{
"NDC": [
{
"NDCCode": "68462-713-08",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68462-713-08) ",
"NDC11Code": "68462-0713-08",
"ProductNDC": "68462-713",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rufinamide",
"NonProprietaryName": "Rufinamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205075",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "RUFINAMIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160516",
"SamplePackage": "N",
"IndicationAndUsage": "Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.",
"Description": "Rufinamide, USP is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide, USP has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide. It has an empirical formula of C10H8F2N4O and a molecular weight of 238.2 g/mol. The drug substance is a white to off-white crystalline powder. Rufinamide, USP is practically insoluble in water, slightly soluble in tetrahydrofuran and in methanol, and very slightly soluble in ethanol and in acetonitrile. Rufinamide Tablets, USP are available for oral administration as film-coated tablets, scored on both sides, containing either 200 mg or 400 mg of rufinamide, USP. Inactive ingredients are colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, talc, iron oxide red, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "68462-713-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68462-713-05) ",
"NDC11Code": "68462-0713-05",
"ProductNDC": "68462-713",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rufinamide",
"NonProprietaryName": "Rufinamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205075",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "RUFINAMIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160516",
"SamplePackage": "N",
"IndicationAndUsage": "Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.",
"Description": "Rufinamide, USP is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide, USP has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide. It has an empirical formula of C10H8F2N4O and a molecular weight of 238.2 g/mol. The drug substance is a white to off-white crystalline powder. Rufinamide, USP is practically insoluble in water, slightly soluble in tetrahydrofuran and in methanol, and very slightly soluble in ethanol and in acetonitrile. Rufinamide Tablets, USP are available for oral administration as film-coated tablets, scored on both sides, containing either 200 mg or 400 mg of rufinamide, USP. Inactive ingredients are colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, talc, iron oxide red, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "68462-713-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68462-713-30) ",
"NDC11Code": "68462-0713-30",
"ProductNDC": "68462-713",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rufinamide",
"NonProprietaryName": "Rufinamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205075",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "RUFINAMIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160516",
"SamplePackage": "N",
"IndicationAndUsage": "Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.",
"Description": "Rufinamide, USP is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide, USP has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide. It has an empirical formula of C10H8F2N4O and a molecular weight of 238.2 g/mol. The drug substance is a white to off-white crystalline powder. Rufinamide, USP is practically insoluble in water, slightly soluble in tetrahydrofuran and in methanol, and very slightly soluble in ethanol and in acetonitrile. Rufinamide Tablets, USP are available for oral administration as film-coated tablets, scored on both sides, containing either 200 mg or 400 mg of rufinamide, USP. Inactive ingredients are colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, talc, iron oxide red, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "68462-135-08",
"PackageDescription": "120 TABLET in 1 BOTTLE (68462-135-08) ",
"NDC11Code": "68462-0135-08",
"ProductNDC": "68462-135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191016",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209227",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191016",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate, USP the active ingredient of Abiraterone Acetate Tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white or almost white, non-hygroscopic, solid powder and freely soluble in methylene chloride, tetrahydrofuran, and toluene, soluble in methanol, ethanol, ethyl acetate, isobutyl methyl ketone, N,N-dimethylformamide, and acetone, sparingly soluble in acetonitrile and dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1 N hydrochloric acid and practically insoluble aqueous media over a wide range of pH values. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.6 g/mol. Abiraterone Acetate Tablets, USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K–30 and sodium lauryl sulfate. The coating, Opadry II 85F500121 Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. , 2 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "68462-545-08",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68462-545-08)",
"NDC11Code": "68462-0545-08",
"ProductNDC": "68462-545",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078234",
"LabelerName": "Glenmark Generics Inc., USA",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2014-07-07"
},
{
"NDCCode": "68462-546-08",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68462-546-08)",
"NDC11Code": "68462-0546-08",
"ProductNDC": "68462-546",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078234",
"LabelerName": "Glenmark Generics Inc., USA",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2014-07-07"
},
{
"NDCCode": "68462-547-08",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68462-547-08)",
"NDC11Code": "68462-0547-08",
"ProductNDC": "68462-547",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078234",
"LabelerName": "Glenmark Generics Inc., USA",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2014-07-07"
},
{
"NDCCode": "68462-714-08",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (68462-714-08) ",
"NDC11Code": "68462-0714-08",
"ProductNDC": "68462-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rufinamide",
"NonProprietaryName": "Rufinamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205075",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "RUFINAMIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160516",
"SamplePackage": "N",
"IndicationAndUsage": "Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.",
"Description": "Rufinamide, USP is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide, USP has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide. It has an empirical formula of C10H8F2N4O and a molecular weight of 238.2 g/mol. The drug substance is a white to off-white crystalline powder. Rufinamide, USP is practically insoluble in water, slightly soluble in tetrahydrofuran and in methanol, and very slightly soluble in ethanol and in acetonitrile. Rufinamide Tablets, USP are available for oral administration as film-coated tablets, scored on both sides, containing either 200 mg or 400 mg of rufinamide, USP. Inactive ingredients are colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, talc, iron oxide red, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "70859-001-01",
"PackageDescription": "1 KIT in 1 KIT (70859-001-01) * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 22 g in 1 TUBE (68462-180-22) * 118 mL in 1 TUBE (68599-0203-4) ",
"NDC11Code": "70859-0001-01",
"ProductNDC": "70859-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nusurgepak Surgical Prep/carepak",
"NonProprietaryName": "Chlorhexidine Gluconate, Mupirocin, Dimethicone",
"DosageFormName": "KIT",
"StartMarketingDate": "20160729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090480",
"LabelerName": "Nucare Pharmaceuticals Inc",
"Status": "Deprecated",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160729",
"SamplePackage": "N"
},
{
"NDCCode": "70859-057-01",
"PackageDescription": "1 KIT in 1 KIT (70859-057-01) * 118 mg in 1 BOTTLE (68599-0213-4) * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 22 g in 1 TUBE (68462-180-22) ",
"NDC11Code": "70859-0057-01",
"ProductNDC": "70859-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nusurgepak Surgical Prep/carepak",
"NonProprietaryName": "Chlorhexidine Gluconate, Mupirocin, Dimethicone",
"DosageFormName": "KIT",
"StartMarketingDate": "20110608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090480",
"LabelerName": "Nucare Pharmaceuticals Inc",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200616",
"SamplePackage": "N",
"Description": "Mupirocin ointment USP 2% contains the RNA synthetase inhibitor antibacterial, mupirocin USP. The chemical name is ( E)-(2 S,3 R,4 R,5 S)-5-[(2 S,3 S,4 S,5 S)-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4dihydroxy-ß-methyl-2 H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin USP is C 26H 44O 9, and the molecular weight is 500.6. The chemical structure is:. Each gram of mupirocin ointment USP 2% contains 20 mg mupirocin USP in a water-miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350."
},
{
"NDCCode": "21749-713-08",
"PackageDescription": "236 mL in 1 BOTTLE (21749-713-08) ",
"NDC11Code": "21749-0713-08",
"ProductNDC": "21749-713",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purell Advanced Soothing",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "GOJO Industries, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "55289-713-08",
"PackageDescription": "8 TABLET in 1 BOTTLE, PLASTIC (55289-713-08)",
"NDC11Code": "55289-0713-08",
"ProductNDC": "55289-713",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenazopyridine Hcl",
"NonProprietaryName": "Phenazopyridine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100910",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-07-14"
},
{
"NDCCode": "58602-713-08",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (58602-713-08) > 50 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "58602-0713-08",
"ProductNDC": "58602-713",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220322",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208865",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220322",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachemuscular aches minor pain of arthritistoothachebackachethe common cold menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "59088-713-00",
"PackageDescription": "1 KIT in 1 KIT (59088-713-00) * 59 mL in 1 TUBE (59088-446-05) * 118 mL in 1 BOTTLE (59088-445-08) ",
"NDC11Code": "59088-0713-00",
"ProductNDC": "59088-713",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Atrix System 1",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "KIT",
"StartMarketingDate": "20211025",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211025",
"SamplePackage": "N"
},
{
"NDCCode": "61786-713-08",
"PackageDescription": "10 mL in 1 VIAL (61786-713-08)",
"NDC11Code": "61786-0713-08",
"ProductNDC": "61786-713",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Novolin",
"ProprietaryNameSuffix": "70/30",
"NonProprietaryName": "Human Insulin",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20160524",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019991",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[USP'U]/mL",
"Status": "Deprecated",
"LastUpdate": "2017-02-17"
},
{
"NDCCode": "69458-713-08",
"PackageDescription": "355 mL in 1 BOTTLE (69458-713-08)",
"NDC11Code": "69458-0713-08",
"ProductNDC": "69458-713",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flanadol Pronto Bismuth",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160415",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "Jomex International Llc",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses relieves diarrhea heartburn indigestion nausea upset stomach."
},
{
"NDCCode": "71919-713-08",
"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-713-08) ",
"NDC11Code": "71919-0713-08",
"ProductNDC": "71919-713",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vinca Minor",
"NonProprietaryName": "Vinca Minor",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "VINCA MINOR",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110517",
"SamplePackage": "N"
},
{
"NDCCode": "74891-713-08",
"PackageDescription": "237 mL in 1 BOTTLE, SPRAY (74891-713-08) ",
"NDC11Code": "74891-0713-08",
"ProductNDC": "74891-713",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Doctors Optimal Formula Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Golden Lab, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N"
},
{
"NDCCode": "68462-390-10",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-390-10) ",
"NDC11Code": "68462-0390-10",
"ProductNDC": "68462-390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20211101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209495",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211101",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is 1H-Benzimidazole-5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), dihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 2 H2O with molecular weight of 749.15 g/mol as a dihydrate and 713.15 g/mol on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored powder. It is slightly soluble in methanol, practically insoluble water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains either 20 mg or 40 mg of esomeprazole (present as 21.75 mg or 43.5 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets containing the following inactive ingredients: hydroxypropyl cellulose, hypromellose, methacrylic acid - ethyl acrylate copolymer, polyethylene glycol, sugar spheres (comprised of sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The capsule shells contain the ingredients FD&C blue# 1, gelatin, iron oxide yellow, shellac, sodium lauryl sulfate, and titanium dioxide. Additionally, black ink contains black iron oxide and potassium hydroxide. Meets USP dissolution test 2."
},
{
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"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is 1H-Benzimidazole-5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), dihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 2 H2O with molecular weight of 749.15 g/mol as a dihydrate and 713.15 g/mol on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored powder. It is slightly soluble in methanol, practically insoluble water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains either 20 mg or 40 mg of esomeprazole (present as 21.75 mg or 43.5 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets containing the following inactive ingredients: hydroxypropyl cellulose, hypromellose, methacrylic acid - ethyl acrylate copolymer, polyethylene glycol, sugar spheres (comprised of sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The capsule shells contain the ingredients FD&C blue# 1, gelatin, iron oxide yellow, shellac, sodium lauryl sulfate, and titanium dioxide. Additionally, black ink contains black iron oxide and potassium hydroxide. Meets USP dissolution test 2."
},
{
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"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is 1H-Benzimidazole-5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), dihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 2 H2O with molecular weight of 749.15 g/mol as a dihydrate and 713.15 g/mol on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored powder. It is slightly soluble in methanol, practically insoluble water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains either 20 mg or 40 mg of esomeprazole (present as 21.75 mg or 43.5 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets containing the following inactive ingredients: hydroxypropyl cellulose, hypromellose, methacrylic acid - ethyl acrylate copolymer, polyethylene glycol, sugar spheres (comprised of sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The capsule shells contain the ingredients FD&C blue# 1, gelatin, iron oxide yellow, shellac, sodium lauryl sulfate, and titanium dioxide. Additionally, black ink contains black iron oxide and potassium hydroxide. Meets USP dissolution test 2."
},
{
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"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is 1H-Benzimidazole-5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), dihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 2 H2O with molecular weight of 749.15 g/mol as a dihydrate and 713.15 g/mol on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored powder. It is slightly soluble in methanol, practically insoluble water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains either 20 mg or 40 mg of esomeprazole (present as 21.75 mg or 43.5 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets containing the following inactive ingredients: hydroxypropyl cellulose, hypromellose, methacrylic acid - ethyl acrylate copolymer, polyethylene glycol, sugar spheres (comprised of sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The capsule shells contain the ingredients FD&C blue# 1, gelatin, iron oxide yellow, shellac, sodium lauryl sulfate, and titanium dioxide. Additionally, black ink contains black iron oxide and potassium hydroxide. Meets USP dissolution test 2."
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{
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"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is 1H-Benzimidazole-5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), dihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 2 H2O with molecular weight of 749.15 g/mol as a dihydrate and 713.15 g/mol on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored powder. It is slightly soluble in methanol, practically insoluble water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains either 20 mg or 40 mg of esomeprazole (present as 21.75 mg or 43.5 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets containing the following inactive ingredients: hydroxypropyl cellulose, hypromellose, methacrylic acid - ethyl acrylate copolymer, polyethylene glycol, sugar spheres (comprised of sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The capsule shells contain the ingredients FD&C blue# 1, gelatin, iron oxide yellow, shellac, sodium lauryl sulfate, and titanium dioxide. Additionally, black ink contains black iron oxide and potassium hydroxide. Meets USP dissolution test 2."
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"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is 1H-Benzimidazole-5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), dihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 2 H2O with molecular weight of 749.15 g/mol as a dihydrate and 713.15 g/mol on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored powder. It is slightly soluble in methanol, practically insoluble water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains either 20 mg or 40 mg of esomeprazole (present as 21.75 mg or 43.5 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets containing the following inactive ingredients: hydroxypropyl cellulose, hypromellose, methacrylic acid - ethyl acrylate copolymer, polyethylene glycol, sugar spheres (comprised of sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The capsule shells contain the ingredients FD&C blue# 1, gelatin, iron oxide yellow, shellac, sodium lauryl sulfate, and titanium dioxide. Additionally, black ink contains black iron oxide and potassium hydroxide. Meets USP dissolution test 2."
},
{
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"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated with GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is 1H-Benzimidazole,5-methoxy-2-[(S)-[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 with molecular weight of 713.12 on an anhydrous basis. The structural formula is. The magnesium salt is an off-white to pale cream colored powder. It is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.25 mg esomeprazole magnesium) or 40 mg of esomeprazole (equivalent to 44.50 mg esomeprazole magnesium) in the form of enteric-coated pellets with the following inactive ingredients: crospovidone, hydroxypropyl cellulose, mannitol, methacrylic acid-ethyl acrylate copolymer dispersion, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin and titanium dioxide, and may contain sodium lauryl sulfate. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
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<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate, USP the active ingredient of Abiraterone Acetate Tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white or almost white, non-hygroscopic, solid powder and freely soluble in methylene chloride, tetrahydrofuran, and toluene, soluble in methanol, ethanol, ethyl acetate, isobutyl methyl ketone, N,N-dimethylformamide, and acetone, sparingly soluble in acetonitrile and dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1 N hydrochloric acid and practically insoluble aqueous media over a wide range of pH values. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.6 g/mol. Abiraterone Acetate Tablets, USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 1 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K–30 and sodium lauryl sulfate. The coating, Opadry II 85F500121 Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. , 2 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate.</Description>
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<StartMarketingDatePackage>20160516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.</IndicationAndUsage>
<Description>Rufinamide, USP is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide, USP has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide. It has an empirical formula of C10H8F2N4O and a molecular weight of 238.2 g/mol. The drug substance is a white to off-white crystalline powder. Rufinamide, USP is practically insoluble in water, slightly soluble in tetrahydrofuran and in methanol, and very slightly soluble in ethanol and in acetonitrile. Rufinamide Tablets, USP are available for oral administration as film-coated tablets, scored on both sides, containing either 200 mg or 400 mg of rufinamide, USP. Inactive ingredients are colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, talc, iron oxide red, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70859-001-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (70859-001-01) * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 22 g in 1 TUBE (68462-180-22) * 118 mL in 1 TUBE (68599-0203-4) </PackageDescription>
<NDC11Code>70859-0001-01</NDC11Code>
<ProductNDC>70859-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nusurgepak Surgical Prep/carepak</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate, Mupirocin, Dimethicone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090480</ApplicationNumber>
<LabelerName>Nucare Pharmaceuticals Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70859-057-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (70859-057-01) * 118 mg in 1 BOTTLE (68599-0213-4) * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 22 g in 1 TUBE (68462-180-22) </PackageDescription>
<NDC11Code>70859-0057-01</NDC11Code>
<ProductNDC>70859-057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nusurgepak Surgical Prep/carepak</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate, Mupirocin, Dimethicone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090480</ApplicationNumber>
<LabelerName>Nucare Pharmaceuticals Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Mupirocin ointment USP 2% contains the RNA synthetase inhibitor antibacterial, mupirocin USP. The chemical name is ( E)-(2 S,3 R,4 R,5 S)-5-[(2 S,3 S,4 S,5 S)-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4dihydroxy-ß-methyl-2 H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin USP is C 26H 44O 9, and the molecular weight is 500.6. The chemical structure is:. Each gram of mupirocin ointment USP 2% contains 20 mg mupirocin USP in a water-miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350.</Description>
</NDC>
<NDC>
<NDCCode>21749-713-08</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE (21749-713-08) </PackageDescription>
<NDC11Code>21749-0713-08</NDC11Code>
<ProductNDC>21749-713</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Purell Advanced Soothing</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>GOJO Industries, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55289-713-08</NDCCode>
<PackageDescription>8 TABLET in 1 BOTTLE, PLASTIC (55289-713-08)</PackageDescription>
<NDC11Code>55289-0713-08</NDC11Code>
<ProductNDC>55289-713</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenazopyridine Hcl</ProprietaryName>
<NonProprietaryName>Phenazopyridine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100910</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-07-14</LastUpdate>
</NDC>
<NDC>
<NDCCode>58602-713-08</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (58602-713-08) > 50 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>58602-0713-08</NDC11Code>
<ProductNDC>58602-713</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220322</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208865</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachemuscular aches minor pain of arthritistoothachebackachethe common cold menstrual cramps. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-713-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-713-00) * 59 mL in 1 TUBE (59088-446-05) * 118 mL in 1 BOTTLE (59088-445-08) </PackageDescription>
<NDC11Code>59088-0713-00</NDC11Code>
<ProductNDC>59088-713</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Atrix System 1</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20211025</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61786-713-08</NDCCode>
<PackageDescription>10 mL in 1 VIAL (61786-713-08)</PackageDescription>
<NDC11Code>61786-0713-08</NDC11Code>
<ProductNDC>61786-713</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Novolin</ProprietaryName>
<ProprietaryNameSuffix>70/30</ProprietaryNameSuffix>
<NonProprietaryName>Human Insulin</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20160524</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019991</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-02-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>69458-713-08</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (69458-713-08)</PackageDescription>
<NDC11Code>69458-0713-08</NDC11Code>
<ProductNDC>69458-713</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flanadol Pronto Bismuth</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160415</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>Jomex International Llc</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>262</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses relieves diarrhea heartburn indigestion nausea upset stomach.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-713-08</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (71919-713-08) </PackageDescription>
<NDC11Code>71919-0713-08</NDC11Code>
<ProductNDC>71919-713</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vinca Minor</ProprietaryName>
<NonProprietaryName>Vinca Minor</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>VINCA MINOR</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>74891-713-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, SPRAY (74891-713-08) </PackageDescription>
<NDC11Code>74891-0713-08</NDC11Code>
<ProductNDC>74891-713</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Doctors Optimal Formula Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Golden Lab, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68462-390-10</NDCCode>
<PackageDescription>1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-390-10) </PackageDescription>
<NDC11Code>68462-0390-10</NDC11Code>
<ProductNDC>68462-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209495</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is 1H-Benzimidazole-5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), dihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 2 H2O with molecular weight of 749.15 g/mol as a dihydrate and 713.15 g/mol on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored powder. It is slightly soluble in methanol, practically insoluble water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains either 20 mg or 40 mg of esomeprazole (present as 21.75 mg or 43.5 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets containing the following inactive ingredients: hydroxypropyl cellulose, hypromellose, methacrylic acid - ethyl acrylate copolymer, polyethylene glycol, sugar spheres (comprised of sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The capsule shells contain the ingredients FD&C blue# 1, gelatin, iron oxide yellow, shellac, sodium lauryl sulfate, and titanium dioxide. Additionally, black ink contains black iron oxide and potassium hydroxide. Meets USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>68462-390-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-390-30) </PackageDescription>
<NDC11Code>68462-0390-30</NDC11Code>
<ProductNDC>68462-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209495</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is 1H-Benzimidazole-5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), dihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 2 H2O with molecular weight of 749.15 g/mol as a dihydrate and 713.15 g/mol on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored powder. It is slightly soluble in methanol, practically insoluble water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains either 20 mg or 40 mg of esomeprazole (present as 21.75 mg or 43.5 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets containing the following inactive ingredients: hydroxypropyl cellulose, hypromellose, methacrylic acid - ethyl acrylate copolymer, polyethylene glycol, sugar spheres (comprised of sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The capsule shells contain the ingredients FD&C blue# 1, gelatin, iron oxide yellow, shellac, sodium lauryl sulfate, and titanium dioxide. Additionally, black ink contains black iron oxide and potassium hydroxide. Meets USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>68462-390-90</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-390-90) </PackageDescription>
<NDC11Code>68462-0390-90</NDC11Code>
<ProductNDC>68462-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209495</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is 1H-Benzimidazole-5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), dihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 2 H2O with molecular weight of 749.15 g/mol as a dihydrate and 713.15 g/mol on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored powder. It is slightly soluble in methanol, practically insoluble water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains either 20 mg or 40 mg of esomeprazole (present as 21.75 mg or 43.5 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets containing the following inactive ingredients: hydroxypropyl cellulose, hypromellose, methacrylic acid - ethyl acrylate copolymer, polyethylene glycol, sugar spheres (comprised of sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The capsule shells contain the ingredients FD&C blue# 1, gelatin, iron oxide yellow, shellac, sodium lauryl sulfate, and titanium dioxide. Additionally, black ink contains black iron oxide and potassium hydroxide. Meets USP dissolution test 2.</Description>
</NDC>
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<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is 1H-Benzimidazole-5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), dihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 2 H2O with molecular weight of 749.15 g/mol as a dihydrate and 713.15 g/mol on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored powder. It is slightly soluble in methanol, practically insoluble water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains either 20 mg or 40 mg of esomeprazole (present as 21.75 mg or 43.5 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets containing the following inactive ingredients: hydroxypropyl cellulose, hypromellose, methacrylic acid - ethyl acrylate copolymer, polyethylene glycol, sugar spheres (comprised of sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The capsule shells contain the ingredients FD&C blue# 1, gelatin, iron oxide yellow, shellac, sodium lauryl sulfate, and titanium dioxide. Additionally, black ink contains black iron oxide and potassium hydroxide. Meets USP dissolution test 2.</Description>
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<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is 1H-Benzimidazole-5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), dihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 2 H2O with molecular weight of 749.15 g/mol as a dihydrate and 713.15 g/mol on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored powder. It is slightly soluble in methanol, practically insoluble water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains either 20 mg or 40 mg of esomeprazole (present as 21.75 mg or 43.5 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets containing the following inactive ingredients: hydroxypropyl cellulose, hypromellose, methacrylic acid - ethyl acrylate copolymer, polyethylene glycol, sugar spheres (comprised of sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The capsule shells contain the ingredients FD&C blue# 1, gelatin, iron oxide yellow, shellac, sodium lauryl sulfate, and titanium dioxide. Additionally, black ink contains black iron oxide and potassium hydroxide. Meets USP dissolution test 2.</Description>
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<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in Esomeprazole Magnesium Delayed-Release Capsules, USP for oral administration is 1H-Benzimidazole-5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), dihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 2 H2O with molecular weight of 749.15 g/mol as a dihydrate and 713.15 g/mol on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored powder. It is slightly soluble in methanol, practically insoluble water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Each Esomeprazole Magnesium Delayed-Release Capsule, USP contains either 20 mg or 40 mg of esomeprazole (present as 21.75 mg or 43.5 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets containing the following inactive ingredients: hydroxypropyl cellulose, hypromellose, methacrylic acid - ethyl acrylate copolymer, polyethylene glycol, sugar spheres (comprised of sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The capsule shells contain the ingredients FD&C blue# 1, gelatin, iron oxide yellow, shellac, sodium lauryl sulfate, and titanium dioxide. Additionally, black ink contains black iron oxide and potassium hydroxide. Meets USP dissolution test 2.</Description>
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<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated with GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is 1H-Benzimidazole,5-methoxy-2-[(S)-[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 with molecular weight of 713.12 on an anhydrous basis. The structural formula is. The magnesium salt is an off-white to pale cream colored powder. It is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.25 mg esomeprazole magnesium) or 40 mg of esomeprazole (equivalent to 44.50 mg esomeprazole magnesium) in the form of enteric-coated pellets with the following inactive ingredients: crospovidone, hydroxypropyl cellulose, mannitol, methacrylic acid-ethyl acrylate copolymer dispersion, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin and titanium dioxide, and may contain sodium lauryl sulfate. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated with GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is 1H-Benzimidazole,5-methoxy-2-[(S)-[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 with molecular weight of 713.12 on an anhydrous basis. The structural formula is. The magnesium salt is an off-white to pale cream colored powder. It is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.25 mg esomeprazole magnesium) or 40 mg of esomeprazole (equivalent to 44.50 mg esomeprazole magnesium) in the form of enteric-coated pellets with the following inactive ingredients: crospovidone, hydroxypropyl cellulose, mannitol, methacrylic acid-ethyl acrylate copolymer dispersion, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin and titanium dioxide, and may contain sodium lauryl sulfate. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated with GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is 1H-Benzimidazole,5-methoxy-2-[(S)-[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 with molecular weight of 713.12 on an anhydrous basis. The structural formula is. The magnesium salt is an off-white to pale cream colored powder. It is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.25 mg esomeprazole magnesium) or 40 mg of esomeprazole (equivalent to 44.50 mg esomeprazole magnesium) in the form of enteric-coated pellets with the following inactive ingredients: crospovidone, hydroxypropyl cellulose, mannitol, methacrylic acid-ethyl acrylate copolymer dispersion, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin and titanium dioxide, and may contain sodium lauryl sulfate. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated with GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is 1H-Benzimidazole,5-methoxy-2-[(S)-[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 with molecular weight of 713.12 on an anhydrous basis. The structural formula is. The magnesium salt is an off-white to pale cream colored powder. It is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.25 mg esomeprazole magnesium) or 40 mg of esomeprazole (equivalent to 44.50 mg esomeprazole magnesium) in the form of enteric-coated pellets with the following inactive ingredients: crospovidone, hydroxypropyl cellulose, mannitol, methacrylic acid-ethyl acrylate copolymer dispersion, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin and titanium dioxide, and may contain sodium lauryl sulfate. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
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<ProprietaryName>Antibacterial</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170114</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-08</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
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<NDC11Code>11344-0713-44</NDC11Code>
<ProductNDC>11344-713</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170114</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
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