{
"NDC": [
{
"NDCCode": "64471-807-48",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (64471-807-48) / 24 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "64471-0807-48",
"ProductNDC": "64471-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Migraine Blocker",
"NonProprietaryName": "Chamomilla, Bryonia (alba), Iris Versicolor, Juglans Cinerea, Pulsatilla (pratensis), Sanguinaria Canadensis, Magnesia Muriatica, Natrum Muriaticum, Phosphorus, Silicea, Zincum Metallicum, Belladonna, Gelsemium Sempervirens, Ignatia Amara, Scutellaria Lateriflora",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20161118",
"EndMarketingDate": "20241206",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals, Inc.",
"SubstanceName": "ATROPA BELLADONNA; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; JUGLANS CINEREA BRANCH BARK/ROOT BARK; MAGNESIUM CHLORIDE; MATRICARIA CHAMOMILLA WHOLE; PHOSPHORUS; PULSATILLA PRATENSIS; SANGUINARIA CANADENSIS ROOT; SCUTELLARIA LATERIFLORA WHOLE; SILICON DIOXIDE; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; ZINC",
"StrengthNumber": "12; 6; 12; 6; 6; 10; 4; 10; 6; 6; 12; 10; 10; 12; 10",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161118",
"EndMarketingDatePackage": "20241206",
"SamplePackage": "N",
"IndicationAndUsage": "Source Naturals MIGRAINE BLOCKER is safe, natural and gives temporary relief of migraine headache pain, pressure the throbbing."
},
{
"NDCCode": "70692-807-48",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (70692-807-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "70692-0807-48",
"ProductNDC": "70692-807",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20230405",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Strive Pharmaceuticals Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230405",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever."
},
{
"NDCCode": "64471-054-48",
"PackageDescription": "14400 mg in 1 BLISTER PACK (64471-054-48)",
"NDC11Code": "64471-0054-48",
"ProductNDC": "64471-054",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wellness Cold And Flu",
"NonProprietaryName": "Echinacea (angustifolia), Allium Cepa, Bryonia (alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Sanguinaria Canadensis, Kali Bichromicum, Phosphorus, Aconitum Napellus, Influenzinum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150608",
"EndMarketingDate": "20190805",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals, Inc.",
"SubstanceName": "ECHINACEA ANGUSTIFOLIA; ONION; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; SANGUINARIA CANADENSIS ROOT; POTASSIUM DICHROMATE; PHOSPHORUS; ACONITUM NAPELLUS; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "3; 4; 4; 4; 4; 4; 6; 6; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg",
"Status": "Deprecated",
"LastUpdate": "2019-08-06",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "64471-116-48",
"PackageDescription": "48 TABLET in 1 BLISTER PACK (64471-116-48)",
"NDC11Code": "64471-0116-48",
"ProductNDC": "64471-116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wellness Cold And Flu",
"NonProprietaryName": "Echinacea (angustifolia), Allium Cepa, Bryonia (alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Sanguinaria Canadensis, Kali Bichromicum, Phosphorus, Aconitum Napellus, Influenzinum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150911",
"EndMarketingDate": "20201002",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals, Inc.",
"SubstanceName": "ECHINACEA ANGUSTIFOLIA; ONION; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; SANGUINARIA CANADENSIS ROOT; POTASSIUM DICHROMATE; PHOSPHORUS; ACONITUM NAPELLUS; INFLUENZA A VIRUS; INFLUENZA B VIRUS",
"StrengthNumber": "3; 4; 4; 4; 4; 4; 6; 6; 12; 12; 12",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-10-03",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "64471-126-48",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (64471-126-48) > 24 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "64471-0126-48",
"ProductNDC": "64471-126",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wellness Earache",
"NonProprietaryName": "Capsicum Annuum, Silicea, Verbascum Thapsus, Ferrum Phosphoricum, Kali Muriaticum, Aconitum Napellus, Belladonna, Calcarea Carbonica, Pulsatilla (pratensis)",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20180613",
"EndMarketingDate": "20231130",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; CAPSICUM; FERRUM PHOSPHORICUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CHLORIDE; PULSATILLA PRATENSIS; SILICON DIOXIDE; VERBASCUM THAPSUS",
"StrengthNumber": "30; 6; 12; 30; 12; 30; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180613",
"EndMarketingDatePackage": "20231130",
"SamplePackage": "N"
},
{
"NDCCode": "64471-164-48",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (64471-164-48) / 24 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "64471-0164-48",
"ProductNDC": "64471-164",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wellness Cold And Flu",
"NonProprietaryName": "Echinacea (angustifolia), Allium Cepa, Bryonia (alba), Gelsemium Sempervirens, Sanguinaria Canadensis, Eupatorium Perfoliatum, Kali Bichromicum, Phosphorus, Aconitum Napellus, Influenzinum 2015-2016,",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20161115",
"EndMarketingDate": "20241217",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals, Inc.",
"SubstanceName": "ACONITUM NAPELLUS WHOLE; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); ONION; PHOSPHORUS; POTASSIUM DICHROMATE; SANGUINARIA CANADENSIS ROOT",
"StrengthNumber": "12; 4; 3; 6; 4; 12; 12; 12; 12; 12; 12; 4; 6; 6; 4",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161117",
"EndMarketingDatePackage": "20241217",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of cold and flu symptoms, runny nose, congestion, sore throat, headache, nausea, cough, body aches, fever and chills. Best taken at first sign of symptoms. Effective at all stages of cold and flu."
},
{
"NDCCode": "64471-165-48",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (64471-165-48) / 24 TABLET in 1 BLISTER PACK",
"NDC11Code": "64471-0165-48",
"ProductNDC": "64471-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wellness Defense",
"NonProprietaryName": "Echinacea (angustifolia), Allium Cepa, Bryonia (alba), Gelsemium Sempervirens, Sanguinaria Canadensis, Eupatorium Perfoliatum, Kali Bichromicum, Phosphorus, Aconitum Napellus, Influenzinum 2019-2020",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200213",
"EndMarketingDate": "20251223",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals, Inc.",
"SubstanceName": "ACONITUM NAPELLUS WHOLE; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED); ONION; PHOSPHORUS; POTASSIUM DICHROMATE; SANGUINARIA CANADENSIS ROOT",
"StrengthNumber": "12; 4; 3; 6; 4; 12; 12; 12; 4; 6; 6; 4",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200213",
"EndMarketingDatePackage": "20251223",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of runny nose, congestion, sore throat, headache, nausea, cough, body aches, fever and chills. Best taken at first sign of immune imbalance."
},
{
"NDCCode": "64471-196-48",
"PackageDescription": "7200 mg in 1 BLISTER PACK (64471-196-48) ",
"NDC11Code": "64471-0196-48",
"ProductNDC": "64471-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allercetin",
"NonProprietaryName": "Euphrasia Officinalis, Kali Iodatum, Sabadilla, Sticta Pulmonaria, Histaminum Hydrochloricum, Quercetin, Succinicum Acidum, Ambrosia Artemisiaefolia",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20140905",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals, Inc.",
"SubstanceName": "EUPHRASIA STRICTA; POTASSIUM IODIDE; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; HISTAMINE DIHYDROCHLORIDE; QUERCETIN; SUCCINIC ACID; AMBROSIA ARTEMISIIFOLIA WHOLE",
"StrengthNumber": "6; 6; 6; 6; 12; 12; 12; 30",
"StrengthUnit": "[hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140905",
"SamplePackage": "N",
"IndicationAndUsage": "*temporary relieves these symptoms due to hay fever or other upper respiratory allergies:. sneezing runny nose itchy and watery eyes sinus congestion and headache. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "64471-263-48",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (64471-263-48) > 24 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "64471-0263-48",
"ProductNDC": "64471-263",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wellness Earache",
"NonProprietaryName": "Capsicum Annuum, Silicea, Verbascum Thapsus, Ferrum Phosphoricum, Kali Muriaticum, Aconitum Napellus, Belladonna, Calcarea Carbonica, Pulsatilla (pratensis)",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20161117",
"EndMarketingDate": "20221130",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; ATROPA BELLADONNA; CAPSICUM; FERRUM PHOSPHORICUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CHLORIDE; PULSATILLA PRATENSIS; SILICON DIOXIDE; VERBASCUM THAPSUS",
"StrengthNumber": "30; 30; 6; 12; 30; 12; 30; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161117",
"EndMarketingDatePackage": "20221130",
"SamplePackage": "N"
},
{
"NDCCode": "64471-416-48",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (64471-416-48) / 24 TABLET in 1 BLISTER PACK",
"NDC11Code": "64471-0416-48",
"ProductNDC": "64471-416",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wellness Defense",
"NonProprietaryName": "Echinacea (angustifolia), Allium Cepa, Bryonia (alba), Gelsemium Sempervirens, Sanguinaria Canadensis, Eupatorium Perfoliatum, Kali Bichromicum, Phosphorus, Aconitum Napellus, Influenzinum 2017-2018",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180723",
"EndMarketingDate": "20241207",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals, Inc.",
"SubstanceName": "ACONITUM NAPELLUS WHOLE; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED); ONION; PHOSPHORUS; POTASSIUM DICHROMATE; SANGUINARIA CANADENSIS ROOT",
"StrengthNumber": "12; 4; 3; 6; 4; 12; 12; 12; 4; 6; 6; 4",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Actively Acquired Immunity [PE], Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Inactivated Influenza B Virus Vaccine [EPC], Increased Histamine Release [PE], Influenza Vaccines [CS], Non-Standardized Food Allergenic Extract [EPC], Vaccines, Inactivated [CS], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180723",
"EndMarketingDatePackage": "20241207",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of runny nose, congestion, sore throat, headache, nausea, cough, body aches, fever and chills. Best taken at first sign of immune imbalance."
},
{
"NDCCode": "70069-807-10",
"PackageDescription": "10 VIAL in 1 CARTON (70069-807-10) > 10 mL in 1 VIAL (70069-807-01) ",
"NDC11Code": "70069-0807-10",
"ProductNDC": "70069-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Milrinone Lactate",
"NonProprietaryName": "Milrinone Lactate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214380",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "MILRINONE LACTATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220923",
"SamplePackage": "N",
"IndicationAndUsage": "Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.",
"Description": "Milrinone Lactate Injection is a member of a class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-dihydro-2-methyl-6-oxo-[3,4´-bipyridine]-5-carbonitrile lactate and has the following structure. Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and a molecular formula of C12H9N3O. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone Lactate is available as sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, Single Dose Vials: Single dose vials of 10, 20 and 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg dextrose anhydrous, USP, in water for injection, USP. The pH is adjusted to between 3.2 and 4.0 with lactic acid and/or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These vials require preparation of dilutions prior to administration to patients intravenously."
},
{
"NDCCode": "64471-185-04",
"PackageDescription": "118 mL in 1 BOTTLE, DISPENSING (64471-185-04)",
"NDC11Code": "64471-0185-04",
"ProductNDC": "64471-185",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wellness With Cherry Flavor",
"ProprietaryNameSuffix": "Cough Syrup",
"NonProprietaryName": "Althaea Officinalis, Prunus Virginiana, Inula Helenium",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20131016",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals",
"SubstanceName": "ALTHAEA OFFICINALIS ROOT; PRUNUS VIRGINIANA BARK; INULA HELENIUM ROOT; MARRUBIUM VULGARE; EUCALYPTUS GLOBULUS LEAF; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT; BRYONIA ALBA WHOLE; CAUSTICUM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; ANEMONE NEMOROSA",
"StrengthNumber": "1; 1; 3; 3; 6; 6; 6; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the temporary relief of coughs and congestion due to cold and flu. . Helps loosen mucus (expectorant) and clear bronchial congestion. Soothes sore throat."
},
{
"NDCCode": "64471-214-01",
"PackageDescription": "25 g in 1 BOTTLE (64471-214-01)",
"NDC11Code": "64471-0214-01",
"ProductNDC": "64471-214",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flu Guard",
"NonProprietaryName": "Aconitum Napellus, Arsenicum Iodatum, Bryonia Alba, Eupatorium Perfoliatum, Gelsemium Sempervirens, Helix Tosta, Hydrogen, Influenzinum, Kreosotum, Phosphorus, Teucrium Scorodonia, Thuja Occidentalis, Veratrum Viride, Anas Barbariae",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150911",
"EndMarketingDate": "20200408",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ESCARGOT SHELL, COOKED; HYDROGEN; INFLUENZA A VIRUS; INFLUENZA B VIRUS; WOOD CREOSOTE; PHOSPHORUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM VIRIDE ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200",
"StrengthUnit": "[hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g",
"Status": "Deprecated",
"LastUpdate": "2020-04-09",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "64471-247-01",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (64471-247-01) > 25 g in 1 BOTTLE, GLASS",
"NDC11Code": "64471-0247-01",
"ProductNDC": "64471-247",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flu Guard",
"NonProprietaryName": "Aconitum Napellus, Arsenicum Iodatum, Bryonia (alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Helix Tosta, Hydrogen, Influenzinum 2015-2016, Kreosotum, Phosphorus, Teucrium Scorodonia, Thuja Occidentalis, Veratrum Viride, Anas Barbariae, Hepatis Et Cordis Extractum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150405",
"EndMarketingDate": "20210902",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ESCARGOT SHELL, COOKED; HYDROGEN; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); WOOD CREOSOTE; PHOSPHORUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM VIRIDE ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200",
"StrengthUnit": "[hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; 1/g; [hp_C]/g; 1/g; [hp_C]/g; 1/g; [kp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g",
"Status": "Deprecated",
"LastUpdate": "2021-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160405",
"EndMarketingDatePackage": "20210902",
"SamplePackage": "N"
},
{
"NDCCode": "64471-330-04",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (64471-330-04)",
"NDC11Code": "64471-0330-04",
"ProductNDC": "64471-330",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wellness4cough Syrup",
"ProprietaryNameSuffix": "Cough Syrup",
"NonProprietaryName": "Althaea Officinalis, Prunus Virginiana, Inula Helenium",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20131016",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals",
"SubstanceName": "ALTHAEA OFFICINALIS ROOT; PRUNUS VIRGINIANA BARK; INULA HELENIUM ROOT; MARRUBIUM VULGARE; EUCALYPTUS GLOBULUS LEAF; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT; BRYONIA ALBA WHOLE; CAUSTICUM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS",
"StrengthNumber": "1; 1; 3; 3; 6; 6; 6; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the temporary relief of coughs and congestion due to cold and flu. . Helps loosen mucus (expectorant) and clear bronchial congestion. Soothes sore throat."
},
{
"NDCCode": "64471-347-01",
"PackageDescription": "25 g in 1 BOTTLE, GLASS (64471-347-01) ",
"NDC11Code": "64471-0347-01",
"ProductNDC": "64471-347",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wellguard",
"NonProprietaryName": "Aconitum Napellus, Arsenicum Iodatum, Bryonia (alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Helix Tosta, Hydrogen, Influenzinum 2017-2018, Kreosotum, Phosphorus, Teucrium Scorodonia, Thuja Occidentalis, Veratrum Viride, Anas Barbariae, Hepatis Et Cordis Extractum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180612",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals, Inc.",
"SubstanceName": "ACONITUM NAPELLUS WHOLE; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ESCARGOT SHELL, COOKED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HYDROGEN; INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED); PHOSPHORUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM VIRIDE ROOT; WOOD CREOSOTE",
"StrengthNumber": "30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g",
"Pharm_Classes": "Actively Acquired Immunity [PE], Inactivated Influenza B Virus Vaccine [EPC], Influenza Vaccines [CS], Vaccines, Inactivated [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180612",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "May reduce the duration and severity of signs of immune imbalance."
},
{
"NDCCode": "64471-348-01",
"PackageDescription": "25 g in 1 BOTTLE, GLASS (64471-348-01) ",
"NDC11Code": "64471-0348-01",
"ProductNDC": "64471-348",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wellguard",
"NonProprietaryName": "Aconitum Napellus, Arsenicum Iodatum, Bryonia (alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Helix Tosta, Hydrogen, Influenzinum 2019-2020, Kreosotum, Phosphorus, Teucrium Scorodonia, Thuja Occidentalis, Veratrum Viride, Anas Barbariae.",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210412",
"EndMarketingDate": "20251208",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Source Naturals, Inc.",
"SubstanceName": "ACONITUM NAPELLUS WHOLE; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ESCARGOT SHELL, COOKED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HYDROGEN; INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED); PHOSPHORUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM VIRIDE ROOT; WOOD CREOSOTE",
"StrengthNumber": "30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210412",
"EndMarketingDatePackage": "20251208",
"SamplePackage": "N",
"IndicationAndUsage": "May reduce the duration and severity of signs of immune imbalance."
},
{
"NDCCode": "0143-9204-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0143-9204-01) / 1 mL in 1 VIAL, GLASS",
"NDC11Code": "00143-9204-01",
"ProductNDC": "0143-9204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204490",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210114",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection, USP is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, anhydrous. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.9. It is highly lipophilic and practically insoluble in water."
},
{
"NDCCode": "0143-9205-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0143-9205-01) / 4 mL in 1 VIAL, GLASS",
"NDC11Code": "00143-9205-01",
"ProductNDC": "0143-9205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204490",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DOCETAXEL",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210114",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection, USP is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, anhydrous. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.9. It is highly lipophilic and practically insoluble in water."
},
{
"NDCCode": "0409-0016-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-0016-01) / 16 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-0016-01",
"ProductNDC": "0409-0016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220110",
"SamplePackage": "N",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous) and multiple-dose vials containing 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "0409-0201-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0201-02) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-0201-02",
"ProductNDC": "0409-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110317",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110317",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
"Description": "Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous), and multiple-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution."
},
{
"NDCCode": "0409-0201-10",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-0201-10) / 8 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-0201-10",
"ProductNDC": "0409-0201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Docetaxel",
"NonProprietaryName": "Docetaxel Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110317",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022234",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DOCETAXEL ANHYDROUS",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110317",
"SamplePackage": "N",
"IndicationAndUsage": "Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).",
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{
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{
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20150911</StartMarketingDate>
<EndMarketingDate>20201002</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Source Naturals, Inc.</LabelerName>
<SubstanceName>ECHINACEA ANGUSTIFOLIA; ONION; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; SANGUINARIA CANADENSIS ROOT; POTASSIUM DICHROMATE; PHOSPHORUS; ACONITUM NAPELLUS; INFLUENZA A VIRUS; INFLUENZA B VIRUS</SubstanceName>
<StrengthNumber>3; 4; 4; 4; 4; 4; 6; 6; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-03</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>64471-126-48</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (64471-126-48) > 24 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64471-0126-48</NDC11Code>
<ProductNDC>64471-126</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wellness Earache</ProprietaryName>
<NonProprietaryName>Capsicum Annuum, Silicea, Verbascum Thapsus, Ferrum Phosphoricum, Kali Muriaticum, Aconitum Napellus, Belladonna, Calcarea Carbonica, Pulsatilla (pratensis)</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180613</StartMarketingDate>
<EndMarketingDate>20231130</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Source Naturals, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; CAPSICUM; FERRUM PHOSPHORICUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CHLORIDE; PULSATILLA PRATENSIS; SILICON DIOXIDE; VERBASCUM THAPSUS</SubstanceName>
<StrengthNumber>30; 6; 12; 30; 12; 30; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180613</StartMarketingDatePackage>
<EndMarketingDatePackage>20231130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64471-164-48</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (64471-164-48) / 24 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64471-0164-48</NDC11Code>
<ProductNDC>64471-164</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wellness Cold And Flu</ProprietaryName>
<NonProprietaryName>Echinacea (angustifolia), Allium Cepa, Bryonia (alba), Gelsemium Sempervirens, Sanguinaria Canadensis, Eupatorium Perfoliatum, Kali Bichromicum, Phosphorus, Aconitum Napellus, Influenzinum 2015-2016,</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161115</StartMarketingDate>
<EndMarketingDate>20241217</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Source Naturals, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS WHOLE; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); ONION; PHOSPHORUS; POTASSIUM DICHROMATE; SANGUINARIA CANADENSIS ROOT</SubstanceName>
<StrengthNumber>12; 4; 3; 6; 4; 12; 12; 12; 12; 12; 12; 4; 6; 6; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161117</StartMarketingDatePackage>
<EndMarketingDatePackage>20241217</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of cold and flu symptoms, runny nose, congestion, sore throat, headache, nausea, cough, body aches, fever and chills. Best taken at first sign of symptoms. Effective at all stages of cold and flu.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64471-165-48</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (64471-165-48) / 24 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64471-0165-48</NDC11Code>
<ProductNDC>64471-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Wellness Defense</ProprietaryName>
<NonProprietaryName>Echinacea (angustifolia), Allium Cepa, Bryonia (alba), Gelsemium Sempervirens, Sanguinaria Canadensis, Eupatorium Perfoliatum, Kali Bichromicum, Phosphorus, Aconitum Napellus, Influenzinum 2019-2020</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200213</StartMarketingDate>
<EndMarketingDate>20251223</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Source Naturals, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS WHOLE; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED); ONION; PHOSPHORUS; POTASSIUM DICHROMATE; SANGUINARIA CANADENSIS ROOT</SubstanceName>
<StrengthNumber>12; 4; 3; 6; 4; 12; 12; 12; 4; 6; 6; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200213</StartMarketingDatePackage>
<EndMarketingDatePackage>20251223</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of runny nose, congestion, sore throat, headache, nausea, cough, body aches, fever and chills. Best taken at first sign of immune imbalance.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64471-196-48</NDCCode>
<PackageDescription>7200 mg in 1 BLISTER PACK (64471-196-48) </PackageDescription>
<NDC11Code>64471-0196-48</NDC11Code>
<ProductNDC>64471-196</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allercetin</ProprietaryName>
<NonProprietaryName>Euphrasia Officinalis, Kali Iodatum, Sabadilla, Sticta Pulmonaria, Histaminum Hydrochloricum, Quercetin, Succinicum Acidum, Ambrosia Artemisiaefolia</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140905</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Source Naturals, Inc.</LabelerName>
<SubstanceName>EUPHRASIA STRICTA; POTASSIUM IODIDE; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; HISTAMINE DIHYDROCHLORIDE; QUERCETIN; SUCCINIC ACID; AMBROSIA ARTEMISIIFOLIA WHOLE</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 12; 12; 12; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>*temporary relieves these symptoms due to hay fever or other upper respiratory allergies:. sneezing runny nose itchy and watery eyes sinus congestion and headache. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64471-263-48</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (64471-263-48) > 24 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64471-0263-48</NDC11Code>
<ProductNDC>64471-263</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wellness Earache</ProprietaryName>
<NonProprietaryName>Capsicum Annuum, Silicea, Verbascum Thapsus, Ferrum Phosphoricum, Kali Muriaticum, Aconitum Napellus, Belladonna, Calcarea Carbonica, Pulsatilla (pratensis)</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161117</StartMarketingDate>
<EndMarketingDate>20221130</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Source Naturals, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ATROPA BELLADONNA; CAPSICUM; FERRUM PHOSPHORICUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CHLORIDE; PULSATILLA PRATENSIS; SILICON DIOXIDE; VERBASCUM THAPSUS</SubstanceName>
<StrengthNumber>30; 30; 6; 12; 30; 12; 30; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161117</StartMarketingDatePackage>
<EndMarketingDatePackage>20221130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64471-416-48</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (64471-416-48) / 24 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64471-0416-48</NDC11Code>
<ProductNDC>64471-416</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wellness Defense</ProprietaryName>
<NonProprietaryName>Echinacea (angustifolia), Allium Cepa, Bryonia (alba), Gelsemium Sempervirens, Sanguinaria Canadensis, Eupatorium Perfoliatum, Kali Bichromicum, Phosphorus, Aconitum Napellus, Influenzinum 2017-2018</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180723</StartMarketingDate>
<EndMarketingDate>20241207</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Source Naturals, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS WHOLE; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED); ONION; PHOSPHORUS; POTASSIUM DICHROMATE; SANGUINARIA CANADENSIS ROOT</SubstanceName>
<StrengthNumber>12; 4; 3; 6; 4; 12; 12; 12; 4; 6; 6; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Inactivated Influenza B Virus Vaccine [EPC], Increased Histamine Release [PE], Influenza Vaccines [CS], Non-Standardized Food Allergenic Extract [EPC], Vaccines, Inactivated [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180723</StartMarketingDatePackage>
<EndMarketingDatePackage>20241207</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of runny nose, congestion, sore throat, headache, nausea, cough, body aches, fever and chills. Best taken at first sign of immune imbalance.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70069-807-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70069-807-10) > 10 mL in 1 VIAL (70069-807-01) </PackageDescription>
<NDC11Code>70069-0807-10</NDC11Code>
<ProductNDC>70069-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Milrinone Lactate</ProprietaryName>
<NonProprietaryName>Milrinone Lactate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214380</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>MILRINONE LACTATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.</IndicationAndUsage>
<Description>Milrinone Lactate Injection is a member of a class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6-dihydro-2-methyl-6-oxo-[3,4´-bipyridine]-5-carbonitrile lactate and has the following structure. Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.2 and a molecular formula of C12H9N3O. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone Lactate is available as sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, Single Dose Vials: Single dose vials of 10, 20 and 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg dextrose anhydrous, USP, in water for injection, USP. The pH is adjusted to between 3.2 and 4.0 with lactic acid and/or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg/mL and 1.29 mg/mL. These vials require preparation of dilutions prior to administration to patients intravenously.</Description>
</NDC>
<NDC>
<NDCCode>64471-185-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DISPENSING (64471-185-04)</PackageDescription>
<NDC11Code>64471-0185-04</NDC11Code>
<ProductNDC>64471-185</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wellness With Cherry Flavor</ProprietaryName>
<ProprietaryNameSuffix>Cough Syrup</ProprietaryNameSuffix>
<NonProprietaryName>Althaea Officinalis, Prunus Virginiana, Inula Helenium</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131016</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Source Naturals</LabelerName>
<SubstanceName>ALTHAEA OFFICINALIS ROOT; PRUNUS VIRGINIANA BARK; INULA HELENIUM ROOT; MARRUBIUM VULGARE; EUCALYPTUS GLOBULUS LEAF; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT; BRYONIA ALBA WHOLE; CAUSTICUM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; ANEMONE NEMOROSA</SubstanceName>
<StrengthNumber>1; 1; 3; 3; 6; 6; 6; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the temporary relief of coughs and congestion due to cold and flu. . Helps loosen mucus (expectorant) and clear bronchial congestion. Soothes sore throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64471-214-01</NDCCode>
<PackageDescription>25 g in 1 BOTTLE (64471-214-01)</PackageDescription>
<NDC11Code>64471-0214-01</NDC11Code>
<ProductNDC>64471-214</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flu Guard</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Arsenicum Iodatum, Bryonia Alba, Eupatorium Perfoliatum, Gelsemium Sempervirens, Helix Tosta, Hydrogen, Influenzinum, Kreosotum, Phosphorus, Teucrium Scorodonia, Thuja Occidentalis, Veratrum Viride, Anas Barbariae</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150911</StartMarketingDate>
<EndMarketingDate>20200408</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Source Naturals, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ESCARGOT SHELL, COOKED; HYDROGEN; INFLUENZA A VIRUS; INFLUENZA B VIRUS; WOOD CREOSOTE; PHOSPHORUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM VIRIDE ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200</StrengthNumber>
<StrengthUnit>[hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-04-09</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>64471-247-01</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (64471-247-01) > 25 g in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>64471-0247-01</NDC11Code>
<ProductNDC>64471-247</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flu Guard</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Arsenicum Iodatum, Bryonia (alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Helix Tosta, Hydrogen, Influenzinum 2015-2016, Kreosotum, Phosphorus, Teucrium Scorodonia, Thuja Occidentalis, Veratrum Viride, Anas Barbariae, Hepatis Et Cordis Extractum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150405</StartMarketingDate>
<EndMarketingDate>20210902</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Source Naturals, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ESCARGOT SHELL, COOKED; HYDROGEN; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); WOOD CREOSOTE; PHOSPHORUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM VIRIDE ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200</StrengthNumber>
<StrengthUnit>[hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; 1/g; [hp_C]/g; 1/g; [hp_C]/g; 1/g; [kp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160405</StartMarketingDatePackage>
<EndMarketingDatePackage>20210902</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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<NDCCode>64471-330-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (64471-330-04)</PackageDescription>
<NDC11Code>64471-0330-04</NDC11Code>
<ProductNDC>64471-330</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wellness4cough Syrup</ProprietaryName>
<ProprietaryNameSuffix>Cough Syrup</ProprietaryNameSuffix>
<NonProprietaryName>Althaea Officinalis, Prunus Virginiana, Inula Helenium</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131016</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Source Naturals</LabelerName>
<SubstanceName>ALTHAEA OFFICINALIS ROOT; PRUNUS VIRGINIANA BARK; INULA HELENIUM ROOT; MARRUBIUM VULGARE; EUCALYPTUS GLOBULUS LEAF; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT; BRYONIA ALBA WHOLE; CAUSTICUM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS</SubstanceName>
<StrengthNumber>1; 1; 3; 3; 6; 6; 6; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the temporary relief of coughs and congestion due to cold and flu. . Helps loosen mucus (expectorant) and clear bronchial congestion. Soothes sore throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64471-347-01</NDCCode>
<PackageDescription>25 g in 1 BOTTLE, GLASS (64471-347-01) </PackageDescription>
<NDC11Code>64471-0347-01</NDC11Code>
<ProductNDC>64471-347</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wellguard</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Arsenicum Iodatum, Bryonia (alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Helix Tosta, Hydrogen, Influenzinum 2017-2018, Kreosotum, Phosphorus, Teucrium Scorodonia, Thuja Occidentalis, Veratrum Viride, Anas Barbariae, Hepatis Et Cordis Extractum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180612</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Source Naturals, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS WHOLE; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ESCARGOT SHELL, COOKED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HYDROGEN; INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED); PHOSPHORUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM VIRIDE ROOT; WOOD CREOSOTE</SubstanceName>
<StrengthNumber>30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Inactivated Influenza B Virus Vaccine [EPC], Influenza Vaccines [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180612</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May reduce the duration and severity of signs of immune imbalance.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64471-348-01</NDCCode>
<PackageDescription>25 g in 1 BOTTLE, GLASS (64471-348-01) </PackageDescription>
<NDC11Code>64471-0348-01</NDC11Code>
<ProductNDC>64471-348</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wellguard</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Arsenicum Iodatum, Bryonia (alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Helix Tosta, Hydrogen, Influenzinum 2019-2020, Kreosotum, Phosphorus, Teucrium Scorodonia, Thuja Occidentalis, Veratrum Viride, Anas Barbariae.</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210412</StartMarketingDate>
<EndMarketingDate>20251208</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Source Naturals, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS WHOLE; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ESCARGOT SHELL, COOKED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HYDROGEN; INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED); PHOSPHORUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM VIRIDE ROOT; WOOD CREOSOTE</SubstanceName>
<StrengthNumber>30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210412</StartMarketingDatePackage>
<EndMarketingDatePackage>20251208</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May reduce the duration and severity of signs of immune imbalance.</IndicationAndUsage>
</NDC>
<NDC>
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<ProductNDC>0143-9204</ProductNDC>
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<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204490</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>0143-9205-01</NDCCode>
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<NDC11Code>00143-9205-01</NDC11Code>
<ProductNDC>0143-9205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
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<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
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<StartMarketingDate>20210114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204490</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DOCETAXEL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Docetaxel Injection, USP is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, anhydrous. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.9. It is highly lipophilic and practically insoluble in water.</Description>
</NDC>
<NDC>
<NDCCode>0409-0016-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0409-0016-01) / 16 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
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<ProductNDC>0409-0016</ProductNDC>
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<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220110</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022234</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous) and multiple-dose vials containing 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>0409-0201-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0201-02) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-0201-02</NDC11Code>
<ProductNDC>0409-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110317</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022234</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous), and multiple-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>0409-0201-10</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0409-0201-10) / 8 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00409-0201-10</NDC11Code>
<ProductNDC>0409-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110317</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022234</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DOCETAXEL ANHYDROUS</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous), and multiple-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
</NDC>
<NDC>
<NDCCode>0409-0201-20</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0409-0201-20) / 16 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00409-0201-20</NDC11Code>
<ProductNDC>0409-0201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Docetaxel</ProprietaryName>
<NonProprietaryName>Docetaxel Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
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<LabelerName>Hospira, Inc.</LabelerName>
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<StrengthUnit>mg/mL</StrengthUnit>
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<LastUpdate>2024-09-11</LastUpdate>
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<IndicationAndUsage>Docetaxel Injection is a microtubule inhibitor indicated for: 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous), and multiple-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
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<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in multiple-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
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<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in single-dose vials containing 20 mg (2 mL) docetaxel (anhydrous) and multiple-dose vials containing 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
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<Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v dehydrated alcohol USP, and polyethylene glycol 300 NF. Docetaxel Injection is available in multiple-dose vials containing 80 mg (8 mL) or 160 mg (16 mL) docetaxel (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution.</Description>
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<LastUpdate>2025-09-16</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of light pink to orange powder contains 1.5 g of potassium chloride, USP, which is equivalent to potassium 20 mEq and chloride 20 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/1.58g</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of light pink to orange powder contains 1.5 g of potassium chloride, USP, which is equivalent to potassium 20 mEq and chloride 20 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose.</Description>
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