RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "50436-0117-8",
      "PackageDescription": "21 CAPSULE in 1 BOTTLE (50436-0117-8)",
      "NDC11Code": "50436-0117-08",
      "ProductNDC": "50436-0117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100621",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062791",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:   Respiratory tract infections caused by and (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.   Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.)   Otitis media due to , , , and   Skin and skin structure infections caused by and/or   Bone infections caused by and/or   Genitourinary tract infections, including acute prostatitis, caused by , , and   — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.   To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Cephalexin Capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C H N O SH O and the molecular weight is 365.41.   Cephalexin, USP has the following structural formula: The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5.   The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty.   The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a ‑phenylglycyl group as substituent at the 7‑amino position and an unsubstituted methyl group at the 3‑position.   Each capsule contains cephalexin monohydrate equivalent to 250 mg (720 µmol) or 500 mg (1439 µmol) of cephalexin. The capsules also contain the following inactive ingredients magnesium stearate, capsule shell contains D & C Yellow No. 10, FD & C Yellow No. 6, FD & C green 3, sodium lauryl sulfate, gelatin, titanium dioxide. In addition, the 500 mg capsule also contains FD & C Blue No. 1.   Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, purified water."
    },
    {
      "NDCCode": "52124-0117-1",
      "PackageDescription": "1 KIT in 1 KIT (52124-0117-1)  *  .8 mL in 1 PACKAGE (52124-0001-1)  *  10 mL in 1 BOTTLE (52124-0005-1)",
      "NDC11Code": "52124-0117-01",
      "ProductNDC": "52124-0117",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Medium Cuts And Scratches",
      "NonProprietaryName": "Benzalkonium Chloride, Water",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20100423",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333",
      "LabelerName": "Genuine First Aid LLC",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "58118-0117-8",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (58118-0117-8)",
      "NDC11Code": "58118-0117-08",
      "ProductNDC": "58118-0117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluphenazine Hydrochloride",
      "NonProprietaryName": "Fluphenazine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19880812",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089804",
      "LabelerName": "Clinical Solutions Wholesale, LLC",
      "SubstanceName": "FLUPHENAZINE HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient]",
      "Status": "Deprecated",
      "LastUpdate": "2017-06-21"
    },
    {
      "NDCCode": "71335-0117-8",
      "PackageDescription": "14 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0117-8) ",
      "NDC11Code": "71335-0117-08",
      "ProductNDC": "71335-0117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Orphenadrine Citrate",
      "NonProprietaryName": "Orphenadrine Citrate",
      "DosageFormName": "TABLET, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20000215",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040327",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "ORPHENADRINE CITRATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20220928",
      "SamplePackage": "N",
      "IndicationAndUsage": "Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculo skeletal conditions.",
      "Description": "Orphenadrine citrate, USP is the citrate salt of orphenadrine (2-dimethyl-aminoethyl 2-methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol and has a molecular weight of 461.51. The molecular formula C18H23NO  C6H8O7 is represented by the following structural formula. Each orphenadrine citrate extended-release tablet, USP contains 100 mg orphenadrine citrate, USP. Orphenadrine citrate extended-release tablets, USP also contain: calcium stearate, ethylcellulose and lactose monohydrate."
    },
    {
      "NDCCode": "50436-0117-1",
      "PackageDescription": "28 CAPSULE in 1 BOTTLE (50436-0117-1)",
      "NDC11Code": "50436-0117-01",
      "ProductNDC": "50436-0117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100621",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062791",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:   Respiratory tract infections caused by and (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.   Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.)   Otitis media due to , , , and   Skin and skin structure infections caused by and/or   Bone infections caused by and/or   Genitourinary tract infections, including acute prostatitis, caused by , , and   — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.   To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Cephalexin Capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C H N O SH O and the molecular weight is 365.41.   Cephalexin, USP has the following structural formula: The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5.   The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty.   The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a ‑phenylglycyl group as substituent at the 7‑amino position and an unsubstituted methyl group at the 3‑position.   Each capsule contains cephalexin monohydrate equivalent to 250 mg (720 µmol) or 500 mg (1439 µmol) of cephalexin. The capsules also contain the following inactive ingredients magnesium stearate, capsule shell contains D & C Yellow No. 10, FD & C Yellow No. 6, FD & C green 3, sodium lauryl sulfate, gelatin, titanium dioxide. In addition, the 500 mg capsule also contains FD & C Blue No. 1.   Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, purified water."
    },
    {
      "NDCCode": "50436-0117-2",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (50436-0117-2)",
      "NDC11Code": "50436-0117-02",
      "ProductNDC": "50436-0117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100621",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062791",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:   Respiratory tract infections caused by and (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.   Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.)   Otitis media due to , , , and   Skin and skin structure infections caused by and/or   Bone infections caused by and/or   Genitourinary tract infections, including acute prostatitis, caused by , , and   — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.   To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Cephalexin Capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C H N O SH O and the molecular weight is 365.41.   Cephalexin, USP has the following structural formula: The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5.   The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty.   The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a ‑phenylglycyl group as substituent at the 7‑amino position and an unsubstituted methyl group at the 3‑position.   Each capsule contains cephalexin monohydrate equivalent to 250 mg (720 µmol) or 500 mg (1439 µmol) of cephalexin. The capsules also contain the following inactive ingredients magnesium stearate, capsule shell contains D & C Yellow No. 10, FD & C Yellow No. 6, FD & C green 3, sodium lauryl sulfate, gelatin, titanium dioxide. In addition, the 500 mg capsule also contains FD & C Blue No. 1.   Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, purified water."
    },
    {
      "NDCCode": "50436-0117-3",
      "PackageDescription": "40 CAPSULE in 1 BOTTLE (50436-0117-3)",
      "NDC11Code": "50436-0117-03",
      "ProductNDC": "50436-0117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100621",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062791",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:   Respiratory tract infections caused by and (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.   Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.)   Otitis media due to , , , and   Skin and skin structure infections caused by and/or   Bone infections caused by and/or   Genitourinary tract infections, including acute prostatitis, caused by , , and   — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.   To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Cephalexin Capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C H N O SH O and the molecular weight is 365.41.   Cephalexin, USP has the following structural formula: The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5.   The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty.   The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a ‑phenylglycyl group as substituent at the 7‑amino position and an unsubstituted methyl group at the 3‑position.   Each capsule contains cephalexin monohydrate equivalent to 250 mg (720 µmol) or 500 mg (1439 µmol) of cephalexin. The capsules also contain the following inactive ingredients magnesium stearate, capsule shell contains D & C Yellow No. 10, FD & C Yellow No. 6, FD & C green 3, sodium lauryl sulfate, gelatin, titanium dioxide. In addition, the 500 mg capsule also contains FD & C Blue No. 1.   Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, purified water."
    },
    {
      "NDCCode": "50436-0117-4",
      "PackageDescription": "14 CAPSULE in 1 BOTTLE (50436-0117-4)",
      "NDC11Code": "50436-0117-04",
      "ProductNDC": "50436-0117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100621",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062791",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:   Respiratory tract infections caused by and (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.   Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.)   Otitis media due to , , , and   Skin and skin structure infections caused by and/or   Bone infections caused by and/or   Genitourinary tract infections, including acute prostatitis, caused by , , and   — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.   To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Cephalexin Capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C H N O SH O and the molecular weight is 365.41.   Cephalexin, USP has the following structural formula: The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5.   The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty.   The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a ‑phenylglycyl group as substituent at the 7‑amino position and an unsubstituted methyl group at the 3‑position.   Each capsule contains cephalexin monohydrate equivalent to 250 mg (720 µmol) or 500 mg (1439 µmol) of cephalexin. The capsules also contain the following inactive ingredients magnesium stearate, capsule shell contains D & C Yellow No. 10, FD & C Yellow No. 6, FD & C green 3, sodium lauryl sulfate, gelatin, titanium dioxide. In addition, the 500 mg capsule also contains FD & C Blue No. 1.   Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, purified water."
    },
    {
      "NDCCode": "50436-0117-5",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE (50436-0117-5)",
      "NDC11Code": "50436-0117-05",
      "ProductNDC": "50436-0117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cephalexin",
      "NonProprietaryName": "Cephalexin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100621",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA062791",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "CEPHALEXIN",
      "StrengthNumber": "500",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:   Respiratory tract infections caused by and (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.   Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.)   Otitis media due to , , , and   Skin and skin structure infections caused by and/or   Bone infections caused by and/or   Genitourinary tract infections, including acute prostatitis, caused by , , and   — Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.   To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Cephalexin Capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-a-Amino-a-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C H N O SH O and the molecular weight is 365.41.   Cephalexin, USP has the following structural formula: The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5.   The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty.   The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a ‑phenylglycyl group as substituent at the 7‑amino position and an unsubstituted methyl group at the 3‑position.   Each capsule contains cephalexin monohydrate equivalent to 250 mg (720 µmol) or 500 mg (1439 µmol) of cephalexin. The capsules also contain the following inactive ingredients magnesium stearate, capsule shell contains D & C Yellow No. 10, FD & C Yellow No. 6, FD & C green 3, sodium lauryl sulfate, gelatin, titanium dioxide. In addition, the 500 mg capsule also contains FD & C Blue No. 1.   Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, purified water."
    },
    {
      "NDCCode": "50436-0136-8",
      "PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (50436-0136-8) ",
      "NDC11Code": "50436-0136-08",
      "ProductNDC": "50436-0136",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride",
      "NonProprietaryName": "Tramadol Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150522",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091498",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20180717",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tramadol hydrochloride tablets are indicated for the management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
      "Description": "Tramadol hydrochloride tablets, USP are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide."
    },
    {
      "NDCCode": "50436-0377-8",
      "PackageDescription": "15 TABLET in 1 BOTTLE (50436-0377-8) ",
      "NDC11Code": "50436-0377-08",
      "ProductNDC": "50436-0377",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride",
      "NonProprietaryName": "Tramadol Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20020622",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA075964",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20180717",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tramadol hydrochloride tablets are indicated for the management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see WARNINGS), reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: 1 Have not been tolerated, or are not expected to be tolerated., 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
      "Description": "Tramadol hydrochloride tablets, USP are an opioid agonist. The chemical name for tramadol hydrochloride, USP is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanolhydrochloride. Its structural formula is. Molecular formula is C16H13NO2HCl. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride,USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/ water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP, for oral administration contain 50 mg of tramadol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80."
    },
    {
      "NDCCode": "50436-3172-4",
      "PackageDescription": "8 TABLET in 1 BOTTLE (50436-3172-4) ",
      "NDC11Code": "50436-3172-04",
      "ProductNDC": "50436-3172",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Misoprostol",
      "NonProprietaryName": "Misoprostol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130412",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA091667",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "MISOPROSTOL",
      "StrengthNumber": "200",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20151201",
      "SamplePackage": "N",
      "IndicationAndUsage": "Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol Tablet has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol Tablets should be taken for the duration of NSAID therapy. Misoprostol Tablets has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.",
      "Description": "Misoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog. Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by (±). Misoprostol is a water-soluble, viscous liquid. Inactive ingredients of tablets are hydrogenated castor oil, microcrystalline cellulose, and crospovidone."
    },
    {
      "NDCCode": "50436-3175-8",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (50436-3175-8) ",
      "NDC11Code": "50436-3175-08",
      "ProductNDC": "50436-3175",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phentermine Hydrochloride",
      "NonProprietaryName": "Phentermine Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120807",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA040886",
      "LabelerName": "UNIT DOSE SERVICES",
      "SubstanceName": "PHENTERMINE HYDROCHLORIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20230222",
      "SamplePackage": "N",
      "IndicationAndUsage": "Phentermine Hydrochloride, USP 15 mg and 30 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride, [ see CLINICAL PHARMACOLOGY ( 12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
      "Description": "Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine Hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride is available as. a) powder-filled capsules containing 15 mg Phentermine hydrochloride (equivalent to 12 mg Phentermine) or 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, gelatin, lactose monohydrate and magnesium stearate. In addition, the 15 mg capsules contain D&C Yellow #10, FD&C Blue #1, FD&C Red #3, FD&C Red #40, titanium dioxide and the 30 mg capsules contain D&C Yellow #10, FD&C Red #3, titanium dioxide. b) bead-filled capsules containing 30 mg Phentermine hydrochloride (equivalent to 24 mg Phentermine) and inactive ingredients: corn starch, sucrose, hypromellose, povidone, and talc. In addition, the capsule contains FD&C blue #1/Brilliant blue FCF Aluminum Lake, D&C red #28 and gelatin."
    },
    {
      "NDCCode": "50436-3918-8",
      "PackageDescription": "12 TABLET in 1 BOTTLE (50436-3918-8)",
      "NDC11Code": "50436-3918-08",
      "ProductNDC": "50436-3918",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090330",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090118",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
      "StrengthNumber": "5; 325",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2019-04-26",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "50436-4388-2",
      "PackageDescription": "8 TABLET in 1 BOTTLE (50436-4388-2)",
      "NDC11Code": "50436-4388-02",
      "ProductNDC": "50436-4388",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phenazopyridine Hydrochloride",
      "NonProprietaryName": "Phenazopyridine",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110201",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2019-05-10",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "50436-4606-8",
      "PackageDescription": "15 TABLET in 1 BOTTLE (50436-4606-8)",
      "NDC11Code": "50436-4606-08",
      "ProductNDC": "50436-4606",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ibuprofen",
      "NonProprietaryName": "Ibuprofen",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091123",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078558",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "IBUPROFEN",
      "StrengthNumber": "800",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen Tablets are indicated for relief of mild to moderate pain. Ibuprofen Tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.",
      "Description": "Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74° to 77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below. Ibuprofen Tablets, USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide."
    },
    {
      "NDCCode": "50436-4842-8",
      "PackageDescription": "12 TABLET, FILM COATED in 1 BOTTLE (50436-4842-8)",
      "NDC11Code": "50436-4842-08",
      "ProductNDC": "50436-4842",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Cyclobenzaprine Hydrochloride",
      "NonProprietaryName": "Cyclobenzaprine Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070228",
      "EndMarketingDate": "20181031",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077797",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-11-01",
      "ProductNdcExcludeFlag": "N"
    },
    {
      "NDCCode": "50436-8787-8",
      "PackageDescription": "240 TABLET, COATED in 1 BOTTLE (50436-8787-8) ",
      "NDC11Code": "50436-8787-08",
      "ProductNDC": "50436-8787",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tramadol Hydrochloride",
      "NonProprietaryName": "Tramadol Hydrochloride",
      "DosageFormName": "TABLET, COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101115",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076003",
      "LabelerName": "Unit Dose Services",
      "SubstanceName": "TRAMADOL HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2021-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20101115",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated. , 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia. .",
      "Description": "Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP and are white in color. Inactive ingredients in the tablet are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide."
    },
    {
      "NDCCode": "10631-117-31",
      "PackageDescription": "3 BLISTER PACK in 1 BOX (10631-117-31)  / 10 CAPSULE in 1 BLISTER PACK (10631-117-69) ",
      "NDC11Code": "10631-0117-31",
      "ProductNDC": "10631-117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Absorica",
      "NonProprietaryName": "Isotretinoin",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20120608",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021951",
      "LabelerName": "Sun Pharmaceutical Industries, Inc.",
      "SubstanceName": "ISOTRETINOIN",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
      "Status": "Active",
      "LastUpdate": "2026-08-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20120608",
      "SamplePackage": "N",
      "IndicationAndUsage": "ABSORICA and ABSORICA LD are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of ABSORICA/ABSORICA LD treatment is needed, it is not recommended before a 2-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of treatment[see Dosage and Administration (2.2)].",
      "Description": "ABSORICA. ABSORICA (isotretinoin) Capsules contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, each capsule contains the following inactive ingredients: propyl gallate, sorbitan monooleate, soybean oil and stearoyl polyoxylglycerides. The gelatin capsules contain the following dye systems. 10 mg – iron oxide (yellow) and titanium dioxide;. 20 mg – iron oxide (red), and titanium dioxide;. 25 mg – FD&C Blue #1, FD&C Yellow #5 [see Warnings and Precautions (5.14)], FD&C Yellow #6 and titanium dioxide;. 30 mg – iron oxide (black, red and yellow) and titanium dioxide;. 35 mg – FD&C Blue #2, iron oxide (black, red and yellow) and titanium dioxide;. 40 mg – iron oxide (black, red and yellow) and titanium dioxide. ABSORICA LD. ABSORICA LD (isotretinoin) Capsules contain 8 mg, 16 mg, 20 mg, 24 mg, 28 mg and 32 mg of micronized isotretinoin (a retinoid) in suspension filled in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, USP each capsule contains the following inactive ingredients: butylated hydroxy anisole, gelatin, hard gelatin capsule shell, polysorbate 80 and soybean oil. The gelatin capsules contain the following dye systems. 8 mg – D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and titanium dioxide. 16 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide. 20 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide. 24 mg – D&C Yellow #10, FD&C Yellow #6 and titanium dioxide. 28 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide. 32 mg – ferrosoferric oxide, ferric oxide (red and yellow) and titanium dioxide. The imprinting ink of 8 mg, 16 mg, 24 mg and 32 mg capsules contain the following ingredients: potassium hydroxide, propylene glycol, shellac and titanium dioxide. The imprinting ink of 20 mg and 28 mg capsules contain the following ingredients: ferrosoferric oxide, propylene glycol and shellac glaze. Isotretinoin. Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44.  It is practically insoluble in water, soluble in chloroform and sparingly soluble in alcohol and in isopropyl alcohol. The structural formula is. ABSORICA meets USP Dissolution Test 3. For ABSORICA LD, FDA approved dissolution test differs from the USP."
    },
    {
      "NDCCode": "11410-117-48",
      "PackageDescription": "75 g in 1 BOTTLE (11410-117-48) ",
      "NDC11Code": "11410-0117-48",
      "ProductNDC": "11410-117",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "X-out Wash-in Treatment",
      "NonProprietaryName": "Benzoyl Peroxide",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110923",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "THE PROACTIV COMPANY LLC",
      "SubstanceName": "BENZOYL PEROXIDE",
      "StrengthNumber": "8.5",
      "StrengthUnit": "mg/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "11410-117-49",
      "PackageDescription": "200 g in 1 BOTTLE (11410-117-49)",
      "NDC11Code": "11410-0117-49",
      "ProductNDC": "11410-117",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "X-out Wash-in Treatment",
      "NonProprietaryName": "Benzoyl Peroxide",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110923",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "Guthy-Renker LLC",
      "SubstanceName": "BENZOYL PEROXIDE",
      "StrengthNumber": "8.5",
      "StrengthUnit": "mg/100g",
      "Status": "Deprecated",
      "LastUpdate": "2017-12-13",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "13668-117-10",
      "PackageDescription": "1000 TABLET in 1 BOTTLE (13668-117-10) ",
      "NDC11Code": "13668-0117-10",
      "ProductNDC": "13668-117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
      "NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100406",
      "EndMarketingDate": "20240630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090528",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM",
      "StrengthNumber": "12.5; 100",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20101006",
      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Losartan potassium and hydrochlorothiazide tablets are combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).",
      "Description": "Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 , losartan potassium and hydrochlorothiazide tablets, USP 100/12.5  and losartan potassium and hydrochlorothiazide tablets, USP 100/25 tablets combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets, USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/25 contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg also contain D&C yellow No. 10 lake. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg contains 8.48 mg (0.216 mEq) of potassium, and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium."
    },
    {
      "NDCCode": "13668-117-30",
      "PackageDescription": "30 TABLET in 1 BOTTLE (13668-117-30) ",
      "NDC11Code": "13668-0117-30",
      "ProductNDC": "13668-117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
      "NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100406",
      "EndMarketingDate": "20240630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090528",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM",
      "StrengthNumber": "12.5; 100",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20101006",
      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Losartan potassium and hydrochlorothiazide tablets are combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).",
      "Description": "Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 , losartan potassium and hydrochlorothiazide tablets, USP 100/12.5  and losartan potassium and hydrochlorothiazide tablets, USP 100/25 tablets combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets, USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/25 contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg also contain D&C yellow No. 10 lake. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg contains 8.48 mg (0.216 mEq) of potassium, and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium."
    },
    {
      "NDCCode": "13668-117-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (13668-117-90) ",
      "NDC11Code": "13668-0117-90",
      "ProductNDC": "13668-117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
      "NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100406",
      "EndMarketingDate": "20240630",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090528",
      "LabelerName": "Torrent Pharmaceuticals Limited",
      "SubstanceName": "HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM",
      "StrengthNumber": "12.5; 100",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2024-07-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20101006",
      "EndMarketingDatePackage": "20240630",
      "SamplePackage": "N",
      "IndicationAndUsage": "Losartan potassium and hydrochlorothiazide tablets are combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2).",
      "Description": "Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 , losartan potassium and hydrochlorothiazide tablets, USP 100/12.5  and losartan potassium and hydrochlorothiazide tablets, USP 100/25 tablets combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide tablets, USP are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 50/12.5 contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/12.5 contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets, USP 100/25 contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg also contain D&C yellow No. 10 lake. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg contains 8.48 mg (0.216 mEq) of potassium, and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium."
    },
    {
      "NDCCode": "18657-117-04",
      "PackageDescription": "4 BOX in 1 CARTON (18657-117-04)  / 1 VIAL in 1 BOX (18657-117-02)  / 1 mL in 1 VIAL (18657-117-01) ",
      "NDC11Code": "18657-0117-04",
      "ProductNDC": "18657-117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hylenex Recombinant",
      "NonProprietaryName": "Hyaluronidase",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20051202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA021859",
      "LabelerName": "Antares Pharma, Inc.",
      "SubstanceName": "HYALURONIDASE (HUMAN RECOMBINANT)",
      "StrengthNumber": "150",
      "StrengthUnit": "[USP'U]/mL",
      "Pharm_Classes": "Endoglycosidase [EPC], Glycoside Hydrolases [CS]",
      "Status": "Active",
      "LastUpdate": "2025-04-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20051202",
      "SamplePackage": "N",
      "IndicationAndUsage": "HYLENEX recombinant is an endoglycosidase indicated as an adjuvant: 1 in subcutaneous fluid administration for achieving hydration (1.1), 2 to increase the dispersion and absorption of other injected drugs (1.2), 3 in subcutaneous urography for improving resorption of radiopaque agents (1.3).",
      "Description": "Hyaluronidase is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase has an approximate molecular weight of 61 kDa. HYLENEX recombinant (hyaluronidase) injection is supplied as a sterile, clear and colorless, nonpreserved, ready-for-use 1 mL solution in a single-dose vial for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, for retrobulbar use, for soft tissue use, or for subcutaneous use. Each mL contains 150 USP units of hyaluronidase with albumin human (1 mg), dibasic sodium phosphate (1.4 mg), methionine (1.5 mg), polysorbate 80 (0.2 mg), and sodium chloride (8.5 mg). Hydrochloric acid and sodium hydroxide may be added during manufacture to adjust the pH. HYLENEX has an approximate pH of 7.0."
    },
    {
      "NDCCode": "24571-117-06",
      "PackageDescription": "2 BAG in 1 CASE (24571-117-06)  / 5 L in 1 BAG",
      "NDC11Code": "24571-0117-06",
      "ProductNDC": "24571-117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Phoxillum",
      "ProprietaryNameSuffix": "B22k4/0",
      "NonProprietaryName": "Magnesium Chloride, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride, And Sodium Phosphate Dibasic Dihydrate",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20150113",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA207026",
      "LabelerName": "Vantive US Healthcare LLC",
      "SubstanceName": "MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC",
      "StrengthNumber": "3.05; 6.95; 2.21; .314; .187",
      "StrengthUnit": "g/L; g/L; g/L; g/L; g/L",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-07-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150113",
      "SamplePackage": "N",
      "IndicationAndUsage": "PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances.",
      "Description": "PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies (CRRT) as a replacement solution in hemofiltration and hemodiafiltration. Depending on the product (see Table 2), the two compartments contain. Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2  2H2O). Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2  6H2O). Sodium chloride, USP, is chemically designated NaCl. Potassium chloride, USP, is chemically designated KCl. Sodium bicarbonate, USP, is chemically designated NaHCO3. Dextrose, USP, is chemically designated D-Glucose anhydrous (C6H12O6) or D-Glucose monohydrate (C6H12O6  H2O). Lactic acid, USP, is chemically designated CH3CH(OH)COOH. Dibasic sodium phosphate, USP, is chemically designated as disodium hydrogen phosphate, dihydrate (Na2HPO4  2H2O). The pH of the final solution is in the range of 7.0 to 8.5."
    },
    {
      "NDCCode": "29300-117-01",
      "PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-117-01) ",
      "NDC11Code": "29300-0117-01",
      "ProductNDC": "29300-117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090162",
      "LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
      "Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
    },
    {
      "NDCCode": "29300-117-05",
      "PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-117-05) ",
      "NDC11Code": "29300-0117-05",
      "ProductNDC": "29300-117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090162",
      "LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
      "Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
    },
    {
      "NDCCode": "29300-117-10",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-117-10) ",
      "NDC11Code": "29300-0117-10",
      "ProductNDC": "29300-117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090162",
      "LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
      "Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
    },
    {
      "NDCCode": "29300-117-16",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-117-16) ",
      "NDC11Code": "29300-0117-16",
      "ProductNDC": "29300-117",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Topiramate",
      "NonProprietaryName": "Topiramate",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20130701",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA090162",
      "LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
      "SubstanceName": "TOPIRAMATE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-10",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20130701",
      "SamplePackage": "N",
      "IndicationAndUsage": "Topiramate tablets are indicated for: : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
      "Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
    }
  ]
}
                    

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