{
"NDC": [
{
"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": "10544-321-40",
"PackageDescription": "40 TABLET in 1 BOTTLE (10544-321-40)",
"NDC11Code": "10544-0321-40",
"ProductNDC": "10544-321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085159",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-01-23"
},
{
"NDCCode": "75543-321-00",
"PackageDescription": "40 PATCH in 1 PACKAGE (75543-321-00) / 1 CLOTH in 1 PATCH",
"NDC11Code": "75543-0321-00",
"ProductNDC": "75543-321",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Biopure Antibacterial Hand Wipe",
"NonProprietaryName": "Antibacterial Hand Wipe",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260828",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Fujian Yifa Healthcare Products Co., Ltd.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "g/401",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260828",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria; For use when soap and water are not available."
},
{
"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": "59469-328-40",
"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": "0054-0264-24",
"PackageDescription": "10 CONTAINER in 1 CARTON (0054-0264-24) / 10 TABLET in 1 CONTAINER",
"NDC11Code": "00054-0264-24",
"ProductNDC": "0054-0264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074597",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090729",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone hydrochloride, USP is a white to off-white powder. It is soluble in water and sparingly soluble in alcohol. The chemical name of hydromorphone hydrochloride is 4,5α-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is. C17H19NO3 ●HCl M.W. 321.80. Each Hydromorphone Hydrochloride Tablet, USP for oral administration, contains 4 mg or 8 mg hydromorphone hydrochloride, USP. In addition, the tablets include lactose anhydrous and magnesium stearate. Hydromorphone Hydrochloride Tablets, USP may contain traces of sodium metabisulfite. Each 5 mL (1 teaspoonful) of Hydromorphone Hydrochloride Oral Solution, USP contains 5 mg of hydromorphone hydrochloride, USP. In addition, other ingredients include FD&C Red No. 40, methyl paraben, propylene glycol, propylparaben, purified water, raspberry blend, saccharin sodium and sorbitol solution. Hydromorphone Hydrochloride Oral Solution, USP may contain traces of sodium metabisulfite."
},
{
"NDCCode": "0054-0264-25",
"PackageDescription": "100 TABLET in 1 BOTTLE (0054-0264-25) ",
"NDC11Code": "00054-0264-25",
"ProductNDC": "0054-0264",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074597",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090729",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone hydrochloride, USP is a white to off-white powder. It is soluble in water and sparingly soluble in alcohol. The chemical name of hydromorphone hydrochloride is 4,5α-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is. C17H19NO3 ●HCl M.W. 321.80. Each Hydromorphone Hydrochloride Tablet, USP for oral administration, contains 4 mg or 8 mg hydromorphone hydrochloride, USP. In addition, the tablets include lactose anhydrous and magnesium stearate. Hydromorphone Hydrochloride Tablets, USP may contain traces of sodium metabisulfite. Each 5 mL (1 teaspoonful) of Hydromorphone Hydrochloride Oral Solution, USP contains 5 mg of hydromorphone hydrochloride, USP. In addition, other ingredients include FD&C Red No. 40, methyl paraben, propylene glycol, propylparaben, purified water, raspberry blend, saccharin sodium and sorbitol solution. Hydromorphone Hydrochloride Oral Solution, USP may contain traces of sodium metabisulfite."
},
{
"NDCCode": "0054-0265-25",
"PackageDescription": "100 TABLET in 1 BOTTLE (0054-0265-25) ",
"NDC11Code": "00054-0265-25",
"ProductNDC": "0054-0265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074597",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090729",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.",
"Description": "Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone hydrochloride, USP is a white to off-white powder. It is soluble in water and sparingly soluble in alcohol. The chemical name of hydromorphone hydrochloride is 4,5α-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is. C17H19NO3 ●HCl M.W. 321.80. Each Hydromorphone Hydrochloride Tablet, USP for oral administration, contains 4 mg or 8 mg hydromorphone hydrochloride, USP. In addition, the tablets include lactose anhydrous and magnesium stearate. Hydromorphone Hydrochloride Tablets, USP may contain traces of sodium metabisulfite. Each 5 mL (1 teaspoonful) of Hydromorphone Hydrochloride Oral Solution, USP contains 5 mg of hydromorphone hydrochloride, USP. In addition, other ingredients include FD&C Red No. 40, methyl paraben, propylene glycol, propylparaben, purified water, raspberry blend, saccharin sodium and sorbitol solution. Hydromorphone Hydrochloride Oral Solution, USP may contain traces of sodium metabisulfite."
},
{
"NDCCode": "0409-1283-05",
"PackageDescription": "10 SYRINGE in 1 CARTON (0409-1283-05) / .5 mL in 1 SYRINGE (0409-1283-04) ",
"NDC11Code": "00409-1283-05",
"ProductNDC": "0409-1283",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200403",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20111201",
"EndMarketingDatePackage": "20240501",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. ."
},
{
"NDCCode": "0409-1283-31",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1283-31) / 1 mL in 1 CARTRIDGE (0409-1283-03) ",
"NDC11Code": "00409-1283-31",
"ProductNDC": "0409-1283",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200403",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. ."
},
{
"NDCCode": "0409-1283-37",
"PackageDescription": "10 SYRINGE in 1 CELLO PACK (0409-1283-37) / 1 mL in 1 SYRINGE (0409-1283-17) ",
"NDC11Code": "00409-1283-37",
"ProductNDC": "0409-1283",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20210111",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200403",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210111",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Hydromorphone Hydrochloride Injection is available as an aqueous sterile solution, for use in intravenous, intramuscular and subcutaneous administration, and contains hydromorphone as active pharmaceutical ingredient in the form hydrochloride salt. Hydromorphone hydrochloride is an opioid agonist. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 0.5 mg, 1 mg or 2 mg of Hydromorphone Hydrochloride USP, equivalent to 0.44 mg, 0.89 mg or 1.77 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5."
},
{
"NDCCode": "0409-1304-31",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1304-31) / 1 mL in 1 CARTRIDGE (0409-1304-03) ",
"NDC11Code": "00409-1304-31",
"ProductNDC": "0409-1304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200403",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. ."
},
{
"NDCCode": "0409-1312-30",
"PackageDescription": "10 CARTRIDGE in 1 CARTON (0409-1312-30) / 1 mL in 1 CARTRIDGE (0409-1312-03) ",
"NDC11Code": "00409-1312-30",
"ProductNDC": "0409-1312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200403",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. ."
},
{
"NDCCode": "0409-1312-36",
"PackageDescription": "10 SYRINGE in 1 CELLO PACK (0409-1312-36) / 1 mL in 1 SYRINGE (0409-1312-16) ",
"NDC11Code": "00409-1312-36",
"ProductNDC": "0409-1312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200403",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Hydromorphone Hydrochloride Injection is available as an aqueous sterile solution, for use in intravenous, intramuscular and subcutaneous administration, and contains hydromorphone as active pharmaceutical ingredient in the form hydrochloride salt. Hydromorphone hydrochloride is an opioid agonist. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 0.5 mg, 1 mg or 2 mg of Hydromorphone Hydrochloride USP, equivalent to 0.44 mg, 0.89 mg or 1.77 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5."
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"Description": "Hydromorphone Hydrochloride Injection is available as an aqueous sterile solution, for use in intravenous, intramuscular and subcutaneous administration, and contains hydromorphone as active pharmaceutical ingredient in the form hydrochloride salt. Hydromorphone hydrochloride is an opioid agonist. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 0.5 mg, 1 mg or 2 mg of Hydromorphone Hydrochloride USP, equivalent to 0.44 mg, 0.89 mg or 1.77 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5."
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"IndicationAndUsage": "Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.",
"Description": "Hydromorphone Hydrochloride Injection is available as an aqueous sterile solution, for use in intravenous, intramuscular and subcutaneous administration, and contains hydromorphone as active pharmaceutical ingredient in the form hydrochloride salt. Hydromorphone hydrochloride is an opioid agonist. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 0.5 mg, 1 mg or 2 mg of Hydromorphone Hydrochloride USP, equivalent to 0.44 mg, 0.89 mg or 1.77 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5."
}
]
}
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of minor tendinitis and inflammation.</IndicationAndUsage>
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<PackageDescription>1 TUBE in 1 BOX (59469-148-40) > 100 g in 1 TUBE</PackageDescription>
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<ProductNDC>59469-148</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<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>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<StartMarketingDate>20080412</StartMarketingDate>
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<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>59469-328-40</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>0054-0264-24</NDCCode>
<PackageDescription>10 CONTAINER in 1 CARTON (0054-0264-24) / 10 TABLET in 1 CONTAINER</PackageDescription>
<NDC11Code>00054-0264-24</NDC11Code>
<ProductNDC>0054-0264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074597</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone hydrochloride, USP is a white to off-white powder. It is soluble in water and sparingly soluble in alcohol. The chemical name of hydromorphone hydrochloride is 4,5α-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is. C17H19NO3 ●HCl M.W. 321.80. Each Hydromorphone Hydrochloride Tablet, USP for oral administration, contains 4 mg or 8 mg hydromorphone hydrochloride, USP. In addition, the tablets include lactose anhydrous and magnesium stearate. Hydromorphone Hydrochloride Tablets, USP may contain traces of sodium metabisulfite. Each 5 mL (1 teaspoonful) of Hydromorphone Hydrochloride Oral Solution, USP contains 5 mg of hydromorphone hydrochloride, USP. In addition, other ingredients include FD&C Red No. 40, methyl paraben, propylene glycol, propylparaben, purified water, raspberry blend, saccharin sodium and sorbitol solution. Hydromorphone Hydrochloride Oral Solution, USP may contain traces of sodium metabisulfite.</Description>
</NDC>
<NDC>
<NDCCode>0054-0264-25</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0054-0264-25) </PackageDescription>
<NDC11Code>00054-0264-25</NDC11Code>
<ProductNDC>0054-0264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074597</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone hydrochloride, USP is a white to off-white powder. It is soluble in water and sparingly soluble in alcohol. The chemical name of hydromorphone hydrochloride is 4,5α-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is. C17H19NO3 ●HCl M.W. 321.80. Each Hydromorphone Hydrochloride Tablet, USP for oral administration, contains 4 mg or 8 mg hydromorphone hydrochloride, USP. In addition, the tablets include lactose anhydrous and magnesium stearate. Hydromorphone Hydrochloride Tablets, USP may contain traces of sodium metabisulfite. Each 5 mL (1 teaspoonful) of Hydromorphone Hydrochloride Oral Solution, USP contains 5 mg of hydromorphone hydrochloride, USP. In addition, other ingredients include FD&C Red No. 40, methyl paraben, propylene glycol, propylparaben, purified water, raspberry blend, saccharin sodium and sorbitol solution. Hydromorphone Hydrochloride Oral Solution, USP may contain traces of sodium metabisulfite.</Description>
</NDC>
<NDC>
<NDCCode>0054-0265-25</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0054-0265-25) </PackageDescription>
<NDC11Code>00054-0265-25</NDC11Code>
<ProductNDC>0054-0265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074597</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist. Hydromorphone hydrochloride, USP is a white to off-white powder. It is soluble in water and sparingly soluble in alcohol. The chemical name of hydromorphone hydrochloride is 4,5α-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is. C17H19NO3 ●HCl M.W. 321.80. Each Hydromorphone Hydrochloride Tablet, USP for oral administration, contains 4 mg or 8 mg hydromorphone hydrochloride, USP. In addition, the tablets include lactose anhydrous and magnesium stearate. Hydromorphone Hydrochloride Tablets, USP may contain traces of sodium metabisulfite. Each 5 mL (1 teaspoonful) of Hydromorphone Hydrochloride Oral Solution, USP contains 5 mg of hydromorphone hydrochloride, USP. In addition, other ingredients include FD&C Red No. 40, methyl paraben, propylene glycol, propylparaben, purified water, raspberry blend, saccharin sodium and sorbitol solution. Hydromorphone Hydrochloride Oral Solution, USP may contain traces of sodium metabisulfite.</Description>
</NDC>
<NDC>
<NDCCode>0409-1283-05</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (0409-1283-05) / .5 mL in 1 SYRINGE (0409-1283-04) </PackageDescription>
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<ProductNDC>0409-1283</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200403</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111201</StartMarketingDatePackage>
<EndMarketingDatePackage>20240501</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. .</Description>
</NDC>
<NDC>
<NDCCode>0409-1283-31</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1283-31) / 1 mL in 1 CARTRIDGE (0409-1283-03) </PackageDescription>
<NDC11Code>00409-1283-31</NDC11Code>
<ProductNDC>0409-1283</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200403</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. .</Description>
</NDC>
<NDC>
<NDCCode>0409-1283-37</NDCCode>
<PackageDescription>10 SYRINGE in 1 CELLO PACK (0409-1283-37) / 1 mL in 1 SYRINGE (0409-1283-17) </PackageDescription>
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<ProductNDC>0409-1283</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
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<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200403</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Injection is available as an aqueous sterile solution, for use in intravenous, intramuscular and subcutaneous administration, and contains hydromorphone as active pharmaceutical ingredient in the form hydrochloride salt. Hydromorphone hydrochloride is an opioid agonist. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 0.5 mg, 1 mg or 2 mg of Hydromorphone Hydrochloride USP, equivalent to 0.44 mg, 0.89 mg or 1.77 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5.</Description>
</NDC>
<NDC>
<NDCCode>0409-1304-31</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1304-31) / 1 mL in 1 CARTRIDGE (0409-1304-03) </PackageDescription>
<NDC11Code>00409-1304-31</NDC11Code>
<ProductNDC>0409-1304</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200403</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. .</Description>
</NDC>
<NDC>
<NDCCode>0409-1312-30</NDCCode>
<PackageDescription>10 CARTRIDGE in 1 CARTON (0409-1312-30) / 1 mL in 1 CARTRIDGE (0409-1312-03) </PackageDescription>
<NDC11Code>00409-1312-30</NDC11Code>
<ProductNDC>0409-1312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200403</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. .</Description>
</NDC>
<NDC>
<NDCCode>0409-1312-36</NDCCode>
<PackageDescription>10 SYRINGE in 1 CELLO PACK (0409-1312-36) / 1 mL in 1 SYRINGE (0409-1312-16) </PackageDescription>
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<ProductNDC>0409-1312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200403</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Injection is available as an aqueous sterile solution, for use in intravenous, intramuscular and subcutaneous administration, and contains hydromorphone as active pharmaceutical ingredient in the form hydrochloride salt. Hydromorphone hydrochloride is an opioid agonist. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 0.5 mg, 1 mg or 2 mg of Hydromorphone Hydrochloride USP, equivalent to 0.44 mg, 0.89 mg or 1.77 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5.</Description>
</NDC>
<NDC>
<NDCCode>0409-1805-01</NDCCode>
<PackageDescription>10 SYRINGE in 1 CELLO PACK (0409-1805-01) / .5 mL in 1 SYRINGE (0409-1805-10) </PackageDescription>
<NDC11Code>00409-1805-01</NDC11Code>
<ProductNDC>0409-1805</ProductNDC>
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<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Injection is available as an aqueous sterile solution, for use in intravenous, intramuscular and subcutaneous administration, and contains hydromorphone as active pharmaceutical ingredient in the form hydrochloride salt. Hydromorphone hydrochloride is an opioid agonist. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 0.5 mg, 1 mg or 2 mg of Hydromorphone Hydrochloride USP, equivalent to 0.44 mg, 0.89 mg or 1.77 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5.</Description>
</NDC>
<NDC>
<NDCCode>0409-2552-01</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (0409-2552-01) / 1 mL in 1 AMPULE (0409-2552-11) </PackageDescription>
<NDC11Code>00409-2552-01</NDC11Code>
<ProductNDC>0409-2552</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200403</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. .</Description>
</NDC>
<NDC>
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<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3365-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-3365-11) </PackageDescription>
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<ProductNDC>0409-3365</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200403</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Injection is an opioid agonist and available as an aqueous sterile solution, for use for intravenous, intramuscular and subcutaneous administration. It contains hydromorphone as active pharmaceutical ingredient in the form of hydrochloride salt. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5. .</Description>
</NDC>
<NDC>
<NDCCode>0409-4264-01</NDCCode>
<PackageDescription>10 SYRINGE in 1 CELLO PACK (0409-4264-01) / .5 mL in 1 SYRINGE (0409-4264-11) </PackageDescription>
<NDC11Code>00409-4264-01</NDC11Code>
<ProductNDC>0409-4264</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220527</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200403</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydromorphone Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Injection is available as an aqueous sterile solution, for use in intravenous, intramuscular and subcutaneous administration, and contains hydromorphone as active pharmaceutical ingredient in the form hydrochloride salt. Hydromorphone hydrochloride is an opioid agonist. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 and it has the following chemical structure. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 0.5 mg, 1 mg or 2 mg of Hydromorphone Hydrochloride USP, equivalent to 0.44 mg, 0.89 mg or 1.77 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5.</Description>
</NDC>
</NDCList>