{
"NDC": [
{
"NDCCode": "51079-443-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-443-20) / 1 TABLET in 1 BLISTER PACK (51079-443-01) ",
"NDC11Code": "51079-0443-20",
"ProductNDC": "51079-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076187",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "125",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070205",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium lauryl sulfate and sucrose. Table 9 provides a listing of the color additives by tablet strength."
},
{
"NDCCode": "12784-443-20",
"PackageDescription": "205 kg in 1 DRUM (12784-443-20) ",
"NDC11Code": "12784-0443-20",
"ProductNDC": "12784-443",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Magaldrate",
"DosageFormName": "GEL",
"StartMarketingDate": "20200110",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "SPI Pharma, Inc.",
"SubstanceName": "MAGALDRATE ANHYDROUS",
"StrengthNumber": "20",
"StrengthUnit": "kg/100kg",
"Status": "Unfinished",
"LastUpdate": "2024-12-28",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "10-JAN-20"
},
{
"NDCCode": "50563-444-01",
"PackageDescription": "1 KIT in 1 KIT (50563-444-01) * 20 APPLICATOR in 1 PACKET (50563-443-01) > 6 mL in 1 APPLICATOR * 20 APPLICATOR in 1 PACKET (50563-442-01) > 6 mL in 1 APPLICATOR * 20 APPLICATOR in 1 PACKET (50563-441-01) > 6 mL in 1 APPLICATOR",
"NDC11Code": "50563-0444-01",
"ProductNDC": "50563-444",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Body Prescriptions Antibacterial Hand Wipes Vanilla Sugar Winter Berry Honey Almond 3 Pack Special Offer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ENCHANTE ACCESSORIES INC.",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210701",
"SamplePackage": "N"
},
{
"NDCCode": "52125-443-20",
"PackageDescription": "100 TABLET in 1 VIAL (52125-443-20)",
"NDC11Code": "52125-0443-20",
"ProductNDC": "52125-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076063",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-13"
},
{
"NDCCode": "57896-443-01",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (57896-443-01) / 5 SUPPOSITORY in 1 BLISTER PACK (57896-443-55) ",
"NDC11Code": "57896-0443-01",
"ProductNDC": "57896-443",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bisacodyl",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "SUPPOSITORY",
"RouteName": "RECTAL",
"StartMarketingDate": "20191101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "GERI-CARE PHARMACEUTICAL CORP",
"SubstanceName": "BISACODYL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191101",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 relieves occasional constipation, 2 this product generally produces a bowel movement in 15 minutes to 1 hour."
},
{
"NDCCode": "65084-443-20",
"PackageDescription": "60 TABLET in 1 BOTTLE (65084-443-20) ",
"NDC11Code": "65084-0443-20",
"ProductNDC": "65084-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078203",
"LabelerName": "McKesson Corporation dba RX Pak",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20071001",
"SamplePackage": "N"
},
{
"NDCCode": "70954-443-20",
"PackageDescription": "120 TABLET in 1 BOTTLE (70954-443-20) ",
"NDC11Code": "70954-0443-20",
"ProductNDC": "70954-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Misoprostol",
"NonProprietaryName": "Misoprostol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076095",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "MISOPROSTOL",
"StrengthNumber": "100",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]",
"Status": "Active",
"LastUpdate": "2025-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220411",
"SamplePackage": "N",
"IndicationAndUsage": "Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.",
"Description": "Misoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog. Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by (±). Misoprostol is a water-soluble, viscous liquid. Inactive ingredients of tablets are hydrogenated vegetable oil, hypromellose, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "71712-004-20",
"PackageDescription": "443 mL in 1 BOTTLE, SPRAY (71712-004-20) ",
"NDC11Code": "71712-0004-20",
"ProductNDC": "71712-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sanitizingspray",
"ProprietaryNameSuffix": "80 V/v",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Wuxi Huoban Daily-Use Chemicals Science and Technology Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease on the skin. recommended for repeated use."
},
{
"NDCCode": "73069-443-51",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (73069-443-51) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-51",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-52",
"PackageDescription": "3 VIAL, MULTI-DOSE in 1 BOX (73069-443-52) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-52",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-53",
"PackageDescription": "5 VIAL, MULTI-DOSE in 1 BOX (73069-443-53) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-53",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-54",
"PackageDescription": "6 VIAL, MULTI-DOSE in 1 BOX (73069-443-54) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-54",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-55",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 BOX (73069-443-55) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-55",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-56",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-443-56) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-56",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-57",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-443-57) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-57",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
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"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-58",
"PackageDescription": "50 VIAL, MULTI-DOSE in 1 BOX (73069-443-58) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-58",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "73069-443-59",
"PackageDescription": "100 VIAL, MULTI-DOSE in 1 BOX (73069-443-59) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0443-59",
"ProductNDC": "73069-443",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-prolo",
"NonProprietaryName": "Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-",
"StrengthNumber": "201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "51079-007-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-007-20) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (51079-007-01) ",
"NDC11Code": "51079-0007-20",
"ProductNDC": "51079-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20030901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075876",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20030901",
"SamplePackage": "N"
},
{
"NDCCode": "51079-023-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-023-20) / 1 TABLET in 1 BLISTER PACK (51079-023-01) ",
"NDC11Code": "51079-0023-20",
"ProductNDC": "51079-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metolazone",
"NonProprietaryName": "Metolazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076698",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "METOLAZONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050415",
"SamplePackage": "N",
"IndicationAndUsage": "Metolazone tablets are indicated for the treatment of salt and water retention including: 1 edema accompanying congestive heart failure; , 2 edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. .",
"Description": "Metolazone Tablets, USP for oral administration contain 2.5 mg, 5 mg or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1, 2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, FD&C Yellow #6 Lake HT, magnesium stearate and microcrystalline cellulose. In addition, the 10 mg strength contains D&C Yellow #10 Lake HT and FD&C Blue #2 Lake HT. Meets USP Dissolution Test 2."
},
{
"NDCCode": "51079-024-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-024-20) / 1 TABLET in 1 BLISTER PACK (51079-024-01) ",
"NDC11Code": "51079-0024-20",
"ProductNDC": "51079-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metolazone",
"NonProprietaryName": "Metolazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076698",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "METOLAZONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050201",
"SamplePackage": "N",
"IndicationAndUsage": "Metolazone tablets are indicated for the treatment of salt and water retention including: 1 edema accompanying congestive heart failure; , 2 edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. .",
"Description": "Metolazone Tablets, USP for oral administration contain 2.5 mg, 5 mg or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1, 2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, FD&C Yellow #6 Lake HT, magnesium stearate and microcrystalline cellulose. In addition, the 10 mg strength contains D&C Yellow #10 Lake HT and FD&C Blue #2 Lake HT. Meets USP Dissolution Test 2."
},
{
"NDCCode": "51079-027-20",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-027-20) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-027-01)",
"NDC11Code": "51079-0027-20",
"ProductNDC": "51079-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinidine Gluconate",
"NonProprietaryName": "Quinidine Gluconate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089338",
"LabelerName": "UDL Laboratories, Inc.",
"SubstanceName": "QUINIDINE GLUCONATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-04-10"
},
{
"NDCCode": "51079-028-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-028-20) / 1 CAPSULE in 1 BLISTER PACK (51079-028-01) ",
"NDC11Code": "51079-0028-20",
"ProductNDC": "51079-028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090596",
"LabelerName": "MylanInstitutional Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101101",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, or heart transplants, and pediatric patients receiving allogenic liver transplants in combination with other immunosuppressants. ( 1.1).",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Red No. 40, the 1 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3 and the 5 mg capsules also contain D&C Red No. 33, D&C Red No. 28 and D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 5."
},
{
"NDCCode": "51079-034-20",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-034-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-034-01)",
"NDC11Code": "51079-0034-20",
"ProductNDC": "51079-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120827",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076276",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-04-17"
},
{
"NDCCode": "51079-035-20",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-035-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-035-01)",
"NDC11Code": "51079-0035-20",
"ProductNDC": "51079-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120827",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076276",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-04-17"
},
{
"NDCCode": "51079-047-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-047-20) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (51079-047-01) ",
"NDC11Code": "51079-0047-20",
"ProductNDC": "51079-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090942",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110323",
"SamplePackage": "N"
},
{
"NDCCode": "51079-051-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-051-20) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (51079-051-01) ",
"NDC11Code": "51079-0051-20",
"ProductNDC": "51079-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090970",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110223",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium salt of 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-Pyridinyl)methyl]sulfinyl]-1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.36. The structural formula is:. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.55 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.10 mg of pantoprazole sodium). Pantoprazole sodium delayed-release tablets contain the following inactive ingredients: anhydrous sodium carbonate, calcium stearate, crospovidone, hypromellose, mannitol, methacrylic acid copolymer type A, povidone, propylene glycol, titanium dioxide, triethyl citrate and yellow iron oxide. The black imprinting ink contains black iron oxide, propylene glycol and shellac glaze. Meets USP Dissolution Test 3."
},
{
"NDCCode": "51079-058-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-058-20) / 1 TABLET in 1 BLISTER PACK (51079-058-01) ",
"NDC11Code": "51079-0058-20",
"ProductNDC": "51079-058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorthalidone",
"NonProprietaryName": "Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19980612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086831",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "CHLORTHALIDONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980612",
"SamplePackage": "N",
"IndicationAndUsage": "Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.",
"Description": "Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide with the following structural formula. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No.10 Aluminum Lake, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate (potato), stearic acid. The 50 mg tablets also contain FD&C Blue No.1 Aluminum Lake."
},
{
"NDCCode": "51079-067-20",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-067-20) > 1 TABLET in 1 BLISTER PACK (51079-067-01)",
"NDC11Code": "51079-0067-20",
"ProductNDC": "51079-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
"NonProprietaryName": "Diphenoxylate Hydrochloride And Atropine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085762",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE",
"StrengthNumber": ".025; 2.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2015-07-31"
},
{
"NDCCode": "51079-072-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-072-20) / 1 TABLET in 1 BLISTER PACK (51079-072-01) ",
"NDC11Code": "51079-0072-20",
"ProductNDC": "51079-072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970206",
"EndMarketingDate": "20240731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018487",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970206",
"EndMarketingDatePackage": "20240731",
"SamplePackage": "N",
"IndicationAndUsage": "Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro- N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid."
},
{
"NDCCode": "51079-073-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (51079-073-20) / 1 TABLET in 1 BLISTER PACK (51079-073-01) ",
"NDC11Code": "51079-0073-20",
"ProductNDC": "51079-073",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970206",
"EndMarketingDate": "20240831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018487",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19970206",
"EndMarketingDatePackage": "20240831",
"SamplePackage": "N",
"IndicationAndUsage": "Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro- N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid."
}
]
}
{"NDC":[{"NDCCode":"51079-443-20","ProprietaryName":"Levothyroxine Sodium","NonProprietaryName":"Levothyroxine Sodium"},{"NDCCode":"12784-443-20","NonProprietaryName":"Magaldrate"},{"NDCCode":"50563-444-01","ProprietaryName":"Body Prescriptions Antibacterial Hand Wipes Vanilla Sugar Winter Berry Honey Almond 3 Pack Special Offer","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"52125-443-20","ProprietaryName":"Lisinopril","NonProprietaryName":"Lisinopril"},{"NDCCode":"57896-443-01","ProprietaryName":"Bisacodyl","NonProprietaryName":"Bisacodyl"},{"NDCCode":"65084-443-20","ProprietaryName":"Lorazepam","NonProprietaryName":"Lorazepam"},{"NDCCode":"70954-443-20","ProprietaryName":"Misoprostol","NonProprietaryName":"Misoprostol"},{"NDCCode":"71712-004-20","ProprietaryName":"Sanitizingspray","NonProprietaryName":"Alcohol"},{"NDCCode":"73069-443-51","ProprietaryName":"Viatrexx-prolo","NonProprietaryName":"Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica 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<NDC>
<NDCCode>51079-443-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-443-20) / 1 TABLET in 1 BLISTER PACK (51079-443-01) </PackageDescription>
<NDC11Code>51079-0443-20</NDC11Code>
<ProductNDC>51079-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076187</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium lauryl sulfate and sucrose. Table 9 provides a listing of the color additives by tablet strength.</Description>
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<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>SPI Pharma, Inc.</LabelerName>
<SubstanceName>MAGALDRATE ANHYDROUS</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-12-28</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-JAN-20</StartMarketingDatePackage>
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<NDC11Code>50563-0444-01</NDC11Code>
<ProductNDC>50563-444</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Body Prescriptions Antibacterial Hand Wipes Vanilla Sugar Winter Berry Honey Almond 3 Pack Special Offer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ENCHANTE ACCESSORIES INC.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>100 TABLET in 1 VIAL (52125-443-20)</PackageDescription>
<NDC11Code>52125-0443-20</NDC11Code>
<ProductNDC>52125-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076063</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>57896-443-01</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 CARTON (57896-443-01) / 5 SUPPOSITORY in 1 BLISTER PACK (57896-443-55) </PackageDescription>
<NDC11Code>57896-0443-01</NDC11Code>
<ProductNDC>57896-443</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bisacodyl</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>SUPPOSITORY</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20191101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>GERI-CARE PHARMACEUTICAL CORP</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
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<LastUpdate>2025-10-24</LastUpdate>
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<IndicationAndUsage>Uses: 1 relieves occasional constipation, 2 this product generally produces a bowel movement in 15 minutes to 1 hour.</IndicationAndUsage>
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<NDCCode>65084-443-20</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (65084-443-20) </PackageDescription>
<NDC11Code>65084-0443-20</NDC11Code>
<ProductNDC>65084-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20071001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078203</ApplicationNumber>
<LabelerName>McKesson Corporation dba RX Pak</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>70954-443-20</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (70954-443-20) </PackageDescription>
<NDC11Code>70954-0443-20</NDC11Code>
<ProductNDC>70954-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Misoprostol</ProprietaryName>
<NonProprietaryName>Misoprostol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076095</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MISOPROSTOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.</IndicationAndUsage>
<Description>Misoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog. Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by (±). Misoprostol is a water-soluble, viscous liquid. Inactive ingredients of tablets are hydrogenated vegetable oil, hypromellose, microcrystalline cellulose and sodium starch glycolate.</Description>
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<NDCCode>71712-004-20</NDCCode>
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<ProductNDC>71712-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<ProprietaryNameSuffix>80 V/v</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Wuxi Huoban Daily-Use Chemicals Science and Technology Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease on the skin. recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73069-443-51</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BOX (73069-443-51) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-51</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
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<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<PackageDescription>3 VIAL, MULTI-DOSE in 1 BOX (73069-443-52) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
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<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
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<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
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<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-443-53</NDCCode>
<PackageDescription>5 VIAL, MULTI-DOSE in 1 BOX (73069-443-53) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-53</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
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<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
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<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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<NDCCode>73069-443-54</NDCCode>
<PackageDescription>6 VIAL, MULTI-DOSE in 1 BOX (73069-443-54) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-54</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
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<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
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<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
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<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
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<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-443-56) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-56</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
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<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-443-57</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 BOX (73069-443-57) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-57</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-443-58</NDCCode>
<PackageDescription>50 VIAL, MULTI-DOSE in 1 BOX (73069-443-58) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-58</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-443-59</NDCCode>
<PackageDescription>100 VIAL, MULTI-DOSE in 1 BOX (73069-443-59) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0443-59</NDC11Code>
<ProductNDC>73069-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-prolo</ProprietaryName>
<NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; ARNICA MONTANA; BOS TAURUS JOINT CAPSULE; ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; SUS SCROFA JOINT CAPSULE; BETA-ENDORPHIN HUMAN; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; BOS TAURUS CARTILAGE; COLCHICUM AUTUMNALE FLOWER; PORK COLLAGEN; INTERLEUKIN-1 .BETA. HUMAN; INTERLEUKIN-1.ALPHA.; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; INTERLEUKIN-3; PORK; BEEF; NADIDE; SUS SCROFA NERVE; BOS TAURUS NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PLACENTA; SUS SCROFA PLACENTA; QUINHYDRONE; SUS SCROFA TENDON; BOS TAURUS TENDON; CETERMIN; THIAMINE; UBIDECARENONE; CYANOCOBALAMIN; RIBOFLAVIN; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; FOLIC ACID; .ALPHA.-TOCOPHEROL SUCCINATE, D-</SubstanceName>
<StrengthNumber>201; 201; 31; 31; 31; 4; 201; 31; 201; 201; 201; 201; 4; 201; 201; 201; 201; 5; 5; 201; 201; 201; 201; 201; 31; 201; 201; 31; 31; 201; 201; 31; 31; 31; 201; 31; 31; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Vitamin B 12 [CS],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51079-007-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-007-20) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (51079-007-01) </PackageDescription>
<NDC11Code>51079-0007-20</NDC11Code>
<ProductNDC>51079-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075876</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51079-023-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-023-20) / 1 TABLET in 1 BLISTER PACK (51079-023-01) </PackageDescription>
<NDC11Code>51079-0023-20</NDC11Code>
<ProductNDC>51079-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metolazone</ProprietaryName>
<NonProprietaryName>Metolazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076698</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>METOLAZONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metolazone tablets are indicated for the treatment of salt and water retention including: 1 edema accompanying congestive heart failure; , 2 edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. .</IndicationAndUsage>
<Description>Metolazone Tablets, USP for oral administration contain 2.5 mg, 5 mg or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1, 2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, FD&C Yellow #6 Lake HT, magnesium stearate and microcrystalline cellulose. In addition, the 10 mg strength contains D&C Yellow #10 Lake HT and FD&C Blue #2 Lake HT. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51079-024-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-024-20) / 1 TABLET in 1 BLISTER PACK (51079-024-01) </PackageDescription>
<NDC11Code>51079-0024-20</NDC11Code>
<ProductNDC>51079-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metolazone</ProprietaryName>
<NonProprietaryName>Metolazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076698</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>METOLAZONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metolazone tablets are indicated for the treatment of salt and water retention including: 1 edema accompanying congestive heart failure; , 2 edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. .</IndicationAndUsage>
<Description>Metolazone Tablets, USP for oral administration contain 2.5 mg, 5 mg or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16H 16ClN 3O 3S, the chemical name 7-chloro-1, 2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is:. Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, FD&C Yellow #6 Lake HT, magnesium stearate and microcrystalline cellulose. In addition, the 10 mg strength contains D&C Yellow #10 Lake HT and FD&C Blue #2 Lake HT. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51079-027-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-027-20) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51079-027-01)</PackageDescription>
<NDC11Code>51079-0027-20</NDC11Code>
<ProductNDC>51079-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quinidine Gluconate</ProprietaryName>
<NonProprietaryName>Quinidine Gluconate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089338</ApplicationNumber>
<LabelerName>UDL Laboratories, Inc.</LabelerName>
<SubstanceName>QUINIDINE GLUCONATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-04-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>51079-028-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-028-20) / 1 CAPSULE in 1 BLISTER PACK (51079-028-01) </PackageDescription>
<NDC11Code>51079-0028-20</NDC11Code>
<ProductNDC>51079-028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090596</ApplicationNumber>
<LabelerName>MylanInstitutional Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, or heart transplants, and pediatric patients receiving allogenic liver transplants in combination with other immunosuppressants. ( 1.1).</IndicationAndUsage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Red No. 40, the 1 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3 and the 5 mg capsules also contain D&C Red No. 33, D&C Red No. 28 and D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>51079-034-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-034-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-034-01)</PackageDescription>
<NDC11Code>51079-0034-20</NDC11Code>
<ProductNDC>51079-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120827</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076276</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-04-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>51079-035-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-035-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-035-01)</PackageDescription>
<NDC11Code>51079-0035-20</NDC11Code>
<ProductNDC>51079-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120827</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076276</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-04-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>51079-047-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-047-20) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (51079-047-01) </PackageDescription>
<NDC11Code>51079-0047-20</NDC11Code>
<ProductNDC>51079-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090942</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51079-051-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-051-20) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (51079-051-01) </PackageDescription>
<NDC11Code>51079-0051-20</NDC11Code>
<ProductNDC>51079-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090970</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium salt of 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-Pyridinyl)methyl]sulfinyl]-1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.36. The structural formula is:. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.55 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.10 mg of pantoprazole sodium). Pantoprazole sodium delayed-release tablets contain the following inactive ingredients: anhydrous sodium carbonate, calcium stearate, crospovidone, hypromellose, mannitol, methacrylic acid copolymer type A, povidone, propylene glycol, titanium dioxide, triethyl citrate and yellow iron oxide. The black imprinting ink contains black iron oxide, propylene glycol and shellac glaze. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>51079-058-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-058-20) / 1 TABLET in 1 BLISTER PACK (51079-058-01) </PackageDescription>
<NDC11Code>51079-0058-20</NDC11Code>
<ProductNDC>51079-058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorthalidone</ProprietaryName>
<NonProprietaryName>Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086831</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>CHLORTHALIDONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
<Description>Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl)benzenesulfonamide with the following structural formula. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No.10 Aluminum Lake, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate (potato), stearic acid. The 50 mg tablets also contain FD&C Blue No.1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>51079-067-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-067-20) > 1 TABLET in 1 BLISTER PACK (51079-067-01)</PackageDescription>
<NDC11Code>51079-0067-20</NDC11Code>
<ProductNDC>51079-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Diphenoxylate Hydrochloride And Atropine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085762</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.025; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-07-31</LastUpdate>
</NDC>
<NDC>
<NDCCode>51079-072-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-072-20) / 1 TABLET in 1 BLISTER PACK (51079-072-01) </PackageDescription>
<NDC11Code>51079-0072-20</NDC11Code>
<ProductNDC>51079-072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970206</StartMarketingDate>
<EndMarketingDate>20240731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018487</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970206</StartMarketingDatePackage>
<EndMarketingDatePackage>20240731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro- N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>51079-073-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (51079-073-20) / 1 TABLET in 1 BLISTER PACK (51079-073-01) </PackageDescription>
<NDC11Code>51079-0073-20</NDC11Code>
<ProductNDC>51079-073</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970206</StartMarketingDate>
<EndMarketingDate>20240831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018487</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970206</StartMarketingDatePackage>
<EndMarketingDatePackage>20240831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-Chloro- N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow odorless, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid.</Description>
</NDC>
</NDCList>
<NDCList><NDC><NDCCode>51079-443-20</NDCCode><ProprietaryName>Levothyroxine Sodium</ProprietaryName><NonProprietaryName>Levothyroxine Sodium</NonProprietaryName></NDC><NDC><NDCCode>12784-443-20</NDCCode><NonProprietaryName>Magaldrate</NonProprietaryName></NDC><NDC><NDCCode>50563-444-01</NDCCode><ProprietaryName>Body Prescriptions Antibacterial Hand Wipes Vanilla Sugar Winter Berry Honey Almond 3 Pack Special Offer</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>52125-443-20</NDCCode><ProprietaryName>Lisinopril</ProprietaryName><NonProprietaryName>Lisinopril</NonProprietaryName></NDC><NDC><NDCCode>57896-443-01</NDCCode><ProprietaryName>Bisacodyl</ProprietaryName><NonProprietaryName>Bisacodyl</NonProprietaryName></NDC><NDC><NDCCode>65084-443-20</NDCCode><ProprietaryName>Lorazepam</ProprietaryName><NonProprietaryName>Lorazepam</NonProprietaryName></NDC><NDC><NDCCode>70954-443-20</NDCCode><ProprietaryName>Misoprostol</ProprietaryName><NonProprietaryName>Misoprostol</NonProprietaryName></NDC><NDC><NDCCode>71712-004-20</NDCCode><ProprietaryName>Sanitizingspray</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>73069-443-51</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-52</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-53</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-54</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-55</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-56</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-57</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, Bryonia, Cartilage, Colchicum Automnale, Collagen, Co-q 10, Erythrocytes, Il-1, Il-3, Mesenchyme, Muscle, Nadid, Nerve, Pituitary Gland, Placenta, Quinhydrone, Tendon, Transforming Growth Factor-2, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B6, Vitamin B9, Vitamin E</NonProprietaryName></NDC><NDC><NDCCode>73069-443-58</NDCCode><ProprietaryName>Viatrexx-prolo</ProprietaryName><NonProprietaryName>Adrenal, Alpha Ketoglutaric Acid, Alpha Lipoic Acid, Apomorphine, Arnica Montana, Articulation Capsule, Ascorbic Acid, Bfgf, Bdnf, Beta Endorphin, 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