{
"NDC": [
{
"NDCCode": "73006-201-53",
"PackageDescription": "50 CLOTH in 1 CANISTER (73006-201-53) ",
"NDC11Code": "73006-0201-53",
"ProductNDC": "73006-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Only For - Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200623",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "O4 Global Trading Usa, Llc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20211012",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "59448-201-00",
"PackageDescription": "1 KIT in 1 BAG (59448-201-00) * 53 mL in 1 BOTTLE, PLASTIC (59448-001-02) * 4.25 g in 1 TUBE",
"NDC11Code": "59448-0201-00",
"ProductNDC": "59448-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Northside Hospital Amenity Kit--gi Dept",
"NonProprietaryName": "Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20160118",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "ASP Global, LLc",
"Status": "Active",
"LastUpdate": "2024-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160118",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "71610-201-53",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-201-53) ",
"NDC11Code": "71610-0201-53",
"ProductNDC": "71610-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078791",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181203",
"SamplePackage": "N",
"IndicationAndUsage": "Divalproex sodium extended-release tablets are an anti-epileptic drug indicated for: 1 Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).",
"Description": "Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium occurs as a white powder with a characteristic odor. Divalproex sodium extended-release 250 mg and 500 mg tablets are for oral administration. Divalproex sodium extended-release tablets contain divalproex sodium in a once-a-day extended-release formulation equivalent to 250 mg and 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium extended-release 250 mg and 500 mg tablets: colloidal silicon dioxide, copovidone, dibasic calcium phosphate (anhydrous), hydrogenated vegetable oil, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, microcrystalline cellulose, stearic acid, and xantham gum. Meets USP Dissolution Test 9."
},
{
"NDCCode": "72835-201-02",
"PackageDescription": "1 KIT in 1 CARTON (72835-201-02) * 1 BOTTLE in 1 CARTON (60505-0399-5) / 150 mL in 1 BOTTLE * 1 TUBE in 1 CARTON (45802-174-53) / 85 g in 1 TUBE",
"NDC11Code": "72835-0201-02",
"ProductNDC": "72835-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varophen",
"NonProprietaryName": "Diclofenac Sodium And Menthol, Methyl Salicylate",
"DosageFormName": "KIT",
"StartMarketingDate": "20190603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202027",
"LabelerName": "V2 Pharma, LLC",
"Status": "Active",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190603",
"SamplePackage": "N",
"Description": "Diclofenac Sodium Topical Solution is a clear, colorless to yellow solution for topical application. Diclofenac sodium topical solution contains 1.5% w/w diclofenac sodium, a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug (NSAID), designated chemically as 2-[(2,6-dichlorophenyl)amino]-benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2 and it has the following structural formula. Each 1 mL of solution contains 16.05 mg of diclofenac sodium. In addition, diclofenac sodium topical solution contains the following inactive ingredients: alcohol, dimethyl sulfoxide USP (DMSO, 45.5% w/w), glycerin, propylene glycol, and purified water."
},
{
"NDCCode": "73006-201-10",
"PackageDescription": "10 SWAB in 1 PACKAGE (73006-201-10) ",
"NDC11Code": "73006-0201-10",
"ProductNDC": "73006-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Only For - Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "O4 Global Trading Usa, Llc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N"
},
{
"NDCCode": "73006-201-50",
"PackageDescription": "50 CLOTH in 1 PACKAGE (73006-201-50) ",
"NDC11Code": "73006-0201-50",
"ProductNDC": "73006-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Only For - Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200623",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "O4 Global Trading Usa, Llc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200623",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "73006-201-51",
"PackageDescription": "100 CLOTH in 1 CANISTER (73006-201-51) ",
"NDC11Code": "73006-0201-51",
"ProductNDC": "73006-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Only For - Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200623",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "O4 Global Trading Usa, Llc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "73006-201-52",
"PackageDescription": "50 CLOTH in 1 BAG (73006-201-52) ",
"NDC11Code": "73006-0201-52",
"ProductNDC": "73006-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Only For - Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200623",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "O4 Global Trading Usa, Llc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20211012",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "51655-320-53",
"PackageDescription": "10 TABLET in 1 BOTTLE, DISPENSING (51655-320-53)",
"NDC11Code": "51655-0320-53",
"ProductNDC": "51655-320",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088832",
"LabelerName": "Northwind Pharmaceuticals",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/201",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Prednisone Tablets, USP are indicated in the following conditions. Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic DiseasesPemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory DiseasesSymptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic DisordersIdiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic DiseasesFor palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone Tablets, USP of 20 mg strength contain anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. C21H26O5 M.W. 358.43Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol."
},
{
"NDCCode": "55150-201-20",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (55150-201-20) / 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55150-0201-20",
"ProductNDC": "55150-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL",
"StartMarketingDate": "20160915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205612",
"LabelerName": "Eugia US LLC",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160915",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.",
"Description": "Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride, USP is chemically described as S-(-)-1-propyl-2’,6’-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. ' C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "73069-024-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-024-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0024-53",
"ProductNDC": "73069-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-adipose",
"NonProprietaryName": "Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 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",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-035-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-035-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0035-53",
"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": "73069-037-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-037-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0037-53",
"ProductNDC": "73069-037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-articula",
"NonProprietaryName": "Anti-interleukin 1, Ankle Articulations, Beta Endorphin, Bfgf, Calcaneal Tendon, Hip Articulation, Knee Articulation, Liver, Transforming Growth Factor-1, Transforming Gf-beta",
"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; BOS TAURUS ANKLE JOINT; SUS SCROFA ANKLE JOINT; METENKEFALIN; ERSOFERMIN; BOS TAURUS ACHILLES TENDON; SUS SCROFA ACHILLES TENDON; BOS TAURUS HIP JOINT; SUS SCROFA HIP JOINT; BOS TAURUS KNEE JOINT; SUS SCROFA KNEE JOINT; BEEF LIVER; PORK LIVER; TRANSFORMING GROWTH FACTOR BETA-1; AVOTERMIN",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-081-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-081-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0081-53",
"ProductNDC": "73069-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-cellulite",
"NonProprietaryName": "Androsterone, Artichoke, Atp, Bfgf, Camp, L-carnitine, Centella Asiatica, Citric Acid, Cobalt, Estrogen, Ferrum Fumaricum, Fumaric Acid, Ginkgo, Hamamelis, Hyaluronidase, Il-3, Kalium Asparticum, Lactic Acid, Lymphatic Vessel, Melilotus, Mn, Natrum Oxalaceticum, Natrum Pyruvicum, Quinhydrone, Succinic Acid, Vein, Vitamin A And Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANDROSTERONE; ARTICHOKE; ADENOSINE TRIPHOSPHATE; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); ERSOFERMIN; ADENOSINE CYCLIC PHOSPHATE; LEVOCARNITINE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COBALT; ESTROGENS, ESTERIFIED; FERROUS FUMARATE; FUMARIC ACID; HEPTAMINOL; HAMAMELIS VIRGINIANA BARK; HYALURONIDASE; INTERLEUKIN-3; POTASSIUM ASPARTATE; LACTIC ACID; BOS TAURUS LYMPH VESSEL; SUS SCROFA LYMPH VESSEL; MELILOTUS OFFICINALIS WHOLE; MANGANESE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS VEIN; SUS SCROFA VEIN; VITAMIN A; ZINC",
"StrengthNumber": "31; 31; 31; 201; 201; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 201; 31; 31; 201; 201; 31; 31; 31; 31; 31; 31; 201; 201; 31; 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",
"Pharm_Classes": "Endoglycosidase [EPC],Glycoside Hydrolases [CS],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin A [CS],Vitamin A [EPC],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Vegetable Proteins [CS],Carnitine [CS],Carnitine Analog [EPC],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-095-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-095-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0095-53",
"ProductNDC": "73069-095",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-collagen",
"NonProprietaryName": "Pork Collagen",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "PORK COLLAGEN",
"StrengthNumber": "201",
"StrengthUnit": "[kp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-100-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-100-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0100-53",
"ProductNDC": "73069-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-connectissue",
"NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Ascorbic Acid, Metenkefalin, Ersofermin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Interleukin-3, Interleukin-3, Beef Liver, Pork Liver, Beef, Pork, Bos Taurus Tendon, Sus Scrofa Tendon, Cetermin",
"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; ASCORBIC ACID; BOS TAURUS RED BLOOD CELL; METENKEFALIN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); SUS SCROFA CARTILAGE; PORK COLLAGEN; SUS SCROFA RED BLOOD CELL; INTERLEUKIN-3; BEEF; PORK; BEEF LIVER; PORK LIVER; BOS TAURUS TENDON; SUS SCROFA TENDON; CETERMIN; BOS TAURUS CARTILAGE",
"StrengthNumber": "201; 31; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
"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",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-102-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-102-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0102-53",
"ProductNDC": "73069-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-mesenchyme",
"NonProprietaryName": "Adrenal, Ascorbic Acid, Bdnf, Dhea, Malic Acid, Bfgf, Fucus Vesiculosus, Histidine, Hyaluronidase, Il-6, Lactic Acid, Lymph Node, Mesenchyme, Nad, Natrum Oxalaceticum, Natrum Pyruvicum, Natrum Sulphuricum, Phenylalanine, Amino Acid, Pyrogenium, Thuja Occidentalis, Trichinoyl, Tyrosine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; PRASTERONE; MALIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); FUCUS VESICULOSUS; HISTIDINE; HYALURONIDASE; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); LACTIC ACID; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SUS SCROFA MESENCHYME; NADIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; PHENYLALANINE; PROLACTIN; RANCID BEEF; THUJA OCCIDENTALIS LEAF; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; TYROSINE",
"StrengthNumber": "201; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 201; 31; 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",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Endoglycosidase [EPC],Glycoside Hydrolases [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-164-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-164-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0164-53",
"ProductNDC": "73069-164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-facial",
"NonProprietaryName": "Adrenal, Collagen, Cutis, Diosorea, Epithelial Growth Factor, Erythrocytes, Fumaric Acid, Funiculus, Gingko, Hyaluronidase, Il 1 - Beta, Kalum Aspariticum, Multi B Vitamin Complex (b 1,2,3,5,6,9,12), Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Quinhydrone, Succinic Acid, Silicea And Trifolium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; PORK COLLAGEN; CUMINALDEHYDE; DIOSCOREA VILLOSA TUBER; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; FUMARIC ACID; SUS SCROFA UMBILICAL CORD; BOS TAURUS UMBILICAL CORD; GINKGO; HYALURONIDASE; POTASSIUM ASPARTATE; THIAMINE; RIBOFLAVIN; PANTOTHENIC ACID; PYRIDOXINE; CYANOCOBALAMIN; FOLIC ACID; PORK; BEEF; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; QUINHYDRONE; SUCCINIC ACID; SILICON DIOXIDE; RED CLOVER; INTERLEUKIN-1 .BETA. HUMAN; BOS TAURUS SKIN; SUS SCROFA SKIN; NIACIN",
"StrengthNumber": "31; 31; 201; 31; 31; 201; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 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",
"Pharm_Classes": "Endoglycosidase [EPC],Glycoside Hydrolases [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],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],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-206-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-206-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0206-53",
"ProductNDC": "73069-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-hair",
"NonProprietaryName": "Pantothenic Acid , Biotin , Estradiol , Pork Collagen , Estriol , Heptaminol , Interleukin-3 , Bos Taurus Pituitary Gland , Sus Scrofa Pituitary Gland , Progesterone , Saw Palmetto , Silicon Dioxide , Thyroid, Unspecified And Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "PANTOTHENIC ACID; BIOTIN; ESTRADIOL; PORK COLLAGEN; ESTRIOL; GINKGO; INTERLEUKIN-3; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; PROGESTERONE; SAW PALMETTO; SILICON DIOXIDE; THYROID, UNSPECIFIED; ZINC; BASIC FIBROBLAST GROWTH FACTOR (HUMAN)",
"StrengthNumber": "31; 31; 201; 201; 201; 31; 201; 201; 201; 201; 31; 201; 31; 31; 201",
"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",
"Pharm_Classes": "Progesterone [CS],Progesterone [EPC],Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-244-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-244-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0244-53",
"ProductNDC": "73069-244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-immunexx",
"NonProprietaryName": "Adrenal Gland, Ascorbic Acid, Bone Marrow, Erythrocytes, Granulocyte Colony-stimulating Factor, Interleukin 2, Interferon Gamma, Lymph Node, Peyers Patches, Thymus",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; ALDESLEUKIN; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCH; SUS SCROFA PEYER'S PATCH; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA SPLEEN; BOS TAURUS SPLEEN",
"StrengthNumber": "201; 201; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
"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",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC],Increased Lymphocyte Activation [PE],Increased Lymphocyte Cell Production [PE],Interleukin-2 [CS],Lymphocyte Growth Factor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-249-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-249-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0249-53",
"ProductNDC": "73069-249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-infla",
"NonProprietaryName": "Aconitum, Anti-interleukin-1, Apis, Adrenal, Belladonna, Beta Endorphin, Citric Acid, Coelliac Plexus, Bryonia, Interleukin-10, Mesenchyme, Natrum Pyruvicum, Pineal, Pituitary Gland, Pyrogenium, Transforming Growth Factor-1, Transforming Growth Factor-3",
"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; ACONITUM NAPELLUS; APIS MELLIFERA; BETA-ENDORPHIN HUMAN; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ATROPA BELLADONNA; CITRIC ACID MONOHYDRATE; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; BRYONIA ALBA ROOT; INTERLEUKIN-10; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; SODIUM PYRUVATE; BOS TAURUS PINEAL GLAND; SUS SCROFA PINEAL GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; RANCID BEEF; TRANSFORMING GROWTH FACTOR BETA-1; AVOTERMIN",
"StrengthNumber": "31; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 201; 201; 201; 31; 31; 31; 201; 201; 201; 31; 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",
"Pharm_Classes": "Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Bee Venoms [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-270-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-270-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0270-53",
"ProductNDC": "73069-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ithurts",
"NonProprietaryName": "Anti-interleukin-1.alpha. Apomorphine, Metenkefalin",
"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; APOMORPHINE; BETA-ENDORPHIN HUMAN",
"StrengthNumber": "201; 201; 201",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-300-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-300-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0300-53",
"ProductNDC": "73069-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-liver",
"NonProprietaryName": "Carduus Benedictus, Carduus Marianus, Ceanothus Americanus, Chelidonium Majus, Chionanthus Virginica, Choline, Coelliac Plexus, Duodenum, Fumaric Acid, Gall Bladder, Inositol, Il 4, Kalium Sulfuricum, Liver, Lycopodium Clavatum, Natrium Oxalaceticum, Natrium Pyruvicum, Natrium Sulphuricum, Niacin, Pancreas, Spleen, Taraxacum, Vein, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B6",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "CENTAUREA BENEDICTA; MILK THISTLE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHOLINE; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; BOS TAURUS DUODENUM; SUS SCROFA DUODENUM; FUMARIC ACID; BOS TAURUS GALLBLADDER; SUS SCROFA GALLBLADDER; INOSITOL; BINETRAKIN; POTASSIUM SULFATE; BEEF LIVER; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; NIACIN; BOS TAURUS PANCREAS; SUS SCROFA PANCREAS; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; TARAXACUM OFFICINALE; BOS TAURUS VEIN; SUS SCROFA VEIN; THIAMINE; CYANOCOBALAMIN; RIBOFLAVIN; PYRIDOXINE",
"StrengthNumber": "31; 31; 4; 31; 4; 31; 201; 201; 31; 31; 31; 31; 31; 31; 201; 31; 201; 201; 31; 31; 31; 31; 31; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-320-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-320-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0320-53",
"ProductNDC": "73069-320",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-male Plus",
"NonProprietaryName": "Adrenal Gland, Aldosterone, Androsterone, Camp / Adenosinum Cyclophosphoricum, Cholesterinum, Dhea, Growth Hormone, Hypothalamus, Melatonin, Pancreas, Pineal, Pituitary, Prostate, Testis, Testosterone, Thalamus, Thymus, Thyroid Gland",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ALDOSTERONE; ANDROSTERONE; ADENOSINE CYCLIC PHOSPHATE; CHOLESTEROL; PRASTERONE; SOMATROPIN; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; MELATONIN; BOS TAURUS PANCREAS; SUS SCROFA PANCREAS; BOS TAURUS PINEAL GLAND; SUS SCROFA PINEAL GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PROSTATE GLAND; SUS SCROFA PROSTATE; BOS TAURUS TESTICLE; SUS SCROFA TESTICLE; TESTOSTERONE; SUS SCROFA THALAMUS; BOS TAURUS THYMUS; THYROID, PORCINE; THYROID, BOVINE",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
"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",
"Pharm_Classes": "Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS],Recombinant Human Growth Hormone [EPC],Human Growth Hormone [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-347-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-347-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0347-53",
"ProductNDC": "73069-347",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-muskelneural",
"NonProprietaryName": "Anti-interleukin-1.alpha.",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; BOS TAURUS ANKLE JOINT; SUS SCROFA ANKLE JOINT; BOS TAURUS JOINT CAPSULE; SUS SCROFA JOINT CAPSULE; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BETA-ENDORPHIN HUMAN; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; CALCITONIN; SUS SCROFA FRONTAL LOBE; BOS TAURUS HIP JOINT; SUS SCROFA HIP JOINT; BOS TAURUS HIPPOCAMPUS; SUS SCROFA HIPPOCAMPUS; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; MECASERMIN RINFABATE; INTERLEUKIN-10; BEEF; PORK; BOS TAURUS NERVE; SUS SCROFA NERVE; BOS TAURUS SPINAL CORD; SUS SCROFA SPINAL CORD; BOS TAURUS SYMPATHETIC NERVE; SUS SCROFA SYMPATHETIC NERVE; TRANSFORMING GROWTH FACTOR BETA-1; BOS TAURUS FRONTAL LOBE",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
"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",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-373-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-373-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0373-53",
"ProductNDC": "73069-373",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-neuro 3",
"NonProprietaryName": "Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201",
"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",
"Pharm_Classes": "Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-375-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-375-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0375-53",
"ProductNDC": "73069-375",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-neuro",
"NonProprietaryName": "Dopamine, Ferrum Arsenicicum, Jequirity, Juniper Sabina, L-dopa, Melatonin, Rubia, Serotonin, Taurine, Upas Antiaris",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "DOPAMINE; FERROUS ARSENATE; ABRUS PRECATORIUS SEED; JUNIPERUS SABINA LEAF; LEVODOPA; MELATONIN; RUBIA TINCTORUM WHOLE; SEROTONIN; TAURINE; ANTIARIS TOXICARIA RESIN",
"StrengthNumber": "201; 31; 31; 31; 201; 201; 3; 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",
"Pharm_Classes": "Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-385-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-385-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0385-53",
"ProductNDC": "73069-385",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-osteo",
"NonProprietaryName": "Bone, Calcitonin, Cartilage, Erythrocytes, Interleukin 3, Parathyroid, Vitamin D",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS BONE; SUS SCROFA BONE; CALCITONIN; BOS TAURUS CARTILAGE; SUS SCROFA CARTILAGE; INTERLEUKIN-3; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; VITAMIN D",
"StrengthNumber": "201; 201; 201; 201; 201; 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",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-402-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-402-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0402-53",
"ProductNDC": "73069-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ouch",
"NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Apomorphine, Arnica Montana, Metenkefalin, Bryonia Alba Root, Hypericum Perforatum, Bos Taurus Hypothalamus, Sus Scrofa Hypothalamus, Bos Taurus Limbic System, Sus Scrofa Limbic System, Bos Taurus Nerve, Sus Scrofa Nerve, Bos Taurus Pituitary Gland, Sus Scrofa Pituitary Gland",
"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; APOMORPHINE; BRYONIA ALBA ROOT; BETA-ENDORPHIN HUMAN; ARNICA MONTANA; ST. JOHN'S WORT; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; BOS TAURUS LIMBIC SYSTEM; SUS SCROFA LIMBIC SYSTEM; BOS TAURUS NERVE; SUS SCROFA NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND",
"StrengthNumber": "31; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 31; 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",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-410-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-410-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0410-53",
"ProductNDC": "73069-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-pigmentation",
"NonProprietaryName": "Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN",
"StrengthNumber": "31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 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",
"Pharm_Classes": "Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
}
]
}
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
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<LabelerName>O4 Global Trading Usa, Llc</LabelerName>
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<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2023-01-03</LastUpdate>
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<IndicationAndUsage>For hand washing to decrease bacteria on the skin.</IndicationAndUsage>
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<PackageDescription>1 KIT in 1 BAG (59448-201-00) * 53 mL in 1 BOTTLE, PLASTIC (59448-001-02) * 4.25 g in 1 TUBE</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Northside Hospital Amenity Kit--gi Dept</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>ASP Global, LLc</LabelerName>
<Status>Active</Status>
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<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-201-53) </PackageDescription>
<NDC11Code>71610-0201-53</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Divalproex sodium extended-release tablets are an anti-epileptic drug indicated for: 1 Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1), 2 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2), 3 Prophylaxis of migraine headaches (1.3).</IndicationAndUsage>
<Description>Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure. Divalproex sodium occurs as a white powder with a characteristic odor. Divalproex sodium extended-release 250 mg and 500 mg tablets are for oral administration. Divalproex sodium extended-release tablets contain divalproex sodium in a once-a-day extended-release formulation equivalent to 250 mg and 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium extended-release 250 mg and 500 mg tablets: colloidal silicon dioxide, copovidone, dibasic calcium phosphate (anhydrous), hydrogenated vegetable oil, hypromellose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, microcrystalline cellulose, stearic acid, and xantham gum. Meets USP Dissolution Test 9.</Description>
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<NDC>
<NDCCode>72835-201-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (72835-201-02) * 1 BOTTLE in 1 CARTON (60505-0399-5) / 150 mL in 1 BOTTLE * 1 TUBE in 1 CARTON (45802-174-53) / 85 g in 1 TUBE</PackageDescription>
<NDC11Code>72835-0201-02</NDC11Code>
<ProductNDC>72835-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varophen</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Menthol, Methyl Salicylate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202027</ApplicationNumber>
<LabelerName>V2 Pharma, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Diclofenac Sodium Topical Solution is a clear, colorless to yellow solution for topical application. Diclofenac sodium topical solution contains 1.5% w/w diclofenac sodium, a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug (NSAID), designated chemically as 2-[(2,6-dichlorophenyl)amino]-benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2 and it has the following structural formula. Each 1 mL of solution contains 16.05 mg of diclofenac sodium. In addition, diclofenac sodium topical solution contains the following inactive ingredients: alcohol, dimethyl sulfoxide USP (DMSO, 45.5% w/w), glycerin, propylene glycol, and purified water.</Description>
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<NDC>
<NDCCode>73006-201-10</NDCCode>
<PackageDescription>10 SWAB in 1 PACKAGE (73006-201-10) </PackageDescription>
<NDC11Code>73006-0201-10</NDC11Code>
<ProductNDC>73006-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Only For - Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>O4 Global Trading Usa, Llc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>73006-201-50</NDCCode>
<PackageDescription>50 CLOTH in 1 PACKAGE (73006-201-50) </PackageDescription>
<NDC11Code>73006-0201-50</NDC11Code>
<ProductNDC>73006-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Only For - Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200623</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>O4 Global Trading Usa, Llc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand washing to decrease bacteria on the skin.</IndicationAndUsage>
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<NDC>
<NDCCode>73006-201-51</NDCCode>
<PackageDescription>100 CLOTH in 1 CANISTER (73006-201-51) </PackageDescription>
<NDC11Code>73006-0201-51</NDC11Code>
<ProductNDC>73006-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Only For - Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200623</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>O4 Global Trading Usa, Llc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand washing to decrease bacteria on the skin.</IndicationAndUsage>
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<NDC>
<NDCCode>73006-201-52</NDCCode>
<PackageDescription>50 CLOTH in 1 BAG (73006-201-52) </PackageDescription>
<NDC11Code>73006-0201-52</NDC11Code>
<ProductNDC>73006-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Only For - Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200623</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>O4 Global Trading Usa, Llc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51655-320-53</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, DISPENSING (51655-320-53)</PackageDescription>
<NDC11Code>51655-0320-53</NDC11Code>
<ProductNDC>51655-320</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088832</ApplicationNumber>
<LabelerName>Northwind Pharmaceuticals</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/201</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prednisone Tablets, USP are indicated in the following conditions. Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic DiseasesPemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory DiseasesSymptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis. Hematologic DisordersIdiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic DiseasesFor palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone Tablets, USP of 20 mg strength contain anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. C21H26O5 M.W. 358.43Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol.</Description>
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<NDCCode>55150-201-20</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (55150-201-20) / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55150-0201-20</NDC11Code>
<ProductNDC>55150-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL</RouteName>
<StartMarketingDate>20160915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205612</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine hydrochloride injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride, USP is chemically described as S-(-)-1-propyl-2’,6’-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula. ' C17H26N2OHClH2O M.W. 328.89. At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>73069-024-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-024-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0024-53</NDC11Code>
<ProductNDC>73069-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-adipose</ProprietaryName>
<NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>EPINEPHRINE; BOS TAURUS ARTERY; SUS SCROFA ARTERY; ADENOSINE TRIPHOSPHATE; ADENOSINE CYCLIC PHOSPHATE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COENZYME A; COLCHICUM AUTUMNALE BULB; FUMARIC ACID; INTERLEUKIN-10; LEVOCARNITINE; LACTIC ACID; PANCRELIPASE LIPASE; BEEF LIVER; PORK LIVER; SUS SCROFA LYMPH; BOS TAURUS LYMPH; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PITUITARY GLAND; BOS TAURUS PITUITARY GLAND; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS VEIN; SUS SCROFA VEIN; YOHIMBINE; FERROUS FUMARATE; MECASERMIN; POTASSIUM ASPARTATE; MOMORDICA BALSAMINA WHOLE</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 31; 201; 201; 31; 31; 201; 31; 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</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Carnitine [CS],Carnitine Analog [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-035-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-035-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0035-53</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>73069-037-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-037-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0037-53</NDC11Code>
<ProductNDC>73069-037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-articula</ProprietaryName>
<NonProprietaryName>Anti-interleukin 1, Ankle Articulations, Beta Endorphin, Bfgf, Calcaneal Tendon, Hip Articulation, Knee Articulation, Liver, Transforming Growth Factor-1, Transforming Gf-beta</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; BOS TAURUS ANKLE JOINT; SUS SCROFA ANKLE JOINT; METENKEFALIN; ERSOFERMIN; BOS TAURUS ACHILLES TENDON; SUS SCROFA ACHILLES TENDON; BOS TAURUS HIP JOINT; SUS SCROFA HIP JOINT; BOS TAURUS KNEE JOINT; SUS SCROFA KNEE JOINT; BEEF LIVER; PORK LIVER; TRANSFORMING GROWTH FACTOR BETA-1; AVOTERMIN</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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</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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-081-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-081-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0081-53</NDC11Code>
<ProductNDC>73069-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-cellulite</ProprietaryName>
<NonProprietaryName>Androsterone, Artichoke, Atp, Bfgf, Camp, L-carnitine, Centella Asiatica, Citric Acid, Cobalt, Estrogen, Ferrum Fumaricum, Fumaric Acid, Ginkgo, Hamamelis, Hyaluronidase, Il-3, Kalium Asparticum, Lactic Acid, Lymphatic Vessel, Melilotus, Mn, Natrum Oxalaceticum, Natrum Pyruvicum, Quinhydrone, Succinic Acid, Vein, Vitamin A And Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANDROSTERONE; ARTICHOKE; ADENOSINE TRIPHOSPHATE; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); ERSOFERMIN; ADENOSINE CYCLIC PHOSPHATE; LEVOCARNITINE; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COBALT; ESTROGENS, ESTERIFIED; FERROUS FUMARATE; FUMARIC ACID; HEPTAMINOL; HAMAMELIS VIRGINIANA BARK; HYALURONIDASE; INTERLEUKIN-3; POTASSIUM ASPARTATE; LACTIC ACID; BOS TAURUS LYMPH VESSEL; SUS SCROFA LYMPH VESSEL; MELILOTUS OFFICINALIS WHOLE; MANGANESE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; QUINHYDRONE; SUCCINIC ACID; BOS TAURUS VEIN; SUS SCROFA VEIN; VITAMIN A; ZINC</SubstanceName>
<StrengthNumber>31; 31; 31; 201; 201; 31; 31; 31; 31; 31; 201; 31; 31; 31; 31; 31; 201; 31; 31; 201; 201; 31; 31; 31; 31; 31; 31; 201; 201; 31; 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</StrengthUnit>
<Pharm_Classes>Endoglycosidase [EPC],Glycoside Hydrolases [CS],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin A [CS],Vitamin A [EPC],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Vegetable Proteins [CS],Carnitine [CS],Carnitine Analog [EPC],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<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>73069-095-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-095-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0095-53</NDC11Code>
<ProductNDC>73069-095</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-collagen</ProprietaryName>
<NonProprietaryName>Pork Collagen</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>PORK COLLAGEN</SubstanceName>
<StrengthNumber>201</StrengthNumber>
<StrengthUnit>[kp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-100-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-100-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0100-53</NDC11Code>
<ProductNDC>73069-100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-connectissue</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Ascorbic Acid, Metenkefalin, Ersofermin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Interleukin-3, Interleukin-3, Beef Liver, Pork Liver, Beef, Pork, Bos Taurus Tendon, Sus Scrofa Tendon, Cetermin</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; ASCORBIC ACID; BOS TAURUS RED BLOOD CELL; METENKEFALIN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); SUS SCROFA CARTILAGE; PORK COLLAGEN; SUS SCROFA RED BLOOD CELL; INTERLEUKIN-3; BEEF; PORK; BEEF LIVER; PORK LIVER; BOS TAURUS TENDON; SUS SCROFA TENDON; CETERMIN; BOS TAURUS CARTILAGE</SubstanceName>
<StrengthNumber>201; 31; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</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</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-102-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-102-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0102-53</NDC11Code>
<ProductNDC>73069-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-mesenchyme</ProprietaryName>
<NonProprietaryName>Adrenal, Ascorbic Acid, Bdnf, Dhea, Malic Acid, Bfgf, Fucus Vesiculosus, Histidine, Hyaluronidase, Il-6, Lactic Acid, Lymph Node, Mesenchyme, Nad, Natrum Oxalaceticum, Natrum Pyruvicum, Natrum Sulphuricum, Phenylalanine, Amino Acid, Pyrogenium, Thuja Occidentalis, Trichinoyl, Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; PRASTERONE; MALIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); FUCUS VESICULOSUS; HISTIDINE; HYALURONIDASE; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); LACTIC ACID; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SUS SCROFA MESENCHYME; NADIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; PHENYLALANINE; PROLACTIN; RANCID BEEF; THUJA OCCIDENTALIS LEAF; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; TYROSINE</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 201; 31; 31; 31; 201; 31; 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</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Endoglycosidase [EPC],Glycoside Hydrolases [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-164-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-164-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0164-53</NDC11Code>
<ProductNDC>73069-164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-facial</ProprietaryName>
<NonProprietaryName>Adrenal, Collagen, Cutis, Diosorea, Epithelial Growth Factor, Erythrocytes, Fumaric Acid, Funiculus, Gingko, Hyaluronidase, Il 1 - Beta, Kalum Aspariticum, Multi B Vitamin Complex (b 1,2,3,5,6,9,12), Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Quinhydrone, Succinic Acid, Silicea And Trifolium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; PORK COLLAGEN; CUMINALDEHYDE; DIOSCOREA VILLOSA TUBER; SUS SCROFA RED BLOOD CELL; BOS TAURUS RED BLOOD CELL; FUMARIC ACID; SUS SCROFA UMBILICAL CORD; BOS TAURUS UMBILICAL CORD; GINKGO; HYALURONIDASE; POTASSIUM ASPARTATE; THIAMINE; RIBOFLAVIN; PANTOTHENIC ACID; PYRIDOXINE; CYANOCOBALAMIN; FOLIC ACID; PORK; BEEF; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUS SCROFA PLACENTA; BOS TAURUS PLACENTA; QUINHYDRONE; SUCCINIC ACID; SILICON DIOXIDE; RED CLOVER; INTERLEUKIN-1 .BETA. HUMAN; BOS TAURUS SKIN; SUS SCROFA SKIN; NIACIN</SubstanceName>
<StrengthNumber>31; 31; 201; 31; 31; 201; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Endoglycosidase [EPC],Glycoside Hydrolases [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],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],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-206-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-206-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0206-53</NDC11Code>
<ProductNDC>73069-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-hair</ProprietaryName>
<NonProprietaryName>Pantothenic Acid , Biotin , Estradiol , Pork Collagen , Estriol , Heptaminol , Interleukin-3 , Bos Taurus Pituitary Gland , Sus Scrofa Pituitary Gland , Progesterone , Saw Palmetto , Silicon Dioxide , Thyroid, Unspecified And Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>PANTOTHENIC ACID; BIOTIN; ESTRADIOL; PORK COLLAGEN; ESTRIOL; GINKGO; INTERLEUKIN-3; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; PROGESTERONE; SAW PALMETTO; SILICON DIOXIDE; THYROID, UNSPECIFIED; ZINC; BASIC FIBROBLAST GROWTH FACTOR (HUMAN)</SubstanceName>
<StrengthNumber>31; 31; 201; 201; 201; 31; 201; 201; 201; 201; 31; 201; 31; 31; 201</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</StrengthUnit>
<Pharm_Classes>Progesterone [CS],Progesterone [EPC],Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-244-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-244-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0244-53</NDC11Code>
<ProductNDC>73069-244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-immunexx</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Ascorbic Acid, Bone Marrow, Erythrocytes, Granulocyte Colony-stimulating Factor, Interleukin 2, Interferon Gamma, Lymph Node, Peyers Patches, Thymus</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; ALDESLEUKIN; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCH; SUS SCROFA PEYER'S PATCH; BOS TAURUS THYMUS; SUS SCROFA THYMUS; SUS SCROFA SPLEEN; BOS TAURUS SPLEEN</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</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</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC],Increased Lymphocyte Activation [PE],Increased Lymphocyte Cell Production [PE],Interleukin-2 [CS],Lymphocyte Growth Factor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-249-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-249-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0249-53</NDC11Code>
<ProductNDC>73069-249</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-infla</ProprietaryName>
<NonProprietaryName>Aconitum, Anti-interleukin-1, Apis, Adrenal, Belladonna, Beta Endorphin, Citric Acid, Coelliac Plexus, Bryonia, Interleukin-10, Mesenchyme, Natrum Pyruvicum, Pineal, Pituitary Gland, Pyrogenium, Transforming Growth Factor-1, Transforming Growth Factor-3</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; ACONITUM NAPELLUS; APIS MELLIFERA; BETA-ENDORPHIN HUMAN; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ATROPA BELLADONNA; CITRIC ACID MONOHYDRATE; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; BRYONIA ALBA ROOT; INTERLEUKIN-10; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; SODIUM PYRUVATE; BOS TAURUS PINEAL GLAND; SUS SCROFA PINEAL GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; RANCID BEEF; TRANSFORMING GROWTH FACTOR BETA-1; AVOTERMIN</SubstanceName>
<StrengthNumber>31; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 201; 201; 201; 31; 31; 31; 201; 201; 201; 31; 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</StrengthUnit>
<Pharm_Classes>Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Bee Venoms [CS],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-270-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-270-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0270-53</NDC11Code>
<ProductNDC>73069-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ithurts</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha. Apomorphine, Metenkefalin</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; APOMORPHINE; BETA-ENDORPHIN HUMAN</SubstanceName>
<StrengthNumber>201; 201; 201</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-300-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-300-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0300-53</NDC11Code>
<ProductNDC>73069-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-liver</ProprietaryName>
<NonProprietaryName>Carduus Benedictus, Carduus Marianus, Ceanothus Americanus, Chelidonium Majus, Chionanthus Virginica, Choline, Coelliac Plexus, Duodenum, Fumaric Acid, Gall Bladder, Inositol, Il 4, Kalium Sulfuricum, Liver, Lycopodium Clavatum, Natrium Oxalaceticum, Natrium Pyruvicum, Natrium Sulphuricum, Niacin, Pancreas, Spleen, Taraxacum, Vein, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B6</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>CENTAUREA BENEDICTA; MILK THISTLE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHOLINE; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; BOS TAURUS DUODENUM; SUS SCROFA DUODENUM; FUMARIC ACID; BOS TAURUS GALLBLADDER; SUS SCROFA GALLBLADDER; INOSITOL; BINETRAKIN; POTASSIUM SULFATE; BEEF LIVER; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; NIACIN; BOS TAURUS PANCREAS; SUS SCROFA PANCREAS; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; TARAXACUM OFFICINALE; BOS TAURUS VEIN; SUS SCROFA VEIN; THIAMINE; CYANOCOBALAMIN; RIBOFLAVIN; PYRIDOXINE</SubstanceName>
<StrengthNumber>31; 31; 4; 31; 4; 31; 201; 201; 31; 31; 31; 31; 31; 31; 201; 31; 201; 201; 31; 31; 31; 31; 31; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-320-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-320-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0320-53</NDC11Code>
<ProductNDC>73069-320</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-male Plus</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Aldosterone, Androsterone, Camp / Adenosinum Cyclophosphoricum, Cholesterinum, Dhea, Growth Hormone, Hypothalamus, Melatonin, Pancreas, Pineal, Pituitary, Prostate, Testis, Testosterone, Thalamus, Thymus, Thyroid Gland</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ALDOSTERONE; ANDROSTERONE; ADENOSINE CYCLIC PHOSPHATE; CHOLESTEROL; PRASTERONE; SOMATROPIN; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; MELATONIN; BOS TAURUS PANCREAS; SUS SCROFA PANCREAS; BOS TAURUS PINEAL GLAND; SUS SCROFA PINEAL GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PROSTATE GLAND; SUS SCROFA PROSTATE; BOS TAURUS TESTICLE; SUS SCROFA TESTICLE; TESTOSTERONE; SUS SCROFA THALAMUS; BOS TAURUS THYMUS; THYROID, PORCINE; THYROID, BOVINE</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</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</StrengthUnit>
<Pharm_Classes>Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS],Recombinant Human Growth Hormone [EPC],Human Growth Hormone [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-347-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-347-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0347-53</NDC11Code>
<ProductNDC>73069-347</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-muskelneural</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha.</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; BOS TAURUS ANKLE JOINT; SUS SCROFA ANKLE JOINT; BOS TAURUS JOINT CAPSULE; SUS SCROFA JOINT CAPSULE; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BETA-ENDORPHIN HUMAN; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; CALCITONIN; SUS SCROFA FRONTAL LOBE; BOS TAURUS HIP JOINT; SUS SCROFA HIP JOINT; BOS TAURUS HIPPOCAMPUS; SUS SCROFA HIPPOCAMPUS; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; MECASERMIN RINFABATE; INTERLEUKIN-10; BEEF; PORK; BOS TAURUS NERVE; SUS SCROFA NERVE; BOS TAURUS SPINAL CORD; SUS SCROFA SPINAL CORD; BOS TAURUS SYMPATHETIC NERVE; SUS SCROFA SYMPATHETIC NERVE; TRANSFORMING GROWTH FACTOR BETA-1; BOS TAURUS FRONTAL LOBE</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</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</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],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-373-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-373-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0373-53</NDC11Code>
<ProductNDC>73069-373</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-neuro 3</ProprietaryName>
<NonProprietaryName>Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201</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</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS],Vasodilation [PE],Vasodilator [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-375-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-375-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0375-53</NDC11Code>
<ProductNDC>73069-375</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-neuro</ProprietaryName>
<NonProprietaryName>Dopamine, Ferrum Arsenicicum, Jequirity, Juniper Sabina, L-dopa, Melatonin, Rubia, Serotonin, Taurine, Upas Antiaris</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>DOPAMINE; FERROUS ARSENATE; ABRUS PRECATORIUS SEED; JUNIPERUS SABINA LEAF; LEVODOPA; MELATONIN; RUBIA TINCTORUM WHOLE; SEROTONIN; TAURINE; ANTIARIS TOXICARIA RESIN</SubstanceName>
<StrengthNumber>201; 31; 31; 31; 201; 201; 3; 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</StrengthUnit>
<Pharm_Classes>Catecholamine [EPC],Catecholamines [CS],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-385-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-385-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0385-53</NDC11Code>
<ProductNDC>73069-385</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-osteo</ProprietaryName>
<NonProprietaryName>Bone, Calcitonin, Cartilage, Erythrocytes, Interleukin 3, Parathyroid, Vitamin D</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS BONE; SUS SCROFA BONE; CALCITONIN; BOS TAURUS CARTILAGE; SUS SCROFA CARTILAGE; INTERLEUKIN-3; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; VITAMIN D</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 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</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-402-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-402-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0402-53</NDC11Code>
<ProductNDC>73069-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ouch</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Apomorphine, Arnica Montana, Metenkefalin, Bryonia Alba Root, Hypericum Perforatum, Bos Taurus Hypothalamus, Sus Scrofa Hypothalamus, Bos Taurus Limbic System, Sus Scrofa Limbic System, Bos Taurus Nerve, Sus Scrofa Nerve, Bos Taurus Pituitary Gland, Sus Scrofa Pituitary Gland</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; APOMORPHINE; BRYONIA ALBA ROOT; BETA-ENDORPHIN HUMAN; ARNICA MONTANA; ST. JOHN'S WORT; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; BOS TAURUS LIMBIC SYSTEM; SUS SCROFA LIMBIC SYSTEM; BOS TAURUS NERVE; SUS SCROFA NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 31; 31; 31; 31; 201; 201; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-410-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-410-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0410-53</NDC11Code>
<ProductNDC>73069-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-pigmentation</ProprietaryName>
<NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 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</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>
<NDCList><NDC><NDCCode>73006-201-53</NDCCode><ProprietaryName>Only For - Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>59448-201-00</NDCCode><ProprietaryName>Northside Hospital Amenity Kit--gi Dept</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>71610-201-53</NDCCode><ProprietaryName>Divalproex Sodium</ProprietaryName><NonProprietaryName>Divalproex Sodium</NonProprietaryName></NDC><NDC><NDCCode>72835-201-02</NDCCode><ProprietaryName>Varophen</ProprietaryName><NonProprietaryName>Diclofenac Sodium And Menthol, Methyl Salicylate</NonProprietaryName></NDC><NDC><NDCCode>73006-201-10</NDCCode><ProprietaryName>Only For - Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>73006-201-50</NDCCode><ProprietaryName>Only For - Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>73006-201-51</NDCCode><ProprietaryName>Only For - Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>73006-201-52</NDCCode><ProprietaryName>Only For - Wipes</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>51655-320-53</NDCCode><ProprietaryName>Prednisone</ProprietaryName><NonProprietaryName>Prednisone</NonProprietaryName></NDC><NDC><NDCCode>55150-201-20</NDCCode><ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName><NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>73069-024-53</NDCCode><ProprietaryName>Viatrexx-adipose</ProprietaryName><NonProprietaryName>Epinephrine , Artery , Metenkefalin , Adenosine Triphosphate , Adenosine Cyclic Phosphate , Centella Asiatica , Citric Acid Monohydrate , Coenzyme A , Colchicum Autumnale Bulb , Fumaric Acid , Interleukin-10 , Levocarnitine , Lactic Acid , Pancrelipase Lipase , Liver , Lymph, Sodium Diethyl Oxalacetate , Sodium Pyruvate , Pituitary Gland, Quinhydrone , Succinic Acid , Parathyroid Gland, Vein, Yohimbine, Ferrous Fumarate, Mecasermin, Potassium Aspartate And Momordica Balsamina Whole</NonProprietaryName></NDC><NDC><NDCCode>73069-035-53</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>73069-037-53</NDCCode><ProprietaryName>Viatrexx-articula</ProprietaryName><NonProprietaryName>Anti-interleukin 1, Ankle Articulations, Beta Endorphin, Bfgf, Calcaneal Tendon, Hip Articulation, Knee Articulation, Liver, Transforming Growth Factor-1, Transforming Gf-beta</NonProprietaryName></NDC><NDC><NDCCode>73069-081-53</NDCCode><ProprietaryName>Viatrexx-cellulite</ProprietaryName><NonProprietaryName>Androsterone, Artichoke, Atp, Bfgf, Camp, L-carnitine, Centella Asiatica, Citric Acid, Cobalt, Estrogen, Ferrum Fumaricum, Fumaric Acid, Ginkgo, Hamamelis, Hyaluronidase, Il-3, Kalium Asparticum, Lactic Acid, Lymphatic Vessel, Melilotus, Mn, Natrum Oxalaceticum, Natrum Pyruvicum, Quinhydrone, Succinic Acid, Vein, Vitamin A And Zinc</NonProprietaryName></NDC><NDC><NDCCode>73069-095-53</NDCCode><ProprietaryName>Viatrexx-collagen</ProprietaryName><NonProprietaryName>Pork Collagen</NonProprietaryName></NDC><NDC><NDCCode>73069-100-53</NDCCode><ProprietaryName>Viatrexx-connectissue</ProprietaryName><NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Ascorbic Acid, Metenkefalin, Ersofermin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Interleukin-3, Interleukin-3, Beef Liver, Pork Liver, Beef, Pork, Bos Taurus Tendon, Sus Scrofa Tendon, Cetermin</NonProprietaryName></NDC><NDC><NDCCode>73069-102-53</NDCCode><ProprietaryName>Viatrexx-mesenchyme</ProprietaryName><NonProprietaryName>Adrenal, Ascorbic Acid, Bdnf, Dhea, Malic Acid, Bfgf, Fucus Vesiculosus, Histidine, Hyaluronidase, Il-6, Lactic Acid, Lymph Node, Mesenchyme, Nad, Natrum Oxalaceticum, Natrum Pyruvicum, Natrum Sulphuricum, Phenylalanine, Amino Acid, Pyrogenium, Thuja Occidentalis, Trichinoyl, Tyrosine</NonProprietaryName></NDC><NDC><NDCCode>73069-164-53</NDCCode><ProprietaryName>Viatrexx-facial</ProprietaryName><NonProprietaryName>Adrenal, Collagen, Cutis, Diosorea, Epithelial Growth Factor, Erythrocytes, Fumaric Acid, Funiculus, Gingko, Hyaluronidase, Il 1 - Beta, Kalum Aspariticum, Multi B Vitamin Complex (b 1,2,3,5,6,9,12), Muscle, Natrum Oxalaceticum, Natrum Pyruvicum, Placenta, Quinhydrone, Succinic Acid, Silicea And Trifolium</NonProprietaryName></NDC><NDC><NDCCode>73069-206-53</NDCCode><ProprietaryName>Viatrexx-hair</ProprietaryName><NonProprietaryName>Pantothenic Acid , Biotin , Estradiol , Pork Collagen , Estriol , Heptaminol , Interleukin-3 , Bos Taurus Pituitary Gland , Sus Scrofa Pituitary Gland , Progesterone , Saw Palmetto , Silicon Dioxide , Thyroid, Unspecified And Zinc</NonProprietaryName></NDC><NDC><NDCCode>73069-244-53</NDCCode><ProprietaryName>Viatrexx-immunexx</ProprietaryName><NonProprietaryName>Adrenal Gland, Ascorbic Acid, Bone Marrow, Erythrocytes, Granulocyte Colony-stimulating Factor, Interleukin 2, Interferon Gamma, Lymph Node, Peyers Patches, Thymus</NonProprietaryName></NDC><NDC><NDCCode>73069-249-53</NDCCode><ProprietaryName>Viatrexx-infla</ProprietaryName><NonProprietaryName>Aconitum, Anti-interleukin-1, Apis, Adrenal, Belladonna, Beta Endorphin, Citric Acid, Coelliac Plexus, Bryonia, Interleukin-10, Mesenchyme, Natrum Pyruvicum, Pineal, Pituitary Gland, Pyrogenium, Transforming Growth Factor-1, Transforming Growth Factor-3</NonProprietaryName></NDC><NDC><NDCCode>73069-270-53</NDCCode><ProprietaryName>Viatrexx-ithurts</ProprietaryName><NonProprietaryName>Anti-interleukin-1.alpha. Apomorphine, Metenkefalin</NonProprietaryName></NDC><NDC><NDCCode>73069-300-53</NDCCode><ProprietaryName>Viatrexx-liver</ProprietaryName><NonProprietaryName>Carduus Benedictus, Carduus Marianus, Ceanothus Americanus, Chelidonium Majus, Chionanthus Virginica, Choline, Coelliac Plexus, Duodenum, Fumaric Acid, Gall Bladder, Inositol, Il 4, Kalium Sulfuricum, Liver, Lycopodium Clavatum, Natrium Oxalaceticum, Natrium Pyruvicum, Natrium Sulphuricum, Niacin, Pancreas, Spleen, Taraxacum, Vein, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B6</NonProprietaryName></NDC><NDC><NDCCode>73069-320-53</NDCCode><ProprietaryName>Viatrexx-male Plus</ProprietaryName><NonProprietaryName>Adrenal Gland, Aldosterone, Androsterone, Camp / Adenosinum Cyclophosphoricum, Cholesterinum, Dhea, Growth Hormone, Hypothalamus, Melatonin, Pancreas, Pineal, Pituitary, Prostate, Testis, Testosterone, Thalamus, Thymus, Thyroid Gland</NonProprietaryName></NDC><NDC><NDCCode>73069-347-53</NDCCode><ProprietaryName>Viatrexx-muskelneural</ProprietaryName><NonProprietaryName>Anti-interleukin-1.alpha.</NonProprietaryName></NDC><NDC><NDCCode>73069-373-53</NDCCode><ProprietaryName>Viatrexx-neuro 3</ProprietaryName><NonProprietaryName>Oxitriptan, Acetylcholinesterase Human, Choline Chloride, Dopamine, Glutamic Acid, Glycine, Histidine, Levodopa, Malvin, Melanin Synthetic (tyrosine, Peroxide), Nitric Oxide, Norepinephrine, Octopamine, O-methyl Serotonin, Phenylalanine, Serotonin, Taurine, Tryptophan, Tyrosine</NonProprietaryName></NDC><NDC><NDCCode>73069-375-53</NDCCode><ProprietaryName>Viatrexx-neuro</ProprietaryName><NonProprietaryName>Dopamine, Ferrum Arsenicicum, Jequirity, Juniper Sabina, L-dopa, Melatonin, Rubia, Serotonin, Taurine, Upas Antiaris</NonProprietaryName></NDC><NDC><NDCCode>73069-385-53</NDCCode><ProprietaryName>Viatrexx-osteo</ProprietaryName><NonProprietaryName>Bone, Calcitonin, Cartilage, Erythrocytes, Interleukin 3, Parathyroid, Vitamin D</NonProprietaryName></NDC><NDC><NDCCode>73069-402-53</NDCCode><ProprietaryName>Viatrexx-ouch</ProprietaryName><NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Apomorphine, Arnica Montana, Metenkefalin, Bryonia Alba Root, Hypericum Perforatum, Bos Taurus Hypothalamus, Sus Scrofa Hypothalamus, Bos Taurus Limbic System, Sus Scrofa Limbic System, Bos Taurus Nerve, Sus Scrofa Nerve, Bos Taurus Pituitary Gland, Sus Scrofa Pituitary Gland</NonProprietaryName></NDC><NDC><NDCCode>73069-410-53</NDCCode><ProprietaryName>Viatrexx-pigmentation</ProprietaryName><NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName></NDC></NDCList>