{
"NDC": [
{
"NDCCode": "38779-2446-8",
"PackageDescription": "500 g in 1 JAR (38779-2446-8)",
"NDC11Code": "38779-2446-08",
"ProductNDC": "38779-2446",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dantrolene Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080227",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Medisca Inc.",
"SubstanceName": "DANTROLENE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "50090-2446-8",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50090-2446-8) ",
"NDC11Code": "50090-2446-08",
"ProductNDC": "50090-2446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062505",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170511",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum., 9 Relapsing fever due to Borrelia recurrentis.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. In addition, the capsules contain the inactive ingredients anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue #1, gelatin, and titanium dioxide. The capsule imprinting ink contains butyl alcohol, denatured alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, propylene glycol, and shellac. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide."
},
{
"NDCCode": "38779-2446-3",
"PackageDescription": "5000 g in 1 JAR (38779-2446-3)",
"NDC11Code": "38779-2446-03",
"ProductNDC": "38779-2446",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dantrolene Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080227",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Medisca Inc.",
"SubstanceName": "DANTROLENE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "38779-2446-5",
"PackageDescription": "100 g in 1 JAR (38779-2446-5)",
"NDC11Code": "38779-2446-05",
"ProductNDC": "38779-2446",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dantrolene Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080227",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Medisca Inc.",
"SubstanceName": "DANTROLENE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "38779-2446-9",
"PackageDescription": "1000 g in 1 JAR (38779-2446-9)",
"NDC11Code": "38779-2446-09",
"ProductNDC": "38779-2446",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dantrolene Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080227",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Medisca Inc.",
"SubstanceName": "DANTROLENE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "50090-2446-0",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (50090-2446-0) ",
"NDC11Code": "50090-2446-00",
"ProductNDC": "50090-2446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062505",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160809",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum., 9 Relapsing fever due to Borrelia recurrentis.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. In addition, the capsules contain the inactive ingredients anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue #1, gelatin, and titanium dioxide. The capsule imprinting ink contains butyl alcohol, denatured alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, propylene glycol, and shellac. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide."
},
{
"NDCCode": "50090-2446-1",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (50090-2446-1) ",
"NDC11Code": "50090-2446-01",
"ProductNDC": "50090-2446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062505",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160930",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum., 9 Relapsing fever due to Borrelia recurrentis.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. In addition, the capsules contain the inactive ingredients anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue #1, gelatin, and titanium dioxide. The capsule imprinting ink contains butyl alcohol, denatured alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, propylene glycol, and shellac. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide."
},
{
"NDCCode": "50090-2446-2",
"PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-2446-2) ",
"NDC11Code": "50090-2446-02",
"ProductNDC": "50090-2446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062505",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160719",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum., 9 Relapsing fever due to Borrelia recurrentis.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. In addition, the capsules contain the inactive ingredients anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue #1, gelatin, and titanium dioxide. The capsule imprinting ink contains butyl alcohol, denatured alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, propylene glycol, and shellac. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide."
},
{
"NDCCode": "50090-2446-3",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (50090-2446-3) ",
"NDC11Code": "50090-2446-03",
"ProductNDC": "50090-2446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062505",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20161013",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum., 9 Relapsing fever due to Borrelia recurrentis.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. In addition, the capsules contain the inactive ingredients anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue #1, gelatin, and titanium dioxide. The capsule imprinting ink contains butyl alcohol, denatured alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, propylene glycol, and shellac. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide."
},
{
"NDCCode": "50090-2446-5",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (50090-2446-5) ",
"NDC11Code": "50090-2446-05",
"ProductNDC": "50090-2446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062505",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170111",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum., 9 Relapsing fever due to Borrelia recurrentis.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. In addition, the capsules contain the inactive ingredients anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue #1, gelatin, and titanium dioxide. The capsule imprinting ink contains butyl alcohol, denatured alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, propylene glycol, and shellac. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide."
},
{
"NDCCode": "50090-2446-6",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50090-2446-6) ",
"NDC11Code": "50090-2446-06",
"ProductNDC": "50090-2446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062505",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170126",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum., 9 Relapsing fever due to Borrelia recurrentis.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. In addition, the capsules contain the inactive ingredients anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue #1, gelatin, and titanium dioxide. The capsule imprinting ink contains butyl alcohol, denatured alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, propylene glycol, and shellac. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide."
},
{
"NDCCode": "50090-2446-9",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (50090-2446-9) ",
"NDC11Code": "50090-2446-09",
"ProductNDC": "50090-2446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062505",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180410",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum., 9 Relapsing fever due to Borrelia recurrentis.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. In addition, the capsules contain the inactive ingredients anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue #1, gelatin, and titanium dioxide. The capsule imprinting ink contains butyl alcohol, denatured alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, propylene glycol, and shellac. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide."
},
{
"NDCCode": "72162-2446-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (72162-2446-3) ",
"NDC11Code": "72162-2446-03",
"ProductNDC": "72162-2446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Silodosin",
"NonProprietaryName": "Silodosin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20241114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213230",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "SILODOSIN",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260316",
"SamplePackage": "N",
"IndicationAndUsage": "Silodosin, a selective alpha‑1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)] . Silodosin capsules is not indicated for the treatment of hypertension.",
"Description": "Silodosin capsules is a selective antagonist of alpha‑1 adrenoreceptors. The chemical name of silodosin is 1‑(3‑Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1 H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.53. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder that melts at approximately 105° to 109°C. It is freely soluble in acetic acid, and in absolute alcohol, and insoluble in water. Each Silodosin 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: mannitol, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The size #1 hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide. The Capsules are imprinted with black ink containing shellac, propylene glycol, ammonia solution- concentrated, black iron oxide and potassium hydroxide. Each Silodosin 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: mannitol, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The size #3 hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide. The Capsules are imprinted with black ink Containing shellac, propylene glycol, ammonia solution-concentrated, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "38779-0005-8",
"PackageDescription": "500 g in 1 JAR (38779-0005-8) ",
"NDC11Code": "38779-0005-08",
"ProductNDC": "38779-0005",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120611",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Medisca Inc.",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-10-08",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "11-JUN-12"
},
{
"NDCCode": "38779-0008-8",
"PackageDescription": "500 g in 1 JAR (38779-0008-8) ",
"NDC11Code": "38779-0008-08",
"ProductNDC": "38779-0008",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Hydrocortisone Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110510",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Medisca Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-14",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "10-MAY-11"
},
{
"NDCCode": "38779-0009-8",
"PackageDescription": "500 g in 1 JAR (38779-0009-8) ",
"NDC11Code": "38779-0009-08",
"ProductNDC": "38779-0009",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140630",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-14",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "30-JUN-14"
},
{
"NDCCode": "38779-0011-8",
"PackageDescription": "500 g in 1 JAR (38779-0011-8) ",
"NDC11Code": "38779-0011-08",
"ProductNDC": "38779-0011",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140703",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-14",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "03-JUL-14"
},
{
"NDCCode": "38779-0013-8",
"PackageDescription": "500 g in 1 JAR (38779-0013-8) ",
"NDC11Code": "38779-0013-08",
"ProductNDC": "38779-0013",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140725",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Medisca Inc.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-14",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "09-SEP-16"
},
{
"NDCCode": "38779-0019-8",
"PackageDescription": "500 g in 1 JAR (38779-0019-8) ",
"NDC11Code": "38779-0019-08",
"ProductNDC": "38779-0019",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130321",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-14",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "21-MAR-13"
},
{
"NDCCode": "38779-0023-8",
"PackageDescription": "500 g in 1 JAR (38779-0023-8)",
"NDC11Code": "38779-0023-08",
"ProductNDC": "38779-0023",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Erythromycin Ethylsuccinate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140821",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "38779-0034-8",
"PackageDescription": "500 g in 1 JAR (38779-0034-8)",
"NDC11Code": "38779-0034-08",
"ProductNDC": "38779-0034",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lincomycin Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140821",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "LINCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "38779-0043-8",
"PackageDescription": "500 g in 1 JAR (38779-0043-8) ",
"NDC11Code": "38779-0043-08",
"ProductNDC": "38779-0043",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Progesterone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130826",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "29-JAN-14"
},
{
"NDCCode": "38779-0049-8",
"PackageDescription": "500 g in 1 JAR (38779-0049-8) ",
"NDC11Code": "38779-0049-08",
"ProductNDC": "38779-0049",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sulfacetamide Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20150526",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "MEDISCA Inc",
"SubstanceName": "SULFACETAMIDE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-14",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "26-MAY-15"
},
{
"NDCCode": "38779-0053-8",
"PackageDescription": "500 g in 1 CONTAINER (38779-0053-8) ",
"NDC11Code": "38779-0053-08",
"ProductNDC": "38779-0053",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120228",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Medisca Inc.",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-01-21",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "28-FEB-12"
},
{
"NDCCode": "38779-0057-8",
"PackageDescription": "500 g in 1 JAR (38779-0057-8) ",
"NDC11Code": "38779-0057-08",
"ProductNDC": "38779-0057",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Progesterone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110511",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-14",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "11-MAY-11"
},
{
"NDCCode": "38779-0059-8",
"PackageDescription": "500 g in 1 JAR (38779-0059-8) ",
"NDC11Code": "38779-0059-08",
"ProductNDC": "38779-0059",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pyrantel Pamoate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140617",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Medisca Inc.",
"SubstanceName": "PYRANTEL PAMOATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-14",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "17-JUN-14"
},
{
"NDCCode": "38779-0063-8",
"PackageDescription": "500 g in 1 JAR (38779-0063-8) ",
"NDC11Code": "38779-0063-08",
"ProductNDC": "38779-0063",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20120417",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19-JUN-17"
},
{
"NDCCode": "38779-0071-8",
"PackageDescription": "500 g in 1 JAR (38779-0071-8) ",
"NDC11Code": "38779-0071-08",
"ProductNDC": "38779-0071",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dexamethasone Sodium Phosphate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140801",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-11-14",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-AUG-14"
},
{
"NDCCode": "38779-0075-8",
"PackageDescription": "500 g in 1 JAR (38779-0075-8) ",
"NDC11Code": "38779-0075-08",
"ProductNDC": "38779-0075",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Hydroquinone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130508",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Medisca Inc.",
"SubstanceName": "HYDROQUINONE",
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<Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. In addition, the capsules contain the inactive ingredients anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue #1, gelatin, and titanium dioxide. The capsule imprinting ink contains butyl alcohol, denatured alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, propylene glycol, and shellac. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide.</Description>
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<PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (50090-2446-5) </PackageDescription>
<NDC11Code>50090-2446-05</NDC11Code>
<ProductNDC>50090-2446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062505</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum., 9 Relapsing fever due to Borrelia recurrentis.</IndicationAndUsage>
<Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. In addition, the capsules contain the inactive ingredients anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue #1, gelatin, and titanium dioxide. The capsule imprinting ink contains butyl alcohol, denatured alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, propylene glycol, and shellac. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-2446-6</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50090-2446-6) </PackageDescription>
<NDC11Code>50090-2446-06</NDC11Code>
<ProductNDC>50090-2446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062505</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum., 9 Relapsing fever due to Borrelia recurrentis.</IndicationAndUsage>
<Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. In addition, the capsules contain the inactive ingredients anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue #1, gelatin, and titanium dioxide. The capsule imprinting ink contains butyl alcohol, denatured alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, propylene glycol, and shellac. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-2446-9</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (50090-2446-9) </PackageDescription>
<NDC11Code>50090-2446-09</NDC11Code>
<ProductNDC>50090-2446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062505</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment. Doxycycline is indicated for the treatment of the following infections: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis., 8 Nongonococcal urethritis caused by Ureaplasma urealyticum., 9 Relapsing fever due to Borrelia recurrentis.</IndicationAndUsage>
<Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) for oral administration. The structural formula of doxycycline hyclate is. with a molecular formula of (C22H24N2O8HCl)2C2H6OH2O and a molecular weight of 1025.89. The chemical designation for doxycycline hyclate is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule, for oral administration, contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline. In addition, the capsules contain the inactive ingredients anhydrous lactose, colloidal silicon dioxide, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and stearic acid. The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue #1, gelatin, and titanium dioxide. The capsule imprinting ink contains butyl alcohol, denatured alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, propylene glycol, and shellac. Each tablet, for oral administration, contains doxycycline hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72162-2446-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (72162-2446-3) </PackageDescription>
<NDC11Code>72162-2446-03</NDC11Code>
<ProductNDC>72162-2446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Silodosin</ProprietaryName>
<NonProprietaryName>Silodosin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213230</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>SILODOSIN</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Silodosin, a selective alpha‑1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)] . Silodosin capsules is not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Silodosin capsules is a selective antagonist of alpha‑1 adrenoreceptors. The chemical name of silodosin is 1‑(3‑Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1 H-indole-7-carboxamide and the molecular formula is C 25H 32F 3N 3O 4with a molecular weight of 495.53. The structural formula of silodosin is:. Silodosin is a white to pale yellowish white powder that melts at approximately 105° to 109°C. It is freely soluble in acetic acid, and in absolute alcohol, and insoluble in water. Each Silodosin 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: mannitol, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The size #1 hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide. The Capsules are imprinted with black ink containing shellac, propylene glycol, ammonia solution- concentrated, black iron oxide and potassium hydroxide. Each Silodosin 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: mannitol, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The size #3 hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide. The Capsules are imprinted with black ink Containing shellac, propylene glycol, ammonia solution-concentrated, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>38779-0005-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0005-8) </PackageDescription>
<NDC11Code>38779-0005-08</NDC11Code>
<ProductNDC>38779-0005</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120611</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-10-08</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-JUN-12</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0008-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0008-8) </PackageDescription>
<NDC11Code>38779-0008-08</NDC11Code>
<ProductNDC>38779-0008</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110510</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-14</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-MAY-11</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0009-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0009-8) </PackageDescription>
<NDC11Code>38779-0009-08</NDC11Code>
<ProductNDC>38779-0009</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140630</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-14</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-JUN-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0011-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0011-8) </PackageDescription>
<NDC11Code>38779-0011-08</NDC11Code>
<ProductNDC>38779-0011</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140703</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-14</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-JUL-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0013-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0013-8) </PackageDescription>
<NDC11Code>38779-0013-08</NDC11Code>
<ProductNDC>38779-0013</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140725</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-14</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>09-SEP-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0019-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0019-8) </PackageDescription>
<NDC11Code>38779-0019-08</NDC11Code>
<ProductNDC>38779-0019</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130321</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-14</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-MAR-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0023-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0023-8)</PackageDescription>
<NDC11Code>38779-0023-08</NDC11Code>
<ProductNDC>38779-0023</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Erythromycin Ethylsuccinate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140821</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>ERYTHROMYCIN ETHYLSUCCINATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>38779-0034-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0034-8)</PackageDescription>
<NDC11Code>38779-0034-08</NDC11Code>
<ProductNDC>38779-0034</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lincomycin Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140821</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>LINCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>38779-0043-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0043-8) </PackageDescription>
<NDC11Code>38779-0043-08</NDC11Code>
<ProductNDC>38779-0043</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130826</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>29-JAN-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0049-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0049-8) </PackageDescription>
<NDC11Code>38779-0049-08</NDC11Code>
<ProductNDC>38779-0049</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sulfacetamide Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20150526</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>MEDISCA Inc</LabelerName>
<SubstanceName>SULFACETAMIDE SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-14</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>26-MAY-15</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0053-8</NDCCode>
<PackageDescription>500 g in 1 CONTAINER (38779-0053-8) </PackageDescription>
<NDC11Code>38779-0053-08</NDC11Code>
<ProductNDC>38779-0053</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120228</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-01-21</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>28-FEB-12</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0057-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0057-8) </PackageDescription>
<NDC11Code>38779-0057-08</NDC11Code>
<ProductNDC>38779-0057</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110511</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-14</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-MAY-11</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0059-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0059-8) </PackageDescription>
<NDC11Code>38779-0059-08</NDC11Code>
<ProductNDC>38779-0059</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pyrantel Pamoate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140617</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>PYRANTEL PAMOATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-14</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>17-JUN-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0063-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0063-8) </PackageDescription>
<NDC11Code>38779-0063-08</NDC11Code>
<ProductNDC>38779-0063</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20120417</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>BENZOCAINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19-JUN-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0071-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0071-8) </PackageDescription>
<NDC11Code>38779-0071-08</NDC11Code>
<ProductNDC>38779-0071</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140801</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-14</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-AUG-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0075-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0075-8) </PackageDescription>
<NDC11Code>38779-0075-08</NDC11Code>
<ProductNDC>38779-0075</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Hydroquinone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130508</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>HYDROQUINONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-MAY-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>38779-0076-8</NDCCode>
<PackageDescription>500 g in 1 JAR (38779-0076-8)</PackageDescription>
<NDC11Code>38779-0076-08</NDC11Code>
<ProductNDC>38779-0076</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140813</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Medisca Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>