{
"NDC": [
{
"NDCCode": "59469-328-40",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-328-40) > 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "59469-0328-40",
"ProductNDC": "59469-328",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Livcalm",
"NonProprietaryName": "Aloe Ferox Leaf, Activated Charcoal, Goldenseal, Strychnos Nux-vomica Seed, Okoubaka Aubrevillei Bark, And Berberis Vulgaris Root Bark",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20200114",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Natuheilmittel GmbH",
"SubstanceName": "ALOE FEROX LEAF; ACTIVATED CHARCOAL; GOLDENSEAL; STRYCHNOS NUX-VOMICA SEED; OKOUBAKA AUBREVILLEI BARK; BERBERIS VULGARIS ROOT BARK",
"StrengthNumber": "6; 6; 6; 6; 6; 12",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200114",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of symptoms related to minor gastritis, indigestion, cramps, and food sensitivities."
},
{
"NDCCode": "37205-328-58",
"PackageDescription": "1 BOTTLE in 1 BOX (37205-328-58) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "37205-0328-58",
"ProductNDC": "37205-328",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20120409",
"EndMarketingDate": "20171231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078682",
"LabelerName": "Cardinal Health (Leader) 37205",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "69168-328-40",
"PackageDescription": "40 TABLET in 1 CARTON (69168-328-40) ",
"NDC11Code": "69168-0328-40",
"ProductNDC": "69168-328",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen 500 Mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141217",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Allegiant Health",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141217",
"SamplePackage": "N",
"IndicationAndUsage": "temporary relief of minor aches and pains associated with ■ the common cold ■ headache ■ toothache ■ muscular aches ■ backache ■ minor pain from arthritis. ■ premenstrual and menstrual cramps ■ temporarily reduces fever."
},
{
"NDCCode": "59469-106-40",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-106-40) > 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "59469-0106-40",
"ProductNDC": "59469-106",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Apo-hepat",
"NonProprietaryName": "Chionanthus Virginicus Bark, Iberis Amara Seed, Lycopodium Clavatum Spore, Mandragora Officinarum Root, Phosphorus, Peumus Boldus Leaf, Cynara Scolymus Whole, And Taraxacum Officinale Whole",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20080412",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Naturheilmittel GmbH",
"SubstanceName": "CHIONANTHUS VIRGINICUS ROOT BARK; IBERIS AMARA SEED; LYCOPODIUM CLAVATUM SPORE; MANDRAGORA OFFICINARUM ROOT; PHOSPHORUS; PEUMUS BOLDUS LEAF; CYNARA SCOLYMUS WHOLE; TARAXACUM OFFICINALE WHOLE",
"StrengthNumber": "2; 6; 4; 12; 10; 6; 8; 8",
"StrengthUnit": "[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL",
"Status": "Active",
"LastUpdate": "2022-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081204",
"SamplePackage": "N",
"IndicationAndUsage": "Helps cleanse and detoxify the body. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
},
{
"NDCCode": "59469-133-40",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-133-40) > 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "59469-0133-40",
"ProductNDC": "59469-133",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Defaeton",
"NonProprietaryName": "Peumus Boldus Leaf, Dioscorea Villosa Tuber, Strychnos Ignatii Seed, Cynara Scolymus Whole, Fumaria Officinalis Whole, Frangula Alnus Bark, And Rheum Officinale Root",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20081211",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Naturheilmittel GmbH",
"SubstanceName": "PEUMUS BOLDUS LEAF; DIOSCOREA VILLOSA TUBER; STRYCHNOS IGNATII SEED; CYNARA SCOLYMUS WHOLE; FUMARIA OFFICINALIS WHOLE; FRANGULA ALNUS BARK; RHEUM OFFICINALE ROOT",
"StrengthNumber": "6; 4; 6; 12; 6; 8; 8",
"StrengthUnit": "[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL",
"Status": "Active",
"LastUpdate": "2023-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170501",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of occasional constipation. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
},
{
"NDCCode": "59469-138-40",
"PackageDescription": "1 TUBE in 1 BOX (59469-138-40) > 100 g in 1 TUBE",
"NDC11Code": "59469-0138-40",
"ProductNDC": "59469-138",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zellulisan",
"NonProprietaryName": "Arnica Montana Root, Ledum Palustre Twig, Toxicodendron Pubescens Shoot, Sulfur, Horse Chestnut, Betula Pendula Leaf, Hedera Helix Flowering Twig, And Melilotus Officinalis Top",
"DosageFormName": "OINTMENT",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20081211",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Naturheilmittel GmbH",
"SubstanceName": "ARNICA MONTANA ROOT; RHODODENDRON TOMENTOSUM LEAFY TWIG; TOXICODENDRON PUBESCENS SHOOT; SULFUR; HORSE CHESTNUT; BETULA PENDULA LEAF; HEDERA HELIX FLOWERING TWIG; MELILOTUS OFFICINALIS TOP",
"StrengthNumber": "8; 3; 8; 15; 4; 8; 6; 4",
"StrengthUnit": "[hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g",
"Status": "Active",
"LastUpdate": "2022-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081211",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of minor tendinitis and inflammation."
},
{
"NDCCode": "59469-148-40",
"PackageDescription": "1 TUBE in 1 BOX (59469-148-40) > 100 g in 1 TUBE",
"NDC11Code": "59469-0148-40",
"ProductNDC": "59469-148",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Inflamyar",
"NonProprietaryName": "Arnica Montana Root, Bryonia Dioica Root, Guaiacum Officinale Resin, Toxicodendron Pubescens Shoot, Bellis Perennis, Ledum Palustre Twig, Ruta Graveolens Flowering Top, And Viscum Album Fruiting Top",
"DosageFormName": "OINTMENT",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20080412",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Naturheilmittel GmbH",
"SubstanceName": "ARNICA MONTANA ROOT; BRYONIA DIOICA ROOT; GUAIACUM OFFICINALE RESIN; TOXICODENDRON PUBESCENS SHOOT; BELLIS PERENNIS WHOLE; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "12; 4; 4; 12; 8; 4; 6; 4",
"StrengthUnit": "[hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g",
"Status": "Active",
"LastUpdate": "2022-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080412",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of minor sports injuries, including muscle strains, joint pain, sprains, and bruises."
},
{
"NDCCode": "59469-155-40",
"PackageDescription": "1 TUBE in 1 BOX (59469-155-40) > 100 g in 1 TUBE",
"NDC11Code": "59469-0155-40",
"ProductNDC": "59469-155",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dercut",
"NonProprietaryName": "Euphorbia Resinifera Resin, Goldenseal, Wood Creosote, Toxicodendron Pubescens Shoot, Sempervivum Tectorum Leaf, Bellis Perennis, Vinca Minor, And Viola Tricolor",
"DosageFormName": "OINTMENT",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20080412",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Naturheilmittel GmbH",
"SubstanceName": "EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; WOOD CREOSOTE; TOXICODENDRON PUBESCENS SHOOT; SEMPERVIVUM TECTORUM LEAF; BELLIS PERENNIS; VINCA MINOR; VIOLA TRICOLOR",
"StrengthNumber": "4; 3; 6; 8; 3; 8; 3; 2",
"StrengthUnit": "[hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g",
"Status": "Deprecated",
"LastUpdate": "2019-11-21",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "59469-156-40",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-156-40) > 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "59469-0156-40",
"ProductNDC": "59469-156",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dalektro N",
"NonProprietaryName": "Silver Nitrate, Oyster Shell Calcium Carbonate, Crude, Cobaltous Nitrate Hexahydrate, Cupric Acetate, Iron, Potassium Carbonate, Magnesium Chloride, Manganese Acetate Tetrahydrate, Selenium, Silicon Dioxide, And Zinc Phosphide",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20080412",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Natruheilmittel GmbH",
"SubstanceName": "SILVER NITRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; COBALTOUS NITRATE HEXAHYDRATE; CUPRIC ACETATE; IRON; POTASSIUM CARBONATE; MAGNESIUM CHLORIDE; MANGANESE ACETATE TETRAHYDRATE; SELENIUM; SILICON DIOXIDE; ZINC PHOSPHIDE",
"StrengthNumber": "4; 6; 6; 12; 6; 4; 4; 8; 12; 12; 12",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20080412",
"SamplePackage": "N"
},
{
"NDCCode": "59469-163-40",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-163-40) > 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "59469-0163-40",
"ProductNDC": "59469-163",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Psy-stabil",
"NonProprietaryName": "Phosphoric Acid, Amanita Muscaria Fruiting Body, Semecarpus Anacardium Fruit, Avena Sativa Flowering Top, Cinchona Officinalis Bark, Strychnos Ignatii Seed, Schoenocaulon Officinale Seed, And Piper Methysticum Root",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20081211",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Naturheilmittel GmbH",
"SubstanceName": "PHOSPHORIC ACID; AMANITA MUSCARIA FRUITING BODY; SEMECARPUS ANACARDIUM FRUIT; AVENA SATIVA FLOWERING TOP; CINCHONA OFFICINALIS BARK; STRYCHNOS IGNATII SEED; SCHOENOCAULON OFFICINALE SEED; MACROPIPER METHYSTICUM ROOT",
"StrengthNumber": "3; 6; 10; 1; 3; 4; 4; 8",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2022-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081211",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of occasional stress. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
},
{
"NDCCode": "59469-165-40",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-165-40) > 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "59469-0165-40",
"ProductNDC": "59469-165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Inflamyar",
"NonProprietaryName": "Arnica Montana Root, Bellis Perennis, Bryonia Dioica Root, Guaiacum Officinale Resin, Ledum Palustre Twig, Ruta Graveolens Flowering Top, Toxicodendron Pubescens Shoot, And Viscum Album Fruiting Top",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20080412",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Naturheilmittel GmbH",
"SubstanceName": "ARNICA MONTANA ROOT; BELLIS PERENNIS WHOLE; BRYONIA DIOICA ROOT; GUAIACUM OFFICINALE RESIN; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS SHOOT; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "4; 4; 4; 6; 12; 4; 8; 4",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Status": "Active",
"LastUpdate": "2022-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080412",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of minor sports injuries, including muscle strains, joint pain, sprains, and bruises. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
},
{
"NDCCode": "59469-171-40",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-171-40) > 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "59469-0171-40",
"ProductNDC": "59469-171",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Opsonat",
"NonProprietaryName": "Silver Nitrate, Sulfuric Acid, Bellis Perennis, Lytta Vesicatoria, Gratiola Officinalis, Goldenseal, Lachesis Muta Venom, And Glechoma Hederacea Flowering Top",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20081122",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Naturheilmittel GmbH",
"SubstanceName": "SILVER NITRATE; SULFURIC ACID; BELLIS PERENNIS; LYTTA VESICATORIA; GRATIOLA OFFICINALIS; GOLDENSEAL; LACHESIS MUTA VENOM; GLECHOMA HEDERACEA FLOWERING TOP",
"StrengthNumber": "4; 4; 1; 4; 4; 4; 7; 1602",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20081211",
"SamplePackage": "N"
},
{
"NDCCode": "59469-305-40",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-305-40) > 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "59469-0305-40",
"ProductNDC": "59469-305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dalektro N",
"NonProprietaryName": "Silver Nitrate, Oyster Shell Calcium Carbonate, Crude, Cobaltous Nitrate Hexahydrate, Cupric Acetate, Iron, Potassium Carbonate, Magnesium Chloride, Manganese Acetate Tetrahydrate, Selenium, Silicon Dioxide, And Zinc Phosphide",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20190624",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Natruheilmittel GmbH",
"SubstanceName": "SILVER NITRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; COBALTOUS NITRATE HEXAHYDRATE; CUPRIC ACETATE; IRON; POTASSIUM CARBONATE; MAGNESIUM CHLORIDE; MANGANESE ACETATE TETRAHYDRATE; SELENIUM; SILICON DIOXIDE; ZINC PHOSPHIDE",
"StrengthNumber": "6; 6; 6; 12; 6; 4; 4; 8; 12; 12; 12",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], 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], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2023-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190624",
"SamplePackage": "N",
"IndicationAndUsage": "Homeopathically processed minerals to help reduce minor stress. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
},
{
"NDCCode": "59469-307-40",
"PackageDescription": "1 TUBE in 1 BOX (59469-307-40) > 100 g in 1 TUBE",
"NDC11Code": "59469-0307-40",
"ProductNDC": "59469-307",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dercut",
"NonProprietaryName": "Euphorbia Resinifera Resin, Goldenseal, Wood Creosote, Toxicodendron Pubescens Shoot, Sempervivum Tectorum Leaf, Bellis Perennis, Vinca Minor, And Viola Tricolor",
"DosageFormName": "OINTMENT",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20190624",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Naturheilmittel GmbH",
"SubstanceName": "EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; WOOD CREOSOTE; TOXICODENDRON PUBESCENS SHOOT; SEMPERVIVUM TECTORUM LEAF; BELLIS PERENNIS WHOLE; PERVINCA MINOR WHOLE; VIOLA TRICOLOR WHOLE",
"StrengthNumber": "4; 4; 6; 8; 3; 8; 3; 2",
"StrengthUnit": "[hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g",
"Status": "Active",
"LastUpdate": "2022-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190624",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of acne, eczema, itching, psoriasis, and skin irritation."
},
{
"NDCCode": "59469-313-40",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-313-40) > 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "59469-0313-40",
"ProductNDC": "59469-313",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Opsonat",
"NonProprietaryName": "Silver Nitrate, Sulfuric Acid, Bellis Perennis, Lytta Vesicatoria, Gratiola Officinalis, Goldenseal, Lachesis Muta Venom, And Glechoma Hederacea Flowering Top",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20190624",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Naturheilmittel GmbH",
"SubstanceName": "SILVER NITRATE; SULFURIC ACID; BELLIS PERENNIS WHOLE; LYTTA VESICATORIA; GRATIOLA OFFICINALIS WHOLE; GOLDENSEAL; LACHESIS MUTA VENOM; GLECHOMA HEDERACEA FLOWERING TOP",
"StrengthNumber": "6; 6; 1; 4; 4; 5; 8; 1602",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; mg/100mL",
"Status": "Active",
"LastUpdate": "2023-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190624",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of minor mucous membrane inflammation, such as the mouth. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
},
{
"NDCCode": "59469-315-40",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-315-40) > 100 mL in 1 BOTTLE, GLASS",
"NDC11Code": "59469-0315-40",
"ProductNDC": "59469-315",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Renelix",
"NonProprietaryName": "Benzoic Acid, Nitric Acid, Apis Mellifera, Berberis Vulgaris Root Bark, Colchicum Autumnale Bulb, Protortonia Cacti, Solidago Virgaurea Flowering Top, And Capsella Bursa-pastoris Top",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20190624",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Naturheilmittel GmbH",
"SubstanceName": "BENZOIC ACID; NITRIC ACID; APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; COLCHICUM AUTUMNALE BULB; PROTORTONIA CACTI; SOLIDAGO VIRGAUREA FLOWERING TOP; CAPSELLA BURSA-PASTORIS TOP",
"StrengthNumber": "4; 6; 4; 3; 12; 631; 2913; 510",
"StrengthUnit": "[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; mg/50mL; mg/50mL",
"Pharm_Classes": "Allergens [CS], Ammonium Ion Binding Activity [MoA], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190624",
"SamplePackage": "N",
"IndicationAndUsage": "Helps cleanse and detoxify the body. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
},
{
"NDCCode": "59469-321-40",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (59469-321-40) > 100 mL in 1 BOTTLE, GLASS (59469-321-30) ",
"NDC11Code": "59469-0321-40",
"ProductNDC": "59469-321",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Citriplus",
"NonProprietaryName": "Juglans Regia Whole And Anhydrous Citric Acid",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20190624",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PEKANA Natuheilmittel GmbH",
"SubstanceName": "JUGLANS REGIA WHOLE; ANHYDROUS CITRIC ACID",
"StrengthNumber": "5; 4",
"StrengthUnit": "[hp_X]/100mL; [hp_X]/100mL",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190624",
"SamplePackage": "N",
"IndicationAndUsage": "For energy. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated."
},
{
"NDCCode": "0071-0527-23",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0071-0527-23) ",
"NDC11Code": "00071-0527-23",
"ProductNDC": "0071-0527",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Accupril",
"NonProprietaryName": "Quinapril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19911119",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019885",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19911119",
"SamplePackage": "N",
"IndicationAndUsage": "ACCUPRIL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with ACCUPRIL. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. ACCUPRIL may be used alone or in combination with thiazide diuretics.",
"Description": "ACCUPRIL® is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 ∙HCl and its structural formula is. Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. ACCUPRIL tablets contain 5 mg (equivalent to 5.416 mg Quinapril Hydrochloride), 10 mg (equivalent to 10.832 mg Quinapril Hydrochloride), 20 mg (equivalent to 21.664 mg Quinapril Hydrochloride), or 40 mg (equivalent to 43.328 mg Quinapril Hydrochloride) of quinapril for oral administration. Each tablet also contains candelilla wax, crospovidone, gelatin, lactose, magnesium carbonate, magnesium stearate, synthetic red iron oxide, and titanium dioxide."
},
{
"NDCCode": "0071-0530-23",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0071-0530-23) ",
"NDC11Code": "00071-0530-23",
"ProductNDC": "0071-0530",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Accupril",
"NonProprietaryName": "Quinapril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19911119",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019885",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19911119",
"SamplePackage": "N",
"IndicationAndUsage": "ACCUPRIL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with ACCUPRIL. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. ACCUPRIL may be used alone or in combination with thiazide diuretics.",
"Description": "ACCUPRIL® is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 ∙HCl and its structural formula is. Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. ACCUPRIL tablets contain 5 mg (equivalent to 5.416 mg Quinapril Hydrochloride), 10 mg (equivalent to 10.832 mg Quinapril Hydrochloride), 20 mg (equivalent to 21.664 mg Quinapril Hydrochloride), or 40 mg (equivalent to 43.328 mg Quinapril Hydrochloride) of quinapril for oral administration. Each tablet also contains candelilla wax, crospovidone, gelatin, lactose, magnesium carbonate, magnesium stearate, synthetic red iron oxide, and titanium dioxide."
},
{
"NDCCode": "0071-0532-23",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0071-0532-23) ",
"NDC11Code": "00071-0532-23",
"ProductNDC": "0071-0532",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Accupril",
"NonProprietaryName": "Quinapril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19911119",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019885",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19911119",
"SamplePackage": "N",
"IndicationAndUsage": "ACCUPRIL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with ACCUPRIL. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. ACCUPRIL may be used alone or in combination with thiazide diuretics.",
"Description": "ACCUPRIL® is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 ∙HCl and its structural formula is. Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. ACCUPRIL tablets contain 5 mg (equivalent to 5.416 mg Quinapril Hydrochloride), 10 mg (equivalent to 10.832 mg Quinapril Hydrochloride), 20 mg (equivalent to 21.664 mg Quinapril Hydrochloride), or 40 mg (equivalent to 43.328 mg Quinapril Hydrochloride) of quinapril for oral administration. Each tablet also contains candelilla wax, crospovidone, gelatin, lactose, magnesium carbonate, magnesium stearate, synthetic red iron oxide, and titanium dioxide."
},
{
"NDCCode": "0071-0535-23",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0071-0535-23) ",
"NDC11Code": "00071-0535-23",
"ProductNDC": "0071-0535",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Accupril",
"NonProprietaryName": "Quinapril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19911119",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019885",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19911119",
"SamplePackage": "N",
"IndicationAndUsage": "ACCUPRIL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with ACCUPRIL. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. ACCUPRIL may be used alone or in combination with thiazide diuretics.",
"Description": "ACCUPRIL® is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 ∙HCl and its structural formula is. Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. ACCUPRIL tablets contain 5 mg (equivalent to 5.416 mg Quinapril Hydrochloride), 10 mg (equivalent to 10.832 mg Quinapril Hydrochloride), 20 mg (equivalent to 21.664 mg Quinapril Hydrochloride), or 40 mg (equivalent to 43.328 mg Quinapril Hydrochloride) of quinapril for oral administration. Each tablet also contains candelilla wax, crospovidone, gelatin, lactose, magnesium carbonate, magnesium stearate, synthetic red iron oxide, and titanium dioxide."
},
{
"NDCCode": "21695-328-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (21695-328-30)",
"NDC11Code": "21695-0328-30",
"ProductNDC": "21695-328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076059",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hypertension: Lisinopril tablets are indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents. Heart Failure: Lisinopril tablets are indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis. Acute Myocardial Infarction: Lisinopril tablets are indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta blockers. In using lisinopril tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.). In considering the use of lisinopril tablets, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients (see WARNINGS, Anaphylactoid and Possibly Related Reactions).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-Carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Each tablet for oral administration contains 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg of lisinopril USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, FD&C Blue #2 Aluminum Lake (10 mg only), FD&C Yellow #5 Aluminum Lake (20 mg, 30 mg, and 40 mg, only), magnesium stearate, mannitol, pregelatinized starch."
},
{
"NDCCode": "21695-328-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (21695-328-90)",
"NDC11Code": "21695-0328-90",
"ProductNDC": "21695-328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076059",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hypertension: Lisinopril tablets are indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents. Heart Failure: Lisinopril tablets are indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis. Acute Myocardial Infarction: Lisinopril tablets are indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta blockers. In using lisinopril tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.). In considering the use of lisinopril tablets, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients (see WARNINGS, Anaphylactoid and Possibly Related Reactions).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-Carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Each tablet for oral administration contains 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg of lisinopril USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, FD&C Blue #2 Aluminum Lake (10 mg only), FD&C Yellow #5 Aluminum Lake (20 mg, 30 mg, and 40 mg, only), magnesium stearate, mannitol, pregelatinized starch."
},
{
"NDCCode": "31722-328-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (31722-328-01)",
"NDC11Code": "31722-0328-01",
"ProductNDC": "31722-328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Camber Pharmaceuticals",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": ". Warfarin sodium tablets, USP are indicated for: 1 ●Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 ●Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 ●Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α- acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, hydroxypropyl cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red #30 aluminum lake2 mg tablet contains: FD&C Red #40 aluminum lake and FD&C Blue#22.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue#23 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue#2 and FD&C Red # 40 aluminum lake4 mg tablet contains: FD&C Blue#25 mg tablet contains: FD&C Yellow # 6 aluminum lake6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue #27.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake 10 mg tablet is dye free."
},
{
"NDCCode": "31722-328-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (31722-328-10)",
"NDC11Code": "31722-0328-10",
"ProductNDC": "31722-328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Camber Pharmaceuticals",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": ". Warfarin sodium tablets, USP are indicated for: 1 ●Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 ●Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 ●Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α- acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, hydroxypropyl cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red #30 aluminum lake2 mg tablet contains: FD&C Red #40 aluminum lake and FD&C Blue#22.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue#23 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue#2 and FD&C Red # 40 aluminum lake4 mg tablet contains: FD&C Blue#25 mg tablet contains: FD&C Yellow # 6 aluminum lake6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue #27.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake 10 mg tablet is dye free."
},
{
"NDCCode": "43063-328-12",
"PackageDescription": "12 TABLET in 1 BOTTLE, PLASTIC (43063-328-12) ",
"NDC11Code": "43063-0328-12",
"ProductNDC": "43063-328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074649",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090811",
"SamplePackage": "N",
"IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). .",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 and 200 mg, tablets of 200 mg, extended-release tablets of 100 mg, 200 mg, and 400 mg, and as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. C 15H 12N 2O. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients:Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg –ammonio methacrylate copolymer, croscarmellose sodium, diethyl phthalate, FD&C red no. 40 lake, magnesium stearate, microcrystalline cellulose, natural cherry flavor, pregelatinized maize starch and sorbitol. Carbamazepine Tablets USP, 200 mg– ammonio methacrylate copolymer, corn starch, croscarmellose sodium, diethyl phthalate, magnesium stearate and microcrystalline cellulose. Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg– ammonio methacrylate copolymer, corn starch, diethyl phthalate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Carbamazepine Oral Suspension USP, 100 mg/5 mL– citric acid monohydrate, FD&C yellow no. 6, orange flavor, poloxamer 188, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose and xanthan gum. The amount of propylene glycol in carbamazepine oral suspension is 50 mg per mL (see WARNINGS Propylene Glycol Toxicity)."
},
{
"NDCCode": "43063-328-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43063-328-30) ",
"NDC11Code": "43063-0328-30",
"ProductNDC": "43063-328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074649",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090811",
"SamplePackage": "N",
"IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). .",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 and 200 mg, tablets of 200 mg, extended-release tablets of 100 mg, 200 mg, and 400 mg, and as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. C 15H 12N 2O. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients:Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg –ammonio methacrylate copolymer, croscarmellose sodium, diethyl phthalate, FD&C red no. 40 lake, magnesium stearate, microcrystalline cellulose, natural cherry flavor, pregelatinized maize starch and sorbitol. Carbamazepine Tablets USP, 200 mg– ammonio methacrylate copolymer, corn starch, croscarmellose sodium, diethyl phthalate, magnesium stearate and microcrystalline cellulose. Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg– ammonio methacrylate copolymer, corn starch, diethyl phthalate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Carbamazepine Oral Suspension USP, 100 mg/5 mL– citric acid monohydrate, FD&C yellow no. 6, orange flavor, poloxamer 188, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose and xanthan gum. The amount of propylene glycol in carbamazepine oral suspension is 50 mg per mL (see WARNINGS Propylene Glycol Toxicity)."
},
{
"NDCCode": "43602-328-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43602-328-05) ",
"NDC11Code": "43602-0328-05",
"ProductNDC": "43602-328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215523",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211208",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].",
"Description": "Dexmethylphenidate hydrochloride extended-release capsules contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Dexmethylphenidate hydrochloride is a white 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. Its molecular weight is 269.77 g/mol. Inactive ingredients: Polyethylene glycol, sugar spheres (which contain corn starch and sucrose), ammonio methacrylate copolymer, methacrylic acid and methyl methacrylate copolymer, triethyl citrate, talc, acetone, isopropyl alcohol, titanium dioxide, gelatin and sodium lauryl sulfate. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, and strong ammonia solution. Additional ink ingredients in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 40 mg strengths are black iron oxide and potassium hydroxide, 35 mg strength is red iron oxide. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: FD&C blue No. 1, FD&C red No. 3, FD&C yellow No. 6 and D&C yellow No. 10, 2 10 mg: contains no colorants, 3 15 mg: FD&C yellow No. 6 and D&C yellow No. 10, 4 20 mg: FD&C red No. 40, FD&C blue No. 1 and D&C yellow No. 10, 5 25 mg: FD&C yellow No. 6 and D&C yellow No. 10, 6 30 mg: contains no colorants, 7 35 mg: Iron oxide yellow, 8 40 mg: FD&C yellow No. 6 and D&C yellow No. 10."
},
{
"NDCCode": "43602-328-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43602-328-30) ",
"NDC11Code": "43602-0328-30",
"ProductNDC": "43602-328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20211208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215523",
"LabelerName": "Ascent Pharmaceuticals, Inc.",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211208",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].",
"Description": "Dexmethylphenidate hydrochloride extended-release capsules contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Dexmethylphenidate hydrochloride is a white 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. Its molecular weight is 269.77 g/mol. Inactive ingredients: Polyethylene glycol, sugar spheres (which contain corn starch and sucrose), ammonio methacrylate copolymer, methacrylic acid and methyl methacrylate copolymer, triethyl citrate, talc, acetone, isopropyl alcohol, titanium dioxide, gelatin and sodium lauryl sulfate. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, and strong ammonia solution. Additional ink ingredients in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 40 mg strengths are black iron oxide and potassium hydroxide, 35 mg strength is red iron oxide. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: FD&C blue No. 1, FD&C red No. 3, FD&C yellow No. 6 and D&C yellow No. 10, 2 10 mg: contains no colorants, 3 15 mg: FD&C yellow No. 6 and D&C yellow No. 10, 4 20 mg: FD&C red No. 40, FD&C blue No. 1 and D&C yellow No. 10, 5 25 mg: FD&C yellow No. 6 and D&C yellow No. 10, 6 30 mg: contains no colorants, 7 35 mg: Iron oxide yellow, 8 40 mg: FD&C yellow No. 6 and D&C yellow No. 10."
},
{
"NDCCode": "49404-139-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (49404-139-02) / 40 mL in 1 CONTAINER",
"NDC11Code": "49404-0139-02",
"ProductNDC": "49404-139",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr.jart Black Label Detox Beauty Balm",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180502",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Have & Be Co., Ltd.",
"SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "2.4; .8; 3.328; .784",
"StrengthUnit": "mg/40mL; mg/40mL; mg/40mL; mg/40mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190618",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N"
}
]
}
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<NDCList>
<NDC>
<NDCCode>59469-328-40</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-328-40) > 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59469-0328-40</NDC11Code>
<ProductNDC>59469-328</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Livcalm</ProprietaryName>
<NonProprietaryName>Aloe Ferox Leaf, Activated Charcoal, Goldenseal, Strychnos Nux-vomica Seed, Okoubaka Aubrevillei Bark, And Berberis Vulgaris Root Bark</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200114</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Natuheilmittel GmbH</LabelerName>
<SubstanceName>ALOE FEROX LEAF; ACTIVATED CHARCOAL; GOLDENSEAL; STRYCHNOS NUX-VOMICA SEED; OKOUBAKA AUBREVILLEI BARK; BERBERIS VULGARIS ROOT BARK</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of symptoms related to minor gastritis, indigestion, cramps, and food sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37205-328-58</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (37205-328-58) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>37205-0328-58</NDC11Code>
<ProductNDC>37205-328</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120409</StartMarketingDate>
<EndMarketingDate>20171231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078682</ApplicationNumber>
<LabelerName>Cardinal Health (Leader) 37205</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69168-328-40</NDCCode>
<PackageDescription>40 TABLET in 1 CARTON (69168-328-40) </PackageDescription>
<NDC11Code>69168-0328-40</NDC11Code>
<ProductNDC>69168-328</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen 500 Mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Allegiant Health</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporary relief of minor aches and pains associated with ■ the common cold ■ headache ■ toothache ■ muscular aches ■ backache ■ minor pain from arthritis. ■ premenstrual and menstrual cramps ■ temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59469-106-40</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-106-40) > 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59469-0106-40</NDC11Code>
<ProductNDC>59469-106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Apo-hepat</ProprietaryName>
<NonProprietaryName>Chionanthus Virginicus Bark, Iberis Amara Seed, Lycopodium Clavatum Spore, Mandragora Officinarum Root, Phosphorus, Peumus Boldus Leaf, Cynara Scolymus Whole, And Taraxacum Officinale Whole</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080412</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
<SubstanceName>CHIONANTHUS VIRGINICUS ROOT BARK; IBERIS AMARA SEED; LYCOPODIUM CLAVATUM SPORE; MANDRAGORA OFFICINARUM ROOT; PHOSPHORUS; PEUMUS BOLDUS LEAF; CYNARA SCOLYMUS WHOLE; TARAXACUM OFFICINALE WHOLE</SubstanceName>
<StrengthNumber>2; 6; 4; 12; 10; 6; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps cleanse and detoxify the body. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59469-133-40</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-133-40) > 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59469-0133-40</NDC11Code>
<ProductNDC>59469-133</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Defaeton</ProprietaryName>
<NonProprietaryName>Peumus Boldus Leaf, Dioscorea Villosa Tuber, Strychnos Ignatii Seed, Cynara Scolymus Whole, Fumaria Officinalis Whole, Frangula Alnus Bark, And Rheum Officinale Root</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081211</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
<SubstanceName>PEUMUS BOLDUS LEAF; DIOSCOREA VILLOSA TUBER; STRYCHNOS IGNATII SEED; CYNARA SCOLYMUS WHOLE; FUMARIA OFFICINALIS WHOLE; FRANGULA ALNUS BARK; RHEUM OFFICINALE ROOT</SubstanceName>
<StrengthNumber>6; 4; 6; 12; 6; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of occasional constipation. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59469-138-40</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (59469-138-40) > 100 g in 1 TUBE</PackageDescription>
<NDC11Code>59469-0138-40</NDC11Code>
<ProductNDC>59469-138</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zellulisan</ProprietaryName>
<NonProprietaryName>Arnica Montana Root, Ledum Palustre Twig, Toxicodendron Pubescens Shoot, Sulfur, Horse Chestnut, Betula Pendula Leaf, Hedera Helix Flowering Twig, And Melilotus Officinalis Top</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20081211</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
<SubstanceName>ARNICA MONTANA ROOT; RHODODENDRON TOMENTOSUM LEAFY TWIG; TOXICODENDRON PUBESCENS SHOOT; SULFUR; HORSE CHESTNUT; BETULA PENDULA LEAF; HEDERA HELIX FLOWERING TWIG; MELILOTUS OFFICINALIS TOP</SubstanceName>
<StrengthNumber>8; 3; 8; 15; 4; 8; 6; 4</StrengthNumber>
<StrengthUnit>[hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of minor tendinitis and inflammation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59469-148-40</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (59469-148-40) > 100 g in 1 TUBE</PackageDescription>
<NDC11Code>59469-0148-40</NDC11Code>
<ProductNDC>59469-148</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Inflamyar</ProprietaryName>
<NonProprietaryName>Arnica Montana Root, Bryonia Dioica Root, Guaiacum Officinale Resin, Toxicodendron Pubescens Shoot, Bellis Perennis, Ledum Palustre Twig, Ruta Graveolens Flowering Top, And Viscum Album Fruiting Top</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20080412</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
<SubstanceName>ARNICA MONTANA ROOT; BRYONIA DIOICA ROOT; GUAIACUM OFFICINALE RESIN; TOXICODENDRON PUBESCENS SHOOT; BELLIS PERENNIS WHOLE; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>12; 4; 4; 12; 8; 4; 6; 4</StrengthNumber>
<StrengthUnit>[hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of minor sports injuries, including muscle strains, joint pain, sprains, and bruises.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59469-155-40</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (59469-155-40) > 100 g in 1 TUBE</PackageDescription>
<NDC11Code>59469-0155-40</NDC11Code>
<ProductNDC>59469-155</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dercut</ProprietaryName>
<NonProprietaryName>Euphorbia Resinifera Resin, Goldenseal, Wood Creosote, Toxicodendron Pubescens Shoot, Sempervivum Tectorum Leaf, Bellis Perennis, Vinca Minor, And Viola Tricolor</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20080412</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
<SubstanceName>EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; WOOD CREOSOTE; TOXICODENDRON PUBESCENS SHOOT; SEMPERVIVUM TECTORUM LEAF; BELLIS PERENNIS; VINCA MINOR; VIOLA TRICOLOR</SubstanceName>
<StrengthNumber>4; 3; 6; 8; 3; 8; 3; 2</StrengthNumber>
<StrengthUnit>[hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-21</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59469-156-40</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-156-40) > 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59469-0156-40</NDC11Code>
<ProductNDC>59469-156</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dalektro N</ProprietaryName>
<NonProprietaryName>Silver Nitrate, Oyster Shell Calcium Carbonate, Crude, Cobaltous Nitrate Hexahydrate, Cupric Acetate, Iron, Potassium Carbonate, Magnesium Chloride, Manganese Acetate Tetrahydrate, Selenium, Silicon Dioxide, And Zinc Phosphide</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080412</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Natruheilmittel GmbH</LabelerName>
<SubstanceName>SILVER NITRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; COBALTOUS NITRATE HEXAHYDRATE; CUPRIC ACETATE; IRON; POTASSIUM CARBONATE; MAGNESIUM CHLORIDE; MANGANESE ACETATE TETRAHYDRATE; SELENIUM; SILICON DIOXIDE; ZINC PHOSPHIDE</SubstanceName>
<StrengthNumber>4; 6; 6; 12; 6; 4; 4; 8; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59469-163-40</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-163-40) > 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59469-0163-40</NDC11Code>
<ProductNDC>59469-163</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Psy-stabil</ProprietaryName>
<NonProprietaryName>Phosphoric Acid, Amanita Muscaria Fruiting Body, Semecarpus Anacardium Fruit, Avena Sativa Flowering Top, Cinchona Officinalis Bark, Strychnos Ignatii Seed, Schoenocaulon Officinale Seed, And Piper Methysticum Root</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081211</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
<SubstanceName>PHOSPHORIC ACID; AMANITA MUSCARIA FRUITING BODY; SEMECARPUS ANACARDIUM FRUIT; AVENA SATIVA FLOWERING TOP; CINCHONA OFFICINALIS BARK; STRYCHNOS IGNATII SEED; SCHOENOCAULON OFFICINALE SEED; MACROPIPER METHYSTICUM ROOT</SubstanceName>
<StrengthNumber>3; 6; 10; 1; 3; 4; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of occasional stress. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59469-165-40</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-165-40) > 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59469-0165-40</NDC11Code>
<ProductNDC>59469-165</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Inflamyar</ProprietaryName>
<NonProprietaryName>Arnica Montana Root, Bellis Perennis, Bryonia Dioica Root, Guaiacum Officinale Resin, Ledum Palustre Twig, Ruta Graveolens Flowering Top, Toxicodendron Pubescens Shoot, And Viscum Album Fruiting Top</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080412</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
<SubstanceName>ARNICA MONTANA ROOT; BELLIS PERENNIS WHOLE; BRYONIA DIOICA ROOT; GUAIACUM OFFICINALE RESIN; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS SHOOT; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>4; 4; 4; 6; 12; 4; 8; 4</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of minor sports injuries, including muscle strains, joint pain, sprains, and bruises. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59469-171-40</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-171-40) > 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59469-0171-40</NDC11Code>
<ProductNDC>59469-171</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Opsonat</ProprietaryName>
<NonProprietaryName>Silver Nitrate, Sulfuric Acid, Bellis Perennis, Lytta Vesicatoria, Gratiola Officinalis, Goldenseal, Lachesis Muta Venom, And Glechoma Hederacea Flowering Top</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081122</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
<SubstanceName>SILVER NITRATE; SULFURIC ACID; BELLIS PERENNIS; LYTTA VESICATORIA; GRATIOLA OFFICINALIS; GOLDENSEAL; LACHESIS MUTA VENOM; GLECHOMA HEDERACEA FLOWERING TOP</SubstanceName>
<StrengthNumber>4; 4; 1; 4; 4; 4; 7; 1602</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59469-305-40</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-305-40) > 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59469-0305-40</NDC11Code>
<ProductNDC>59469-305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dalektro N</ProprietaryName>
<NonProprietaryName>Silver Nitrate, Oyster Shell Calcium Carbonate, Crude, Cobaltous Nitrate Hexahydrate, Cupric Acetate, Iron, Potassium Carbonate, Magnesium Chloride, Manganese Acetate Tetrahydrate, Selenium, Silicon Dioxide, And Zinc Phosphide</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190624</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Natruheilmittel GmbH</LabelerName>
<SubstanceName>SILVER NITRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; COBALTOUS NITRATE HEXAHYDRATE; CUPRIC ACETATE; IRON; POTASSIUM CARBONATE; MAGNESIUM CHLORIDE; MANGANESE ACETATE TETRAHYDRATE; SELENIUM; SILICON DIOXIDE; ZINC PHOSPHIDE</SubstanceName>
<StrengthNumber>6; 6; 6; 12; 6; 4; 4; 8; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], 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], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Homeopathically processed minerals to help reduce minor stress. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59469-307-40</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (59469-307-40) > 100 g in 1 TUBE</PackageDescription>
<NDC11Code>59469-0307-40</NDC11Code>
<ProductNDC>59469-307</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dercut</ProprietaryName>
<NonProprietaryName>Euphorbia Resinifera Resin, Goldenseal, Wood Creosote, Toxicodendron Pubescens Shoot, Sempervivum Tectorum Leaf, Bellis Perennis, Vinca Minor, And Viola Tricolor</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20190624</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
<SubstanceName>EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; WOOD CREOSOTE; TOXICODENDRON PUBESCENS SHOOT; SEMPERVIVUM TECTORUM LEAF; BELLIS PERENNIS WHOLE; PERVINCA MINOR WHOLE; VIOLA TRICOLOR WHOLE</SubstanceName>
<StrengthNumber>4; 4; 6; 8; 3; 8; 3; 2</StrengthNumber>
<StrengthUnit>[hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of acne, eczema, itching, psoriasis, and skin irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59469-313-40</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-313-40) > 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59469-0313-40</NDC11Code>
<ProductNDC>59469-313</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Opsonat</ProprietaryName>
<NonProprietaryName>Silver Nitrate, Sulfuric Acid, Bellis Perennis, Lytta Vesicatoria, Gratiola Officinalis, Goldenseal, Lachesis Muta Venom, And Glechoma Hederacea Flowering Top</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190624</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
<SubstanceName>SILVER NITRATE; SULFURIC ACID; BELLIS PERENNIS WHOLE; LYTTA VESICATORIA; GRATIOLA OFFICINALIS WHOLE; GOLDENSEAL; LACHESIS MUTA VENOM; GLECHOMA HEDERACEA FLOWERING TOP</SubstanceName>
<StrengthNumber>6; 6; 1; 4; 4; 5; 8; 1602</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of minor mucous membrane inflammation, such as the mouth. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59469-315-40</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-315-40) > 100 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>59469-0315-40</NDC11Code>
<ProductNDC>59469-315</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Renelix</ProprietaryName>
<NonProprietaryName>Benzoic Acid, Nitric Acid, Apis Mellifera, Berberis Vulgaris Root Bark, Colchicum Autumnale Bulb, Protortonia Cacti, Solidago Virgaurea Flowering Top, And Capsella Bursa-pastoris Top</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190624</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Naturheilmittel GmbH</LabelerName>
<SubstanceName>BENZOIC ACID; NITRIC ACID; APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; COLCHICUM AUTUMNALE BULB; PROTORTONIA CACTI; SOLIDAGO VIRGAUREA FLOWERING TOP; CAPSELLA BURSA-PASTORIS TOP</SubstanceName>
<StrengthNumber>4; 6; 4; 3; 12; 631; 2913; 510</StrengthNumber>
<StrengthUnit>[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; mg/50mL; mg/50mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ammonium Ion Binding Activity [MoA], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps cleanse and detoxify the body. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59469-321-40</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 BOX (59469-321-40) > 100 mL in 1 BOTTLE, GLASS (59469-321-30) </PackageDescription>
<NDC11Code>59469-0321-40</NDC11Code>
<ProductNDC>59469-321</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Citriplus</ProprietaryName>
<NonProprietaryName>Juglans Regia Whole And Anhydrous Citric Acid</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190624</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PEKANA Natuheilmittel GmbH</LabelerName>
<SubstanceName>JUGLANS REGIA WHOLE; ANHYDROUS CITRIC ACID</SubstanceName>
<StrengthNumber>5; 4</StrengthNumber>
<StrengthUnit>[hp_X]/100mL; [hp_X]/100mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For energy. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0071-0527-23</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0071-0527-23) </PackageDescription>
<NDC11Code>00071-0527-23</NDC11Code>
<ProductNDC>0071-0527</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Accupril</ProprietaryName>
<NonProprietaryName>Quinapril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911119</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019885</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>QUINAPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19911119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ACCUPRIL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with ACCUPRIL. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. ACCUPRIL may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
<Description>ACCUPRIL® is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 ∙HCl and its structural formula is. Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. ACCUPRIL tablets contain 5 mg (equivalent to 5.416 mg Quinapril Hydrochloride), 10 mg (equivalent to 10.832 mg Quinapril Hydrochloride), 20 mg (equivalent to 21.664 mg Quinapril Hydrochloride), or 40 mg (equivalent to 43.328 mg Quinapril Hydrochloride) of quinapril for oral administration. Each tablet also contains candelilla wax, crospovidone, gelatin, lactose, magnesium carbonate, magnesium stearate, synthetic red iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0071-0530-23</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0071-0530-23) </PackageDescription>
<NDC11Code>00071-0530-23</NDC11Code>
<ProductNDC>0071-0530</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Accupril</ProprietaryName>
<NonProprietaryName>Quinapril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911119</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019885</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>QUINAPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19911119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ACCUPRIL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with ACCUPRIL. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. ACCUPRIL may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
<Description>ACCUPRIL® is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 ∙HCl and its structural formula is. Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. ACCUPRIL tablets contain 5 mg (equivalent to 5.416 mg Quinapril Hydrochloride), 10 mg (equivalent to 10.832 mg Quinapril Hydrochloride), 20 mg (equivalent to 21.664 mg Quinapril Hydrochloride), or 40 mg (equivalent to 43.328 mg Quinapril Hydrochloride) of quinapril for oral administration. Each tablet also contains candelilla wax, crospovidone, gelatin, lactose, magnesium carbonate, magnesium stearate, synthetic red iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0071-0532-23</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0071-0532-23) </PackageDescription>
<NDC11Code>00071-0532-23</NDC11Code>
<ProductNDC>0071-0532</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Accupril</ProprietaryName>
<NonProprietaryName>Quinapril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911119</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019885</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>QUINAPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19911119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ACCUPRIL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with ACCUPRIL. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. ACCUPRIL may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
<Description>ACCUPRIL® is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 ∙HCl and its structural formula is. Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. ACCUPRIL tablets contain 5 mg (equivalent to 5.416 mg Quinapril Hydrochloride), 10 mg (equivalent to 10.832 mg Quinapril Hydrochloride), 20 mg (equivalent to 21.664 mg Quinapril Hydrochloride), or 40 mg (equivalent to 43.328 mg Quinapril Hydrochloride) of quinapril for oral administration. Each tablet also contains candelilla wax, crospovidone, gelatin, lactose, magnesium carbonate, magnesium stearate, synthetic red iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0071-0535-23</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0071-0535-23) </PackageDescription>
<NDC11Code>00071-0535-23</NDC11Code>
<ProductNDC>0071-0535</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Accupril</ProprietaryName>
<NonProprietaryName>Quinapril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911119</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019885</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>QUINAPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19911119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ACCUPRIL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with ACCUPRIL. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. ACCUPRIL may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
<Description>ACCUPRIL® is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 ∙HCl and its structural formula is. Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. ACCUPRIL tablets contain 5 mg (equivalent to 5.416 mg Quinapril Hydrochloride), 10 mg (equivalent to 10.832 mg Quinapril Hydrochloride), 20 mg (equivalent to 21.664 mg Quinapril Hydrochloride), or 40 mg (equivalent to 43.328 mg Quinapril Hydrochloride) of quinapril for oral administration. Each tablet also contains candelilla wax, crospovidone, gelatin, lactose, magnesium carbonate, magnesium stearate, synthetic red iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-328-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (21695-328-30)</PackageDescription>
<NDC11Code>21695-0328-30</NDC11Code>
<ProductNDC>21695-328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076059</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hypertension: Lisinopril tablets are indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents. Heart Failure: Lisinopril tablets are indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis. Acute Myocardial Infarction: Lisinopril tablets are indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta blockers. In using lisinopril tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.). In considering the use of lisinopril tablets, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients (see WARNINGS, Anaphylactoid and Possibly Related Reactions).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-Carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Each tablet for oral administration contains 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg of lisinopril USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, FD&C Blue #2 Aluminum Lake (10 mg only), FD&C Yellow #5 Aluminum Lake (20 mg, 30 mg, and 40 mg, only), magnesium stearate, mannitol, pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>21695-328-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (21695-328-90)</PackageDescription>
<NDC11Code>21695-0328-90</NDC11Code>
<ProductNDC>21695-328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076059</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hypertension: Lisinopril tablets are indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents. Heart Failure: Lisinopril tablets are indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis. Acute Myocardial Infarction: Lisinopril tablets are indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta blockers. In using lisinopril tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.). In considering the use of lisinopril tablets, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients (see WARNINGS, Anaphylactoid and Possibly Related Reactions).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-Carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Each tablet for oral administration contains 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg of lisinopril USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, FD&C Blue #2 Aluminum Lake (10 mg only), FD&C Yellow #5 Aluminum Lake (20 mg, 30 mg, and 40 mg, only), magnesium stearate, mannitol, pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>31722-328-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (31722-328-01)</PackageDescription>
<NDC11Code>31722-0328-01</NDC11Code>
<ProductNDC>31722-328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>. Warfarin sodium tablets, USP are indicated for: 1 ●Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 ●Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 ●Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α- acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, hydroxypropyl cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red #30 aluminum lake2 mg tablet contains: FD&C Red #40 aluminum lake and FD&C Blue#22.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue#23 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue#2 and FD&C Red # 40 aluminum lake4 mg tablet contains: FD&C Blue#25 mg tablet contains: FD&C Yellow # 6 aluminum lake6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue #27.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>31722-328-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (31722-328-10)</PackageDescription>
<NDC11Code>31722-0328-10</NDC11Code>
<ProductNDC>31722-328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>. Warfarin sodium tablets, USP are indicated for: 1 ●Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 ●Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 ●Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α- acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, hydroxypropyl cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red #30 aluminum lake2 mg tablet contains: FD&C Red #40 aluminum lake and FD&C Blue#22.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue#23 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue#2 and FD&C Red # 40 aluminum lake4 mg tablet contains: FD&C Blue#25 mg tablet contains: FD&C Yellow # 6 aluminum lake6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue #27.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>43063-328-12</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE, PLASTIC (43063-328-12) </PackageDescription>
<NDC11Code>43063-0328-12</NDC11Code>
<ProductNDC>43063-328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074649</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). .</IndicationAndUsage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 and 200 mg, tablets of 200 mg, extended-release tablets of 100 mg, 200 mg, and 400 mg, and as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. C 15H 12N 2O. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients:Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg –ammonio methacrylate copolymer, croscarmellose sodium, diethyl phthalate, FD&C red no. 40 lake, magnesium stearate, microcrystalline cellulose, natural cherry flavor, pregelatinized maize starch and sorbitol. Carbamazepine Tablets USP, 200 mg– ammonio methacrylate copolymer, corn starch, croscarmellose sodium, diethyl phthalate, magnesium stearate and microcrystalline cellulose. Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg– ammonio methacrylate copolymer, corn starch, diethyl phthalate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Carbamazepine Oral Suspension USP, 100 mg/5 mL– citric acid monohydrate, FD&C yellow no. 6, orange flavor, poloxamer 188, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose and xanthan gum. The amount of propylene glycol in carbamazepine oral suspension is 50 mg per mL (see WARNINGS Propylene Glycol Toxicity).</Description>
</NDC>
<NDC>
<NDCCode>43063-328-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43063-328-30) </PackageDescription>
<NDC11Code>43063-0328-30</NDC11Code>
<ProductNDC>43063-328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074649</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). .</IndicationAndUsage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 and 200 mg, tablets of 200 mg, extended-release tablets of 100 mg, 200 mg, and 400 mg, and as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. C 15H 12N 2O. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients:Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg –ammonio methacrylate copolymer, croscarmellose sodium, diethyl phthalate, FD&C red no. 40 lake, magnesium stearate, microcrystalline cellulose, natural cherry flavor, pregelatinized maize starch and sorbitol. Carbamazepine Tablets USP, 200 mg– ammonio methacrylate copolymer, corn starch, croscarmellose sodium, diethyl phthalate, magnesium stearate and microcrystalline cellulose. Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg– ammonio methacrylate copolymer, corn starch, diethyl phthalate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Carbamazepine Oral Suspension USP, 100 mg/5 mL– citric acid monohydrate, FD&C yellow no. 6, orange flavor, poloxamer 188, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose and xanthan gum. The amount of propylene glycol in carbamazepine oral suspension is 50 mg per mL (see WARNINGS Propylene Glycol Toxicity).</Description>
</NDC>
<NDC>
<NDCCode>43602-328-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43602-328-05) </PackageDescription>
<NDC11Code>43602-0328-05</NDC11Code>
<ProductNDC>43602-328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215523</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride extended-release capsules contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Dexmethylphenidate hydrochloride is a white 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. Its molecular weight is 269.77 g/mol. Inactive ingredients: Polyethylene glycol, sugar spheres (which contain corn starch and sucrose), ammonio methacrylate copolymer, methacrylic acid and methyl methacrylate copolymer, triethyl citrate, talc, acetone, isopropyl alcohol, titanium dioxide, gelatin and sodium lauryl sulfate. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, and strong ammonia solution. Additional ink ingredients in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 40 mg strengths are black iron oxide and potassium hydroxide, 35 mg strength is red iron oxide. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: FD&C blue No. 1, FD&C red No. 3, FD&C yellow No. 6 and D&C yellow No. 10, 2 10 mg: contains no colorants, 3 15 mg: FD&C yellow No. 6 and D&C yellow No. 10, 4 20 mg: FD&C red No. 40, FD&C blue No. 1 and D&C yellow No. 10, 5 25 mg: FD&C yellow No. 6 and D&C yellow No. 10, 6 30 mg: contains no colorants, 7 35 mg: Iron oxide yellow, 8 40 mg: FD&C yellow No. 6 and D&C yellow No. 10.</Description>
</NDC>
<NDC>
<NDCCode>43602-328-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43602-328-30) </PackageDescription>
<NDC11Code>43602-0328-30</NDC11Code>
<ProductNDC>43602-328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215523</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride extended-release capsules contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2HCl. Its structural formula is. Dexmethylphenidate hydrochloride is a white 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. Its molecular weight is 269.77 g/mol. Inactive ingredients: Polyethylene glycol, sugar spheres (which contain corn starch and sucrose), ammonio methacrylate copolymer, methacrylic acid and methyl methacrylate copolymer, triethyl citrate, talc, acetone, isopropyl alcohol, titanium dioxide, gelatin and sodium lauryl sulfate. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, and strong ammonia solution. Additional ink ingredients in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 40 mg strengths are black iron oxide and potassium hydroxide, 35 mg strength is red iron oxide. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 1 5 mg: FD&C blue No. 1, FD&C red No. 3, FD&C yellow No. 6 and D&C yellow No. 10, 2 10 mg: contains no colorants, 3 15 mg: FD&C yellow No. 6 and D&C yellow No. 10, 4 20 mg: FD&C red No. 40, FD&C blue No. 1 and D&C yellow No. 10, 5 25 mg: FD&C yellow No. 6 and D&C yellow No. 10, 6 30 mg: contains no colorants, 7 35 mg: Iron oxide yellow, 8 40 mg: FD&C yellow No. 6 and D&C yellow No. 10.</Description>
</NDC>
<NDC>
<NDCCode>49404-139-02</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (49404-139-02) / 40 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>49404-0139-02</NDC11Code>
<ProductNDC>49404-139</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr.jart Black Label Detox Beauty Balm</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180502</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Have & Be Co., Ltd.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>2.4; .8; 3.328; .784</StrengthNumber>
<StrengthUnit>mg/40mL; mg/40mL; mg/40mL; mg/40mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190618</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>