{
"NDC": [
{
"NDCCode": "83324-035-12",
"PackageDescription": "1 TUBE in 1 CARTON (83324-035-12) / 11.9 g in 1 TUBE",
"NDC11Code": "83324-0035-12",
"ProductNDC": "83324-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quality Choice Oral Pain Relief",
"NonProprietaryName": "Benzocaine 20%, Benzalkonium Chloride 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)",
"SubstanceName": "BENZOCAINE; BENZALKONIUM CHLORIDE",
"StrengthNumber": "200; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of pain due to toothaches. to help protect against infection in minor oral irritation."
},
{
"NDCCode": "16110-035-12",
"PackageDescription": "1 TUBE in 1 CARTON (16110-035-12) / 120 g in 1 TUBE",
"NDC11Code": "16110-0035-12",
"ProductNDC": "16110-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cordran",
"NonProprietaryName": "Flurandrenolide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19651018",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012806",
"LabelerName": "Almirall, LLC",
"SubstanceName": "FLURANDRENOLIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19651018",
"SamplePackage": "N",
"IndicationAndUsage": "Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Cordran® (flurandrenolide, USP) is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of Cordran® Cream (flurandrenolide Cream, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. Each gram of Cordran® Ointment (flurandrenolide Ointment, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "17312-035-16",
"PackageDescription": "12 BLISTER PACK in 1 CARTON (17312-035-16) > 8 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "17312-0035-16",
"ProductNDC": "17312-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smokers Nicotine Relief",
"NonProprietaryName": "Aspidosperma Quebracho Blanco, Avena Sativa, Epinephrine, Lobelia Inflata, Milk Thistle, St Johns Wort, Strychnos Nux Vomica Seed, Valerian, Wood Creosote",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20150322",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "MILK THISTLE; ST. JOHN'S WORT; WOOD CREOSOTE; EPINEPHRINE; AVENA SATIVA FLOWERING TOP; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; VALERIAN",
"StrengthNumber": "6; 18; 18; 18; 9; 12; 18; 18; 18",
"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",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "According to homeopathic indications, these ingredients temporarily relieve and calm smoker’s nicotine related symptoms of: cravings withdrawal irritability nicotine cleansing cough/lung support after diagnosis by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "24385-035-62",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (24385-035-62) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "24385-0035-62",
"ProductNDC": "24385-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy Night Time",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20060419",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "33342-035-12",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (33342-035-12) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "33342-0035-12",
"ProductNDC": "33342-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole Dihydrochloride",
"NonProprietaryName": "Pramipexole Dihydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202164",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120921",
"SamplePackage": "N",
"IndicationAndUsage": "Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of. · Parkinson’s disease (PD) (1.1) Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).",
"Description": "Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S2HClH2O, and its molecular weight is 302.26. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1 mg tablets: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1.5 mg tablets: Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride.Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, pregelatinized starch, colloidal silicon dioxide, povidone, and magnesium stearate."
},
{
"NDCCode": "37000-035-01",
"PackageDescription": "1 KIT in 1 PACKAGE (37000-035-01) * 354 mL in 1 BOTTLE, PLASTIC (37000-500-12) * 12 BLISTER PACK in 1 CARTON (37000-501-24) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "37000-0035-01",
"ProductNDC": "37000-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vicks Zzzquil",
"ProprietaryNameSuffix": "Liquid And Liquicaps Combo",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20130501",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part338",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"Status": "Deprecated",
"LastUpdate": "2019-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130501",
"SamplePackage": "N"
},
{
"NDCCode": "51121-035-12",
"PackageDescription": "3.5 g in 1 PACKET (51121-035-12)",
"NDC11Code": "51121-0035-12",
"ProductNDC": "51121-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Burnaid Burn Gel",
"NonProprietaryName": "Tea Tree Oil",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131104",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Clear Healthcare LLC",
"SubstanceName": "TEA TREE OIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the first aid treatment of minor burns, scalds and sunburn."
},
{
"NDCCode": "51346-035-01",
"PackageDescription": "12 g in 1 CARTON (51346-035-01)",
"NDC11Code": "51346-0035-01",
"ProductNDC": "51346-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Orchid Secret Pact",
"ProprietaryNameSuffix": "Spf35 Pa Plus Plus Plus 23 Orchid Beige",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Zinc Oxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120115",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "1.03; .72; .35",
"StrengthUnit": "g/12g; g/12g; g/12g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55695-035-00",
"PackageDescription": "12 CARTON in 1 BOX (55695-035-00) > 12 BOTTLE in 1 CARTON > 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "55695-0035-00",
"ProductNDC": "55695-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ethambutol Hydrochloride",
"NonProprietaryName": "Ethambutol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061215",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA016320",
"LabelerName": "Department of State Health Services, Pharmacy Branch",
"SubstanceName": "ETHAMBUTOL HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimycobacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "ETHAMBUTOL HCI is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety, and appropriate in vitro susceptibility studies. In patients who have not received previous antituberculous therapy, ie, initial treatment, the most frequently used regimens have been the following: : 1 ETHAMBUTOL HCI plus isoniazid , 2 ETHAMBUTOL HCI plus isoniazid plus streptomycin. .",
"Description": "ETHAMBUTOL HYDROCHLORIDE is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus Mycobacterium, including M. tuberculosis. The structural formula is:. ETHAMBUTOL HYDROCHLORIDE (HCI) 100 and 400 mg tablets contain the following inactive ingredients: Gelatin, Hydroxypropyl Methylcellulose, Magnesium Stearate, Sodium Lauryl Sulfate, Sorbitol, Stearic Acid, Sucrose, Titanium Dioxide and other ingredients."
},
{
"NDCCode": "55910-035-08",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (55910-035-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55910-0035-08",
"ProductNDC": "55910-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold Multi-symptom Severe",
"ProprietaryNameSuffix": "Day Time",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050804",
"EndMarketingDate": "20231209",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "DOLGENCORP, LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050804",
"EndMarketingDatePackage": "20231209",
"SamplePackage": "N"
},
{
"NDCCode": "69745-035-12",
"PackageDescription": "125 g in 1 BOTTLE, PUMP (69745-035-12)",
"NDC11Code": "69745-0035-12",
"ProductNDC": "69745-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ms Apf",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "DENTAL",
"StartMarketingDate": "20141001",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "M&S Dental Supply Co., LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.5375",
"StrengthUnit": "g/125g",
"Status": "Deprecated",
"LastUpdate": "2019-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "70157-035-01",
"PackageDescription": "12.5 g in 1 TUBE (70157-035-01) ",
"NDC11Code": "70157-0035-01",
"ProductNDC": "70157-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum Spf30",
"NonProprietaryName": "Avobenzone, Oxtinoxate, Octocrylene, Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251114",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Baxter Laboratories Pty. Ltd.",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3; 4; 2.7; 3",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251114",
"SamplePackage": "N"
},
{
"NDCCode": "70157-035-02",
"PackageDescription": "1 TUBE in 1 CARTON (70157-035-02) / 12.5 g in 1 TUBE (70157-035-01) ",
"NDC11Code": "70157-0035-02",
"ProductNDC": "70157-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum Spf30",
"NonProprietaryName": "Avobenzone, Oxtinoxate, Octocrylene, Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251114",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Baxter Laboratories Pty. Ltd.",
"SubstanceName": "OCTINOXATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE",
"StrengthNumber": "4; 3; 3; 2.7",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251114",
"SamplePackage": "N",
"IndicationAndUsage": "Stop use and ask a doctor if rash occurs."
},
{
"NDCCode": "70377-035-12",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70377-035-12) ",
"NDC11Code": "70377-0035-12",
"ProductNDC": "70377-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211020",
"LabelerName": "Biocon Pharma Inc.,",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190128",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).",
"Description": "Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg which are white to pale yellow round biconvex coated tablets imprinted with '188' and '189' in black ink on one side and plain on other side respectively. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opadry®(it contains hypromellose, tricetin and talc), opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14."
},
{
"NDCCode": "71288-035-52",
"PackageDescription": "12 VIAL, GLASS in 1 CARTON (71288-035-52) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (71288-035-51) ",
"NDC11Code": "71288-0035-52",
"ProductNDC": "71288-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Contepo",
"NonProprietaryName": "Fosfomycin Disodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251022",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212271",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "FOSFOMYCIN SODIUM",
"StrengthNumber": "6",
"StrengthUnit": "g/1",
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251022",
"SamplePackage": "N",
"IndicationAndUsage": "CONTEPO is an epoxide antibacterial indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including acute pyelonephritis caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae. (1.1). Usage to Reduce Development of Drug-Resistant Bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CONTEPO and other antibacterial drugs, CONTEPO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.2).",
"Description": "CONTEPO (fosfomycin) for injection, for intravenous use, contains fosfomycin disodium, an epoxide antibacterial drug. Fosfomycin disodium is a powder with the chemical name of disodium [(2R,3S)-3-methyloxiran-2-yl]-dioxido-oxophosphorane, an empirical formula of C3H5Na2O4P and molecular weight of 182. Figure 1 Chemical Structure of Fosfomycin Disodium. Each CONTEPO for Injection single-dose vial contains white to almost white sterile powder with 6 grams of fosfomycin (equivalent to 7.9 grams fosfomycin disodium) and the inactive ingredient succinic acid (150 mg) for pH adjustment. It is intended for constitution and further dilution prior to intravenous infusion . Each gram of fosfomycin disodium contains 330 mg of sodium (i.e., each vial contains 1,980 mg of sodium)."
},
{
"NDCCode": "71930-035-12",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (71930-035-12) ",
"NDC11Code": "71930-0035-12",
"ProductNDC": "71930-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207863",
"LabelerName": "Eywa Pharma Inc",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20190524",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol Hydrochloride is indicated in the management of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including beta adrenergic blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Labetalol Hydrochloride Tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol Hydrochloride Tablets, USP contain labetalol hydrochloride, an adrenergic receptor blocking agent that has both selective alpha1 adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride, and it has the following structural formula. Labetalol hydrochloride has the empirical formula C19H24N2O3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets, USP contain 100 mg, 200 mg, or 300 mg of labetalol hydrochloride and are for oral administration. The tablets also contain the inactive ingredients lactose monohydrate, magnesium stearate, pregelatinized corn starch, sodium starch glycolate. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "73069-035-12",
"PackageDescription": "3 VIAL, MULTI-DOSE in 1 BOX (73069-035-12) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0035-12",
"ProductNDC": "73069-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-arthros",
"NonProprietaryName": "Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein",
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"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR",
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"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-035-16",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-035-16) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0035-16",
"ProductNDC": "73069-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-arthros",
"NonProprietaryName": "Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR",
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"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-035-26",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-035-26) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0035-26",
"ProductNDC": "73069-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-arthros",
"NonProprietaryName": "Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR",
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"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-035-36",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-035-36) > 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0035-36",
"ProductNDC": "73069-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-arthros",
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"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR",
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"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-035-46",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-035-46) > 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0035-46",
"ProductNDC": "73069-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-arthros",
"NonProprietaryName": "Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR",
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"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190505",
"SamplePackage": "N"
},
{
"NDCCode": "73069-035-56",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-035-56) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0035-56",
"ProductNDC": "73069-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-arthros",
"NonProprietaryName": "Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-035-66",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-035-66) > 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0035-66",
"ProductNDC": "73069-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-arthros",
"NonProprietaryName": "Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR",
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"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-035-76",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-035-76) > 50 mL in 1 VIAL, MULTI-DOSE",
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"ProductNDC": "73069-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-arthros",
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"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR",
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"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-035-86",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-035-86) > 100 mL in 1 VIAL, MULTI-DOSE",
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"ProductNDC": "73069-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-arthros",
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"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR",
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"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
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"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73212-035-12",
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"NDC11Code": "73212-0035-12",
"ProductNDC": "73212-035",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bromocriptine Mesylate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230102",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Qingdao Biopeptek Co., Ltd.",
"SubstanceName": "BROMOCRIPTINE MESYLATE",
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"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-01-12",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "02-JAN-23"
},
{
"NDCCode": "73774-016-12",
"PackageDescription": ".035 kg in 1 POUCH (73774-016-12) ",
"NDC11Code": "73774-0016-12",
"ProductNDC": "73774-016",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SHAKTI LIFESCIENCE PRIVATE LIMITED",
"SubstanceName": "TESTOSTERONE CYPIONATE",
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"StrengthUnit": "kg/kg",
"DEASchedule": "CIII",
"Status": "Unfinished",
"LastUpdate": "2026-05-11",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "12-JAN-24"
},
{
"NDCCode": "79903-035-08",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (79903-035-08) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
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"ProductNDC": "79903-035",
"ProductTypeName": "HUMAN OTC DRUG",
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"RouteName": "ORAL",
"StartMarketingDate": "20201203",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "WALMART INC.",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
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"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20201203",
"SamplePackage": "N"
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{
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"NonProprietaryName": "Methylnaltrexone Bromide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250929",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "STHREE CHEMICALS PRIVATE LIMITED",
"SubstanceName": "METHYLNALTREXONE BROMIDE",
"StrengthNumber": "35",
"StrengthUnit": "kg/35kg",
"Status": "Unfinished",
"LastUpdate": "2025-10-08",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "29-SEP-25"
},
{
"NDCCode": "84126-035-12",
"PackageDescription": "122 g in 1 CAN (84126-035-12) ",
"NDC11Code": "84126-0035-12",
"ProductNDC": "84126-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Old Spice Fiji Dry",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
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"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240201",
"SamplePackage": "N",
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}
]
}
{"NDC":[{"NDCCode":"83324-035-12","ProprietaryName":"Quality Choice Oral Pain Relief","NonProprietaryName":"Benzocaine 20%, Benzalkonium Chloride 1%"},{"NDCCode":"16110-035-12","ProprietaryName":"Cordran","NonProprietaryName":"Flurandrenolide"},{"NDCCode":"17312-035-16","ProprietaryName":"Smokers Nicotine Relief","NonProprietaryName":"Aspidosperma Quebracho Blanco, Avena Sativa, Epinephrine, Lobelia Inflata, Milk Thistle, St Johns Wort, Strychnos Nux Vomica Seed, Valerian, Wood Creosote"},{"NDCCode":"24385-035-62","ProprietaryName":"Good Neighbor Pharmacy Night Time","NonProprietaryName":"Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate"},{"NDCCode":"33342-035-12","ProprietaryName":"Pramipexole Dihydrochloride","NonProprietaryName":"Pramipexole Dihydrochloride"},{"NDCCode":"37000-035-01","ProprietaryName":"Vicks Zzzquil","NonProprietaryName":"Diphenhydramine Hydrochloride"},{"NDCCode":"51121-035-12","ProprietaryName":"Burnaid Burn Gel","NonProprietaryName":"Tea Tree 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<NDCCode>83324-035-12</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (83324-035-12) / 11.9 g in 1 TUBE</PackageDescription>
<NDC11Code>83324-0035-12</NDC11Code>
<ProductNDC>83324-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quality Choice Oral Pain Relief</ProprietaryName>
<NonProprietaryName>Benzocaine 20%, Benzalkonium Chloride 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)</LabelerName>
<SubstanceName>BENZOCAINE; BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>200; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-17</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of pain due to toothaches. to help protect against infection in minor oral irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16110-035-12</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (16110-035-12) / 120 g in 1 TUBE</PackageDescription>
<NDC11Code>16110-0035-12</NDC11Code>
<ProductNDC>16110-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cordran</ProprietaryName>
<NonProprietaryName>Flurandrenolide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19651018</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012806</ApplicationNumber>
<LabelerName>Almirall, LLC</LabelerName>
<SubstanceName>FLURANDRENOLIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-06</LastUpdate>
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<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Cordran® (flurandrenolide, USP) is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram of flurandrenolide dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows. Each gram of Cordran® Cream (flurandrenolide Cream, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water. Each gram of Cordran® Ointment (flurandrenolide Ointment, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum.</Description>
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<NDCCode>17312-035-16</NDCCode>
<PackageDescription>12 BLISTER PACK in 1 CARTON (17312-035-16) > 8 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>17312-0035-16</NDC11Code>
<ProductNDC>17312-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smokers Nicotine Relief</ProprietaryName>
<NonProprietaryName>Aspidosperma Quebracho Blanco, Avena Sativa, Epinephrine, Lobelia Inflata, Milk Thistle, St Johns Wort, Strychnos Nux Vomica Seed, Valerian, Wood Creosote</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150322</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>MILK THISTLE; ST. JOHN'S WORT; WOOD CREOSOTE; EPINEPHRINE; AVENA SATIVA FLOWERING TOP; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; VALERIAN</SubstanceName>
<StrengthNumber>6; 18; 18; 18; 9; 12; 18; 18; 18</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>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>According to homeopathic indications, these ingredients temporarily relieve and calm smoker’s nicotine related symptoms of: cravings withdrawal irritability nicotine cleansing cough/lung support after diagnosis by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24385-035-62</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (24385-035-62) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>24385-0035-62</NDC11Code>
<ProductNDC>24385-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Neighbor Pharmacy Night Time</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060419</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>33342-035-12</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (33342-035-12) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0035-12</NDC11Code>
<ProductNDC>33342-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
<NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202164</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of. · Parkinson’s disease (PD) (1.1) Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
<Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S2HClH2O, and its molecular weight is 302.26. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1 mg tablets: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1.5 mg tablets: Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride.Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, pregelatinized starch, colloidal silicon dioxide, povidone, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>37000-035-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (37000-035-01) * 354 mL in 1 BOTTLE, PLASTIC (37000-500-12) * 12 BLISTER PACK in 1 CARTON (37000-501-24) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37000-0035-01</NDC11Code>
<ProductNDC>37000-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vicks Zzzquil</ProprietaryName>
<ProprietaryNameSuffix>Liquid And Liquicaps Combo</ProprietaryNameSuffix>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part338</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51121-035-12</NDCCode>
<PackageDescription>3.5 g in 1 PACKET (51121-035-12)</PackageDescription>
<NDC11Code>51121-0035-12</NDC11Code>
<ProductNDC>51121-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Burnaid Burn Gel</ProprietaryName>
<NonProprietaryName>Tea Tree Oil</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131104</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Clear Healthcare LLC</LabelerName>
<SubstanceName>TEA TREE OIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the first aid treatment of minor burns, scalds and sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51346-035-01</NDCCode>
<PackageDescription>12 g in 1 CARTON (51346-035-01)</PackageDescription>
<NDC11Code>51346-0035-01</NDC11Code>
<ProductNDC>51346-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Orchid Secret Pact</ProprietaryName>
<ProprietaryNameSuffix>Spf35 Pa Plus Plus Plus 23 Orchid Beige</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>1.03; .72; .35</StrengthNumber>
<StrengthUnit>g/12g; g/12g; g/12g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55695-035-00</NDCCode>
<PackageDescription>12 CARTON in 1 BOX (55695-035-00) > 12 BOTTLE in 1 CARTON > 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>55695-0035-00</NDC11Code>
<ProductNDC>55695-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ethambutol Hydrochloride</ProprietaryName>
<NonProprietaryName>Ethambutol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061215</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA016320</ApplicationNumber>
<LabelerName>Department of State Health Services, Pharmacy Branch</LabelerName>
<SubstanceName>ETHAMBUTOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ETHAMBUTOL HCI is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety, and appropriate in vitro susceptibility studies. In patients who have not received previous antituberculous therapy, ie, initial treatment, the most frequently used regimens have been the following: : 1 ETHAMBUTOL HCI plus isoniazid , 2 ETHAMBUTOL HCI plus isoniazid plus streptomycin. .</IndicationAndUsage>
<Description>ETHAMBUTOL HYDROCHLORIDE is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus Mycobacterium, including M. tuberculosis. The structural formula is:. ETHAMBUTOL HYDROCHLORIDE (HCI) 100 and 400 mg tablets contain the following inactive ingredients: Gelatin, Hydroxypropyl Methylcellulose, Magnesium Stearate, Sodium Lauryl Sulfate, Sorbitol, Stearic Acid, Sucrose, Titanium Dioxide and other ingredients.</Description>
</NDC>
<NDC>
<NDCCode>55910-035-08</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (55910-035-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55910-0035-08</NDC11Code>
<ProductNDC>55910-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold Multi-symptom Severe</ProprietaryName>
<ProprietaryNameSuffix>Day Time</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050804</StartMarketingDate>
<EndMarketingDate>20231209</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>DOLGENCORP, LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050804</StartMarketingDatePackage>
<EndMarketingDatePackage>20231209</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69745-035-12</NDCCode>
<PackageDescription>125 g in 1 BOTTLE, PUMP (69745-035-12)</PackageDescription>
<NDC11Code>69745-0035-12</NDC11Code>
<ProductNDC>69745-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ms Apf</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20141001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>M&S Dental Supply Co., LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.5375</StrengthNumber>
<StrengthUnit>g/125g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70157-035-01</NDCCode>
<PackageDescription>12.5 g in 1 TUBE (70157-035-01) </PackageDescription>
<NDC11Code>70157-0035-01</NDC11Code>
<ProductNDC>70157-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum Spf30</ProprietaryName>
<NonProprietaryName>Avobenzone, Oxtinoxate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251114</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Baxter Laboratories Pty. Ltd.</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>3; 4; 2.7; 3</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70157-035-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (70157-035-02) / 12.5 g in 1 TUBE (70157-035-01) </PackageDescription>
<NDC11Code>70157-0035-02</NDC11Code>
<ProductNDC>70157-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lanolips Sun Balm Tropical Untinted Lip Balm Broad Spectrum Spf30</ProprietaryName>
<NonProprietaryName>Avobenzone, Oxtinoxate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251114</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Baxter Laboratories Pty. Ltd.</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>4; 3; 3; 2.7</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stop use and ask a doctor if rash occurs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70377-035-12</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70377-035-12) </PackageDescription>
<NDC11Code>70377-0035-12</NDC11Code>
<ProductNDC>70377-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211020</ApplicationNumber>
<LabelerName>Biocon Pharma Inc.,</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) (1.1), 2 prevention of seasonal affective disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Bupropion hydrochloride USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg which are white to pale yellow round biconvex coated tablets imprinted with '188' and '189' in black ink on one side and plain on other side respectively. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ethylcellulose, glyceryl behenate, hydrochloric acid, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, methylene chloride, opadry®(it contains hypromellose, tricetin and talc), opacode® (it contains shellac glaze, ferrosoferric oxide, propylene glycol and ammonium hydroxide), polyethylene glycol, povidone, silicon dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. The drug Product meets the requirements of USP Dissolution Test 14.</Description>
</NDC>
<NDC>
<NDCCode>71288-035-52</NDCCode>
<PackageDescription>12 VIAL, GLASS in 1 CARTON (71288-035-52) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (71288-035-51) </PackageDescription>
<NDC11Code>71288-0035-52</NDC11Code>
<ProductNDC>71288-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Contepo</ProprietaryName>
<NonProprietaryName>Fosfomycin Disodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251022</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212271</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FOSFOMYCIN SODIUM</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CONTEPO is an epoxide antibacterial indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including acute pyelonephritis caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae. (1.1). Usage to Reduce Development of Drug-Resistant Bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CONTEPO and other antibacterial drugs, CONTEPO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.2).</IndicationAndUsage>
<Description>CONTEPO (fosfomycin) for injection, for intravenous use, contains fosfomycin disodium, an epoxide antibacterial drug. Fosfomycin disodium is a powder with the chemical name of disodium [(2R,3S)-3-methyloxiran-2-yl]-dioxido-oxophosphorane, an empirical formula of C3H5Na2O4P and molecular weight of 182. Figure 1 Chemical Structure of Fosfomycin Disodium. Each CONTEPO for Injection single-dose vial contains white to almost white sterile powder with 6 grams of fosfomycin (equivalent to 7.9 grams fosfomycin disodium) and the inactive ingredient succinic acid (150 mg) for pH adjustment. It is intended for constitution and further dilution prior to intravenous infusion . Each gram of fosfomycin disodium contains 330 mg of sodium (i.e., each vial contains 1,980 mg of sodium).</Description>
</NDC>
<NDC>
<NDCCode>71930-035-12</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (71930-035-12) </PackageDescription>
<NDC11Code>71930-0035-12</NDC11Code>
<ProductNDC>71930-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207863</ApplicationNumber>
<LabelerName>Eywa Pharma Inc</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol Hydrochloride is indicated in the management of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including beta adrenergic blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Labetalol Hydrochloride Tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol Hydrochloride Tablets, USP contain labetalol hydrochloride, an adrenergic receptor blocking agent that has both selective alpha1 adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride, and it has the following structural formula. Labetalol hydrochloride has the empirical formula C19H24N2O3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets, USP contain 100 mg, 200 mg, or 300 mg of labetalol hydrochloride and are for oral administration. The tablets also contain the inactive ingredients lactose monohydrate, magnesium stearate, pregelatinized corn starch, sodium starch glycolate. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>73069-035-12</NDCCode>
<PackageDescription>3 VIAL, MULTI-DOSE in 1 BOX (73069-035-12) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0035-12</NDC11Code>
<ProductNDC>73069-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-arthros</ProprietaryName>
<NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-035-16</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-035-16) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0035-16</NDC11Code>
<ProductNDC>73069-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-arthros</ProprietaryName>
<NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-035-26</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-035-26) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0035-26</NDC11Code>
<ProductNDC>73069-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-arthros</ProprietaryName>
<NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-035-36</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-035-36) > 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0035-36</NDC11Code>
<ProductNDC>73069-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-arthros</ProprietaryName>
<NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-035-46</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-035-46) > 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0035-46</NDC11Code>
<ProductNDC>73069-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-arthros</ProprietaryName>
<NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-035-56</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-035-56) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0035-56</NDC11Code>
<ProductNDC>73069-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-arthros</ProprietaryName>
<NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-035-66</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-035-66) > 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0035-66</NDC11Code>
<ProductNDC>73069-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-arthros</ProprietaryName>
<NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-035-76</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-035-76) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0035-76</NDC11Code>
<ProductNDC>73069-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-arthros</ProprietaryName>
<NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-035-86</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-035-86) > 100 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0035-86</NDC11Code>
<ProductNDC>73069-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-arthros</ProprietaryName>
<NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-LIPOIC ACID; SUS SCROFA JOINT CAPSULE; BOS TAURUS JOINT CAPSULE; SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; BETA-ENDORPHIN HUMAN; SUS SCROFA SOLAR PLEXUS; BOS TAURUS SOLAR PLEXUS; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; PORK COLLAGEN; INTERLEUKIN-12 HUMAN; PORK LIVER; BEEF LIVER; SUS SCROFA MESENCHYME; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; QUINHYDRONE; BOS TAURUS VEIN; SUS SCROFA VEIN; .ALPHA.-KETOGLUTARIC ACID; APOMORPHINE; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); CALCITONIN; COLCHICUM AUTUMNALE BULB; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; INTERFERON GAMMA-1A; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; NADIDE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; HUMAN PLACENTAL TISSUE; SULFUR</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73212-035-12</NDCCode>
<PackageDescription>100 g in 1 BOTTLE (73212-035-12) </PackageDescription>
<NDC11Code>73212-0035-12</NDC11Code>
<ProductNDC>73212-035</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bromocriptine Mesylate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230102</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Qingdao Biopeptek Co., Ltd.</LabelerName>
<SubstanceName>BROMOCRIPTINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-01-12</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>02-JAN-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>73774-016-12</NDCCode>
<PackageDescription>.035 kg in 1 POUCH (73774-016-12) </PackageDescription>
<NDC11Code>73774-0016-12</NDC11Code>
<ProductNDC>73774-016</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>SHAKTI LIFESCIENCE PRIVATE LIMITED</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIII</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2026-05-11</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-JAN-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>79903-035-08</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (79903-035-08) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>79903-0035-08</NDC11Code>
<ProductNDC>79903-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<ProprietaryNameSuffix>Dye-free</ProprietaryNameSuffix>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201203</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>WALMART INC.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>83511-035-12</NDCCode>
<PackageDescription>.001 kg in 1 DRUM (83511-035-12) </PackageDescription>
<NDC11Code>83511-0035-12</NDC11Code>
<ProductNDC>83511-035</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Methylnaltrexone Bromide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250929</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>STHREE CHEMICALS PRIVATE LIMITED</LabelerName>
<SubstanceName>METHYLNALTREXONE BROMIDE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>kg/35kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-10-08</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>29-SEP-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>84126-035-12</NDCCode>
<PackageDescription>122 g in 1 CAN (84126-035-12) </PackageDescription>
<NDC11Code>84126-0035-12</NDC11Code>
<ProductNDC>84126-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Old Spice Fiji Dry</ProprietaryName>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>24.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
</NDC>
</NDCList>
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Vein</NonProprietaryName></NDC><NDC><NDCCode>73069-035-86</NDCCode><ProprietaryName>Viatrexx-arthros</ProprietaryName><NonProprietaryName>Anti-interleukin 1, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Articulation Capsule, Ascorbic Acid, Adrenal, Bdnf, Beta Endorphin, Bfgf, Coelliac Plexus, Calcitonin, Cartilage, Colchicum Automnale, Collagen, Erythrocytes, Interleukin-12, Interferon Gamma, Liver, Lymph Node, Mesenchyme, Nadid, Parathyroid, Placenta, Quinhydrone, Sulphur, Vein</NonProprietaryName></NDC><NDC><NDCCode>73212-035-12</NDCCode><NonProprietaryName>Bromocriptine Mesylate</NonProprietaryName></NDC><NDC><NDCCode>73774-016-12</NDCCode><NonProprietaryName>Testosterone Cypionate</NonProprietaryName></NDC><NDC><NDCCode>79903-035-08</NDCCode><ProprietaryName>Allergy Relief</ProprietaryName><NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName></NDC><NDC><NDCCode>83511-035-12</NDCCode><NonProprietaryName>Methylnaltrexone Bromide</NonProprietaryName></NDC><NDC><NDCCode>84126-035-12</NDCCode><ProprietaryName>Old Spice Fiji Dry</ProprietaryName><NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName></NDC></NDCList>