{
"NDC": [
{
"NDCCode": "43547-525-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (43547-525-50) ",
"NDC11Code": "43547-0525-50",
"ProductNDC": "43547-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212682",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "NEBIVOLOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220214",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg)."
},
{
"NDCCode": "43547-525-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (43547-525-03) ",
"NDC11Code": "43547-0525-03",
"ProductNDC": "43547-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212682",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "NEBIVOLOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220214",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg)."
},
{
"NDCCode": "43547-525-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (43547-525-09) ",
"NDC11Code": "43547-0525-09",
"ProductNDC": "43547-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212682",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "NEBIVOLOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220214",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg)."
},
{
"NDCCode": "50268-525-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-525-15) / 1 TABLET in 1 BLISTER PACK (50268-525-11) ",
"NDC11Code": "50268-0525-15",
"ProductNDC": "50268-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077918",
"LabelerName": "AvPAK",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121009",
"SamplePackage": "N",
"Description": "Meloxicam Tablets are a nonsteroidal anti-inflammatory drug (NSAID). Each pastel yellow Meloxicam Tablets contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam Tablets are available as tablets for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam Tablets include Colloidal Silicon Dioxide, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Povidone K-30, and Sodium Citrate."
},
{
"NDCCode": "54312-525-16",
"PackageDescription": "1 TUBE in 1 PACKAGE (54312-525-16) / 50 g in 1 TUBE",
"NDC11Code": "54312-0525-16",
"ProductNDC": "54312-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitacilina Bebe Diaper Rash",
"NonProprietaryName": "Allantoin, Zinc Oxide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130930",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Compania Internacional de Comercio, S.A.P.I de C.V.",
"SubstanceName": "ALLANTOIN; ZINC OXIDE",
"StrengthNumber": "10; 250",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130930",
"SamplePackage": "N",
"IndicationAndUsage": " Helps treat and prevent diaper rash Protects against minor skin irritation associated with diaper rash Helps seal out wetness."
},
{
"NDCCode": "54860-525-01",
"PackageDescription": "50 mL in 1 BOTTLE, SPRAY (54860-525-01) ",
"NDC11Code": "54860-0525-01",
"ProductNDC": "54860-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Care Luxury Hand Sanitizer Cashmere Char",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251019",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Shenzhen Lantern Scicence Co.,Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251019",
"SamplePackage": "Y",
"IndicationAndUsage": "Adults and children 6 years and older Spray onto hands and rub together unil dry. Recommended for repeat use. Children under 6 years of age should be supervised when using this product."
},
{
"NDCCode": "58411-525-60",
"PackageDescription": "1 TUBE in 1 CARTON (58411-525-60) > 50 mL in 1 TUBE",
"NDC11Code": "58411-0525-60",
"ProductNDC": "58411-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laura Mercier Tinted Moisturizer Broad Spectrum Spf 30 Sunscreen - 4c1 Almond",
"NonProprietaryName": "Avobenzone, Octinoxate, Oxybenzone, And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Laura Mercier Cosmetics",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OXYBENZONE; OCTOCRYLENE",
"StrengthNumber": "1.25; 3.745; .5; 1",
"StrengthUnit": "g/50mL; g/50mL; g/50mL; g/50mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N"
},
{
"NDCCode": "59726-525-50",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (59726-525-50) > 50 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "59726-0525-50",
"ProductNDC": "59726-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Headache Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen, Aspirin, Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160630",
"EndMarketingDate": "20240628",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "P & L Development, LLC",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160630",
"EndMarketingDatePackage": "20240628",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps."
},
{
"NDCCode": "63776-525-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-525-15) > 50 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0525-15",
"ProductNDC": "63776-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thyro",
"NonProprietaryName": "Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Fucus Vesiculosus, Iodine, Iridium, Bos Taurus Parathyroid Gland, Sus Scrofa Parathyroid Gland, Bos Taurus Pituitary Gland, Sus Scrofa Pituitary Gland, Bos Taurus Spleen, Sus Scrofa Spleen, Spongia Officinalis Whole, Bos Taurus Thymus, Sus Scrofa Thymus, Thyroid, Bovine, Thyroid, Porcine, Levothyroxine, Liothyronine",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BOS TAURUS ADRENAL GLAND; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; FUCUS VESICULOSUS; IODINE; IRIDIUM; LEVOTHYROXINE; LIOTHYRONINE; SPONGIA OFFICINALIS WHOLE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PARATHYROID GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE",
"StrengthNumber": "200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200",
"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": "Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "To help support the structure & function of the thyroid."
},
{
"NDCCode": "68001-525-27",
"PackageDescription": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68001-525-27) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "68001-0525-27",
"ProductNDC": "68001-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluorouracil",
"NonProprietaryName": "Fluorouracil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210124",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "FLUOROURACIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220218",
"SamplePackage": "N",
"Description": "Fluorouracil injection USP, a nucleoside metabolic inhibitor, is a colorless to faint yellow, aqueous, sterile, nonpyrogenic injectable solution available in 50 mL and 100 mL pharmacy bulk package, a sterile preparation that contains doses for multiple patients for intravenous administration. Each mL contains 50 mg fluorouracil in water for injection, USP. The pH is adjusted to approximately 9.2 with sodium hydroxide. Chemically, fluorouracil, a fluorinated pyrimidine, is 5-fluoro-2,4 (1H,3H)-pyrimidinedione. Its structural formula is. Molecular formula: C 4H 3FN 2O2 Molecular weight : 130.08 g/mole."
},
{
"NDCCode": "69101-525-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (69101-525-50) ",
"NDC11Code": "69101-0525-50",
"ProductNDC": "69101-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Conjupri",
"NonProprietaryName": "Levamlodipine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200901",
"EndMarketingDate": "20220811",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212895",
"LabelerName": "Burke Therapeutics, LLC",
"SubstanceName": "LEVAMLODIPINE MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200901",
"EndMarketingDatePackage": "20220811",
"SamplePackage": "N"
},
{
"NDCCode": "69842-525-50",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (69842-525-50) / 50 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "69842-0525-50",
"ProductNDC": "69842-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Headache Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen, Aspirin, Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171231",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171231",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps."
},
{
"NDCCode": "71780-525-50",
"PackageDescription": "1 TUBE in 1 CARTON (71780-525-50) / 50 g in 1 TUBE",
"NDC11Code": "71780-0525-50",
"ProductNDC": "71780-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laspa Tinted Matte Sunscreen Spf 20 Deep Umber",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211011",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "The Green Cricket Inc",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211011",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "71919-525-09",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-525-09) ",
"NDC11Code": "71919-0525-09",
"ProductNDC": "71919-525",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Penthorum Sedoides",
"NonProprietaryName": "Penthorum Sedoides",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "PENTHORUM SEDOIDES",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110401",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-18",
"PackageDescription": "50 VIAL, MULTI-DOSE in 1 BOX (73069-525-18) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-18",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-28",
"PackageDescription": "50 VIAL, MULTI-DOSE in 1 BOX (73069-525-28) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-28",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-38",
"PackageDescription": "50 VIAL, MULTI-DOSE in 1 BOX (73069-525-38) > 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-38",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-48",
"PackageDescription": "50 VIAL, MULTI-DOSE in 1 BOX (73069-525-48) > 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-48",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-58",
"PackageDescription": "50 VIAL, MULTI-DOSE in 1 BOX (73069-525-58) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-58",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-68",
"PackageDescription": "50 VIAL, MULTI-DOSE in 1 BOX (73069-525-68) > 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-68",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-71",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (73069-525-71) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-71",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-72",
"PackageDescription": "3 VIAL, MULTI-DOSE in 1 BOX (73069-525-72) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-72",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-73",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-525-73) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-73",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-74",
"PackageDescription": "6 VIAL, MULTI-DOSE in 1 BOX (73069-525-74) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-74",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-75",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 BOX (73069-525-75) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-75",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-76",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-525-76) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-76",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-77",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-525-77) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-77",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-78",
"PackageDescription": "50 VIAL, MULTI-DOSE in 1 BOX (73069-525-78) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-78",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-79",
"PackageDescription": "100 VIAL, MULTI-DOSE in 1 BOX (73069-525-79) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-79",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-525-88",
"PackageDescription": "50 VIAL, MULTI-DOSE in 1 BOX (73069-525-88) > 100 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0525-88",
"ProductNDC": "73069-525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-thyro",
"NonProprietaryName": "Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)",
"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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND",
"StrengthNumber": "201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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": "l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
}
]
}
{"NDC":[{"NDCCode":"43547-525-50","ProprietaryName":"Nebivolol","NonProprietaryName":"Nebivolol"},{"NDCCode":"43547-525-03","ProprietaryName":"Nebivolol","NonProprietaryName":"Nebivolol"},{"NDCCode":"43547-525-09","ProprietaryName":"Nebivolol","NonProprietaryName":"Nebivolol"},{"NDCCode":"50268-525-15","ProprietaryName":"Meloxicam","NonProprietaryName":"Meloxicam"},{"NDCCode":"54312-525-16","ProprietaryName":"Vitacilina Bebe Diaper Rash","NonProprietaryName":"Allantoin, Zinc Oxide"},{"NDCCode":"54860-525-01","ProprietaryName":"Smart Care Luxury Hand Sanitizer Cashmere Char","NonProprietaryName":"Alcohol"},{"NDCCode":"58411-525-60","ProprietaryName":"Laura Mercier Tinted Moisturizer Broad Spectrum Spf 30 Sunscreen - 4c1 Almond","NonProprietaryName":"Avobenzone, Octinoxate, Oxybenzone, And Octocrylene"},{"NDCCode":"59726-525-50","ProprietaryName":"Headache Relief","NonProprietaryName":"Acetaminophen, Aspirin, Caffeine"},{"NDCCode":"63776-525-15","ProprietaryName":"Thyro","NonProprietaryName":"Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Fucus Vesiculosus, Iodine, Iridium, Bos Taurus Parathyroid Gland, Sus Scrofa Parathyroid Gland, Bos Taurus Pituitary Gland, Sus Scrofa Pituitary Gland, Bos Taurus Spleen, Sus Scrofa Spleen, Spongia Officinalis Whole, Bos Taurus Thymus, Sus Scrofa Thymus, Thyroid, Bovine, Thyroid, Porcine, Levothyroxine, Liothyronine"},{"NDCCode":"68001-525-27","ProprietaryName":"Fluorouracil","NonProprietaryName":"Fluorouracil"},{"NDCCode":"69101-525-50","ProprietaryName":"Conjupri","NonProprietaryName":"Levamlodipine"},{"NDCCode":"69842-525-50","ProprietaryName":"Headache Relief","NonProprietaryName":"Acetaminophen, Aspirin, Caffeine"},{"NDCCode":"71780-525-50","ProprietaryName":"Laspa Tinted Matte Sunscreen Spf 20 Deep Umber","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"71919-525-09","ProprietaryName":"Penthorum Sedoides","NonProprietaryName":"Penthorum Sedoides"},{"NDCCode":"73069-525-18","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-28","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-38","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-48","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-58","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-68","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-71","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-72","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-73","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-74","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-75","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-76","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-77","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-78","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-79","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"},{"NDCCode":"73069-525-88","ProprietaryName":"Viatrexx-thyro","NonProprietaryName":"Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)"}]}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>43547-525-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43547-525-50) </PackageDescription>
<NDC11Code>43547-0525-50</NDC11Code>
<ProductNDC>43547-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212682</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>NEBIVOLOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg).</Description>
</NDC>
<NDC>
<NDCCode>43547-525-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43547-525-03) </PackageDescription>
<NDC11Code>43547-0525-03</NDC11Code>
<ProductNDC>43547-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212682</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>NEBIVOLOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg).</Description>
</NDC>
<NDC>
<NDCCode>43547-525-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (43547-525-09) </PackageDescription>
<NDC11Code>43547-0525-09</NDC11Code>
<ProductNDC>43547-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212682</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>NEBIVOLOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, pregelatinized starch, sodium lauryl sulfate, D&C Red No. 27 Aluminum Lake (10 mg), FD&C Blue No. 2 Aluminum Lake (2.5 mg and 20 mg), and FD&C Yellow No. 6 Aluminum Lake (5 mg).</Description>
</NDC>
<NDC>
<NDCCode>50268-525-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-525-15) / 1 TABLET in 1 BLISTER PACK (50268-525-11) </PackageDescription>
<NDC11Code>50268-0525-15</NDC11Code>
<ProductNDC>50268-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077918</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Meloxicam Tablets are a nonsteroidal anti-inflammatory drug (NSAID). Each pastel yellow Meloxicam Tablets contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam Tablets are available as tablets for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam Tablets include Colloidal Silicon Dioxide, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Povidone K-30, and Sodium Citrate.</Description>
</NDC>
<NDC>
<NDCCode>54312-525-16</NDCCode>
<PackageDescription>1 TUBE in 1 PACKAGE (54312-525-16) / 50 g in 1 TUBE</PackageDescription>
<NDC11Code>54312-0525-16</NDC11Code>
<ProductNDC>54312-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitacilina Bebe Diaper Rash</ProprietaryName>
<NonProprietaryName>Allantoin, Zinc Oxide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130930</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Compania Internacional de Comercio, S.A.P.I de C.V.</LabelerName>
<SubstanceName>ALLANTOIN; ZINC OXIDE</SubstanceName>
<StrengthNumber>10; 250</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Helps treat and prevent diaper rash Protects against minor skin irritation associated with diaper rash Helps seal out wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54860-525-01</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, SPRAY (54860-525-01) </PackageDescription>
<NDC11Code>54860-0525-01</NDC11Code>
<ProductNDC>54860-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Care Luxury Hand Sanitizer Cashmere Char</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251019</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Shenzhen Lantern Scicence Co.,Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251019</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Adults and children 6 years and older Spray onto hands and rub together unil dry. Recommended for repeat use. Children under 6 years of age should be supervised when using this product.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58411-525-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-525-60) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0525-60</NDC11Code>
<ProductNDC>58411-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laura Mercier Tinted Moisturizer Broad Spectrum Spf 30 Sunscreen - 4c1 Almond</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate, Oxybenzone, And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Laura Mercier Cosmetics</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OXYBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1.25; 3.745; .5; 1</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL; g/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59726-525-50</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (59726-525-50) > 50 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>59726-0525-50</NDC11Code>
<ProductNDC>59726-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Headache Relief</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin, Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160630</StartMarketingDate>
<EndMarketingDate>20240628</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>P & L Development, LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160630</StartMarketingDatePackage>
<EndMarketingDatePackage>20240628</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-525-15</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-525-15) > 50 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0525-15</NDC11Code>
<ProductNDC>63776-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thyro</ProprietaryName>
<NonProprietaryName>Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Fucus Vesiculosus, Iodine, Iridium, Bos Taurus Parathyroid Gland, Sus Scrofa Parathyroid Gland, Bos Taurus Pituitary Gland, Sus Scrofa Pituitary Gland, Bos Taurus Spleen, Sus Scrofa Spleen, Spongia Officinalis Whole, Bos Taurus Thymus, Sus Scrofa Thymus, Thyroid, Bovine, Thyroid, Porcine, Levothyroxine, Liothyronine</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BOS TAURUS ADRENAL GLAND; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; FUCUS VESICULOSUS; IODINE; IRIDIUM; LEVOTHYROXINE; LIOTHYRONINE; SPONGIA OFFICINALIS WHOLE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PARATHYROID GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200</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>Thyroxine [CS], Triiodothyronine [CS], l-Thyroxine [EPC], l-Triiodothyronine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To help support the structure & function of the thyroid.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68001-525-27</NDCCode>
<PackageDescription>1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68001-525-27) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
<NDC11Code>68001-0525-27</NDC11Code>
<ProductNDC>68001-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluorouracil</ProprietaryName>
<NonProprietaryName>Fluorouracil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210124</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>FLUOROURACIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Fluorouracil injection USP, a nucleoside metabolic inhibitor, is a colorless to faint yellow, aqueous, sterile, nonpyrogenic injectable solution available in 50 mL and 100 mL pharmacy bulk package, a sterile preparation that contains doses for multiple patients for intravenous administration. Each mL contains 50 mg fluorouracil in water for injection, USP. The pH is adjusted to approximately 9.2 with sodium hydroxide. Chemically, fluorouracil, a fluorinated pyrimidine, is 5-fluoro-2,4 (1H,3H)-pyrimidinedione. Its structural formula is. Molecular formula: C 4H 3FN 2O2 Molecular weight : 130.08 g/mole.</Description>
</NDC>
<NDC>
<NDCCode>69101-525-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (69101-525-50) </PackageDescription>
<NDC11Code>69101-0525-50</NDC11Code>
<ProductNDC>69101-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Conjupri</ProprietaryName>
<NonProprietaryName>Levamlodipine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<EndMarketingDate>20220811</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212895</ApplicationNumber>
<LabelerName>Burke Therapeutics, LLC</LabelerName>
<SubstanceName>LEVAMLODIPINE MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<EndMarketingDatePackage>20220811</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69842-525-50</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (69842-525-50) / 50 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69842-0525-50</NDC11Code>
<ProductNDC>69842-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Headache Relief</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin, Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171231</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171231</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71780-525-50</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (71780-525-50) / 50 g in 1 TUBE</PackageDescription>
<NDC11Code>71780-0525-50</NDC11Code>
<ProductNDC>71780-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laspa Tinted Matte Sunscreen Spf 20 Deep Umber</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211011</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>The Green Cricket Inc</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211011</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-525-09</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (71919-525-09) </PackageDescription>
<NDC11Code>71919-0525-09</NDC11Code>
<ProductNDC>71919-525</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Penthorum Sedoides</ProprietaryName>
<NonProprietaryName>Penthorum Sedoides</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>PENTHORUM SEDOIDES</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-525-18</NDCCode>
<PackageDescription>50 VIAL, MULTI-DOSE in 1 BOX (73069-525-18) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-18</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-28</NDCCode>
<PackageDescription>50 VIAL, MULTI-DOSE in 1 BOX (73069-525-28) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-28</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-38</NDCCode>
<PackageDescription>50 VIAL, MULTI-DOSE in 1 BOX (73069-525-38) > 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-38</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-48</NDCCode>
<PackageDescription>50 VIAL, MULTI-DOSE in 1 BOX (73069-525-48) > 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-48</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-58</NDCCode>
<PackageDescription>50 VIAL, MULTI-DOSE in 1 BOX (73069-525-58) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-58</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-68</NDCCode>
<PackageDescription>50 VIAL, MULTI-DOSE in 1 BOX (73069-525-68) > 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-68</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-71</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BOX (73069-525-71) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-71</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-72</NDCCode>
<PackageDescription>3 VIAL, MULTI-DOSE in 1 BOX (73069-525-72) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-72</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-73</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-525-73) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-73</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-74</NDCCode>
<PackageDescription>6 VIAL, MULTI-DOSE in 1 BOX (73069-525-74) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-74</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-75</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 BOX (73069-525-75) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-75</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-76</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-525-76) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-76</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-77</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-525-77) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-77</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-78</NDCCode>
<PackageDescription>50 VIAL, MULTI-DOSE in 1 BOX (73069-525-78) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-78</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-79</NDCCode>
<PackageDescription>100 VIAL, MULTI-DOSE in 1 BOX (73069-525-79) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-79</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>73069-525-88</NDCCode>
<PackageDescription>50 VIAL, MULTI-DOSE in 1 BOX (73069-525-88) > 100 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0525-88</NDC11Code>
<ProductNDC>73069-525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-thyro</ProprietaryName>
<NonProprietaryName>Adrenal Gland, Fucus Vesiculosus, Iodum, Iridium, Parathyroid, Pituitary, Spleen, Spongia, Thymus Gland, Thyroid Gland, Thyroxine (t4), Triiodothyronine (t3)</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; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE; FUCUS VESICULOSUS; SUS SCROFA PARATHYROID GLAND</SubstanceName>
<StrengthNumber>201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 201; 31; 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>l-Thyroxine [EPC],Thyroxine [CS],l-Triiodothyronine [EPC],Triiodothyronine [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>
</NDCList>