water. It has a molecular weight of 290.22 and the molecular formula C11H16ClN5HCl. The compound has the following structural formula. Each MALARONE tablet (adult strength) contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride (equivalent to 87.4 mg of proguanil). Each MALARONE pediatric tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride (equivalent to 21.9 mg of proguanil). The inactive ingredients in both tablets are low‑substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, povidone K30, and sodium starch glycolate. The tablet coating contains hypromellose, polyethylene glycol 400, polyethylene glycol 8000, red iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0378-4160-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4160-01) </PackageDescription>
<NDC11Code>00378-4160-01</NDC11Code>
<ProductNDC>0378-4160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atovaquone And Proguanil Hydrochloride</ProprietaryName>
<NonProprietaryName>Atovaquone And Proguanil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202362</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ATOVAQUONE; PROGUANIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>62.5; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for: 1 prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. (1.1), 2 treatment of acute, uncomplicated P. falciparum malaria. (1.2).</IndicationAndUsage>
<Description>Atovaquone and proguanil hydrochloride tablets (adult strength) and atovaquone and proguanil hydrochloride pediatric tablets, for oral administration, contain a fixed-dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is 2-[trans-4-(p-Chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthoquinone. Atovaquone, USP is a yellow powder that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. The chemical name of proguanil hydrochloride is 1-(4-chlorophenyl)-5-(1-methylethyl)biguanide hydrochloride. Proguanil hydrochloride, USP is a white crystalline powder that is sparingly soluble in water. It has a molecular weight of 290.19 and the molecular formula C11H16ClN5HCl. The compound has the following structural formula. Each atovaquone and proguanil hydrochloride tablet (adult strength) contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride (equivalent to 87.4 mg of proguanil). Each atovaquone and proguanil hydrochloride pediatric tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride (equivalent to 21.9 mg of proguanil). The inactive ingredients in both tablets are black iron oxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, povidone, red iron oxide, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0378-4162-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4162-01) </PackageDescription>
<NDC11Code>00378-4162-01</NDC11Code>
<ProductNDC>0378-4162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atovaquone And Proguanil Hydrochloride</ProprietaryName>
<NonProprietaryName>Atovaquone And Proguanil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202362</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ATOVAQUONE; PROGUANIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for: 1 prophylaxis of Plasmodium falciparum (P. falciparum) malaria, including in areas where chloroquine resistance has been reported. (1.1), 2 treatment of acute, uncomplicated P. falciparum malaria. (1.2).</IndicationAndUsage>
<Description>Atovaquone and proguanil hydrochloride tablets (adult strength) and atovaquone and proguanil hydrochloride pediatric tablets, for oral administration, contain a fixed-dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is 2-[trans-4-(p-Chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthoquinone. Atovaquone, USP is a yellow powder that is practically insoluble in water. It has a molecular weight of 366.84 and the molecular formula C22H19ClO3. The compound has the following structural formula. The chemical name of proguanil hydrochloride is 1-(4-chlorophenyl)-5-(1-methylethyl)biguanide hydrochloride. Proguanil hydrochloride, USP is a white crystalline powder that is sparingly soluble in water. It has a molecular weight of 290.19 and the molecular formula C11H16ClN5HCl. The compound has the following structural formula. Each atovaquone and proguanil hydrochloride tablet (adult strength) contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride (equivalent to 87.4 mg of proguanil). Each atovaquone and proguanil hydrochloride pediatric tablet contains 62.5 mg of atovaquone and 25 mg of proguanil hydrochloride (equivalent to 21.9 mg of proguanil). The inactive ingredients in both tablets are black iron oxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, povidone, red iron oxide, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>10544-576-84</NDCCode>
<PackageDescription>84 TABLET in 1 BOTTLE (10544-576-84)</PackageDescription>
<NDC11Code>10544-0576-84</NDC11Code>
<ProductNDC>10544-576</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076533</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].</IndicationAndUsage>
<Description>Tizanidine hydrochloride is a central alpha2-adrenergic agonist. Tizanidine HCl (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole hydrochloride. Tizanidine’s molecular formula is C9H8ClN5S-HCl, its molecular weight is 290.2 and its structural formula is. Tizanidine Tablets, USP are supplied as 2, and 4 mg tablets for oral administration. Tizanidine Tablets, USP are composed of the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base, and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose and stearic acid. Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>10544-863-84</NDCCode>
<PackageDescription>84 TABLET in 1 BOTTLE (10544-863-84)</PackageDescription>
<NDC11Code>10544-0863-84</NDC11Code>
<ProductNDC>10544-863</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076533</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].</IndicationAndUsage>
<Description>Tizanidine hydrochloride is a central alpha 2-adrenergic agonist. Tizanidine HCl (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole hydrochloride. Tizanidine’s molecular formula is C 9H 8ClN 5S-HCl, its molecular weight is 290.2 and its structural formula is:. Tizanidine Tablets, USP are supplied as 2, and 4 mg tablets for oral administration. Tizanidine Tablets, USP are composed of the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base, and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose and stearic acid. Dissolution Test 2.</Description>
</NDC>
</NDCList>