{
"NDC": [
{
"NDCCode": "54868-0024-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (54868-0024-3)",
"NDC11Code": "54868-0024-03",
"ProductNDC": "54868-0024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060704",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
"Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide."
},
{
"NDCCode": "54868-0024-1",
"PackageDescription": "40 CAPSULE in 1 BOTTLE (54868-0024-1)",
"NDC11Code": "54868-0024-01",
"ProductNDC": "54868-0024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060704",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
"Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide."
},
{
"NDCCode": "54868-0024-4",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (54868-0024-4)",
"NDC11Code": "54868-0024-04",
"ProductNDC": "54868-0024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060704",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
"Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide."
},
{
"NDCCode": "54868-0024-5",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (54868-0024-5)",
"NDC11Code": "54868-0024-05",
"ProductNDC": "54868-0024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060704",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
"Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide."
},
{
"NDCCode": "54868-0024-7",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (54868-0024-7)",
"NDC11Code": "54868-0024-07",
"ProductNDC": "54868-0024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060704",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
"Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide."
},
{
"NDCCode": "54868-0024-8",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (54868-0024-8)",
"NDC11Code": "54868-0024-08",
"ProductNDC": "54868-0024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19880301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060704",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.",
"Description": "Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide."
},
{
"NDCCode": "0024-1332-30",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0024-1332-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00024-1332-30",
"ProductNDC": "0024-1332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plavix",
"NonProprietaryName": "Clopidogrel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090509",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020839",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200713",
"SamplePackage": "N",
"IndicationAndUsage": "Plavix is a P2Y12 platelet inhibitor indicated for: 1 Acute coronary syndrome –For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1)–For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. (1.1), 2 Recent MI, recent stroke, or established peripheral arterial disease. Plavix has been shown to reduce the rate of MI and stroke. (1.2).",
"Description": "Plavix (clopidogrel tablets) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Plavix for oral administration is provided as either pink, round, biconvex, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink, oblong, debossed, film-coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains hydrogenated castor oil, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains ferric oxide, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin. The tablets are polished with Carnauba wax."
},
{
"NDCCode": "0024-5150-10",
"PackageDescription": "3 KIT in 1 CARTON (0024-5150-10) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, SINGLE-USE (0024-5154-11) * 1 mL in 1 AMPULE (0024-5152-11) ",
"NDC11Code": "00024-5150-10",
"ProductNDC": "0024-5150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elitek",
"NonProprietaryName": "Rasburicase",
"DosageFormName": "KIT",
"StartMarketingDate": "20020712",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103946",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20020712",
"SamplePackage": "N",
"IndicationAndUsage": "Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.",
"Description": "Elitek (rasburicase) is a recombinant urate-oxidase produced by a genetically modified Saccharomyces cerevisiae strain. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus. Rasburicase is a tetrameric protein with identical subunits. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kDa. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. Elitek is supplied in 2 mL or 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1.5 mg/mL after reconstitution. Elitek 1.5 mg presentation contains 1.5 mg rasburicase, 10.6 mg mannitol, 15.9 mg L-alanine, between 12.6 and 14.3 mg of dibasic sodium phosphate (lyophilized powder), and a diluent (1 mL Water for Injection, USP, and 1 mg Poloxamer 188). Elitek 7.5 mg presentation contains 7.5 mg of rasburicase, 53 mg mannitol, 79.5 mg L-alanine, and between 63 and 71.5 mg dibasic sodium phosphate (lyophilized powder) and a diluent (5 mL Water for Injection, USP, and 5 mg Poloxamer 188)."
},
{
"NDCCode": "0024-5501-10",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0024-5501-10) > 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "00024-5501-10",
"ProductNDC": "0024-5501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ambien",
"ProprietaryNameSuffix": "Cr",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050919",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021774",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20050919",
"SamplePackage": "N"
},
{
"NDCCode": "0024-5521-10",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0024-5521-10) > 10 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "00024-5521-10",
"ProductNDC": "0024-5521",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ambien",
"ProprietaryNameSuffix": "Cr",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050919",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021774",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-09-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0024-5745-02",
"PackageDescription": "1 KIT in 1 CARTON (0024-5745-02) * 3 mL in 1 SYRINGE (0024-5741-01) * 3 mL in 1 SYRINGE (0024-5740-00) ",
"NDC11Code": "00024-5745-02",
"ProductNDC": "0024-5745",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adlyxin",
"NonProprietaryName": "Lixisenatide",
"DosageFormName": "KIT",
"StartMarketingDate": "20160727",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA208471",
"LabelerName": "sanofi-aventis U.S. LLC",
"Status": "Deprecated",
"LastUpdate": "2023-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160727",
"SamplePackage": "N"
},
{
"NDCCode": "0024-5747-02",
"PackageDescription": "2 SYRINGE in 1 CARTON (0024-5747-02) / 3 mL in 1 SYRINGE",
"NDC11Code": "00024-5747-02",
"ProductNDC": "0024-5747",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adlyxin",
"NonProprietaryName": "Lixisenatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20160727",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA208471",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "LIXISENATIDE",
"StrengthNumber": "100",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160727",
"SamplePackage": "N"
},
{
"NDCCode": "0024-5761-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (0024-5761-01) / 3 mL in 1 SYRINGE",
"NDC11Code": "00024-5761-01",
"ProductNDC": "0024-5761",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Soliqua 100/33",
"NonProprietaryName": "Insulin Glargine And Lixisenatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20161121",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA208673",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN GLARGINE; LIXISENATIDE",
"StrengthNumber": "100; 33",
"StrengthUnit": "U/mL; ug/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161121",
"SamplePackage": "N",
"IndicationAndUsage": "SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. The minimum potency of insulin glargine is NLT 15 units/mg. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added at the C-terminus of the B-chain. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. It has a molecular weight of 6.063 kDa. Lixisenatide is a synthetic analogue of human GLP-1, which acts as a GLP-1 receptor agonist. Lixisenatide is a protein containing 44 amino acids, which is amidated at the C-terminal amino acid (position 44) and has a molecular weight of 4.8585 kDa. SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a sterile, colorless to almost colorless solution for subcutaneous use. SOLIQUA 100/33 is supplied as a prefilled single-patient-use disposable pen contain 300 units of insulin glargine and 100 mcg of lixisenatide in 3 mL of a clear, colorless to almost colorless, sterile, and aqueous solution. Each mL contains 100 units of insulin glargine and 33 mcg of lixisenatide and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), methionine (3 mg), zinc (30 mcg), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. The approximate pH is 4.5."
},
{
"NDCCode": "0024-5761-05",
"PackageDescription": "5 SYRINGE in 1 CARTON (0024-5761-05) / 3 mL in 1 SYRINGE (0024-5761-02) ",
"NDC11Code": "00024-5761-05",
"ProductNDC": "0024-5761",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Soliqua 100/33",
"NonProprietaryName": "Insulin Glargine And Lixisenatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20161121",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA208673",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN GLARGINE; LIXISENATIDE",
"StrengthNumber": "100; 33",
"StrengthUnit": "U/mL; ug/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161121",
"SamplePackage": "N",
"IndicationAndUsage": "SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. The minimum potency of insulin glargine is NLT 15 units/mg. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added at the C-terminus of the B-chain. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. It has a molecular weight of 6.063 kDa. Lixisenatide is a synthetic analogue of human GLP-1, which acts as a GLP-1 receptor agonist. Lixisenatide is a protein containing 44 amino acids, which is amidated at the C-terminal amino acid (position 44) and has a molecular weight of 4.8585 kDa. SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a sterile, colorless to almost colorless solution for subcutaneous use. SOLIQUA 100/33 is supplied as a prefilled single-patient-use disposable pen contain 300 units of insulin glargine and 100 mcg of lixisenatide in 3 mL of a clear, colorless to almost colorless, sterile, and aqueous solution. Each mL contains 100 units of insulin glargine and 33 mcg of lixisenatide and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), methionine (3 mg), zinc (30 mcg), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. The approximate pH is 4.5."
},
{
"NDCCode": "0024-5820-15",
"PackageDescription": "3 BLISTER PACK in 1 BOTTLE (0024-5820-15) > 5 TABLET, FILM COATED in 1 BLISTER PACK (0024-5820-05)",
"NDC11Code": "00024-5820-15",
"ProductNDC": "0024-5820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oforta",
"NonProprietaryName": "Fludarabine Phosphate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022273",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "FLUDARABINE PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "0024-5840-03",
"PackageDescription": "3 VIAL in 1 CARTON (0024-5840-03) > 4 mL in 1 VIAL",
"NDC11Code": "00024-5840-03",
"ProductNDC": "0024-5840",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zaltrap",
"NonProprietaryName": "Ziv-aflibercept",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120803",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125418",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "AFLIBERCEPT",
"StrengthNumber": "100",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC],Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20120803",
"SamplePackage": "N"
},
{
"NDCCode": "0024-5869-03",
"PackageDescription": "3 SYRINGE in 1 CARTON (0024-5869-03) / 1.5 mL in 1 SYRINGE (0024-5869-01) ",
"NDC11Code": "00024-5869-03",
"ProductNDC": "0024-5869",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Toujeo",
"NonProprietaryName": "Insulin Glargine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA206538",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "300",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150215",
"SamplePackage": "N",
"IndicationAndUsage": "TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.",
"Description": "Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4."
},
{
"NDCCode": "0024-5871-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (0024-5871-01) / 3 mL in 1 SYRINGE",
"NDC11Code": "00024-5871-01",
"ProductNDC": "0024-5871",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Toujeo Max",
"NonProprietaryName": "Insulin Glargine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA206538",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "300",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180326",
"SamplePackage": "Y",
"IndicationAndUsage": "TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.",
"Description": "Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4."
},
{
"NDCCode": "0024-5871-02",
"PackageDescription": "2 SYRINGE in 1 CARTON (0024-5871-02) / 3 mL in 1 SYRINGE (0024-5871-00) ",
"NDC11Code": "00024-5871-02",
"ProductNDC": "0024-5871",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Toujeo Max",
"NonProprietaryName": "Insulin Glargine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA206538",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN GLARGINE",
"StrengthNumber": "300",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2025-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180326",
"SamplePackage": "N",
"IndicationAndUsage": "TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.",
"Description": "Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4."
},
{
"NDCCode": "0024-5925-00",
"PackageDescription": "1 SYRINGE in 1 CARTON (0024-5925-00) / 3 mL in 1 SYRINGE",
"NDC11Code": "00024-5925-00",
"ProductNDC": "0024-5925",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Admelog",
"NonProprietaryName": "Insulin Lispro",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20171211",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA209196",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171211",
"SamplePackage": "Y",
"IndicationAndUsage": "ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free."
},
{
"NDCCode": "0024-5925-05",
"PackageDescription": "5 SYRINGE in 1 CARTON (0024-5925-05) / 3 mL in 1 SYRINGE (0024-5925-01) ",
"NDC11Code": "00024-5925-05",
"ProductNDC": "0024-5925",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Admelog",
"NonProprietaryName": "Insulin Lispro",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20171211",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA209196",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171211",
"SamplePackage": "N",
"IndicationAndUsage": "ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free."
},
{
"NDCCode": "0024-5926-05",
"PackageDescription": "1 VIAL in 1 CARTON (0024-5926-05) / 3 mL in 1 VIAL",
"NDC11Code": "00024-5926-05",
"ProductNDC": "0024-5926",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Admelog",
"NonProprietaryName": "Insulin Lispro",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20181019",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA209196",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "U/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [Chemical/Ingredient]",
"Status": "Active",
"LastUpdate": "2025-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181019",
"SamplePackage": "N",
"IndicationAndUsage": "ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free."
},
{
"NDCCode": "0024-5928-05",
"PackageDescription": "5 SYRINGE in 1 BOX (0024-5928-05) / 3 mL in 1 SYRINGE (0024-5928-00) ",
"NDC11Code": "00024-5928-05",
"ProductNDC": "0024-5928",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Merilog",
"NonProprietaryName": "Insulin Aspart-szjj",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761325",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN ASPART",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250214",
"SamplePackage": "N",
"IndicationAndUsage": "MERILOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.",
"Description": "Insulin aspart-szjj is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Escherichia coli. Insulin aspart-szjj has a molecular weight of 5825.8 Da. MERILOG (insulin aspart-szjj) injection is a sterile, clear, and colorless solution for subcutaneous use. Each mL contains 100 units of insulin aspart-szjj and the inactive ingredients: 1.72 mg metacresol, 1.50 mg phenol, 0.02 mg polysorbate 20, 6.80 mg sodium chloride, 0.04 mg zinc chloride and Water for Injection, USP. MERILOG has a pH of 7.0–7.8. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH."
},
{
"NDCCode": "0363-0024-04",
"PackageDescription": "3 BOTTLE in 1 CARTON (0363-0024-04) > 120 SPRAY, METERED in 1 BOTTLE",
"NDC11Code": "00363-0024-04",
"ProductNDC": "0363-0024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "24 Hour Allergy Nasal",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20160527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207957",
"LabelerName": "Walgreen Company",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Status": "Deprecated",
"LastUpdate": "2020-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160527",
"SamplePackage": "N"
},
{
"NDCCode": "10210-0024-2",
"PackageDescription": "3 CYLINDER in 1 CARTON (10210-0024-2) > 4.25 g in 1 CYLINDER",
"NDC11Code": "10210-0024-02",
"ProductNDC": "10210-0024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carmex Classic Lip Balm Cherry Spf 15",
"NonProprietaryName": "Octinoxate, Oxybenzone, Petrolatum",
"DosageFormName": "SALVE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160926",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Carma Laboratories, Inc.",
"SubstanceName": "OCTINOXATE; OXYBENZONE; PETROLATUM",
"StrengthNumber": "7.5; 4; 35",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-12-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "10210-0024-3",
"PackageDescription": "4.25 g in 1 CYLINDER (10210-0024-3)",
"NDC11Code": "10210-0024-03",
"ProductNDC": "10210-0024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carmex Classic Lip Balm Cherry Spf 15",
"NonProprietaryName": "Octinoxate, Oxybenzone, Petrolatum",
"DosageFormName": "SALVE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160926",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Carma Laboratories, Inc.",
"SubstanceName": "OCTINOXATE; OXYBENZONE; PETROLATUM",
"StrengthNumber": "7.5; 4; 35",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-12-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "10210-0024-5",
"PackageDescription": "3 TUBE in 1 BLISTER PACK (10210-0024-5) > 4.25 g in 1 TUBE",
"NDC11Code": "10210-0024-05",
"ProductNDC": "10210-0024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carmex Classic Lip Balm Cherry Spf 15",
"NonProprietaryName": "Octinoxate, Oxybenzone, Petrolatum",
"DosageFormName": "SALVE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160926",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Carma Laboratories, Inc.",
"SubstanceName": "OCTINOXATE; OXYBENZONE; PETROLATUM",
"StrengthNumber": "7.5; 4; 35",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-12-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "11822-0024-7",
"PackageDescription": "3 BOTTLE in 1 CARTON (11822-0024-7) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "11822-0024-07",
"ProductNDC": "11822-0024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200626",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207193",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "ESOMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200626",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "14403-0024-3",
"PackageDescription": "25 g in 1 BOTTLE (14403-0024-3) ",
"NDC11Code": "14403-0024-03",
"ProductNDC": "14403-0024",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Semaglutide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260205",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Hybio Pharmaceutical Co. Ltd",
"SubstanceName": "SEMAGLUTIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-02-16",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "05-FEB-26"
},
{
"NDCCode": "15631-0024-3",
"PackageDescription": "750 PELLET in 1 PACKAGE (15631-0024-3) ",
"NDC11Code": "15631-0024-03",
"ProductNDC": "15631-0024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ambrosia Artemisiaefolia",
"NonProprietaryName": "Ambrosia Artemisiaefolia",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150906",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "AMBROSIA ARTEMISIIFOLIA",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>54868-0024-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (54868-0024-3)</PackageDescription>
<NDC11Code>54868-0024-03</NDC11Code>
<ProductNDC>54868-0024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060704</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.</IndicationAndUsage>
<Description>Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-0024-1</NDCCode>
<PackageDescription>40 CAPSULE in 1 BOTTLE (54868-0024-1)</PackageDescription>
<NDC11Code>54868-0024-01</NDC11Code>
<ProductNDC>54868-0024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060704</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.</IndicationAndUsage>
<Description>Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-0024-4</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (54868-0024-4)</PackageDescription>
<NDC11Code>54868-0024-04</NDC11Code>
<ProductNDC>54868-0024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060704</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.</IndicationAndUsage>
<Description>Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-0024-5</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (54868-0024-5)</PackageDescription>
<NDC11Code>54868-0024-05</NDC11Code>
<ProductNDC>54868-0024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060704</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.</IndicationAndUsage>
<Description>Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-0024-7</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (54868-0024-7)</PackageDescription>
<NDC11Code>54868-0024-07</NDC11Code>
<ProductNDC>54868-0024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060704</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.</IndicationAndUsage>
<Description>Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-0024-8</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (54868-0024-8)</PackageDescription>
<NDC11Code>54868-0024-08</NDC11Code>
<ProductNDC>54868-0024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060704</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: 1 Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. , 2 Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.), 3 Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.), 4 Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox., 5 Psittacosis or ornithosis caused by Chlamydia Psittaci., 6 Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum., 7 Granuloma inquinale caused by Calymmatobacterium granulomatis., 8 Relapsing fever caused by Borrelia sp., 9 Bartonellosis caused by Bartonella bacilliformis., 10 Chancroid caused by Hemophilus ducreyi., 11 Tularemia caused by Francisella tularensis., 12 Plaque caused by Yersinia pestis., 13 Cholera caused by Vibrio cholerae., 14 Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside)., 15 Infections due to Campylobacter fetus., 16 As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica., 17 Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc., 18 Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp., 19 In severe acne, adjunctive therapy with tetracycline may be useful.</IndicationAndUsage>
<Description>Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows. C22H24N208HCI M.W. 480.90. Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, pregelatinized starch and stearic acid. The inactive ingredients for the gelatin capsules include: (250 mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500 mg): FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0024-1332-30</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (0024-1332-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00024-1332-30</NDC11Code>
<ProductNDC>0024-1332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plavix</ProprietaryName>
<NonProprietaryName>Clopidogrel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090509</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020839</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Plavix is a P2Y12 platelet inhibitor indicated for: 1 Acute coronary syndrome –For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1)–For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. (1.1), 2 Recent MI, recent stroke, or established peripheral arterial disease. Plavix has been shown to reduce the rate of MI and stroke. (1.2).</IndicationAndUsage>
<Description>Plavix (clopidogrel tablets) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Plavix for oral administration is provided as either pink, round, biconvex, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink, oblong, debossed, film-coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains hydrogenated castor oil, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains ferric oxide, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin. The tablets are polished with Carnauba wax.</Description>
</NDC>
<NDC>
<NDCCode>0024-5150-10</NDCCode>
<PackageDescription>3 KIT in 1 CARTON (0024-5150-10) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, SINGLE-USE (0024-5154-11) * 1 mL in 1 AMPULE (0024-5152-11) </PackageDescription>
<NDC11Code>00024-5150-10</NDC11Code>
<ProductNDC>0024-5150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elitek</ProprietaryName>
<NonProprietaryName>Rasburicase</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20020712</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103946</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.</IndicationAndUsage>
<Description>Elitek (rasburicase) is a recombinant urate-oxidase produced by a genetically modified Saccharomyces cerevisiae strain. The cDNA coding for rasburicase was cloned from a strain of Aspergillus flavus. Rasburicase is a tetrameric protein with identical subunits. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kDa. The drug product is a sterile, white to off-white, lyophilized powder intended for intravenous administration following reconstitution with a diluent. Elitek is supplied in 2 mL or 3 mL and 10 mL colorless, glass vials containing rasburicase at a concentration of 1.5 mg/mL after reconstitution. Elitek 1.5 mg presentation contains 1.5 mg rasburicase, 10.6 mg mannitol, 15.9 mg L-alanine, between 12.6 and 14.3 mg of dibasic sodium phosphate (lyophilized powder), and a diluent (1 mL Water for Injection, USP, and 1 mg Poloxamer 188). Elitek 7.5 mg presentation contains 7.5 mg of rasburicase, 53 mg mannitol, 79.5 mg L-alanine, and between 63 and 71.5 mg dibasic sodium phosphate (lyophilized powder) and a diluent (5 mL Water for Injection, USP, and 5 mg Poloxamer 188).</Description>
</NDC>
<NDC>
<NDCCode>0024-5501-10</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (0024-5501-10) > 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00024-5501-10</NDC11Code>
<ProductNDC>0024-5501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ambien</ProprietaryName>
<ProprietaryNameSuffix>Cr</ProprietaryNameSuffix>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050919</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021774</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5521-10</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (0024-5521-10) > 10 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00024-5521-10</NDC11Code>
<ProductNDC>0024-5521</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ambien</ProprietaryName>
<ProprietaryNameSuffix>Cr</ProprietaryNameSuffix>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050919</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021774</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-09-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0024-5745-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0024-5745-02) * 3 mL in 1 SYRINGE (0024-5741-01) * 3 mL in 1 SYRINGE (0024-5740-00) </PackageDescription>
<NDC11Code>00024-5745-02</NDC11Code>
<ProductNDC>0024-5745</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adlyxin</ProprietaryName>
<NonProprietaryName>Lixisenatide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160727</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA208471</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5747-02</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0024-5747-02) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00024-5747-02</NDC11Code>
<ProductNDC>0024-5747</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adlyxin</ProprietaryName>
<NonProprietaryName>Lixisenatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20160727</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA208471</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>LIXISENATIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5761-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0024-5761-01) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00024-5761-01</NDC11Code>
<ProductNDC>0024-5761</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Soliqua 100/33</ProprietaryName>
<NonProprietaryName>Insulin Glargine And Lixisenatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20161121</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA208673</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE; LIXISENATIDE</SubstanceName>
<StrengthNumber>100; 33</StrengthNumber>
<StrengthUnit>U/mL; ug/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. The minimum potency of insulin glargine is NLT 15 units/mg. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added at the C-terminus of the B-chain. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. It has a molecular weight of 6.063 kDa. Lixisenatide is a synthetic analogue of human GLP-1, which acts as a GLP-1 receptor agonist. Lixisenatide is a protein containing 44 amino acids, which is amidated at the C-terminal amino acid (position 44) and has a molecular weight of 4.8585 kDa. SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a sterile, colorless to almost colorless solution for subcutaneous use. SOLIQUA 100/33 is supplied as a prefilled single-patient-use disposable pen contain 300 units of insulin glargine and 100 mcg of lixisenatide in 3 mL of a clear, colorless to almost colorless, sterile, and aqueous solution. Each mL contains 100 units of insulin glargine and 33 mcg of lixisenatide and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), methionine (3 mg), zinc (30 mcg), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. The approximate pH is 4.5.</Description>
</NDC>
<NDC>
<NDCCode>0024-5761-05</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (0024-5761-05) / 3 mL in 1 SYRINGE (0024-5761-02) </PackageDescription>
<NDC11Code>00024-5761-05</NDC11Code>
<ProductNDC>0024-5761</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Soliqua 100/33</ProprietaryName>
<NonProprietaryName>Insulin Glargine And Lixisenatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20161121</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA208673</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE; LIXISENATIDE</SubstanceName>
<StrengthNumber>100; 33</StrengthNumber>
<StrengthUnit>U/mL; ug/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. The minimum potency of insulin glargine is NLT 15 units/mg. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added at the C-terminus of the B-chain. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. It has a molecular weight of 6.063 kDa. Lixisenatide is a synthetic analogue of human GLP-1, which acts as a GLP-1 receptor agonist. Lixisenatide is a protein containing 44 amino acids, which is amidated at the C-terminal amino acid (position 44) and has a molecular weight of 4.8585 kDa. SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a sterile, colorless to almost colorless solution for subcutaneous use. SOLIQUA 100/33 is supplied as a prefilled single-patient-use disposable pen contain 300 units of insulin glargine and 100 mcg of lixisenatide in 3 mL of a clear, colorless to almost colorless, sterile, and aqueous solution. Each mL contains 100 units of insulin glargine and 33 mcg of lixisenatide and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), methionine (3 mg), zinc (30 mcg), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. The approximate pH is 4.5.</Description>
</NDC>
<NDC>
<NDCCode>0024-5820-15</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 BOTTLE (0024-5820-15) > 5 TABLET, FILM COATED in 1 BLISTER PACK (0024-5820-05)</PackageDescription>
<NDC11Code>00024-5820-15</NDC11Code>
<ProductNDC>0024-5820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oforta</ProprietaryName>
<NonProprietaryName>Fludarabine Phosphate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091231</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022273</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>FLUDARABINE PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>0024-5840-03</NDCCode>
<PackageDescription>3 VIAL in 1 CARTON (0024-5840-03) > 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>00024-5840-03</NDC11Code>
<ProductNDC>0024-5840</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zaltrap</ProprietaryName>
<NonProprietaryName>Ziv-aflibercept</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120803</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125418</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>AFLIBERCEPT</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC],Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0024-5869-03</NDCCode>
<PackageDescription>3 SYRINGE in 1 CARTON (0024-5869-03) / 1.5 mL in 1 SYRINGE (0024-5869-01) </PackageDescription>
<NDC11Code>00024-5869-03</NDC11Code>
<ProductNDC>0024-5869</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Toujeo</ProprietaryName>
<NonProprietaryName>Insulin Glargine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150215</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA206538</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>0024-5871-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0024-5871-01) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00024-5871-01</NDC11Code>
<ProductNDC>0024-5871</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Toujeo Max</ProprietaryName>
<NonProprietaryName>Insulin Glargine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150215</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA206538</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180326</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>0024-5871-02</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0024-5871-02) / 3 mL in 1 SYRINGE (0024-5871-00) </PackageDescription>
<NDC11Code>00024-5871-02</NDC11Code>
<ProductNDC>0024-5871</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Toujeo Max</ProprietaryName>
<NonProprietaryName>Insulin Glargine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150215</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA206538</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4.</Description>
</NDC>
<NDC>
<NDCCode>0024-5925-00</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0024-5925-00) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00024-5925-00</NDC11Code>
<ProductNDC>0024-5925</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Admelog</ProprietaryName>
<NonProprietaryName>Insulin Lispro</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20171211</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA209196</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171211</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free.</Description>
</NDC>
<NDC>
<NDCCode>0024-5925-05</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (0024-5925-05) / 3 mL in 1 SYRINGE (0024-5925-01) </PackageDescription>
<NDC11Code>00024-5925-05</NDC11Code>
<ProductNDC>0024-5925</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Admelog</ProprietaryName>
<NonProprietaryName>Insulin Lispro</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20171211</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA209196</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free.</Description>
</NDC>
<NDC>
<NDCCode>0024-5926-05</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0024-5926-05) / 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>00024-5926-05</NDC11Code>
<ProductNDC>0024-5926</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Admelog</ProprietaryName>
<NonProprietaryName>Insulin Lispro</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20181019</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA209196</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>U/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [Chemical/Ingredient]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin. ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin lispro has a pH of 7.0 to 7.8. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free.</Description>
</NDC>
<NDC>
<NDCCode>0024-5928-05</NDCCode>
<PackageDescription>5 SYRINGE in 1 BOX (0024-5928-05) / 3 mL in 1 SYRINGE (0024-5928-00) </PackageDescription>
<NDC11Code>00024-5928-05</NDC11Code>
<ProductNDC>0024-5928</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Merilog</ProprietaryName>
<NonProprietaryName>Insulin Aspart-szjj</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761325</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN ASPART</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MERILOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin aspart-szjj is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Escherichia coli. Insulin aspart-szjj has a molecular weight of 5825.8 Da. MERILOG (insulin aspart-szjj) injection is a sterile, clear, and colorless solution for subcutaneous use. Each mL contains 100 units of insulin aspart-szjj and the inactive ingredients: 1.72 mg metacresol, 1.50 mg phenol, 0.02 mg polysorbate 20, 6.80 mg sodium chloride, 0.04 mg zinc chloride and Water for Injection, USP. MERILOG has a pH of 7.0–7.8. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0363-0024-04</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (0363-0024-04) > 120 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>00363-0024-04</NDC11Code>
<ProductNDC>0363-0024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>24 Hour Allergy Nasal</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20160527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207957</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10210-0024-2</NDCCode>
<PackageDescription>3 CYLINDER in 1 CARTON (10210-0024-2) > 4.25 g in 1 CYLINDER</PackageDescription>
<NDC11Code>10210-0024-02</NDC11Code>
<ProductNDC>10210-0024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carmex Classic Lip Balm Cherry Spf 15</ProprietaryName>
<NonProprietaryName>Octinoxate, Oxybenzone, Petrolatum</NonProprietaryName>
<DosageFormName>SALVE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160926</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Carma Laboratories, Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE; PETROLATUM</SubstanceName>
<StrengthNumber>7.5; 4; 35</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10210-0024-3</NDCCode>
<PackageDescription>4.25 g in 1 CYLINDER (10210-0024-3)</PackageDescription>
<NDC11Code>10210-0024-03</NDC11Code>
<ProductNDC>10210-0024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carmex Classic Lip Balm Cherry Spf 15</ProprietaryName>
<NonProprietaryName>Octinoxate, Oxybenzone, Petrolatum</NonProprietaryName>
<DosageFormName>SALVE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160926</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Carma Laboratories, Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE; PETROLATUM</SubstanceName>
<StrengthNumber>7.5; 4; 35</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10210-0024-5</NDCCode>
<PackageDescription>3 TUBE in 1 BLISTER PACK (10210-0024-5) > 4.25 g in 1 TUBE</PackageDescription>
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<ProductNDC>10210-0024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carmex Classic Lip Balm Cherry Spf 15</ProprietaryName>
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<DosageFormName>SALVE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160926</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Carma Laboratories, Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE; PETROLATUM</SubstanceName>
<StrengthNumber>7.5; 4; 35</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
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<PackageDescription>3 BOTTLE in 1 CARTON (11822-0024-7) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
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<ProductNDC>11822-0024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>ESOMEPRAZOLE</SubstanceName>
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<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
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<ProductNDC>14403-0024</ProductNDC>
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<LabelerName>Hybio Pharmaceutical Co. Ltd</LabelerName>
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<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-02-16</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-FEB-26</StartMarketingDatePackage>
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<NDC>
<NDCCode>15631-0024-3</NDCCode>
<PackageDescription>750 PELLET in 1 PACKAGE (15631-0024-3) </PackageDescription>
<NDC11Code>15631-0024-03</NDC11Code>
<ProductNDC>15631-0024</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ambrosia Artemisiaefolia</ProprietaryName>
<NonProprietaryName>Ambrosia Artemisiaefolia</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150906</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>AMBROSIA ARTEMISIIFOLIA</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
</NDCList>