{
"NDC": [
{
"NDCCode": "23359-700-30",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (23359-700-30)",
"NDC11Code": "23359-0700-30",
"ProductNDC": "23359-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Puralor",
"NonProprietaryName": "1-(c14-c18 Esteroyl)-2-docosahexanoyl-sn-glycero-3-phosphocholine, 1-(c14-c18 Esteroyl)-2-docosahexanoyl-sn-glycero-3-phosphoethanolamine, Egg Phospholipids , Folic Acid, Leucovorin, Levomefolic Acid, Anhydrous Citric Acid, Sodium Citrate, Magnesium Glycinate, Acetylcysteine Amide, Cholecalciferol, Thiamine, Riboflavin, Pantethine, Niacin, Cobamamide, Ascorbic Acid, Magnesium L-threonate, Papain And Intrinsic Factor",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOCHOLINE; 1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE; EGG PHOSPHOLIPIDS; FOLIC ACID; LEUCOVORIN; LEVOMEFOLIC ACID; ANHYDROUS CITRIC ACID; SODIUM CITRATE; MAGNESIUM GLYCINATE; ACETYLCYSTEINE AMIDE; CHOLECALCIFEROL; THIAMINE; RIBOFLAVIN; PANTETHINE; NIACIN; COBAMAMIDE; ASCORBIC ACID; MAGNESIUM L-THREONATE; PAPAIN; INTRINSIC FACTOR",
"StrengthNumber": "5; 2.5; 42.5; .2; 3; .4; 1.6; .8; 1; 5; 100; .5; .5; 2.5; .5; 2; 25; 2.5; 20; 2.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-09-13"
},
{
"NDCCode": "23359-100-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (23359-100-30) ",
"NDC11Code": "23359-0100-30",
"ProductNDC": "23359-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Centratex",
"NonProprietaryName": "Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, And Cupric Sulfate Anhydrous",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090614",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "CALCIUM PANTOTHENATE; CUPRIC SULFATE ANHYDROUS; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM SULFATE, UNSPECIFIED; MANGANESE SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE",
"StrengthNumber": "10; .8; 15; 1; 106; 6.9; 1.3; 30; 5; 6; 200; 10; 18.2",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090614",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of anemia due to lack of iron and low folate as in menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of conditions where iron and vitamin C deficiency occur together, along with a poor intake or increased need for B-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in periods of extended recovery."
},
{
"NDCCode": "23359-105-30",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE (23359-105-30) ",
"NDC11Code": "23359-0105-30",
"ProductNDC": "23359-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "C-nate Dha",
"NonProprietaryName": "Omega-3 Fatty Acids, Icosapent, Doconexent, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol, D-, Cupric Sulfate, Zinc Oxide, Ferrous Fumarate And Magnesium Oxide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE",
"StrengthNumber": "30; 100; 400; 1; 15; 28; 1; 30; 200; 20; 3; 3; 20",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130101",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers."
},
{
"NDCCode": "23359-301-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (23359-301-30)",
"NDC11Code": "23359-0301-30",
"ProductNDC": "23359-301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bump Dha",
"NonProprietaryName": "Folate, Vitamin B2, Vitamin B6, Vitamin B12, Potassium Iodide, Zinc Biglycinate, Magnesium Oxide, Nadh, Dha, Carbonyl Iron",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170324",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "LEVOMEFOLATE MAGNESIUM; LEUCOVORIN; FLAVIN ADENINE DINUCLEOTIDE; FLAVIN MONONUCLEOTIDE; PYRIDOXINE HYDROCHLORIDE; PYRIDOXAL PHOSPHATE ANHYDROUS; COBAMAMIDE; POTASSIUM IODIDE; ZINC GLYCINATE; MAGNESIUM OXIDE; NADH; OMEGA-3 FATTY ACIDS; IRON PENTACARBONYL",
"StrengthNumber": "1; 1; 1; 2; 20; 5; 500; 250; 15; 125; 25; 300; 15",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; 1/1; mg/1; ug/1; mg/1; mg/1",
"Pharm_Classes": "Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-04-24"
},
{
"NDCCode": "23359-032-04",
"PackageDescription": "120 mL in 1 BOTTLE (23359-032-04) ",
"NDC11Code": "23359-0032-04",
"ProductNDC": "23359-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ninjacof",
"NonProprietaryName": "Chlophedianol Hcl And Pyrilamine Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20141015",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE",
"StrengthNumber": "12.5; 12.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170919",
"SamplePackage": "N",
"IndicationAndUsage": "Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 calms the cough control center and relieves coughing, 3 runny nose, 4 sneezing, 5 itching of the nose and throat, 6 itchy, watery eyes."
},
{
"NDCCode": "23359-032-10",
"PackageDescription": "10 mL in 1 BOTTLE (23359-032-10) ",
"NDC11Code": "23359-0032-10",
"ProductNDC": "23359-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ninjacof",
"NonProprietaryName": "Chlophedianol Hcl And Pyrilamine Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20141015",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE",
"StrengthNumber": "12.5; 12.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170918",
"SamplePackage": "N",
"IndicationAndUsage": "Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 calms the cough control center and relieves coughing, 3 runny nose, 4 sneezing, 5 itching of the nose and throat, 6 itchy, watery eyes."
},
{
"NDCCode": "23359-032-16",
"PackageDescription": "473 mL in 1 BOTTLE (23359-032-16) ",
"NDC11Code": "23359-0032-16",
"ProductNDC": "23359-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ninjacof",
"NonProprietaryName": "Chlophedianol Hcl And Pyrilamine Maleate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20141015",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE",
"StrengthNumber": "12.5; 12.5",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141015",
"SamplePackage": "N",
"IndicationAndUsage": "Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 calms the cough control center and relieves coughing, 3 runny nose, 4 sneezing, 5 itching of the nose and throat, 6 itchy, watery eyes."
},
{
"NDCCode": "23359-034-04",
"PackageDescription": "120 mL in 1 BOTTLE (23359-034-04) ",
"NDC11Code": "23359-0034-04",
"ProductNDC": "23359-034",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ninjacof-d",
"NonProprietaryName": "Chlophedianol Hydrochloride, Pyrilamine Maleate, Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170816",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "12.5; 12.5; 30",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181112",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies. : 1 Cough due to minor throat and bronchial irritation, 2 Runny Nose, 3 Sneezing, 4 Itching of the nose or throat, 5 Itchy, watery eyes, 6 Nasal Congestion, 7 Reduces swelling of nasal passages."
},
{
"NDCCode": "23359-034-16",
"PackageDescription": "473 mL in 1 BOTTLE (23359-034-16) ",
"NDC11Code": "23359-0034-16",
"ProductNDC": "23359-034",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ninjacof-d",
"NonProprietaryName": "Chlophedianol Hydrochloride, Pyrilamine Maleate, Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170816",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "12.5; 12.5; 30",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170816",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies. : 1 Cough due to minor throat and bronchial irritation, 2 Runny Nose, 3 Sneezing, 4 Itching of the nose or throat, 5 Itchy, watery eyes, 6 Nasal Congestion, 7 Reduces swelling of nasal passages."
},
{
"NDCCode": "23359-100-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (23359-100-10) ",
"NDC11Code": "23359-0100-10",
"ProductNDC": "23359-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Centratex",
"NonProprietaryName": "Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, And Cupric Sulfate Anhydrous",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090614",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": "CALCIUM PANTOTHENATE; CUPRIC SULFATE ANHYDROUS; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM SULFATE, UNSPECIFIED; MANGANESE SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE",
"StrengthNumber": "10; .8; 15; 1; 106; 6.9; 1.3; 30; 5; 6; 200; 10; 18.2",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20090614",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of anemia due to lack of iron and low folate as in menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of conditions where iron and vitamin C deficiency occur together, along with a poor intake or increased need for B-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in periods of extended recovery."
},
{
"NDCCode": "23359-105-01",
"PackageDescription": "1 CAPSULE, GELATIN COATED in 1 PACKET (23359-105-01) ",
"NDC11Code": "23359-0105-01",
"ProductNDC": "23359-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "C-nate Dha",
"NonProprietaryName": "Omega-3 Fatty Acids, Icosapent, Doconexent, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol, D-, Cupric Sulfate, Zinc Oxide, Ferrous Fumarate And Magnesium Oxide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE",
"StrengthNumber": "30; 100; 400; 1; 15; 28; 1; 30; 200; 20; 3; 3; 20",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130101",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers."
},
{
"NDCCode": "23359-105-05",
"PackageDescription": "5 CAPSULE, GELATIN COATED in 1 CARTON (23359-105-05) ",
"NDC11Code": "23359-0105-05",
"ProductNDC": "23359-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "C-nate Dha",
"NonProprietaryName": "Omega-3 Fatty Acids, Icosapent, Doconexent, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol, D-, Cupric Sulfate, Zinc Oxide, Ferrous Fumarate And Magnesium Oxide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Centurion Labs, LLC",
"SubstanceName": ".ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE",
"StrengthNumber": "30; 100; 400; 1; 15; 28; 1; 30; 200; 20; 3; 3; 20",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130101",
"SamplePackage": "N",
"IndicationAndUsage": "INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers."
},
{
"NDCCode": "13811-700-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-700-30) ",
"NDC11Code": "13811-0700-30",
"ProductNDC": "13811-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220623",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA216117",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "63",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220623",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [see Clinical Studies (14)]. Limitations of Use. The use of methylphenidate hydrochloride extended-release tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Methylphenidate hydrochloride extended-release tablets contain methylphenidate a CNS stimulant, present as methylphenidate hydrochloride salt. Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. It has a pKa of 8.71 (at 21.5°C). Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets are for oral administration and is available in the following strengths: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, and 72 mg containing methylphenidate hydrochloride (equivalent to 15.6 mg, 23.4 mg, 31.1 mg, 38.9 mg, 46.7 mg, 54.5 mg, and 62.3 mg methylphenidate respectively). Methylphenidate hydrochloride extended-release tablets contain the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, triacetin. Methylphenidate hydrochloride extended-release tablets also contain the following color additives:. 27 mg: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake. 45 mg: FD&C Red #40 Aluminum Lake. 54 mg: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. 18 and 63 mg: iron oxide red, iron oxide yellow. 72 mg: FD&C Blue #1 Aluminum Lake. System Components and Performance. Methylphenidate hydrochloride extended-release tablets use osmotic pressure to deliver methylphenidate hydrochloride at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of core of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized."
},
{
"NDCCode": "16590-700-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (16590-700-30)",
"NDC11Code": "16590-0700-30",
"ProductNDC": "16590-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
},
{
"NDCCode": "17271-700-05",
"PackageDescription": "30 BAG in 1 CASE (17271-700-05) / 250 mL in 1 BAG",
"NDC11Code": "17271-0700-05",
"ProductNDC": "17271-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208122",
"LabelerName": "Becton Dickinson and Company",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "450",
"StrengthUnit": "mg/100mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180723",
"SamplePackage": "N",
"IndicationAndUsage": "Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.",
"Description": "0.45% Sodium Chloride Injection, USP solution is a sterile and nonpyrogenic solution intended for intravenous administration. Each 100 mL of 0.45% Sodium Chloride Injection, USP contains 450 mg sodium chloride in water for injection. Electrolytes per 1,000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 0.45% Sodium Chloride Injection, USP is a parenteral fluid and electrolyte replenisher. Sodium chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "21695-700-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (21695-700-30)",
"NDC11Code": "21695-0700-30",
"ProductNDC": "21695-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20091113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078783",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tramadol hydrochloride ER tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.",
"Description": "Tramadol hydrochloride is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.8. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride Extended-Release (ER) tablets contain 100 mg or 200 mg of tramadol hydrochloride in an extended-release formulation. The tablets are white to off-white in color and contain the inactive ingredients colloidal silicone dioxide, dibutyl sebacate, ethylcellulose, magnesium stearate, polyvinyl alcohol, povidone K-90, and an imprinting agent, Opacode S-1-17823 black, which contains the following ingredients: shellac, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "21749-700-01",
"PackageDescription": "30 mL in 1 BOTTLE (21749-700-01) ",
"NDC11Code": "21749-0700-01",
"ProductNDC": "21749-700",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purell Advanced Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110510",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110510",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin that could cause disease."
},
{
"NDCCode": "31722-700-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (31722-700-30) ",
"NDC11Code": "31722-0700-30",
"ProductNDC": "31722-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203835",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150819",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT 1receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "44224-2999-0",
"PackageDescription": "1 KIT in 1 BOX (44224-2999-0) * .7 mL in 1 PACKAGE (44224-0001-2) * 2 TABLET, COATED in 1 PACKET (47682-700-99) * 59 mL in 1 TUBE (44224-5120-0) * 2 TABLET, FILM COATED in 1 PACKET (47682-097-99) * 2 TABLET, FILM COATED in 1 PACKET (47682-125-99) * 30 mL in 1 BOTTLE (44224-3300-0) * 1 TABLET, FILM COATED in 1 PACKET (47682-184-46)",
"NDC11Code": "44224-2999-00",
"ProductNDC": "44224-2999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Easy Care First Aid Kit - Comprehensive",
"NonProprietaryName": "Ammonia, Aspirin, Diphenhydramine Hydrochloride, Ibuprofen, Acetaminophen, Lidocaine Hydrochloride, Benzalkonium Chloride",
"DosageFormName": "KIT",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Tender Corporation",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "45802-700-00",
"PackageDescription": "1 TUBE in 1 CARTON (45802-700-00) / 30 g in 1 TUBE",
"NDC11Code": "45802-0700-00",
"ProductNDC": "45802-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050777",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141120",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).",
"Description": "Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax."
},
{
"NDCCode": "49349-700-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-700-02)",
"NDC11Code": "49349-0700-02",
"ProductNDC": "49349-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040715",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "49852-700-01",
"PackageDescription": "30 mL in 1 BOTTLE (49852-700-01) ",
"NDC11Code": "49852-0700-01",
"ProductNDC": "49852-700",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200730",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "TRI-COASTAL DESIGN GROUP INC.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200730",
"SamplePackage": "N",
"IndicationAndUsage": "■ For handwashing to decrease bacteria on the skin ■ Recommended for repeated use."
},
{
"NDCCode": "50804-700-01",
"PackageDescription": "30 BOTTLE, UNIT-DOSE in 1 CARTON (50804-700-01) / .4 mL in 1 BOTTLE, UNIT-DOSE",
"NDC11Code": "50804-0700-01",
"ProductNDC": "50804-700",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Sense Lubricating Plus Lubricant Eye Drops",
"NonProprietaryName": "Carboxymethylcellulose Sodium",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20230719",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "GoodSense",
"SubstanceName": "CARBOXYMETHYLCELLULOSE SODIUM",
"StrengthNumber": ".5",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230719",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 for the temporary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun, 2 may be used as a protectant against further irritation."
},
{
"NDCCode": "51386-700-30",
"PackageDescription": "1 TUBE in 1 PACKAGE (51386-700-30) > 30 mL in 1 TUBE",
"NDC11Code": "51386-0700-30",
"ProductNDC": "51386-700",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Napoleon Perdis Auto Pilot Bbb Beauty Boosting Balm Broad Spectrum Spf 30 Medium-dark",
"NonProprietaryName": "Ethylhexyl Methoxycinnamate, Titanium Dioxide, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130228",
"EndMarketingDate": "20170531",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Napoleon Perdis Cosmetics Pty Ltd",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "70; 61.4; 69",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-06-08"
},
{
"NDCCode": "51414-700-09",
"PackageDescription": "30 g in 1 PACKAGE (51414-700-09) ",
"NDC11Code": "51414-0700-09",
"ProductNDC": "51414-700",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lens Cleaner",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121128",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part344",
"LabelerName": "Yuyao Jessie Commodity Co.,Ltd.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "15",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180105",
"SamplePackage": "N",
"IndicationAndUsage": "Clean smudged and dirty lenses at your convenience with these handy individual packets.Also ,ideal for use on cameras,camcorders,computer&TV screens."
},
{
"NDCCode": "53489-700-07",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (53489-700-07) ",
"NDC11Code": "53489-0700-07",
"ProductNDC": "53489-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinine Sulfate",
"NonProprietaryName": "Quinine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120723",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021799",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "QUININE SULFATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120723",
"SamplePackage": "N",
"IndicationAndUsage": "Quinine sulfate capsules are an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. Limitations of Use. Quinine sulfate oral capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].",
"Description": "Quinine sulfate capsules are a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. Quinine sulfate capsules, USP are supplied for oral administration as capsules containing 324 mg of the active ingredient, quinine sulfate, USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc."
},
{
"NDCCode": "54162-700-30",
"PackageDescription": "30 mL in 1 CUP, UNIT-DOSE (54162-700-30) ",
"NDC11Code": "54162-0700-30",
"ProductNDC": "54162-700",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sorbitol",
"NonProprietaryName": "Sorbitol",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20120717",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Geritrex LLC",
"SubstanceName": "SORBITOL",
"StrengthNumber": "258.2",
"StrengthUnit": "g/474mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150731",
"SamplePackage": "N",
"IndicationAndUsage": "For adults or children 12 years or over. Use 2-4 TBSP (30-60ml)daily or as directed by a Physician."
},
{
"NDCCode": "59448-700-00",
"PackageDescription": "30 BAG in 1 BOX (59448-700-00) / 1 KIT in 1 BAG * 10 g in 1 TUBE (42555-060-45) * 4.25 g in 1 TUBE * 14 g in 1 BOTTLE, WITH APPLICATOR * 53 mL in 1 BOTTLE, PLASTIC (59448-004-01) ",
"NDC11Code": "59448-0700-00",
"ProductNDC": "59448-700",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Emory Johns Creek Amenity",
"NonProprietaryName": "Alcohol And Sodium Monofluorophospate",
"DosageFormName": "KIT",
"StartMarketingDate": "20200727",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "ASP Global",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200727",
"SamplePackage": "N"
},
{
"NDCCode": "60760-700-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (60760-700-30) ",
"NDC11Code": "60760-0700-30",
"ProductNDC": "60760-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191025",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206948",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191025",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules, USP are indicated for the symptomatic relief of cough.",
"Description": "Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink."
},
{
"NDCCode": "61919-700-30",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-700-30) ",
"NDC11Code": "61919-0700-30",
"ProductNDC": "61919-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium D/r",
"NonProprietaryName": "Pantoprazole Sodium D/r",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090074",
"LabelerName": "Direct_Rx",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190829",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for. 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD). Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis. Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome. Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl] -1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is: [Image]. Pantoprazole sodium sesquihydrate, USP is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate, USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium). Pantoprazole sodium delayed-release tablet, USP contains the following inactive ingredients: calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid copolymer dispersion, propylene glycol, sodium carbonate, talc, titanium dioxide, and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP ( 40 mg and 20 mg) complies with USP dissolution test 3."
}
]
}
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<NDC>
<NDCCode>23359-700-30</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (23359-700-30)</PackageDescription>
<NDC11Code>23359-0700-30</NDC11Code>
<ProductNDC>23359-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Puralor</ProprietaryName>
<NonProprietaryName>1-(c14-c18 Esteroyl)-2-docosahexanoyl-sn-glycero-3-phosphocholine, 1-(c14-c18 Esteroyl)-2-docosahexanoyl-sn-glycero-3-phosphoethanolamine, Egg Phospholipids , Folic Acid, Leucovorin, Levomefolic Acid, Anhydrous Citric Acid, Sodium Citrate, Magnesium Glycinate, Acetylcysteine Amide, Cholecalciferol, Thiamine, Riboflavin, Pantethine, Niacin, Cobamamide, Ascorbic Acid, Magnesium L-threonate, Papain And Intrinsic Factor</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOCHOLINE; 1-(C14-C18 ESTEROYL)-2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE; EGG PHOSPHOLIPIDS; FOLIC ACID; LEUCOVORIN; LEVOMEFOLIC ACID; ANHYDROUS CITRIC ACID; SODIUM CITRATE; MAGNESIUM GLYCINATE; ACETYLCYSTEINE AMIDE; CHOLECALCIFEROL; THIAMINE; RIBOFLAVIN; PANTETHINE; NIACIN; COBAMAMIDE; ASCORBIC ACID; MAGNESIUM L-THREONATE; PAPAIN; INTRINSIC FACTOR</SubstanceName>
<StrengthNumber>5; 2.5; 42.5; .2; 3; .4; 1.6; .8; 1; 5; 100; .5; .5; 2.5; .5; 2; 25; 2.5; 20; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>23359-100-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (23359-100-30) </PackageDescription>
<NDC11Code>23359-0100-30</NDC11Code>
<ProductNDC>23359-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Centratex</ProprietaryName>
<NonProprietaryName>Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, And Cupric Sulfate Anhydrous</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090614</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>CALCIUM PANTOTHENATE; CUPRIC SULFATE ANHYDROUS; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM SULFATE, UNSPECIFIED; MANGANESE SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE</SubstanceName>
<StrengthNumber>10; .8; 15; 1; 106; 6.9; 1.3; 30; 5; 6; 200; 10; 18.2</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of anemia due to lack of iron and low folate as in menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of conditions where iron and vitamin C deficiency occur together, along with a poor intake or increased need for B-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in periods of extended recovery.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-105-30</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE (23359-105-30) </PackageDescription>
<NDC11Code>23359-0105-30</NDC11Code>
<ProductNDC>23359-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>C-nate Dha</ProprietaryName>
<NonProprietaryName>Omega-3 Fatty Acids, Icosapent, Doconexent, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol, D-, Cupric Sulfate, Zinc Oxide, Ferrous Fumarate And Magnesium Oxide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>30; 100; 400; 1; 15; 28; 1; 30; 200; 20; 3; 3; 20</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-301-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (23359-301-30)</PackageDescription>
<NDC11Code>23359-0301-30</NDC11Code>
<ProductNDC>23359-301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bump Dha</ProprietaryName>
<NonProprietaryName>Folate, Vitamin B2, Vitamin B6, Vitamin B12, Potassium Iodide, Zinc Biglycinate, Magnesium Oxide, Nadh, Dha, Carbonyl Iron</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170324</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>LEVOMEFOLATE MAGNESIUM; LEUCOVORIN; FLAVIN ADENINE DINUCLEOTIDE; FLAVIN MONONUCLEOTIDE; PYRIDOXINE HYDROCHLORIDE; PYRIDOXAL PHOSPHATE ANHYDROUS; COBAMAMIDE; POTASSIUM IODIDE; ZINC GLYCINATE; MAGNESIUM OXIDE; NADH; OMEGA-3 FATTY ACIDS; IRON PENTACARBONYL</SubstanceName>
<StrengthNumber>1; 1; 1; 2; 20; 5; 500; 250; 15; 125; 25; 300; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; 1/1; mg/1; ug/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-24</LastUpdate>
</NDC>
<NDC>
<NDCCode>23359-032-04</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (23359-032-04) </PackageDescription>
<NDC11Code>23359-0032-04</NDC11Code>
<ProductNDC>23359-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ninjacof</ProprietaryName>
<NonProprietaryName>Chlophedianol Hcl And Pyrilamine Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>12.5; 12.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 calms the cough control center and relieves coughing, 3 runny nose, 4 sneezing, 5 itching of the nose and throat, 6 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-032-10</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE (23359-032-10) </PackageDescription>
<NDC11Code>23359-0032-10</NDC11Code>
<ProductNDC>23359-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ninjacof</ProprietaryName>
<NonProprietaryName>Chlophedianol Hcl And Pyrilamine Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>12.5; 12.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 calms the cough control center and relieves coughing, 3 runny nose, 4 sneezing, 5 itching of the nose and throat, 6 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-032-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (23359-032-16) </PackageDescription>
<NDC11Code>23359-0032-16</NDC11Code>
<ProductNDC>23359-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ninjacof</ProprietaryName>
<NonProprietaryName>Chlophedianol Hcl And Pyrilamine Maleate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>12.5; 12.5</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 calms the cough control center and relieves coughing, 3 runny nose, 4 sneezing, 5 itching of the nose and throat, 6 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-034-04</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (23359-034-04) </PackageDescription>
<NDC11Code>23359-0034-04</NDC11Code>
<ProductNDC>23359-034</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ninjacof-d</ProprietaryName>
<NonProprietaryName>Chlophedianol Hydrochloride, Pyrilamine Maleate, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170816</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 12.5; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies. : 1 Cough due to minor throat and bronchial irritation, 2 Runny Nose, 3 Sneezing, 4 Itching of the nose or throat, 5 Itchy, watery eyes, 6 Nasal Congestion, 7 Reduces swelling of nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-034-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (23359-034-16) </PackageDescription>
<NDC11Code>23359-0034-16</NDC11Code>
<ProductNDC>23359-034</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ninjacof-d</ProprietaryName>
<NonProprietaryName>Chlophedianol Hydrochloride, Pyrilamine Maleate, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170816</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 12.5; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies. : 1 Cough due to minor throat and bronchial irritation, 2 Runny Nose, 3 Sneezing, 4 Itching of the nose or throat, 5 Itchy, watery eyes, 6 Nasal Congestion, 7 Reduces swelling of nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-100-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (23359-100-10) </PackageDescription>
<NDC11Code>23359-0100-10</NDC11Code>
<ProductNDC>23359-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Centratex</ProprietaryName>
<NonProprietaryName>Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, And Cupric Sulfate Anhydrous</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090614</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>CALCIUM PANTOTHENATE; CUPRIC SULFATE ANHYDROUS; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM SULFATE, UNSPECIFIED; MANGANESE SULFATE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE</SubstanceName>
<StrengthNumber>10; .8; 15; 1; 106; 6.9; 1.3; 30; 5; 6; 200; 10; 18.2</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of anemia due to lack of iron and low folate as in menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of conditions where iron and vitamin C deficiency occur together, along with a poor intake or increased need for B-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in periods of extended recovery.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-105-01</NDCCode>
<PackageDescription>1 CAPSULE, GELATIN COATED in 1 PACKET (23359-105-01) </PackageDescription>
<NDC11Code>23359-0105-01</NDC11Code>
<ProductNDC>23359-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>C-nate Dha</ProprietaryName>
<NonProprietaryName>Omega-3 Fatty Acids, Icosapent, Doconexent, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol, D-, Cupric Sulfate, Zinc Oxide, Ferrous Fumarate And Magnesium Oxide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>30; 100; 400; 1; 15; 28; 1; 30; 200; 20; 3; 3; 20</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>23359-105-05</NDCCode>
<PackageDescription>5 CAPSULE, GELATIN COATED in 1 CARTON (23359-105-05) </PackageDescription>
<NDC11Code>23359-0105-05</NDC11Code>
<ProductNDC>23359-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>C-nate Dha</ProprietaryName>
<NonProprietaryName>Omega-3 Fatty Acids, Icosapent, Doconexent, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol, D-, Cupric Sulfate, Zinc Oxide, Ferrous Fumarate And Magnesium Oxide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Centurion Labs, LLC</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL, D-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; MAGNESIUM; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>30; 100; 400; 1; 15; 28; 1; 30; 200; 20; 3; 3; 20</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE: C-NATE DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13811-700-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-700-30) </PackageDescription>
<NDC11Code>13811-0700-30</NDC11Code>
<ProductNDC>13811-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220623</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA216117</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>63</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [see Clinical Studies (14)]. Limitations of Use. The use of methylphenidate hydrochloride extended-release tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release tablets contain methylphenidate a CNS stimulant, present as methylphenidate hydrochloride salt. Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. It has a pKa of 8.71 (at 21.5°C). Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets are for oral administration and is available in the following strengths: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, and 72 mg containing methylphenidate hydrochloride (equivalent to 15.6 mg, 23.4 mg, 31.1 mg, 38.9 mg, 46.7 mg, 54.5 mg, and 62.3 mg methylphenidate respectively). Methylphenidate hydrochloride extended-release tablets contain the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, triacetin. Methylphenidate hydrochloride extended-release tablets also contain the following color additives:. 27 mg: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake. 45 mg: FD&C Red #40 Aluminum Lake. 54 mg: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake. 18 and 63 mg: iron oxide red, iron oxide yellow. 72 mg: FD&C Blue #1 Aluminum Lake. System Components and Performance. Methylphenidate hydrochloride extended-release tablets use osmotic pressure to deliver methylphenidate hydrochloride at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of core of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.</Description>
</NDC>
<NDC>
<NDCCode>16590-700-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16590-700-30)</PackageDescription>
<NDC11Code>16590-0700-30</NDC11Code>
<ProductNDC>16590-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>17271-700-05</NDCCode>
<PackageDescription>30 BAG in 1 CASE (17271-700-05) / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>17271-0700-05</NDC11Code>
<ProductNDC>17271-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208122</ApplicationNumber>
<LabelerName>Becton Dickinson and Company</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>450</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.</IndicationAndUsage>
<Description>0.45% Sodium Chloride Injection, USP solution is a sterile and nonpyrogenic solution intended for intravenous administration. Each 100 mL of 0.45% Sodium Chloride Injection, USP contains 450 mg sodium chloride in water for injection. Electrolytes per 1,000 mL: sodium 77 mEq; chloride 77 mEq. The osmolarity is 154 mOsmol/L (calc.). The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and larger containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all containers. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded. 0.45% Sodium Chloride Injection, USP is a parenteral fluid and electrolyte replenisher. Sodium chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (freeflex® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>21695-700-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (21695-700-30)</PackageDescription>
<NDC11Code>21695-0700-30</NDC11Code>
<ProductNDC>21695-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078783</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tramadol hydrochloride ER tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.</IndicationAndUsage>
<Description>Tramadol hydrochloride is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.8. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride Extended-Release (ER) tablets contain 100 mg or 200 mg of tramadol hydrochloride in an extended-release formulation. The tablets are white to off-white in color and contain the inactive ingredients colloidal silicone dioxide, dibutyl sebacate, ethylcellulose, magnesium stearate, polyvinyl alcohol, povidone K-90, and an imprinting agent, Opacode S-1-17823 black, which contains the following ingredients: shellac, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol, and ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>21749-700-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (21749-700-01) </PackageDescription>
<NDC11Code>21749-0700-01</NDC11Code>
<ProductNDC>21749-700</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Purell Advanced Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110510</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin that could cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>31722-700-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (31722-700-30) </PackageDescription>
<NDC11Code>31722-0700-30</NDC11Code>
<ProductNDC>31722-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203835</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT 1receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>44224-2999-0</NDCCode>
<PackageDescription>1 KIT in 1 BOX (44224-2999-0) * .7 mL in 1 PACKAGE (44224-0001-2) * 2 TABLET, COATED in 1 PACKET (47682-700-99) * 59 mL in 1 TUBE (44224-5120-0) * 2 TABLET, FILM COATED in 1 PACKET (47682-097-99) * 2 TABLET, FILM COATED in 1 PACKET (47682-125-99) * 30 mL in 1 BOTTLE (44224-3300-0) * 1 TABLET, FILM COATED in 1 PACKET (47682-184-46)</PackageDescription>
<NDC11Code>44224-2999-00</NDC11Code>
<ProductNDC>44224-2999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Easy Care First Aid Kit - Comprehensive</ProprietaryName>
<NonProprietaryName>Ammonia, Aspirin, Diphenhydramine Hydrochloride, Ibuprofen, Acetaminophen, Lidocaine Hydrochloride, Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Tender Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>45802-700-00</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (45802-700-00) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0700-00</NDC11Code>
<ProductNDC>45802-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050777</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
<Description>Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus is designated as [3S-[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus has an empirical formula of C44H69NO12∙H2O and a formula weight of 822.03. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil with all-rac-α-tocopherol, paraffin, propylene carbonate, white petrolatum with butylhydroxytoluene, and white wax.</Description>
</NDC>
<NDC>
<NDCCode>49349-700-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (49349-700-02)</PackageDescription>
<NDC11Code>49349-0700-02</NDC11Code>
<ProductNDC>49349-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040715</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>49852-700-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (49852-700-01) </PackageDescription>
<NDC11Code>49852-0700-01</NDC11Code>
<ProductNDC>49852-700</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200730</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>TRI-COASTAL DESIGN GROUP INC.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ For handwashing to decrease bacteria on the skin ■ Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50804-700-01</NDCCode>
<PackageDescription>30 BOTTLE, UNIT-DOSE in 1 CARTON (50804-700-01) / .4 mL in 1 BOTTLE, UNIT-DOSE</PackageDescription>
<NDC11Code>50804-0700-01</NDC11Code>
<ProductNDC>50804-700</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Sense Lubricating Plus Lubricant Eye Drops</ProprietaryName>
<NonProprietaryName>Carboxymethylcellulose Sodium</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20230719</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>GoodSense</LabelerName>
<SubstanceName>CARBOXYMETHYLCELLULOSE SODIUM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 for the temporary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun, 2 may be used as a protectant against further irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51386-700-30</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (51386-700-30) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>51386-0700-30</NDC11Code>
<ProductNDC>51386-700</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Napoleon Perdis Auto Pilot Bbb Beauty Boosting Balm Broad Spectrum Spf 30 Medium-dark</ProprietaryName>
<NonProprietaryName>Ethylhexyl Methoxycinnamate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130228</StartMarketingDate>
<EndMarketingDate>20170531</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Napoleon Perdis Cosmetics Pty Ltd</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>70; 61.4; 69</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-06-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>51414-700-09</NDCCode>
<PackageDescription>30 g in 1 PACKAGE (51414-700-09) </PackageDescription>
<NDC11Code>51414-0700-09</NDC11Code>
<ProductNDC>51414-700</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lens Cleaner</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121128</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part344</ApplicationNumber>
<LabelerName>Yuyao Jessie Commodity Co.,Ltd.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clean smudged and dirty lenses at your convenience with these handy individual packets.Also ,ideal for use on cameras,camcorders,computer&TV screens.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53489-700-07</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (53489-700-07) </PackageDescription>
<NDC11Code>53489-0700-07</NDC11Code>
<ProductNDC>53489-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quinine Sulfate</ProprietaryName>
<NonProprietaryName>Quinine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120723</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021799</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>QUININE SULFATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quinine sulfate capsules are an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. Limitations of Use. Quinine sulfate oral capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>Quinine sulfate capsules are a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. Quinine sulfate capsules, USP are supplied for oral administration as capsules containing 324 mg of the active ingredient, quinine sulfate, USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc.</Description>
</NDC>
<NDC>
<NDCCode>54162-700-30</NDCCode>
<PackageDescription>30 mL in 1 CUP, UNIT-DOSE (54162-700-30) </PackageDescription>
<NDC11Code>54162-0700-30</NDC11Code>
<ProductNDC>54162-700</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sorbitol</ProprietaryName>
<NonProprietaryName>Sorbitol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120717</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Geritrex LLC</LabelerName>
<SubstanceName>SORBITOL</SubstanceName>
<StrengthNumber>258.2</StrengthNumber>
<StrengthUnit>g/474mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For adults or children 12 years or over. Use 2-4 TBSP (30-60ml)daily or as directed by a Physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59448-700-00</NDCCode>
<PackageDescription>30 BAG in 1 BOX (59448-700-00) / 1 KIT in 1 BAG * 10 g in 1 TUBE (42555-060-45) * 4.25 g in 1 TUBE * 14 g in 1 BOTTLE, WITH APPLICATOR * 53 mL in 1 BOTTLE, PLASTIC (59448-004-01) </PackageDescription>
<NDC11Code>59448-0700-00</NDC11Code>
<ProductNDC>59448-700</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Emory Johns Creek Amenity</ProprietaryName>
<NonProprietaryName>Alcohol And Sodium Monofluorophospate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200727</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>ASP Global</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60760-700-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (60760-700-30) </PackageDescription>
<NDC11Code>60760-0700-30</NDC11Code>
<ProductNDC>60760-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191025</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206948</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules, USP are indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink.</Description>
</NDC>
<NDC>
<NDCCode>61919-700-30</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-700-30) </PackageDescription>
<NDC11Code>61919-0700-30</NDC11Code>
<ProductNDC>61919-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium D/r</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium D/r</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090074</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for. 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD). Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis. Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome. Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl] -1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is: [Image]. Pantoprazole sodium sesquihydrate, USP is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate, USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium). Pantoprazole sodium delayed-release tablet, USP contains the following inactive ingredients: calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid copolymer dispersion, propylene glycol, sodium carbonate, talc, titanium dioxide, and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP ( 40 mg and 20 mg) complies with USP dissolution test 3.</Description>
</NDC>
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