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{
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"StartMarketingDate": "20200701",
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"LabelerName": "Cumberland Pharmaceuticals Inc.",
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"StrengthUnit": "mg/.9mL",
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"LastUpdate": "2023-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N"
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{
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"PackageDescription": "4 CARTON in 1 CASE (69605-807-22) > 1 SYRINGE in 1 CARTON (69605-807-11) > .3 mL in 1 SYRINGE",
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"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
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"LastUpdate": "2022-02-23",
"PackageNdcExcludeFlag": "N",
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{
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"PackageDescription": "4 CARTON in 1 CASE (69605-810-22) > 1 SYRINGE in 1 CARTON (69605-810-11) > .4 mL in 1 SYRINGE",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210737",
"LabelerName": "CENEXI - BLA",
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"StrengthUnit": "mg/.4mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N"
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{
"NDCCode": "69605-812-22",
"PackageDescription": "4 CARTON in 1 CASE (69605-812-22) > 1 SYRINGE in 1 CARTON (69605-812-11) > .5 mL in 1 SYRINGE",
"NDC11Code": "69605-0812-22",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reditrex",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210737",
"LabelerName": "CENEXI - BLA",
"SubstanceName": "METHOTREXATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N"
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{
"NDCCode": "69605-815-22",
"PackageDescription": "4 CARTON in 1 CASE (69605-815-22) > 1 SYRINGE in 1 CARTON (69605-815-11) > .6 mL in 1 SYRINGE",
"NDC11Code": "69605-0815-22",
"ProductNDC": "69605-815",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reditrex",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210737",
"LabelerName": "CENEXI - BLA",
"SubstanceName": "METHOTREXATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/.6mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N"
},
{
"NDCCode": "69605-817-22",
"PackageDescription": "4 CARTON in 1 CASE (69605-817-22) > 1 SYRINGE in 1 CARTON (69605-817-11) > .7 mL in 1 SYRINGE",
"NDC11Code": "69605-0817-22",
"ProductNDC": "69605-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reditrex",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210737",
"LabelerName": "CENEXI - BLA",
"SubstanceName": "METHOTREXATE",
"StrengthNumber": "17.5",
"StrengthUnit": "mg/.7mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N"
},
{
"NDCCode": "69605-820-22",
"PackageDescription": "4 CARTON in 1 CASE (69605-820-22) > 1 SYRINGE in 1 CARTON (69605-820-11) > .8 mL in 1 SYRINGE",
"NDC11Code": "69605-0820-22",
"ProductNDC": "69605-820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reditrex",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210737",
"LabelerName": "CENEXI - BLA",
"SubstanceName": "METHOTREXATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/.8mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N"
},
{
"NDCCode": "69605-825-22",
"PackageDescription": "4 CARTON in 1 CASE (69605-825-22) > 1 SYRINGE in 1 CARTON (69605-825-11) > 1 mL in 1 SYRINGE",
"NDC11Code": "69605-0825-22",
"ProductNDC": "69605-825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reditrex",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210737",
"LabelerName": "CENEXI - BLA",
"SubstanceName": "METHOTREXATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-02-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N"
},
{
"NDCCode": "69605-600-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (69605-600-10) > 10 mL in 1 VIAL, SINGLE-DOSE (69605-600-07) ",
"NDC11Code": "69605-0600-10",
"ProductNDC": "69605-600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arsenic Trioxide",
"NonProprietaryName": "Arsenic Trioxide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20181119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209780",
"LabelerName": "Cenexi - BLA",
"SubstanceName": "ARSENIC TRIOXIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20181119",
"SamplePackage": "N"
},
{
"NDCCode": "0068-0597-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0068-0597-01) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00068-0597-01",
"ProductNDC": "0068-0597",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifadin Iv",
"NonProprietaryName": "Rifampin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19890525",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050627",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19890525",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "RIFADIN (rifampin capsules USP) for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. RIFADIN IV (rifampin for injection USP) contains rifampin 600 mg, sodium formaldehyde sulfoxylate 10 mg, and sodium hydroxide to adjust pH. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is."
},
{
"NDCCode": "0068-0599-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0068-0599-01) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00068-0599-01",
"ProductNDC": "0068-0599",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifadin Iv Novaplus",
"NonProprietaryName": "Rifampin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170201",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050627",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170201",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "RIFADIN (rifampin capsules USP) for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. RIFADIN IV (rifampin for injection USP) contains rifampin 600 mg, sodium formaldehyde sulfoxylate 10 mg, and sodium hydroxide to adjust pH. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-Hexahydroxy-23-methoxy-2,4,12,16,18,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is."
},
{
"NDCCode": "0143-9230-01",
"PackageDescription": "1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9230-01) ",
"NDC11Code": "00143-9230-01",
"ProductNDC": "0143-9230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205039",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Active",
"LastUpdate": "2022-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160303",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to Rifampin for Injection, USP and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to Rifampin for Injection, USP and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin for Injection, USP contains rifampin 600 mg, sodium formaldehyde sulfoxylate 10 mg, and sodium hydroxide to adjust pH. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22– heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is."
},
{
"NDCCode": "0185-0799-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0185-0799-01) ",
"NDC11Code": "00185-0799-01",
"ProductNDC": "0185-0799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19970528",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064150",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970528",
"EndMarketingDatePackage": "20250301",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22-. heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca. [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
},
{
"NDCCode": "0185-0799-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (0185-0799-05) ",
"NDC11Code": "00185-0799-05",
"ProductNDC": "0185-0799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19970528",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064150",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970528",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22-. heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca. [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
},
{
"NDCCode": "0185-0799-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0185-0799-30) ",
"NDC11Code": "00185-0799-30",
"ProductNDC": "0185-0799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19970528",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064150",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970528",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22-. heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca. [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
},
{
"NDCCode": "0185-0799-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0185-0799-60) ",
"NDC11Code": "00185-0799-60",
"ProductNDC": "0185-0799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19970528",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064150",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970528",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22-. heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca. [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
},
{
"NDCCode": "0185-0801-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0185-0801-01) ",
"NDC11Code": "00185-0801-01",
"ProductNDC": "0185-0801",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980102",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064150",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19980102",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22-. heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca. [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
},
{
"NDCCode": "0185-0801-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0185-0801-30) ",
"NDC11Code": "00185-0801-30",
"ProductNDC": "0185-0801",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19980102",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064150",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19980102",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22-. heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca. [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
},
{
"NDCCode": "0904-7315-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7315-61) / 1 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00904-7315-61",
"ProductNDC": "0904-7315",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090034",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250225",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin Capsules USP for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, crospovidone, D & C Red no. 28, FD & C Blue no. 1, FD & C Red no. 40, gelatin, magnesium stearate, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium lauryl sulphate and titanium dioxide. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is."
},
{
"NDCCode": "17478-151-42",
"PackageDescription": "1 VIAL in 1 BOX, UNIT-DOSE (17478-151-42) > 10 mL in 1 VIAL",
"NDC11Code": "17478-0151-42",
"ProductNDC": "17478-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065502",
"LabelerName": "Akorn",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120601",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin for injection USP contains rifampin 600 mg, sodium formaldehyde sulfoxylate dihydrate 10 mg, and sodium hydroxide to adjust pH. Rifampin for injection is a sterile, lyophilized powder for intravenous infusion only. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7- (epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is."
},
{
"NDCCode": "21695-527-15",
"PackageDescription": "15 CAPSULE in 1 BOTTLE (21695-527-15)",
"NDC11Code": "21695-0527-15",
"ProductNDC": "21695-527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19970528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064150",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC],Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin capsule and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-Methyl-1-piperazinyl) imino]-methyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino) naphtho [2,1-b]furan-1,11(2H)-dione 21-acetate. The structural formula is. Rifampin capsules for oral administration contain 150 mg or 300 mg rifampin per capsule. In addition, the 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, calcium stearate, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, synthetic black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain, D&C yellow #10, D&C Red #28."
},
{
"NDCCode": "21695-527-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (21695-527-20)",
"NDC11Code": "21695-0527-20",
"ProductNDC": "21695-527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19970528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064150",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC],Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin capsule and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-Methyl-1-piperazinyl) imino]-methyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino) naphtho [2,1-b]furan-1,11(2H)-dione 21-acetate. The structural formula is. Rifampin capsules for oral administration contain 150 mg or 300 mg rifampin per capsule. In addition, the 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, calcium stearate, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, synthetic black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain, D&C yellow #10, D&C Red #28."
},
{
"NDCCode": "21695-527-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (21695-527-30)",
"NDC11Code": "21695-0527-30",
"ProductNDC": "21695-527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19970528",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064150",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC],Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin capsule and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-Methyl-1-piperazinyl) imino]-methyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino) naphtho [2,1-b]furan-1,11(2H)-dione 21-acetate. The structural formula is. Rifampin capsules for oral administration contain 150 mg or 300 mg rifampin per capsule. In addition, the 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, calcium stearate, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, synthetic black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain, D&C yellow #10, D&C Red #28."
},
{
"NDCCode": "24658-801-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (24658-801-30) ",
"NDC11Code": "24658-0801-30",
"ProductNDC": "24658-801",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064150",
"LabelerName": "PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230314",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
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"LabelerName": "PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS",
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"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
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{
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"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "RIFAMPIN",
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"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin capsules, USP for oral administration contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules contain a powder that is brick-red in color. The 150 mg and 300 mg capsules also contain, as inactive ingredients: pregelatinized starch, colloidal silicon dioxide, talc, magnesium stearate, D&C Red # 28, FD&C Blue # 1, FD&C Red # 40, gelatin, and titanium dioxide. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycinor5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22– heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is."
},
{
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"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
},
{
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"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
},
{
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"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
}
]
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<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2022-02-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-02-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arsenic Trioxide</ProprietaryName>
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<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Cenexi - BLA</LabelerName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<PackageDescription>1 VIAL, GLASS in 1 CARTON (0068-0597-01) / 10 mL in 1 VIAL, GLASS</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifadin Iv</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
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<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050627</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19890525</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>RIFADIN (rifampin capsules USP) for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. RIFADIN IV (rifampin for injection USP) contains rifampin 600 mg, sodium formaldehyde sulfoxylate 10 mg, and sodium hydroxide to adjust pH. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is.</Description>
</NDC>
<NDC>
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<PackageDescription>1 VIAL, GLASS in 1 CARTON (0068-0599-01) / 10 mL in 1 VIAL, GLASS</PackageDescription>
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<ProductNDC>0068-0599</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifadin Iv Novaplus</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050627</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>RIFADIN (rifampin capsules USP) for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide. RIFADIN IV (rifampin for injection USP) contains rifampin 600 mg, sodium formaldehyde sulfoxylate 10 mg, and sodium hydroxide to adjust pH. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-Hexahydroxy-23-methoxy-2,4,12,16,18,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0143-9230-01</NDCCode>
<PackageDescription>1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9230-01) </PackageDescription>
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<ProductNDC>0143-9230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205039</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to Rifampin for Injection, USP and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to Rifampin for Injection, USP and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin for Injection, USP contains rifampin 600 mg, sodium formaldehyde sulfoxylate 10 mg, and sodium hydroxide to adjust pH. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22– heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0185-0799-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0185-0799-01) </PackageDescription>
<NDC11Code>00185-0799-01</NDC11Code>
<ProductNDC>0185-0799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970528</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970528</StartMarketingDatePackage>
<EndMarketingDatePackage>20250301</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22-. heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca. [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
</NDC>
<NDC>
<NDCCode>0185-0799-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (0185-0799-05) </PackageDescription>
<NDC11Code>00185-0799-05</NDC11Code>
<ProductNDC>0185-0799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970528</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970528</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22-. heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca. [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
</NDC>
<NDC>
<NDCCode>0185-0799-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0185-0799-30) </PackageDescription>
<NDC11Code>00185-0799-30</NDC11Code>
<ProductNDC>0185-0799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970528</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970528</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22-. heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca. [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
</NDC>
<NDC>
<NDCCode>0185-0799-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0185-0799-60) </PackageDescription>
<NDC11Code>00185-0799-60</NDC11Code>
<ProductNDC>0185-0799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970528</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970528</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22-. heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca. [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
</NDC>
<NDC>
<NDCCode>0185-0801-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0185-0801-01) </PackageDescription>
<NDC11Code>00185-0801-01</NDC11Code>
<ProductNDC>0185-0801</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980102</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19980102</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22-. heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca. [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
</NDC>
<NDC>
<NDCCode>0185-0801-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0185-0801-30) </PackageDescription>
<NDC11Code>00185-0801-30</NDC11Code>
<ProductNDC>0185-0801</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980102</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19980102</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18, 20,22-. heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca. [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
</NDC>
<NDC>
<NDCCode>0904-7315-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7315-61) / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7315-61</NDC11Code>
<ProductNDC>0904-7315</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090034</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin Capsules USP for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: corn starch, crospovidone, D & C Red no. 28, FD & C Blue no. 1, FD & C Red no. 40, gelatin, magnesium stearate, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium lauryl sulphate and titanium dioxide. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is.</Description>
</NDC>
<NDC>
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<PackageDescription>1 VIAL in 1 BOX, UNIT-DOSE (17478-151-42) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>17478-0151-42</NDC11Code>
<ProductNDC>17478-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065502</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin for injection USP contains rifampin 600 mg, sodium formaldehyde sulfoxylate dihydrate 10 mg, and sodium hydroxide to adjust pH. Rifampin for injection is a sterile, lyophilized powder for intravenous infusion only. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either:. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22–heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7- (epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>21695-527-15</NDCCode>
<PackageDescription>15 CAPSULE in 1 BOTTLE (21695-527-15)</PackageDescription>
<NDC11Code>21695-0527-15</NDC11Code>
<ProductNDC>21695-527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC],Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin capsule and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-Methyl-1-piperazinyl) imino]-methyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino) naphtho [2,1-b]furan-1,11(2H)-dione 21-acetate. The structural formula is. Rifampin capsules for oral administration contain 150 mg or 300 mg rifampin per capsule. In addition, the 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, calcium stearate, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, synthetic black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain, D&C yellow #10, D&C Red #28.</Description>
</NDC>
<NDC>
<NDCCode>21695-527-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (21695-527-20)</PackageDescription>
<NDC11Code>21695-0527-20</NDC11Code>
<ProductNDC>21695-527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC],Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin capsule and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-Methyl-1-piperazinyl) imino]-methyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino) naphtho [2,1-b]furan-1,11(2H)-dione 21-acetate. The structural formula is. Rifampin capsules for oral administration contain 150 mg or 300 mg rifampin per capsule. In addition, the 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, calcium stearate, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, synthetic black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain, D&C yellow #10, D&C Red #28.</Description>
</NDC>
<NDC>
<NDCCode>21695-527-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (21695-527-30)</PackageDescription>
<NDC11Code>21695-0527-30</NDC11Code>
<ProductNDC>21695-527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970528</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC],Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin capsule and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-Methyl-1-piperazinyl) imino]-methyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino) naphtho [2,1-b]furan-1,11(2H)-dione 21-acetate. The structural formula is. Rifampin capsules for oral administration contain 150 mg or 300 mg rifampin per capsule. In addition, the 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, calcium stearate, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, synthetic black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain, D&C yellow #10, D&C Red #28.</Description>
</NDC>
<NDC>
<NDCCode>24658-801-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (24658-801-30) </PackageDescription>
<NDC11Code>24658-0801-30</NDC11Code>
<ProductNDC>24658-801</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
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<StartMarketingDate>20230314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
</NDC>
<NDC>
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<PackageDescription>60 CAPSULE in 1 BOTTLE (24658-802-60) </PackageDescription>
<NDC11Code>24658-0802-60</NDC11Code>
<ProductNDC>24658-802</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
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<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
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<DosageFormName>CAPSULE</DosageFormName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065390</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC],Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin capsules, USP for oral administration contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules contain a powder that is brick-red in color. The 150 mg and 300 mg capsules also contain, as inactive ingredients: pregelatinized starch, colloidal silicon dioxide, talc, magnesium stearate, D&C Red # 28, FD&C Blue # 1, FD&C Red # 40, gelatin, and titanium dioxide. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycinor5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,20,22– heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca [1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is.</Description>
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<PackageDescription>100 CAPSULE in 1 BOTTLE (42806-799-01) </PackageDescription>
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<ProprietaryName>Rifampin</ProprietaryName>
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<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>EPIC PHARMA, LLC</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
</NDC>
<NDC>
<NDCCode>42806-799-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (42806-799-05) </PackageDescription>
<NDC11Code>42806-0799-05</NDC11Code>
<ProductNDC>42806-799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>EPIC PHARMA, LLC</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
</NDC>
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<PackageDescription>30 CAPSULE in 1 BOTTLE (42806-799-30) </PackageDescription>
<NDC11Code>42806-0799-30</NDC11Code>
<ProductNDC>42806-799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>EPIC PHARMA, LLC</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
</NDC>
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