{
"NDC": [
{
"NDCCode": "75053-0010-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0010-1) ",
"NDC11Code": "75053-0010-01",
"ProductNDC": "75053-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hypothaltem",
"NonProprietaryName": "Eupatorium Perfoliatum, Berberis Vulgaris, Mentha Pulegium, Moschus, Benzinum, Sepia, Baryta Carbonica, Glandula Suprarenalis Suis, Hypophysis Suis, Hypothalamus Suis, Thyroidinum (suis), Pyridoxinum Hydrochloricum, Gelsemium Sempervirens, Natrum Carbonicum, Nux Vomica, Staphysagria",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210511",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "EUPATORIUM PERFOLIATUM FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; MENTHA PULEGIUM WHOLE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; BENZENE; SEPIA OFFICINALIS JUICE; BARIUM CARBONATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; THYROID, UNSPECIFIED; PYRIDOXINE HYDROCHLORIDE; GELSEMIUM SEMPERVIRENS ROOT; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; DELPHINIUM STAPHISAGRIA SEED",
"StrengthNumber": "6; 9; 9; 9; 9; 9; 12; 7; 7; 7; 7; 12; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], 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], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210511",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily helps alleviate symptoms of hormone imbalance.**These “uses” have not been evaluated by the Food and Drug Administration."
},
{
"NDCCode": "75053-0001-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0001-1) ",
"NDC11Code": "75053-0001-01",
"ProductNDC": "75053-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neuroinflammacil",
"NonProprietaryName": "Aurum Muriaticum, Hyoscyaminum, Cerebrum Suis, Hedera Helix, Hura Brasiliensis, Cedron, Hypericum Perforatum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20200629",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "GOLD TRICHLORIDE; HYOSCYAMINE; SUS SCROFA CEREBRUM; HEDERA HELIX FLOWERING TWIG; HURA CREPITANS SAP; SIMABA CEDRON SEED; HYPERICUM PERFORATUM WHOLE",
"StrengthNumber": "12; 16; 3; 30; 30; 200; 200",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200629",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily alleviates symptoms of neuroinflammation while promoting drainage. *These \"uses\" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions see www.hpus.com."
},
{
"NDCCode": "75053-0002-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0002-1) ",
"NDC11Code": "75053-0002-01",
"ProductNDC": "75053-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lymphocil",
"NonProprietaryName": "Phytolacca Decandra, Arsenicum Iodatum, Agraphis Nutans, Apium Graveolens, Eriodictyon Californicum, Allium Sativum, Erigeron Canadensis, Euonymus Atropurpureus, Aconitum Lycoctonum, Aethiops Antimonialis, Euonymus Europaeus, Absinthium, Apis Mellifica, Causticum, Sanguinaria Canadensis, Uva Ursi, Capsicum Annuum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20200629",
"EndMarketingDate": "20301202",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "PHYTOLACCA AMERICANA ROOT; ARSENIC TRIIODIDE; HYACINTHOIDES NON-SCRIPTA WHOLE; CELERY SEED; ERIODICTYON CALIFORNICUM LEAF; GARLIC; ERIGERON CANADENSIS WHOLE; EUONYMUS ATROPURPUREUS BRANCH BARK/ROOT BARK; ACONITUM LYCOCTONUM WHOLE; MERCURIC SULFIDE; EUONYMUS EUROPAEUS SEED; WORMWOOD; APIS MELLIFERA; CAUSTICUM; SANGUINARIA CANADENSIS ROOT; ARCTOSTAPHYLOS UVA-URSI LEAF; CAPSICUM",
"StrengthNumber": "4; 12; 12; 3; 3; 6; 6; 6; 9; 9; 9; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200629",
"EndMarketingDatePackage": "20301202",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves symptoms of lymphatic congestions and swelling. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated. *These \"uses\" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions see www.hpus.com."
},
{
"NDCCode": "75053-0003-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0003-1) ",
"NDC11Code": "75053-0003-01",
"ProductNDC": "75053-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Celltem",
"NonProprietaryName": "Carbo Vegetabilis, Anilinum, Radium Bromatum, Millefolium, Medulla Ossis Suis, Rna, Dna, Methylene Blue, Abrotanum, Calcarea Oxalica, Conium Maculatum, Euphorbia Corollata, Euphorbium Officinarum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210503",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "ACTIVATED CHARCOAL; ANILINE; RADIUM BROMIDE; ACHILLEA MILLEFOLIUM WHOLE; SUS SCROFA BONE MARROW; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; METHYLENE BLUE; ARTEMISIA ABROTANUM FLOWERING TOP; CALCIUM OXALATE MONOHYDRATE; CONIUM MACULATUM FLOWERING TOP; EUPHORBIA COROLLATA ROOT; EUPHORBIA RESINIFERA RESIN",
"StrengthNumber": "9; 9; 12; 13; 3; 5; 6; 9; 200; 200; 200; 200; 200",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210503",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily regulates cellular metabolism and fortifies RNA and DNA.*. *These \"uses\" have not been evaluated by the Food and Drug Administration."
},
{
"NDCCode": "75053-0004-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0004-1) ",
"NDC11Code": "75053-0004-01",
"ProductNDC": "75053-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excitathyrotem",
"NonProprietaryName": "Iodium, Kali Iodatum, Hypothalamus Suis, Hypophysis Suis, Thyroidinum (suis), Lithium Muriaticum, Ephedra Vulgaris",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20201013",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "IODINE; POTASSIUM IODIDE; BOS TAURUS HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED; LITHIUM CHLORIDE; EPHEDRA DISTACHYA FLOWERING TWIG",
"StrengthNumber": "9; 9; 7; 7; 9; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201013",
"SamplePackage": "N",
"IndicationAndUsage": "Homeopathic medicine for the minor effects of increased metabolism such as anxiety, heart palpitation and irritability. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "75053-0005-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0005-1) ",
"NDC11Code": "75053-0005-01",
"ProductNDC": "75053-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerebellutem",
"NonProprietaryName": "Causticum, Absinthium, Ranunculus Glacialis, Theridion, Heloderma, Picrotoxinum, Succinum, Helleborus Niger",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210419",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "CAUSTICUM; WORMWOOD; RANUNCULUS GLACIALIS WHOLE; THERIDION CURASSAVICUM; HELODERMA HORRIDUM VENOM; PICROTOXIN; AMBER; HELLEBORUS NIGER ROOT",
"StrengthNumber": "5; 6; 10; 10; 12; 16; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210419",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily alleviates symptoms of concussion or trauma.*These “uses” have not been evaluated by the Food and Drug Administration."
},
{
"NDCCode": "75053-0006-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0006-1) ",
"NDC11Code": "75053-0006-01",
"ProductNDC": "75053-0006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gallcill",
"NonProprietaryName": "Chelidonium Majus, Berberis Aquifolium, Berberis Vulgaris, Dioscorea Villosa, Calcarea Sulphurica, Cupressus Lawsoniana, Hepar Sulphurica Calcareum, Cholesterinum, Fel Tauri, Lycopodium Clavatum, Magnesia Sulphurica",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210419",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "CHELIDONIUM MAJUS WHOLE; BERBERIS AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; DIOSCOREA VILLOSA TUBER; CALCIUM SULFATE ANHYDROUS; CHAMAECYPARIS LAWSONIANA FRUITING TWIG; CALCIUM SULFIDE; CHOLESTEROL; BOS TAURUS BILE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM SULFATE HEPTAHYDRATE",
"StrengthNumber": "5; 5; 5; 6; 6; 9; 12; 12; 12; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210419",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily alleviates symptoms of pain in the upper right quadrant and gas associated with gastric upset. *These \"uses\" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions: see www.hpus.com."
},
{
"NDCCode": "75053-0007-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0007-1) ",
"NDC11Code": "75053-0007-01",
"ProductNDC": "75053-0007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenseg",
"NonProprietaryName": "Galphimia Glauca, Causticum, Eupatorium Perfoliatum, Ipecacuanha, Aconitum Napellus, Kali Bichromicum, Avena Sativa, Influenzinum (2020 2021), Lobelia Purpurescens, Anas Barbariae, Hepatis Et Cordis Extractum, Echinacea (angustifolia), Canchalagua",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210504",
"EndMarketingDate": "20260312",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "ACONITUM NAPELLUS WHOLE; AVENA SATIVA FLOWERING TOP; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; CAUSTICUM; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); IPECAC; POTASSIUM DICHROMATE; PRATIA PURPURASCENS; ZELTNERA VENUSTA WHOLE FLOWERING",
"StrengthNumber": "9; 12; 16; 6; 3; 6; 4; 12; 12; 12; 12; 6; 9; 16; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2026-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210504",
"EndMarketingDatePackage": "20260312",
"SamplePackage": "N",
"IndicationAndUsage": "Homeopathic medicine for the minor relief of headache, body heat, lethargy, fatigue and congestion. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "75053-0008-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0008-1) ",
"NDC11Code": "75053-0008-01",
"ProductNDC": "75053-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Apnetem",
"NonProprietaryName": "Phosphoricum Acidum, Alumen, Phosphorus, Senega Officinalis, Adenosinum Cyclophosphoricum, Antimonium Tartaricum, Grindelia, Sabadilla, Alumina, Cuprum Metallicum, Sanguinarinum Nitricum, Silicea, Lachesis Mutus, Rheum (palmatum), Zincum Metallicum, Lycopodium Clavatum, Manganum Phosphoricum, Antipyrinum, Coenzyme A",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210518",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "PHOSPHORIC ACID; POTASSIUM ALUM; PHOSPHORUS; POLYGALA SENEGA ROOT; ADENOSINE CYCLIC PHOSPHATE; ANTIMONY POTASSIUM TARTRATE; GRINDELIA HIRSUTULA FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; ALUMINUM OXIDE; COPPER; SANGUINARINE NITRATE; SILICON DIOXIDE; LACHESIS MUTA VENOM; RHEUM PALMATUM ROOT; ZINC; LYCOPODIUM CLAVATUM SPORE; MANGANESE PHOSPHATE, DIBASIC; ANTIPYRINE; COENZYME A",
"StrengthNumber": "6; 6; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 13; 15; 18; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210518",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily alleviates symptoms of sleep disorders. These \"uses\" have not been evaluated by the Food and Drug Administration."
},
{
"NDCCode": "75053-0009-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0009-1) ",
"NDC11Code": "75053-0009-01",
"ProductNDC": "75053-0009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oxaltem",
"NonProprietaryName": "Berberis Vulgaris, Oxalicum Acidum, Sanguinaria Canadensis, Chimaphila Umbellata, Calcarea Fluorica, Calcarea Silicata, Uricum Acidum, Calcarea Phosphorica, Parathormonum, Pyridoxinum Hydrochloricum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220131",
"EndMarketingDate": "20280726",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK; OXALIC ACID; SANGUINARIA CANADENSIS WHOLE; CHIMAPHILA UMBELLATA WHOLE; CALCIUM FLUORIDE; CALCIUM SILICATE; URIC ACID; TRIBASIC CALCIUM PHOSPHATE; PARATHYROID HORMONE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "6; 6; 9; 9; 12; 12; 12; 6; 9; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Cations, Divalent [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Parathyroid Hormone [CS], Parathyroid Hormone [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220131",
"EndMarketingDatePackage": "20280726",
"SamplePackage": "N",
"IndicationAndUsage": "Homeopathic medicine for the regulation of oxalate deposition and related dysfunctions of drainage. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "75053-0011-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0011-1) ",
"NDC11Code": "75053-0011-01",
"ProductNDC": "75053-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenseg",
"NonProprietaryName": "Galphimia Glauca, Causticum, Eupatorium Perfoliatum, Ipecacuanha, Aconitum Napellus, Kali Bichromicum, Avena Sativa, Influenzinum (2021-2022), Lobelia Purpurescens, Anas Barbariae, Hepatis Et Cordis Extractum, Echinacea (angustifolia), Canchalagua",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220620",
"EndMarketingDate": "20270620",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "GALPHIMIA GLAUCA FLOWERING TOP; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; IPECAC; ACONITUM NAPELLUS WHOLE; POTASSIUM DICHROMATE; AVENA SATIVA FLOWERING TOP; INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); PRATIA PURPURASCENS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ECHINACEA ANGUSTIFOLIA WHOLE; ZELTNERA VENUSTA WHOLE FLOWERING",
"StrengthNumber": "4; 6; 6; 6; 9; 9; 12; 12; 12; 12; 12; 16; 16; 3; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220620",
"EndMarketingDatePackage": "20270620",
"SamplePackage": "N",
"IndicationAndUsage": "Homeopathic medicine for the minor relief of headache, body heat, lethargy, fatigue and congestion. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "75053-0012-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0012-1) ",
"NDC11Code": "75053-0012-01",
"ProductNDC": "75053-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oxaltem",
"NonProprietaryName": "Berberis Vulgaris, Oxalicum Acidum, Sanguinaria Canadensis, Chimaphila Umbellata, Calcarea Fluorica, Calcarea Silicata, Uricum Acidum, Calcarea Phosphorica, Parathormonum, Pyridoxinum Hydrochloricum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240521",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK; OXALIC ACID DIHYDRATE; SANGUINARIA CANADENSIS ROOT; CHIMAPHILA UMBELLATA WHOLE; CALCIUM FLUORIDE; CALCIUM SILICATE; URIC ACID; TRIBASIC CALCIUM PHOSPHATE; PARATHYROID HORMONE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "6; 6; 9; 9; 12; 12; 12; 6; 9; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Cations, Divalent [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Parathyroid Hormone [CS], Parathyroid Hormone [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240521",
"SamplePackage": "N",
"IndicationAndUsage": "Homeopathic remedy that regulates oxalate in the body. *These \"uses\" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions see www.hpus.com."
},
{
"NDCCode": "75053-0100-1",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (75053-0100-1) ",
"NDC11Code": "75053-0100-01",
"ProductNDC": "75053-0100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenseg",
"NonProprietaryName": "Gelsemium Sempervirens, Sambucus Nigra, Galphimia Glauca, Causticum, Eupatorium Perfoliatum, Ipecacuanha, Aconitum Napellus, Kali Bichromicum, Avena Sativa, Influenzinum (2024-2025), Lobelia Purpurescens, Anas Barbariae, Hepatis Et Cordis Extractum, Echinacea (angustifolia), Canchalagua",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260227",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nucleic Products, LLC",
"SubstanceName": "GELSEMIUM SEMPERVIRENS ROOT; SAMBUCUS NIGRA FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; IPECAC; ACONITUM NAPELLUS WHOLE; POTASSIUM DICHROMATE; AVENA SATIVA FLOWERING TOP; INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 WHOLE; INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B WHOLE; PRATIA PURPURASCENS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ECHINACEA ANGUSTIFOLIA WHOLE; ZELTNERA VENUSTA WHOLE FLOWERING",
"StrengthNumber": "3; 3; 4; 6; 6; 6; 9; 9; 12; 12; 12; 12; 12; 16; 16; 3; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260227",
"SamplePackage": "N",
"IndicationAndUsage": "Homeopathic medicine for the minor relief of headache, body heat, lethargy, fatigue and congestion. These \"uses\" have not been evaluated by the Food and Drug Administration."
},
{
"NDCCode": "0054-0010-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0054-0010-20) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00054-0010-20",
"ProductNDC": "0054-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076278",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030114",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.",
"Description": "Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 ."
},
{
"NDCCode": "0054-0010-21",
"PackageDescription": "60 TABLET in 1 BOTTLE (0054-0010-21) ",
"NDC11Code": "00054-0010-21",
"ProductNDC": "0054-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076278",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030114",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.",
"Description": "Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 ."
},
{
"NDCCode": "0054-0010-25",
"PackageDescription": "100 TABLET in 1 BOTTLE (0054-0010-25) ",
"NDC11Code": "00054-0010-25",
"ProductNDC": "0054-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076278",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030114",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.",
"Description": "Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 ."
},
{
"NDCCode": "0074-3575-01",
"PackageDescription": "1 KIT in 1 CARTON (0074-3575-01) * 1.5 mL in 1 SYRINGE (0074-3410-01) * 2 SWAB in 1 PACKET (0074-0010-01) ",
"NDC11Code": "00074-3575-01",
"ProductNDC": "0074-3575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lupron Depot-ped",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "KIT",
"StartMarketingDate": "20230414",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020263",
"LabelerName": "AbbVie Inc.",
"Status": "Active",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230414",
"SamplePackage": "N",
"IndicationAndUsage": "LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).",
"Description": "LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH."
},
{
"NDCCode": "0093-0010-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (0093-0010-05) ",
"NDC11Code": "00093-0010-05",
"ProductNDC": "0093-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077006",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20151101",
"SamplePackage": "N"
},
{
"NDCCode": "0093-0010-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0093-0010-06) ",
"NDC11Code": "00093-0010-06",
"ProductNDC": "0093-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolterodine Tartrate",
"NonProprietaryName": "Tolterodine Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077006",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "TOLTERODINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151101",
"SamplePackage": "N",
"IndicationAndUsage": "Tolterodine tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.",
"Description": "This product contains tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). It has the following structural formula. C26H37NO7 M.W. 475.6. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Each tolterodine tartrate tablet, for oral administration, contains 1 mg or 2 mg of tolterodine tartrate. In addition, each tablet contains the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, and titanium dioxide."
},
{
"NDCCode": "0185-0010-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0185-0010-01) ",
"NDC11Code": "00185-0010-01",
"ProductNDC": "0185-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl",
"NonProprietaryName": "Labetalol Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980804",
"EndMarketingDate": "20230930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075113",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19980804",
"EndMarketingDatePackage": "20230930",
"SamplePackage": "N"
},
{
"NDCCode": "0185-0010-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (0185-0010-05) ",
"NDC11Code": "00185-0010-05",
"ProductNDC": "0185-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl",
"NonProprietaryName": "Labetalol Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980804",
"EndMarketingDate": "20230930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075113",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19980804",
"EndMarketingDatePackage": "20230930",
"SamplePackage": "N"
},
{
"NDCCode": "0185-0010-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (0185-0010-10) ",
"NDC11Code": "00185-0010-10",
"ProductNDC": "0185-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl",
"NonProprietaryName": "Labetalol Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075113",
"LabelerName": "Eon Labs, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19980804",
"SamplePackage": "N"
},
{
"NDCCode": "0187-0010-50",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0187-0010-50) / 50 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00187-0010-50",
"ProductNDC": "0187-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ammonul",
"NonProprietaryName": "Sodium Phenylacetate And Sodium Benzoate",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050217",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020645",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "SODIUM BENZOATE; SODIUM PHENYLACETATE",
"StrengthNumber": "100; 100",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Nitrogen Binding Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050217",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "AMMONUL is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. During acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see Warnings and Precautions (5)].",
"Description": "AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10% per 10% (a nitrogen binding agent) is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. The pH of the solution is between 6 and 8. Sodium phenylacetate is a white to off-white powder. It is soluble in water. Sodium benzoate is a white to off-white powder that is readily soluble in water. Figure 1. Sodium phenylacetate has a molecular weight of 158.14 and the molecular formula C 8H 7NaO 2. Sodium benzoate has a molecular weight of 144.10 and the molecular formula C 7H 5NaO 2. Each mL of AMMONUL contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment. AMMONUL injection is a sterile, concentrated solution intended for intravenous administration via a central venous catheter only after dilution [see Dosage and Administration (2)]."
},
{
"NDCCode": "0220-0010-41",
"PackageDescription": "5 [hp_C] in 1 TUBE (0220-0010-41) ",
"NDC11Code": "00220-0010-41",
"ProductNDC": "0220-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Abies Nigra",
"NonProprietaryName": "Picea Mariana Resin",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "PICEA MARIANA RESIN",
"StrengthNumber": "5",
"StrengthUnit": "[hp_C]/5[hp_C]",
"Status": "Active",
"LastUpdate": "2025-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: See symptoms on front panel. Relieves acid indigestion, sour stomach, heartburn *."
},
{
"NDCCode": "0268-0010-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-0010-10)",
"NDC11Code": "00268-0010-10",
"ProductNDC": "0268-0010",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "House Dust",
"NonProprietaryName": "House Dust",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "HOUSE DUST",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0295-0010-06",
"PackageDescription": "28.35 g in 1 TUBE (0295-0010-06) ",
"NDC11Code": "00295-0010-06",
"ProductNDC": "0295-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zapzyt Acne",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Denison Pharmaceuticals, Inc.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "10",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20171201",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment & prevention of acne pimples, blemishes, blackheads or whiteheads."
},
{
"NDCCode": "0338-0010-20",
"PackageDescription": "20 BAG in 1 CARTON (0338-0010-20) / 250 mL in 1 BAG",
"NDC11Code": "00338-0010-20",
"ProductNDC": "0338-0010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20261019",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218475",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "EPINEPHRINE BITARTRATE",
"StrengthNumber": "32",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261019",
"SamplePackage": "N",
"IndicationAndUsage": "Epinephrine in 0.9% Sodium Chloride Injection is a non-selective alpha- and beta-adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. (1.1).",
"Description": "Epinephrine in Sodium Chloride injection contains active moiety, Epinephrine, a sympathomimetic catecholamine (adrenergic agent) in the form of Bitartrate salt. The chemical name of Epinephrine Bitartrate, USP, is 1,2-Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-, (R)-,[R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1) (salt). It is a white or greyish-white or light brownish-grey, odourless, crystalline powder, and slowly darkens on exposure to air and light. It has the following structural formula. The molecular weight of epinephrine bitartrate is 333.3 and molecular formula is C9H13NO3 C4H6O6. Epinephrine in 0.9% Sodium Chloride Injection is a clear, colorless sterile solution for intravenous administration, available in three strengths 4 mg/250 mL (16 mcg/mL), 8 mg/250 mL (32 mcg/mL) and 16 mg/250 mL (64 mcg/mL). The lower strength contains 4 mg (16 mcg epinephrine base per mL which is equivalent to 29.1 mcg epinephrine bitartrate), the middle strength contains 8 mg (32 mcg epinephrine base per mL which is equivalent to 58.2 mcg epinephrine bitartrate) and the higher strength contains 16 mg (64 mcg epinephrine base per mL which is equivalent to 116.4 mcg epinephrine bitartrate), in 250 mL VIAFLO bag. In 250 ml, each 1 mL of Epinephrine in 0.9% Sodium Chloride Injection solution contains 0.032 mg edetate disodium, 9 mg sodium chloride, 0.05 mg sodium metabisulfite, water for injection, hydrochloric acid (q.s) and/or sodium hydroxide (q.s) to adjust pH range of 3.4 to 4.5. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. VIAFLO bag is a flexible plastic container fabricated from a multilayer sheeting composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE). The amount of water that can permeate from the container into the overpouch is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0360-0010-02",
"PackageDescription": "1 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0360-0010-02) ",
"NDC11Code": "00360-0010-02",
"ProductNDC": "0360-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Argentum Nitricum",
"NonProprietaryName": "Argentum Nitricum",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Standard Homeopathic Company",
"SubstanceName": "SILVER NITRATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2022-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "0363-0010-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (0363-0010-01) > 200 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "00363-0010-01",
"ProductNDC": "0363-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wal-zan",
"NonProprietaryName": "Ranitidine Hydrochloride Tablets 150mg",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078192",
"LabelerName": "Walgreens Company",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-11-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231"
},
{
"NDCCode": "0363-0010-23",
"PackageDescription": "1 BOTTLE in 1 CARTON (0363-0010-23) > 36 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "00363-0010-23",
"ProductNDC": "0363-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wal-zan",
"NonProprietaryName": "Ranitidine Hydrochloride Tablets 150mg",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078192",
"LabelerName": "Walgreens Company",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-11-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231"
}
]
}
{"NDC":[{"NDCCode":"75053-0010-1","ProprietaryName":"Hypothaltem","NonProprietaryName":"Eupatorium Perfoliatum, Berberis Vulgaris, Mentha Pulegium, Moschus, Benzinum, Sepia, Baryta Carbonica, Glandula Suprarenalis Suis, Hypophysis Suis, Hypothalamus Suis, Thyroidinum (suis), Pyridoxinum Hydrochloricum, Gelsemium Sempervirens, Natrum Carbonicum, Nux Vomica, Staphysagria"},{"NDCCode":"75053-0001-1","ProprietaryName":"Neuroinflammacil","NonProprietaryName":"Aurum Muriaticum, Hyoscyaminum, Cerebrum Suis, Hedera Helix, Hura Brasiliensis, Cedron, Hypericum Perforatum"},{"NDCCode":"75053-0002-1","ProprietaryName":"Lymphocil","NonProprietaryName":"Phytolacca Decandra, Arsenicum Iodatum, Agraphis Nutans, Apium Graveolens, Eriodictyon Californicum, Allium Sativum, Erigeron Canadensis, Euonymus Atropurpureus, Aconitum Lycoctonum, Aethiops Antimonialis, Euonymus Europaeus, Absinthium, Apis Mellifica, Causticum, Sanguinaria Canadensis, Uva Ursi, Capsicum Annuum"},{"NDCCode":"75053-0003-1","ProprietaryName":"Celltem","NonProprietaryName":"Carbo Vegetabilis, Anilinum, Radium Bromatum, Millefolium, Medulla Ossis Suis, Rna, Dna, Methylene Blue, Abrotanum, Calcarea Oxalica, Conium Maculatum, Euphorbia Corollata, Euphorbium Officinarum"},{"NDCCode":"75053-0004-1","ProprietaryName":"Excitathyrotem","NonProprietaryName":"Iodium, Kali Iodatum, Hypothalamus Suis, Hypophysis Suis, Thyroidinum (suis), Lithium Muriaticum, Ephedra Vulgaris"},{"NDCCode":"75053-0005-1","ProprietaryName":"Cerebellutem","NonProprietaryName":"Causticum, Absinthium, Ranunculus Glacialis, Theridion, Heloderma, Picrotoxinum, Succinum, Helleborus Niger"},{"NDCCode":"75053-0006-1","ProprietaryName":"Gallcill","NonProprietaryName":"Chelidonium Majus, Berberis Aquifolium, Berberis Vulgaris, Dioscorea Villosa, Calcarea Sulphurica, Cupressus Lawsoniana, Hepar Sulphurica Calcareum, Cholesterinum, Fel Tauri, Lycopodium Clavatum, Magnesia Sulphurica"},{"NDCCode":"75053-0007-1","ProprietaryName":"Influenseg","NonProprietaryName":"Galphimia Glauca, Causticum, Eupatorium Perfoliatum, Ipecacuanha, Aconitum Napellus, Kali Bichromicum, Avena Sativa, Influenzinum (2020 2021), Lobelia Purpurescens, Anas Barbariae, Hepatis Et Cordis Extractum, Echinacea (angustifolia), Canchalagua"},{"NDCCode":"75053-0008-1","ProprietaryName":"Apnetem","NonProprietaryName":"Phosphoricum Acidum, Alumen, Phosphorus, Senega Officinalis, Adenosinum Cyclophosphoricum, Antimonium Tartaricum, Grindelia, Sabadilla, Alumina, Cuprum Metallicum, Sanguinarinum Nitricum, Silicea, Lachesis Mutus, Rheum (palmatum), Zincum Metallicum, Lycopodium Clavatum, Manganum Phosphoricum, Antipyrinum, Coenzyme A"},{"NDCCode":"75053-0009-1","ProprietaryName":"Oxaltem","NonProprietaryName":"Berberis Vulgaris, Oxalicum Acidum, Sanguinaria Canadensis, Chimaphila Umbellata, Calcarea Fluorica, Calcarea Silicata, Uricum Acidum, Calcarea Phosphorica, Parathormonum, Pyridoxinum Hydrochloricum"},{"NDCCode":"75053-0011-1","ProprietaryName":"Influenseg","NonProprietaryName":"Galphimia Glauca, Causticum, Eupatorium Perfoliatum, Ipecacuanha, Aconitum Napellus, Kali Bichromicum, Avena Sativa, Influenzinum (2021-2022), Lobelia Purpurescens, Anas Barbariae, Hepatis Et Cordis Extractum, Echinacea (angustifolia), Canchalagua"},{"NDCCode":"75053-0012-1","ProprietaryName":"Oxaltem","NonProprietaryName":"Berberis Vulgaris, Oxalicum Acidum, Sanguinaria Canadensis, Chimaphila Umbellata, Calcarea Fluorica, Calcarea Silicata, Uricum Acidum, Calcarea Phosphorica, Parathormonum, Pyridoxinum Hydrochloricum"},{"NDCCode":"75053-0100-1","ProprietaryName":"Influenseg","NonProprietaryName":"Gelsemium Sempervirens, Sambucus Nigra, Galphimia Glauca, Causticum, Eupatorium Perfoliatum, Ipecacuanha, Aconitum Napellus, Kali Bichromicum, Avena Sativa, Influenzinum (2024-2025), Lobelia Purpurescens, Anas Barbariae, Hepatis Et Cordis Extractum, Echinacea (angustifolia), Canchalagua"},{"NDCCode":"0054-0010-20","ProprietaryName":"Flecainide Acetate","NonProprietaryName":"Flecainide Acetate"},{"NDCCode":"0054-0010-21","ProprietaryName":"Flecainide Acetate","NonProprietaryName":"Flecainide Acetate"},{"NDCCode":"0054-0010-25","ProprietaryName":"Flecainide Acetate","NonProprietaryName":"Flecainide Acetate"},{"NDCCode":"0074-3575-01","ProprietaryName":"Lupron Depot-ped","NonProprietaryName":"Leuprolide Acetate"},{"NDCCode":"0093-0010-05","ProprietaryName":"Tolterodine Tartrate","NonProprietaryName":"Tolterodine Tartrate"},{"NDCCode":"0093-0010-06","ProprietaryName":"Tolterodine Tartrate","NonProprietaryName":"Tolterodine Tartrate"},{"NDCCode":"0185-0010-01","ProprietaryName":"Labetalol Hcl","NonProprietaryName":"Labetalol Hcl"},{"NDCCode":"0185-0010-05","ProprietaryName":"Labetalol Hcl","NonProprietaryName":"Labetalol Hcl"},{"NDCCode":"0185-0010-10","ProprietaryName":"Labetalol Hcl","NonProprietaryName":"Labetalol Hcl"},{"NDCCode":"0187-0010-50","ProprietaryName":"Ammonul","NonProprietaryName":"Sodium Phenylacetate And Sodium Benzoate"},{"NDCCode":"0220-0010-41","ProprietaryName":"Abies Nigra","NonProprietaryName":"Picea Mariana Resin"},{"NDCCode":"0268-0010-10","ProprietaryName":"House Dust","NonProprietaryName":"House Dust"},{"NDCCode":"0295-0010-06","ProprietaryName":"Zapzyt Acne","NonProprietaryName":"Benzoyl Peroxide"},{"NDCCode":"0338-0010-20","ProprietaryName":"Epinephrine","NonProprietaryName":"Epinephrine"},{"NDCCode":"0360-0010-02","ProprietaryName":"Argentum Nitricum","NonProprietaryName":"Argentum Nitricum"},{"NDCCode":"0363-0010-01","ProprietaryName":"Wal-zan","NonProprietaryName":"Ranitidine Hydrochloride Tablets 150mg"},{"NDCCode":"0363-0010-23","ProprietaryName":"Wal-zan","NonProprietaryName":"Ranitidine Hydrochloride Tablets 150mg"}]}
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<NDCList>
<NDC>
<NDCCode>75053-0010-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0010-1) </PackageDescription>
<NDC11Code>75053-0010-01</NDC11Code>
<ProductNDC>75053-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hypothaltem</ProprietaryName>
<NonProprietaryName>Eupatorium Perfoliatum, Berberis Vulgaris, Mentha Pulegium, Moschus, Benzinum, Sepia, Baryta Carbonica, Glandula Suprarenalis Suis, Hypophysis Suis, Hypothalamus Suis, Thyroidinum (suis), Pyridoxinum Hydrochloricum, Gelsemium Sempervirens, Natrum Carbonicum, Nux Vomica, Staphysagria</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210511</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>EUPATORIUM PERFOLIATUM FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; MENTHA PULEGIUM WHOLE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; BENZENE; SEPIA OFFICINALIS JUICE; BARIUM CARBONATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; THYROID, UNSPECIFIED; PYRIDOXINE HYDROCHLORIDE; GELSEMIUM SEMPERVIRENS ROOT; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; DELPHINIUM STAPHISAGRIA SEED</SubstanceName>
<StrengthNumber>6; 9; 9; 9; 9; 9; 12; 7; 7; 7; 7; 12; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Analogs/Derivatives [Chemical/Ingredient], 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], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily helps alleviate symptoms of hormone imbalance.**These “uses” have not been evaluated by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0001-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0001-1) </PackageDescription>
<NDC11Code>75053-0001-01</NDC11Code>
<ProductNDC>75053-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neuroinflammacil</ProprietaryName>
<NonProprietaryName>Aurum Muriaticum, Hyoscyaminum, Cerebrum Suis, Hedera Helix, Hura Brasiliensis, Cedron, Hypericum Perforatum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200629</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>GOLD TRICHLORIDE; HYOSCYAMINE; SUS SCROFA CEREBRUM; HEDERA HELIX FLOWERING TWIG; HURA CREPITANS SAP; SIMABA CEDRON SEED; HYPERICUM PERFORATUM WHOLE</SubstanceName>
<StrengthNumber>12; 16; 3; 30; 30; 200; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily alleviates symptoms of neuroinflammation while promoting drainage. *These "uses" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions see www.hpus.com.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0002-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0002-1) </PackageDescription>
<NDC11Code>75053-0002-01</NDC11Code>
<ProductNDC>75053-0002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lymphocil</ProprietaryName>
<NonProprietaryName>Phytolacca Decandra, Arsenicum Iodatum, Agraphis Nutans, Apium Graveolens, Eriodictyon Californicum, Allium Sativum, Erigeron Canadensis, Euonymus Atropurpureus, Aconitum Lycoctonum, Aethiops Antimonialis, Euonymus Europaeus, Absinthium, Apis Mellifica, Causticum, Sanguinaria Canadensis, Uva Ursi, Capsicum Annuum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200629</StartMarketingDate>
<EndMarketingDate>20301202</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>PHYTOLACCA AMERICANA ROOT; ARSENIC TRIIODIDE; HYACINTHOIDES NON-SCRIPTA WHOLE; CELERY SEED; ERIODICTYON CALIFORNICUM LEAF; GARLIC; ERIGERON CANADENSIS WHOLE; EUONYMUS ATROPURPUREUS BRANCH BARK/ROOT BARK; ACONITUM LYCOCTONUM WHOLE; MERCURIC SULFIDE; EUONYMUS EUROPAEUS SEED; WORMWOOD; APIS MELLIFERA; CAUSTICUM; SANGUINARIA CANADENSIS ROOT; ARCTOSTAPHYLOS UVA-URSI LEAF; CAPSICUM</SubstanceName>
<StrengthNumber>4; 12; 12; 3; 3; 6; 6; 6; 9; 9; 9; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200629</StartMarketingDatePackage>
<EndMarketingDatePackage>20301202</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves symptoms of lymphatic congestions and swelling. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated. *These "uses" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions see www.hpus.com.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0003-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0003-1) </PackageDescription>
<NDC11Code>75053-0003-01</NDC11Code>
<ProductNDC>75053-0003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Celltem</ProprietaryName>
<NonProprietaryName>Carbo Vegetabilis, Anilinum, Radium Bromatum, Millefolium, Medulla Ossis Suis, Rna, Dna, Methylene Blue, Abrotanum, Calcarea Oxalica, Conium Maculatum, Euphorbia Corollata, Euphorbium Officinarum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210503</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; ANILINE; RADIUM BROMIDE; ACHILLEA MILLEFOLIUM WHOLE; SUS SCROFA BONE MARROW; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; METHYLENE BLUE; ARTEMISIA ABROTANUM FLOWERING TOP; CALCIUM OXALATE MONOHYDRATE; CONIUM MACULATUM FLOWERING TOP; EUPHORBIA COROLLATA ROOT; EUPHORBIA RESINIFERA RESIN</SubstanceName>
<StrengthNumber>9; 9; 12; 13; 3; 5; 6; 9; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily regulates cellular metabolism and fortifies RNA and DNA.*. *These "uses" have not been evaluated by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0004-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0004-1) </PackageDescription>
<NDC11Code>75053-0004-01</NDC11Code>
<ProductNDC>75053-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excitathyrotem</ProprietaryName>
<NonProprietaryName>Iodium, Kali Iodatum, Hypothalamus Suis, Hypophysis Suis, Thyroidinum (suis), Lithium Muriaticum, Ephedra Vulgaris</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201013</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>IODINE; POTASSIUM IODIDE; BOS TAURUS HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED; LITHIUM CHLORIDE; EPHEDRA DISTACHYA FLOWERING TWIG</SubstanceName>
<StrengthNumber>9; 9; 7; 7; 9; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Homeopathic medicine for the minor effects of increased metabolism such as anxiety, heart palpitation and irritability. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0005-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0005-1) </PackageDescription>
<NDC11Code>75053-0005-01</NDC11Code>
<ProductNDC>75053-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerebellutem</ProprietaryName>
<NonProprietaryName>Causticum, Absinthium, Ranunculus Glacialis, Theridion, Heloderma, Picrotoxinum, Succinum, Helleborus Niger</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210419</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>CAUSTICUM; WORMWOOD; RANUNCULUS GLACIALIS WHOLE; THERIDION CURASSAVICUM; HELODERMA HORRIDUM VENOM; PICROTOXIN; AMBER; HELLEBORUS NIGER ROOT</SubstanceName>
<StrengthNumber>5; 6; 10; 10; 12; 16; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily alleviates symptoms of concussion or trauma.*These “uses” have not been evaluated by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0006-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0006-1) </PackageDescription>
<NDC11Code>75053-0006-01</NDC11Code>
<ProductNDC>75053-0006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gallcill</ProprietaryName>
<NonProprietaryName>Chelidonium Majus, Berberis Aquifolium, Berberis Vulgaris, Dioscorea Villosa, Calcarea Sulphurica, Cupressus Lawsoniana, Hepar Sulphurica Calcareum, Cholesterinum, Fel Tauri, Lycopodium Clavatum, Magnesia Sulphurica</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210419</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>CHELIDONIUM MAJUS WHOLE; BERBERIS AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; DIOSCOREA VILLOSA TUBER; CALCIUM SULFATE ANHYDROUS; CHAMAECYPARIS LAWSONIANA FRUITING TWIG; CALCIUM SULFIDE; CHOLESTEROL; BOS TAURUS BILE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
<StrengthNumber>5; 5; 5; 6; 6; 9; 12; 12; 12; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily alleviates symptoms of pain in the upper right quadrant and gas associated with gastric upset. *These "uses" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions: see www.hpus.com.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0007-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0007-1) </PackageDescription>
<NDC11Code>75053-0007-01</NDC11Code>
<ProductNDC>75053-0007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenseg</ProprietaryName>
<NonProprietaryName>Galphimia Glauca, Causticum, Eupatorium Perfoliatum, Ipecacuanha, Aconitum Napellus, Kali Bichromicum, Avena Sativa, Influenzinum (2020 2021), Lobelia Purpurescens, Anas Barbariae, Hepatis Et Cordis Extractum, Echinacea (angustifolia), Canchalagua</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210504</StartMarketingDate>
<EndMarketingDate>20260312</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>ACONITUM NAPELLUS WHOLE; AVENA SATIVA FLOWERING TOP; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; CAUSTICUM; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); IPECAC; POTASSIUM DICHROMATE; PRATIA PURPURASCENS; ZELTNERA VENUSTA WHOLE FLOWERING</SubstanceName>
<StrengthNumber>9; 12; 16; 6; 3; 6; 4; 12; 12; 12; 12; 6; 9; 16; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210504</StartMarketingDatePackage>
<EndMarketingDatePackage>20260312</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Homeopathic medicine for the minor relief of headache, body heat, lethargy, fatigue and congestion. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0008-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0008-1) </PackageDescription>
<NDC11Code>75053-0008-01</NDC11Code>
<ProductNDC>75053-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Apnetem</ProprietaryName>
<NonProprietaryName>Phosphoricum Acidum, Alumen, Phosphorus, Senega Officinalis, Adenosinum Cyclophosphoricum, Antimonium Tartaricum, Grindelia, Sabadilla, Alumina, Cuprum Metallicum, Sanguinarinum Nitricum, Silicea, Lachesis Mutus, Rheum (palmatum), Zincum Metallicum, Lycopodium Clavatum, Manganum Phosphoricum, Antipyrinum, Coenzyme A</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210518</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>PHOSPHORIC ACID; POTASSIUM ALUM; PHOSPHORUS; POLYGALA SENEGA ROOT; ADENOSINE CYCLIC PHOSPHATE; ANTIMONY POTASSIUM TARTRATE; GRINDELIA HIRSUTULA FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; ALUMINUM OXIDE; COPPER; SANGUINARINE NITRATE; SILICON DIOXIDE; LACHESIS MUTA VENOM; RHEUM PALMATUM ROOT; ZINC; LYCOPODIUM CLAVATUM SPORE; MANGANESE PHOSPHATE, DIBASIC; ANTIPYRINE; COENZYME A</SubstanceName>
<StrengthNumber>6; 6; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 13; 15; 18; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily alleviates symptoms of sleep disorders. These "uses" have not been evaluated by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0009-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0009-1) </PackageDescription>
<NDC11Code>75053-0009-01</NDC11Code>
<ProductNDC>75053-0009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oxaltem</ProprietaryName>
<NonProprietaryName>Berberis Vulgaris, Oxalicum Acidum, Sanguinaria Canadensis, Chimaphila Umbellata, Calcarea Fluorica, Calcarea Silicata, Uricum Acidum, Calcarea Phosphorica, Parathormonum, Pyridoxinum Hydrochloricum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220131</StartMarketingDate>
<EndMarketingDate>20280726</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>BERBERIS VULGARIS ROOT BARK; OXALIC ACID; SANGUINARIA CANADENSIS WHOLE; CHIMAPHILA UMBELLATA WHOLE; CALCIUM FLUORIDE; CALCIUM SILICATE; URIC ACID; TRIBASIC CALCIUM PHOSPHATE; PARATHYROID HORMONE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6; 6; 9; 9; 12; 12; 12; 6; 9; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Cations, Divalent [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Parathyroid Hormone [CS], Parathyroid Hormone [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220131</StartMarketingDatePackage>
<EndMarketingDatePackage>20280726</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Homeopathic medicine for the regulation of oxalate deposition and related dysfunctions of drainage. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0011-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0011-1) </PackageDescription>
<NDC11Code>75053-0011-01</NDC11Code>
<ProductNDC>75053-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenseg</ProprietaryName>
<NonProprietaryName>Galphimia Glauca, Causticum, Eupatorium Perfoliatum, Ipecacuanha, Aconitum Napellus, Kali Bichromicum, Avena Sativa, Influenzinum (2021-2022), Lobelia Purpurescens, Anas Barbariae, Hepatis Et Cordis Extractum, Echinacea (angustifolia), Canchalagua</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220620</StartMarketingDate>
<EndMarketingDate>20270620</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>GALPHIMIA GLAUCA FLOWERING TOP; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; IPECAC; ACONITUM NAPELLUS WHOLE; POTASSIUM DICHROMATE; AVENA SATIVA FLOWERING TOP; INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); PRATIA PURPURASCENS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ECHINACEA ANGUSTIFOLIA WHOLE; ZELTNERA VENUSTA WHOLE FLOWERING</SubstanceName>
<StrengthNumber>4; 6; 6; 6; 9; 9; 12; 12; 12; 12; 12; 16; 16; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220620</StartMarketingDatePackage>
<EndMarketingDatePackage>20270620</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Homeopathic medicine for the minor relief of headache, body heat, lethargy, fatigue and congestion. Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0012-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0012-1) </PackageDescription>
<NDC11Code>75053-0012-01</NDC11Code>
<ProductNDC>75053-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Oxaltem</ProprietaryName>
<NonProprietaryName>Berberis Vulgaris, Oxalicum Acidum, Sanguinaria Canadensis, Chimaphila Umbellata, Calcarea Fluorica, Calcarea Silicata, Uricum Acidum, Calcarea Phosphorica, Parathormonum, Pyridoxinum Hydrochloricum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240521</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>BERBERIS VULGARIS ROOT BARK; OXALIC ACID DIHYDRATE; SANGUINARIA CANADENSIS ROOT; CHIMAPHILA UMBELLATA WHOLE; CALCIUM FLUORIDE; CALCIUM SILICATE; URIC ACID; TRIBASIC CALCIUM PHOSPHATE; PARATHYROID HORMONE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6; 6; 9; 9; 12; 12; 12; 6; 9; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Blood Coagulation Factor [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Cations, Divalent [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Parathyroid Hormone [CS], Parathyroid Hormone [EPC], Phosphate Binder [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Phosphate Chelating Activity [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Homeopathic remedy that regulates oxalate in the body. *These "uses" have not been evaluated by the Food and Drug Administration. **C, K, CK, and X are homeopathic dilutions see www.hpus.com.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75053-0100-1</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (75053-0100-1) </PackageDescription>
<NDC11Code>75053-0100-01</NDC11Code>
<ProductNDC>75053-0100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenseg</ProprietaryName>
<NonProprietaryName>Gelsemium Sempervirens, Sambucus Nigra, Galphimia Glauca, Causticum, Eupatorium Perfoliatum, Ipecacuanha, Aconitum Napellus, Kali Bichromicum, Avena Sativa, Influenzinum (2024-2025), Lobelia Purpurescens, Anas Barbariae, Hepatis Et Cordis Extractum, Echinacea (angustifolia), Canchalagua</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260227</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nucleic Products, LLC</LabelerName>
<SubstanceName>GELSEMIUM SEMPERVIRENS ROOT; SAMBUCUS NIGRA FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; IPECAC; ACONITUM NAPELLUS WHOLE; POTASSIUM DICHROMATE; AVENA SATIVA FLOWERING TOP; INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 WHOLE; INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B WHOLE; PRATIA PURPURASCENS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ECHINACEA ANGUSTIFOLIA WHOLE; ZELTNERA VENUSTA WHOLE FLOWERING</SubstanceName>
<StrengthNumber>3; 3; 4; 6; 6; 6; 9; 9; 12; 12; 12; 12; 12; 16; 16; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Homeopathic medicine for the minor relief of headache, body heat, lethargy, fatigue and congestion. These "uses" have not been evaluated by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0054-0010-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0054-0010-20) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00054-0010-20</NDC11Code>
<ProductNDC>0054-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076278</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.</IndicationAndUsage>
<Description>Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 .</Description>
</NDC>
<NDC>
<NDCCode>0054-0010-21</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (0054-0010-21) </PackageDescription>
<NDC11Code>00054-0010-21</NDC11Code>
<ProductNDC>0054-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076278</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.</IndicationAndUsage>
<Description>Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 .</Description>
</NDC>
<NDC>
<NDCCode>0054-0010-25</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0054-0010-25) </PackageDescription>
<NDC11Code>00054-0010-25</NDC11Code>
<ProductNDC>0054-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076278</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.</IndicationAndUsage>
<Description>Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 .</Description>
</NDC>
<NDC>
<NDCCode>0074-3575-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0074-3575-01) * 1.5 mL in 1 SYRINGE (0074-3410-01) * 2 SWAB in 1 PACKET (0074-0010-01) </PackageDescription>
<NDC11Code>00074-3575-01</NDC11Code>
<ProductNDC>0074-3575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lupron Depot-ped</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230414</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020263</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).</IndicationAndUsage>
<Description>LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C59H84N16O12.(C2H4O2)n, n=1 or 2, with the following structural formula:. LUPRON DEPOT-PED for 1-month administration. LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 3-month administration. LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1.5 milliliters of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg, equivalent to 10.24 - 10.72 mg leuprolide), D-mannitol (19.45 mg), and polylactic acid (99.3 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg, equivalent to 27.30 - 28.59 mg leuprolide), D-mannitol (51.9 mg), and polylactic acid (264.8 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH. LUPRON DEPOT-PED for 6-month administration. LUPRON DEPOT-PED 45 mg for 6-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection. The front chamber of LUPRON DEPOT-PED 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg, equivalent to 40.95 - 42.89 mg leuprolide), D-mannitol (39.7 mg), polylactic acid (169.9 mg), and stearic acid (10.1 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.</Description>
</NDC>
<NDC>
<NDCCode>0093-0010-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0093-0010-05) </PackageDescription>
<NDC11Code>00093-0010-05</NDC11Code>
<ProductNDC>0093-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
<NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077006</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0093-0010-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0093-0010-06) </PackageDescription>
<NDC11Code>00093-0010-06</NDC11Code>
<ProductNDC>0093-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolterodine Tartrate</ProprietaryName>
<NonProprietaryName>Tolterodine Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077006</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>TOLTERODINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolterodine tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.</IndicationAndUsage>
<Description>This product contains tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3dihydroxybutanedioate (1:1) (salt). It has the following structural formula. C26H37NO7 M.W. 475.6. Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3. Each tolterodine tartrate tablet, for oral administration, contains 1 mg or 2 mg of tolterodine tartrate. In addition, each tablet contains the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0185-0010-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0185-0010-01) </PackageDescription>
<NDC11Code>00185-0010-01</NDC11Code>
<ProductNDC>0185-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hcl</ProprietaryName>
<NonProprietaryName>Labetalol Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980804</StartMarketingDate>
<EndMarketingDate>20230930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075113</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19980804</StartMarketingDatePackage>
<EndMarketingDatePackage>20230930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0185-0010-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (0185-0010-05) </PackageDescription>
<NDC11Code>00185-0010-05</NDC11Code>
<ProductNDC>0185-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hcl</ProprietaryName>
<NonProprietaryName>Labetalol Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980804</StartMarketingDate>
<EndMarketingDate>20230930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075113</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19980804</StartMarketingDatePackage>
<EndMarketingDatePackage>20230930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0185-0010-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (0185-0010-10) </PackageDescription>
<NDC11Code>00185-0010-10</NDC11Code>
<ProductNDC>0185-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hcl</ProprietaryName>
<NonProprietaryName>Labetalol Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075113</ApplicationNumber>
<LabelerName>Eon Labs, Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0187-0010-50</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0187-0010-50) / 50 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00187-0010-50</NDC11Code>
<ProductNDC>0187-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ammonul</ProprietaryName>
<NonProprietaryName>Sodium Phenylacetate And Sodium Benzoate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050217</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020645</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>SODIUM BENZOATE; SODIUM PHENYLACETATE</SubstanceName>
<StrengthNumber>100; 100</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Nitrogen Binding Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050217</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AMMONUL is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. During acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10% per 10% (a nitrogen binding agent) is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. The pH of the solution is between 6 and 8. Sodium phenylacetate is a white to off-white powder. It is soluble in water. Sodium benzoate is a white to off-white powder that is readily soluble in water. Figure 1. Sodium phenylacetate has a molecular weight of 158.14 and the molecular formula C 8H 7NaO 2. Sodium benzoate has a molecular weight of 144.10 and the molecular formula C 7H 5NaO 2. Each mL of AMMONUL contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment. AMMONUL injection is a sterile, concentrated solution intended for intravenous administration via a central venous catheter only after dilution [see Dosage and Administration (2)].</Description>
</NDC>
<NDC>
<NDCCode>0220-0010-41</NDCCode>
<PackageDescription>5 [hp_C] in 1 TUBE (0220-0010-41) </PackageDescription>
<NDC11Code>00220-0010-41</NDC11Code>
<ProductNDC>0220-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Abies Nigra</ProprietaryName>
<NonProprietaryName>Picea Mariana Resin</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>PICEA MARIANA RESIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>[hp_C]/5[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: See symptoms on front panel. Relieves acid indigestion, sour stomach, heartburn *.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0268-0010-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-0010-10)</PackageDescription>
<NDC11Code>00268-0010-10</NDC11Code>
<ProductNDC>0268-0010</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>House Dust</ProprietaryName>
<NonProprietaryName>House Dust</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>HOUSE DUST</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0295-0010-06</NDCCode>
<PackageDescription>28.35 g in 1 TUBE (0295-0010-06) </PackageDescription>
<NDC11Code>00295-0010-06</NDC11Code>
<ProductNDC>0295-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zapzyt Acne</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Denison Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment & prevention of acne pimples, blemishes, blackheads or whiteheads.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0338-0010-20</NDCCode>
<PackageDescription>20 BAG in 1 CARTON (0338-0010-20) / 250 mL in 1 BAG</PackageDescription>
<NDC11Code>00338-0010-20</NDC11Code>
<ProductNDC>0338-0010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20261019</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218475</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>EPINEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>32</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Epinephrine in 0.9% Sodium Chloride Injection is a non-selective alpha- and beta-adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. (1.1).</IndicationAndUsage>
<Description>Epinephrine in Sodium Chloride injection contains active moiety, Epinephrine, a sympathomimetic catecholamine (adrenergic agent) in the form of Bitartrate salt. The chemical name of Epinephrine Bitartrate, USP, is 1,2-Benzenediol, 4-[1-hydroxy-2-(methylamino)ethyl]-, (R)-,[R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1) (salt). It is a white or greyish-white or light brownish-grey, odourless, crystalline powder, and slowly darkens on exposure to air and light. It has the following structural formula. The molecular weight of epinephrine bitartrate is 333.3 and molecular formula is C9H13NO3 C4H6O6. Epinephrine in 0.9% Sodium Chloride Injection is a clear, colorless sterile solution for intravenous administration, available in three strengths 4 mg/250 mL (16 mcg/mL), 8 mg/250 mL (32 mcg/mL) and 16 mg/250 mL (64 mcg/mL). The lower strength contains 4 mg (16 mcg epinephrine base per mL which is equivalent to 29.1 mcg epinephrine bitartrate), the middle strength contains 8 mg (32 mcg epinephrine base per mL which is equivalent to 58.2 mcg epinephrine bitartrate) and the higher strength contains 16 mg (64 mcg epinephrine base per mL which is equivalent to 116.4 mcg epinephrine bitartrate), in 250 mL VIAFLO bag. In 250 ml, each 1 mL of Epinephrine in 0.9% Sodium Chloride Injection solution contains 0.032 mg edetate disodium, 9 mg sodium chloride, 0.05 mg sodium metabisulfite, water for injection, hydrochloric acid (q.s) and/or sodium hydroxide (q.s) to adjust pH range of 3.4 to 4.5. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. VIAFLO bag is a flexible plastic container fabricated from a multilayer sheeting composed of Polypropylene (PP), Polyamide (PA) and Polyethylene (PE). The amount of water that can permeate from the container into the overpouch is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container’s chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0360-0010-02</NDCCode>
<PackageDescription>1 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0360-0010-02) </PackageDescription>
<NDC11Code>00360-0010-02</NDC11Code>
<ProductNDC>0360-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Argentum Nitricum</ProprietaryName>
<NonProprietaryName>Argentum Nitricum</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Standard Homeopathic Company</LabelerName>
<SubstanceName>SILVER NITRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0363-0010-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0363-0010-01) > 200 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00363-0010-01</NDC11Code>
<ProductNDC>0363-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wal-zan</ProprietaryName>
<NonProprietaryName>Ranitidine Hydrochloride Tablets 150mg</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078192</ApplicationNumber>
<LabelerName>Walgreens Company</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0363-0010-23</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0363-0010-23) > 36 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00363-0010-23</NDC11Code>
<ProductNDC>0363-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wal-zan</ProprietaryName>
<NonProprietaryName>Ranitidine Hydrochloride Tablets 150mg</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078192</ApplicationNumber>
<LabelerName>Walgreens Company</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>