{
"NDC": [
{
"NDCCode": "55681-041-80",
"PackageDescription": "800 mL in 1 BAG (55681-041-80) ",
"NDC11Code": "55681-0041-80",
"ProductNDC": "55681-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Procure Antimicrobial Hand",
"NonProprietaryName": "Hand Soap Benzalkonium Chloride (0.13%)",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250904",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Twin Med LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250904",
"SamplePackage": "N",
"IndicationAndUsage": "Uses handwashing to help decrease bacteria on the skin."
},
{
"NDCCode": "55681-039-80",
"PackageDescription": "800 mL in 1 BAG (55681-039-80) ",
"NDC11Code": "55681-0039-80",
"ProductNDC": "55681-039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Procure Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol 70%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Twin Med LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Uses hand sanitizer to help reduce bacteria on the skin that could cause disease."
},
{
"NDCCode": "55681-041-10",
"PackageDescription": "1000 mL in 1 BAG (55681-041-10) ",
"NDC11Code": "55681-0041-10",
"ProductNDC": "55681-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Procure Antimicrobial Hand",
"NonProprietaryName": "Hand Soap Benzalkonium Chloride (0.13%)",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250904",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Twin Med LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250904",
"SamplePackage": "N",
"IndicationAndUsage": "Uses handwashing to help decrease bacteria on the skin."
},
{
"NDCCode": "55681-041-75",
"PackageDescription": "222 mL in 1 BOTTLE, PUMP (55681-041-75) ",
"NDC11Code": "55681-0041-75",
"ProductNDC": "55681-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Procure Antimicrobial Hand",
"NonProprietaryName": "Hand Soap Benzalkonium Chloride (0.13%)",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250904",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Twin Med LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250904",
"SamplePackage": "N",
"IndicationAndUsage": "Uses handwashing to help decrease bacteria on the skin."
},
{
"NDCCode": "37012-041-80",
"PackageDescription": "80 LOZENGE in 1 BAG (37012-041-80) ",
"NDC11Code": "37012-0041-80",
"ProductNDC": "37012-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menthol Cough Drop",
"NonProprietaryName": "Menthol",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20130814",
"EndMarketingDate": "20190301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Shopko Stores Operating Co. LLC",
"SubstanceName": "MENTHOL",
"StrengthNumber": "5.4",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130814",
"EndMarketingDatePackage": "20190301",
"SamplePackage": "N"
},
{
"NDCCode": "43353-041-80",
"PackageDescription": "180 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (43353-041-80)",
"NDC11Code": "43353-0041-80",
"ProductNDC": "43353-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20120626",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231"
},
{
"NDCCode": "43744-041-80",
"PackageDescription": "20000 g in 1 DRUM (43744-041-80)",
"NDC11Code": "43744-0041-80",
"ProductNDC": "43744-041",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Amoxicillin Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130624",
"EndMarketingDate": "20130630",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130630"
},
{
"NDCCode": "45861-041-80",
"PackageDescription": ".1 kg in 1 BOTTLE (45861-041-80)",
"NDC11Code": "45861-0041-80",
"ProductNDC": "45861-041",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140310",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Pharmaceutica North America, Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "53217-041-01",
"PackageDescription": "80 g in 1 TUBE (53217-041-01) ",
"NDC11Code": "53217-0041-01",
"ProductNDC": "53217-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088042",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20171113",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is. Each gram of Triamcinolone Acetonide Cream USP, 0.025 % contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.Each gram of Triamcinolone Acetonide Cream USP, 0.1 % contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.Each gram of Triamcinolone Acetonide Cream USP, 0.5 % contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate."
},
{
"NDCCode": "69555-041-01",
"PackageDescription": "80 g in 1 JAR (69555-041-01) ",
"NDC11Code": "69555-0041-01",
"ProductNDC": "69555-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sport Sunscreen Spf40",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230327",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Stream2Sea, LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": ".2",
"StrengthUnit": "g/80g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230327",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "21695-041-05",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (21695-041-05)",
"NDC11Code": "21695-0041-05",
"ProductNDC": "21695-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076361",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Clinical Pharmacology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.",
"Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. C18H20FN3O4½ H2O M.W. 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3 > Cu+2 > Zn+2 > Mg+2 > Ca+2. Excipients and Description of Dosage Form. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 2 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "21695-041-10",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (21695-041-10)",
"NDC11Code": "21695-0041-10",
"ProductNDC": "21695-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076361",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Clinical Pharmacology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.",
"Description": "Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. C18H20FN3O4½ H2O M.W. 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3 > Cu+2 > Zn+2 > Mg+2 > Ca+2. Excipients and Description of Dosage Form. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 2 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "42708-041-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42708-041-60) ",
"NDC11Code": "42708-0041-60",
"ProductNDC": "42708-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077739",
"LabelerName": "QPharma Inc",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180330",
"SamplePackage": "Y",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3) .",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents."
},
{
"NDCCode": "58394-633-03",
"PackageDescription": "1 KIT in 1 CARTON (58394-633-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-133-03) ",
"NDC11Code": "58394-0633-03",
"ProductNDC": "58394-633",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Benefix",
"NonProprietaryName": "Coagulation Factor Ix (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "19970201",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103677",
"LabelerName": "Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC",
"Status": "Active",
"LastUpdate": "2025-02-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19970201",
"SamplePackage": "N",
"IndicationAndUsage": "BeneFIX®, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: 1 oOn-demand treatment and control of bleeding episodes, 2 oPerioperative management of bleeding, 3 oRoutine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "BeneFIX, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA technology. The product is formulated as a sterile, non-pyrogenic, lyophilized powder preparation intended to be reconstituted for intravenous injection. It is available in single-use vials containing the labeled amount of factor IX activity, expressed in International Units (IU). Each vial contains nominally 250, 500, 1000, 2000, or 3000 IU of recombinant coagulation factor IX. The potency (in IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One IU is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. After reconstitution of the lyophilized drug product, the concentrations of excipients are 0.234% sodium chloride, 8 mM L-histidine, 0.8% sucrose, 208 mM glycine, 0.004% polysorbate 80. The specific activity of BeneFIX is greater than or equal to 200 IU per milligram of protein. BeneFIX contains no preservatives and all dosage strengths yield a clear, colorless solution upon reconstitution. Coagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. BeneFIX is not derived from human blood. It is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized. No additives of animal or human origin are used during the cell culture, purification, and formulation processes of BeneFIX. The stored cell banks are free of human blood or plasma products. The CHO cell line secretes recombinant factor IX into a defined cell culture medium, and the recombinant factor IX is purified by a four-step chromatography purification process that does not require a monoclonal antibody step. The process also includes a membrane nanofiltration step that has the ability to retain molecules with apparent molecular weights >70,000 Da (such as large proteins and viral particles). BeneFIX is a single component by SDS-polyacrylamide gel electrophoresis evaluation."
},
{
"NDCCode": "58394-634-03",
"PackageDescription": "1 KIT in 1 CARTON (58394-634-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-134-03) ",
"NDC11Code": "58394-0634-03",
"ProductNDC": "58394-634",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Benefix",
"NonProprietaryName": "Coagulation Factor Ix (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "19970201",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103677",
"LabelerName": "Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC",
"Status": "Active",
"LastUpdate": "2025-02-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19970201",
"SamplePackage": "N",
"IndicationAndUsage": "BeneFIX®, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: 1 oOn-demand treatment and control of bleeding episodes, 2 oPerioperative management of bleeding, 3 oRoutine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "BeneFIX, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA technology. The product is formulated as a sterile, non-pyrogenic, lyophilized powder preparation intended to be reconstituted for intravenous injection. It is available in single-use vials containing the labeled amount of factor IX activity, expressed in International Units (IU). Each vial contains nominally 250, 500, 1000, 2000, or 3000 IU of recombinant coagulation factor IX. The potency (in IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One IU is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. After reconstitution of the lyophilized drug product, the concentrations of excipients are 0.234% sodium chloride, 8 mM L-histidine, 0.8% sucrose, 208 mM glycine, 0.004% polysorbate 80. The specific activity of BeneFIX is greater than or equal to 200 IU per milligram of protein. BeneFIX contains no preservatives and all dosage strengths yield a clear, colorless solution upon reconstitution. Coagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. BeneFIX is not derived from human blood. It is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized. No additives of animal or human origin are used during the cell culture, purification, and formulation processes of BeneFIX. The stored cell banks are free of human blood or plasma products. The CHO cell line secretes recombinant factor IX into a defined cell culture medium, and the recombinant factor IX is purified by a four-step chromatography purification process that does not require a monoclonal antibody step. The process also includes a membrane nanofiltration step that has the ability to retain molecules with apparent molecular weights >70,000 Da (such as large proteins and viral particles). BeneFIX is a single component by SDS-polyacrylamide gel electrophoresis evaluation."
},
{
"NDCCode": "58394-635-03",
"PackageDescription": "1 KIT in 1 CARTON (58394-635-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-135-03) ",
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"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103677",
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"IndicationAndUsage": "BeneFIX®, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: 1 oOn-demand treatment and control of bleeding episodes, 2 oPerioperative management of bleeding, 3 oRoutine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "BeneFIX, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA technology. The product is formulated as a sterile, non-pyrogenic, lyophilized powder preparation intended to be reconstituted for intravenous injection. It is available in single-use vials containing the labeled amount of factor IX activity, expressed in International Units (IU). Each vial contains nominally 250, 500, 1000, 2000, or 3000 IU of recombinant coagulation factor IX. The potency (in IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One IU is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. After reconstitution of the lyophilized drug product, the concentrations of excipients are 0.234% sodium chloride, 8 mM L-histidine, 0.8% sucrose, 208 mM glycine, 0.004% polysorbate 80. The specific activity of BeneFIX is greater than or equal to 200 IU per milligram of protein. BeneFIX contains no preservatives and all dosage strengths yield a clear, colorless solution upon reconstitution. Coagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. BeneFIX is not derived from human blood. It is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized. No additives of animal or human origin are used during the cell culture, purification, and formulation processes of BeneFIX. The stored cell banks are free of human blood or plasma products. The CHO cell line secretes recombinant factor IX into a defined cell culture medium, and the recombinant factor IX is purified by a four-step chromatography purification process that does not require a monoclonal antibody step. The process also includes a membrane nanofiltration step that has the ability to retain molecules with apparent molecular weights >70,000 Da (such as large proteins and viral particles). BeneFIX is a single component by SDS-polyacrylamide gel electrophoresis evaluation."
},
{
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"PackageDescription": "1 KIT in 1 CARTON (58394-636-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-136-03) ",
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"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "BeneFIX®, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: 1 oOn-demand treatment and control of bleeding episodes, 2 oPerioperative management of bleeding, 3 oRoutine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "BeneFIX, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA technology. The product is formulated as a sterile, non-pyrogenic, lyophilized powder preparation intended to be reconstituted for intravenous injection. It is available in single-use vials containing the labeled amount of factor IX activity, expressed in International Units (IU). Each vial contains nominally 250, 500, 1000, 2000, or 3000 IU of recombinant coagulation factor IX. The potency (in IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One IU is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. After reconstitution of the lyophilized drug product, the concentrations of excipients are 0.234% sodium chloride, 8 mM L-histidine, 0.8% sucrose, 208 mM glycine, 0.004% polysorbate 80. The specific activity of BeneFIX is greater than or equal to 200 IU per milligram of protein. BeneFIX contains no preservatives and all dosage strengths yield a clear, colorless solution upon reconstitution. Coagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. BeneFIX is not derived from human blood. It is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized. No additives of animal or human origin are used during the cell culture, purification, and formulation processes of BeneFIX. The stored cell banks are free of human blood or plasma products. The CHO cell line secretes recombinant factor IX into a defined cell culture medium, and the recombinant factor IX is purified by a four-step chromatography purification process that does not require a monoclonal antibody step. The process also includes a membrane nanofiltration step that has the ability to retain molecules with apparent molecular weights >70,000 Da (such as large proteins and viral particles). BeneFIX is a single component by SDS-polyacrylamide gel electrophoresis evaluation."
},
{
"NDCCode": "58394-637-03",
"PackageDescription": "1 KIT in 1 CARTON (58394-637-03) * 5 mL in 1 VIAL, SINGLE-USE (58394-137-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) ",
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"ProductNDC": "58394-637",
"ProductTypeName": "PLASMA DERIVATIVE",
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"StartMarketingDate": "20120201",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103677",
"LabelerName": "Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC",
"Status": "Active",
"LastUpdate": "2025-02-26",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "BeneFIX®, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: 1 oOn-demand treatment and control of bleeding episodes, 2 oPerioperative management of bleeding, 3 oRoutine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "BeneFIX, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA technology. The product is formulated as a sterile, non-pyrogenic, lyophilized powder preparation intended to be reconstituted for intravenous injection. It is available in single-use vials containing the labeled amount of factor IX activity, expressed in International Units (IU). Each vial contains nominally 250, 500, 1000, 2000, or 3000 IU of recombinant coagulation factor IX. The potency (in IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One IU is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. After reconstitution of the lyophilized drug product, the concentrations of excipients are 0.234% sodium chloride, 8 mM L-histidine, 0.8% sucrose, 208 mM glycine, 0.004% polysorbate 80. The specific activity of BeneFIX is greater than or equal to 200 IU per milligram of protein. BeneFIX contains no preservatives and all dosage strengths yield a clear, colorless solution upon reconstitution. Coagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. BeneFIX is not derived from human blood. It is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized. No additives of animal or human origin are used during the cell culture, purification, and formulation processes of BeneFIX. The stored cell banks are free of human blood or plasma products. The CHO cell line secretes recombinant factor IX into a defined cell culture medium, and the recombinant factor IX is purified by a four-step chromatography purification process that does not require a monoclonal antibody step. The process also includes a membrane nanofiltration step that has the ability to retain molecules with apparent molecular weights >70,000 Da (such as large proteins and viral particles). BeneFIX is a single component by SDS-polyacrylamide gel electrophoresis evaluation."
},
{
"NDCCode": "60290-041-01",
"PackageDescription": "90 TABLET in 1 BOTTLE (60290-041-01) ",
"NDC11Code": "60290-0041-01",
"ProductNDC": "60290-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213853",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "ATORVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets is indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H- pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is C 66H 68CaF 2N 4O 10.3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium is a white to off-white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.359 mg, 20.718 mg, 41.436 mg, or 82.872 mg atorvastatin calcium trihydrate) and the following inactive ingredients: Croscarmellose sodium, NF; Hydroxy propyl cellulose, NF; Lactose monohydrate, NF; Magnesium stearate, NF;, Microcrystalline cellulose, NF; Polysorbate 80, NF; Precipitated calcium carbonate, NF; Hypromellose; Macrogol; Talc and Titanium dioxide."
},
{
"NDCCode": "60290-041-02",
"PackageDescription": "500 TABLET in 1 BOTTLE (60290-041-02) ",
"NDC11Code": "60290-0041-02",
"ProductNDC": "60290-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213853",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "ATORVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets is indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H- pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is C 66H 68CaF 2N 4O 10.3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium is a white to off-white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.359 mg, 20.718 mg, 41.436 mg, or 82.872 mg atorvastatin calcium trihydrate) and the following inactive ingredients: Croscarmellose sodium, NF; Hydroxy propyl cellulose, NF; Lactose monohydrate, NF; Magnesium stearate, NF;, Microcrystalline cellulose, NF; Polysorbate 80, NF; Precipitated calcium carbonate, NF; Hypromellose; Macrogol; Talc and Titanium dioxide."
},
{
"NDCCode": "60290-041-03",
"PackageDescription": "2500 TABLET in 1 BOTTLE (60290-041-03) ",
"NDC11Code": "60290-0041-03",
"ProductNDC": "60290-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213853",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "ATORVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets is indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H- pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is C 66H 68CaF 2N 4O 10.3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium is a white to off-white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.359 mg, 20.718 mg, 41.436 mg, or 82.872 mg atorvastatin calcium trihydrate) and the following inactive ingredients: Croscarmellose sodium, NF; Hydroxy propyl cellulose, NF; Lactose monohydrate, NF; Magnesium stearate, NF;, Microcrystalline cellulose, NF; Polysorbate 80, NF; Precipitated calcium carbonate, NF; Hypromellose; Macrogol; Talc and Titanium dioxide."
},
{
"NDCCode": "60290-041-04",
"PackageDescription": "1000 TABLET in 1 BOTTLE (60290-041-04) ",
"NDC11Code": "60290-0041-04",
"ProductNDC": "60290-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213853",
"LabelerName": "Umedica Laboratories USA Inc.",
"SubstanceName": "ATORVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260215",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets is indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H- pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is C 66H 68CaF 2N 4O 10.3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium is a white to off-white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.359 mg, 20.718 mg, 41.436 mg, or 82.872 mg atorvastatin calcium trihydrate) and the following inactive ingredients: Croscarmellose sodium, NF; Hydroxy propyl cellulose, NF; Lactose monohydrate, NF; Magnesium stearate, NF;, Microcrystalline cellulose, NF; Polysorbate 80, NF; Precipitated calcium carbonate, NF; Hypromellose; Macrogol; Talc and Titanium dioxide."
},
{
"NDCCode": "70436-041-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-041-01) ",
"NDC11Code": "70436-0041-01",
"ProductNDC": "70436-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Guanfacine",
"NonProprietaryName": "Guanfacine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213428",
"LabelerName": "Slate Run Pharmaceuticals, LLC",
"SubstanceName": "GUANFACINE HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220801",
"SamplePackage": "N",
"IndicationAndUsage": "Guanfacine Extended-Release Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)].",
"Description": "Guanfacine Extended-Release Tablets, USP are a once-daily, extended-release formulation of guanfacine hydrochloride (HCl) in a matrix tablet formulation for oral administration only. The chemical designation is N-amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride. The molecular formula is C 9H 9Cl 2N 3OHCl corresponding to a molecular weight of 282.55 g/mol. The chemical structure is:. Guanfacine HCl is a white to off-white crystalline powder, sparingly soluble in water (approximately 1 mg/mL) and alcohol and slightly soluble in acetone. The only organic solvent in which it has relatively high solubility is methanol (>30 mg/mL). Each tablet contains guanfacine HCl equivalent to 1 mg, 2 mg, 3 mg, or 4 mg of guanfacine base. The tablets also contain copovidone, fumaric acid, glyceryl dibehenate, hypromellose, lactose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80 and sodium lauryl sulfate. In addition, the 3-mg and 4-mg tablets also contain FD&C Yellow #6 Aluminum Lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72578-041-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (72578-041-01) ",
"NDC11Code": "72578-0041-01",
"ProductNDC": "72578-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220704",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077625",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2023-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220704",
"SamplePackage": "N",
"IndicationAndUsage": "Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
"Description": "Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide, USP is a white to off white crystalline powder, pKa=10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is. Zonisamide capsules, USP contain 25 mg or 50 mg or 100 mg zonisamide. Each capsule contains the inactive ingredients FD&C Blue #1, FD&C Red #4, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive. ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "72578-041-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (72578-041-05) ",
"NDC11Code": "72578-0041-05",
"ProductNDC": "72578-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220704",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077625",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2023-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20220704",
"SamplePackage": "N",
"IndicationAndUsage": "Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
"Description": "Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide, USP is a white to off white crystalline powder, pKa=10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is. Zonisamide capsules, USP contain 25 mg or 50 mg or 100 mg zonisamide. Each capsule contains the inactive ingredients FD&C Blue #1, FD&C Red #4, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive. ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "72606-041-01",
"PackageDescription": "2 KIT in 1 CARTON (72606-041-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .2 mL in 1 SYRINGE * 1 mL in 1 PACKET",
"NDC11Code": "72606-0041-01",
"ProductNDC": "72606-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalimumab",
"NonProprietaryName": "Adalimumab-aaty",
"DosageFormName": "KIT",
"StartMarketingDate": "20231130",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761219",
"LabelerName": "CELLTRION USA, Inc.",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231130",
"SamplePackage": "N",
"IndicationAndUsage": "Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).",
"Description": "Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP."
},
{
"NDCCode": "73746-041-01",
"PackageDescription": "118 mL in 1 BOTTLE (73746-041-01) ",
"NDC11Code": "73746-0041-01",
"ProductNDC": "73746-041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Savon De Provence Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200805",
"EndMarketingDate": "20221012",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "HOME & BODY COMPANY",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200805",
"EndMarketingDatePackage": "20221012",
"SamplePackage": "N"
},
{
"NDCCode": "82009-041-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (82009-041-90) ",
"NDC11Code": "82009-0041-90",
"ProductNDC": "82009-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir",
"NonProprietaryName": "Valacyclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20221014",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203047",
"LabelerName": "Quallent Pharmaceuticals Health LLC",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221014",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir tablet is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients( 1.1) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1−infected patients Reduction of transmission Herpes Zoster Pediatric Patients ( 1.2) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use ( 1.3) The efficacy and safety of valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1−infected patients.",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 556.0 mg or 1.112 grams of valacyclovir hydrochloride USP equivalent to 500 mg or 1 gm of valacyclovir, respectively, and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. In addition to this 500 mg contains FD&C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L-valine2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula:. Valacyclovir hydrochloride USP (monohydrate) is a white or almost white powder with the molecular formula C 13H 23N 6O 5Cl and a molecular weight of 378.81. Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "82293-041-10",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (82293-041-10) / 15 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "82293-0041-10",
"ProductNDC": "82293-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Macitentan",
"NonProprietaryName": "Macitentan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260507",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211026",
"LabelerName": "Novugen Pharma (USA) LLC",
"SubstanceName": "MACITENTAN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260605",
"SamplePackage": "N",
"IndicationAndUsage": "Macitentan is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH ( 1.1).",
"Description": "Macitentan is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C 19H 20Br 2N 6O 4S and a molecular weight of 588.27. Macitentan is achiral and has the following structural formula:. Macitentan is a crystalline powder that is insoluble in water. In the solid state macitentan is very stable, is not hygroscopic, and is not light sensitive. Macitentan is available as a 10 mg film-coated tablet for once daily oral administration. The tablets include the following inactive ingredients: mannitol, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone, and sodium starch glycolate Type A. The tablets are film-coated with a coating material containing polyvinyl alcohol, soya lecithin, talc, titanium dioxide, and xanthan gum."
},
{
"NDCCode": "82293-041-20",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (82293-041-20) ",
"NDC11Code": "82293-0041-20",
"ProductNDC": "82293-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Macitentan",
"NonProprietaryName": "Macitentan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260507",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211026",
"LabelerName": "Novugen Pharma (USA) LLC",
"SubstanceName": "MACITENTAN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260605",
"SamplePackage": "N",
"IndicationAndUsage": "Macitentan is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH ( 1.1).",
"Description": "Macitentan is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C 19H 20Br 2N 6O 4S and a molecular weight of 588.27. Macitentan is achiral and has the following structural formula:. Macitentan is a crystalline powder that is insoluble in water. In the solid state macitentan is very stable, is not hygroscopic, and is not light sensitive. Macitentan is available as a 10 mg film-coated tablet for once daily oral administration. The tablets include the following inactive ingredients: mannitol, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone, and sodium starch glycolate Type A. The tablets are film-coated with a coating material containing polyvinyl alcohol, soya lecithin, talc, titanium dioxide, and xanthan gum."
}
]
}
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Menthol Cough Drop</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
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<LabelerName>Shopko Stores Operating Co. LLC</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<ProductNDC>43353-041</ProductNDC>
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<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
</NDC>
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<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Amoxicillin Sodium</NonProprietaryName>
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<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130630</ListingRecordCertifiedThrough>
</NDC>
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<NDCCode>45861-041-80</NDCCode>
<PackageDescription>.1 kg in 1 BOTTLE (45861-041-80)</PackageDescription>
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<ProductNDC>45861-041</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140310</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Pharmaceutica North America, Inc.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
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<NDCCode>53217-041-01</NDCCode>
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<ProductNDC>53217-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088042</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is. Each gram of Triamcinolone Acetonide Cream USP, 0.025 % contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.Each gram of Triamcinolone Acetonide Cream USP, 0.1 % contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.Each gram of Triamcinolone Acetonide Cream USP, 0.5 % contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.</Description>
</NDC>
<NDC>
<NDCCode>69555-041-01</NDCCode>
<PackageDescription>80 g in 1 JAR (69555-041-01) </PackageDescription>
<NDC11Code>69555-0041-01</NDC11Code>
<ProductNDC>69555-041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sport Sunscreen Spf40</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230327</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Stream2Sea, LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/80g</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-041-05</NDCCode>
<PackageDescription>5 TABLET, FILM COATED in 1 BOTTLE (21695-041-05)</PackageDescription>
<NDC11Code>21695-0041-05</NDC11Code>
<ProductNDC>21695-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076361</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Clinical Pharmacology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.</IndicationAndUsage>
<Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. C18H20FN3O4½ H2O M.W. 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3 > Cu+2 > Zn+2 > Mg+2 > Ca+2. Excipients and Description of Dosage Form. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 2 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-041-10</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (21695-041-10)</PackageDescription>
<NDC11Code>21695-0041-10</NDC11Code>
<ProductNDC>21695-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076361</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. Culture and susceptibility testing. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Clinical Pharmacology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.</IndicationAndUsage>
<Description>Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. C18H20FN3O4½ H2O M.W. 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3 > Cu+2 > Zn+2 > Mg+2 > Ca+2. Excipients and Description of Dosage Form. Levofloxacin tablets are available as film-coated tablets and contain the following inactive ingredients: 1 250 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 2 500 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide., 3 750 mg (as expressed in the anhydrous form): colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42708-041-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (42708-041-60) </PackageDescription>
<NDC11Code>42708-0041-60</NDC11Code>
<ProductNDC>42708-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077739</ApplicationNumber>
<LabelerName>QPharma Inc</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180330</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-(2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. The tablets contain the following inactive ingredients: microcrystalline cellulose, corn starch, sodium starch glycollate, colloidal silicon dioxide, sodium lauryl sulfate, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, 50 mg tablet contains D&C Red #30 Aluminium Lake and 100 mg tablet contains FD&C Blue #2 Aluminium Lake as coloring agents.</Description>
</NDC>
<NDC>
<NDCCode>58394-633-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58394-633-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-133-03) </PackageDescription>
<NDC11Code>58394-0633-03</NDC11Code>
<ProductNDC>58394-633</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Benefix</ProprietaryName>
<NonProprietaryName>Coagulation Factor Ix (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19970201</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103677</ApplicationNumber>
<LabelerName>Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BeneFIX®, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: 1 oOn-demand treatment and control of bleeding episodes, 2 oPerioperative management of bleeding, 3 oRoutine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>BeneFIX, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA technology. The product is formulated as a sterile, non-pyrogenic, lyophilized powder preparation intended to be reconstituted for intravenous injection. It is available in single-use vials containing the labeled amount of factor IX activity, expressed in International Units (IU). Each vial contains nominally 250, 500, 1000, 2000, or 3000 IU of recombinant coagulation factor IX. The potency (in IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One IU is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. After reconstitution of the lyophilized drug product, the concentrations of excipients are 0.234% sodium chloride, 8 mM L-histidine, 0.8% sucrose, 208 mM glycine, 0.004% polysorbate 80. The specific activity of BeneFIX is greater than or equal to 200 IU per milligram of protein. BeneFIX contains no preservatives and all dosage strengths yield a clear, colorless solution upon reconstitution. Coagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. BeneFIX is not derived from human blood. It is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized. No additives of animal or human origin are used during the cell culture, purification, and formulation processes of BeneFIX. The stored cell banks are free of human blood or plasma products. The CHO cell line secretes recombinant factor IX into a defined cell culture medium, and the recombinant factor IX is purified by a four-step chromatography purification process that does not require a monoclonal antibody step. The process also includes a membrane nanofiltration step that has the ability to retain molecules with apparent molecular weights >70,000 Da (such as large proteins and viral particles). BeneFIX is a single component by SDS-polyacrylamide gel electrophoresis evaluation.</Description>
</NDC>
<NDC>
<NDCCode>58394-634-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58394-634-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-134-03) </PackageDescription>
<NDC11Code>58394-0634-03</NDC11Code>
<ProductNDC>58394-634</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Benefix</ProprietaryName>
<NonProprietaryName>Coagulation Factor Ix (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19970201</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103677</ApplicationNumber>
<LabelerName>Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BeneFIX®, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: 1 oOn-demand treatment and control of bleeding episodes, 2 oPerioperative management of bleeding, 3 oRoutine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>BeneFIX, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA technology. The product is formulated as a sterile, non-pyrogenic, lyophilized powder preparation intended to be reconstituted for intravenous injection. It is available in single-use vials containing the labeled amount of factor IX activity, expressed in International Units (IU). Each vial contains nominally 250, 500, 1000, 2000, or 3000 IU of recombinant coagulation factor IX. The potency (in IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One IU is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. After reconstitution of the lyophilized drug product, the concentrations of excipients are 0.234% sodium chloride, 8 mM L-histidine, 0.8% sucrose, 208 mM glycine, 0.004% polysorbate 80. The specific activity of BeneFIX is greater than or equal to 200 IU per milligram of protein. BeneFIX contains no preservatives and all dosage strengths yield a clear, colorless solution upon reconstitution. Coagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. BeneFIX is not derived from human blood. It is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized. No additives of animal or human origin are used during the cell culture, purification, and formulation processes of BeneFIX. The stored cell banks are free of human blood or plasma products. The CHO cell line secretes recombinant factor IX into a defined cell culture medium, and the recombinant factor IX is purified by a four-step chromatography purification process that does not require a monoclonal antibody step. The process also includes a membrane nanofiltration step that has the ability to retain molecules with apparent molecular weights >70,000 Da (such as large proteins and viral particles). BeneFIX is a single component by SDS-polyacrylamide gel electrophoresis evaluation.</Description>
</NDC>
<NDC>
<NDCCode>58394-635-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58394-635-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-135-03) </PackageDescription>
<NDC11Code>58394-0635-03</NDC11Code>
<ProductNDC>58394-635</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Benefix</ProprietaryName>
<NonProprietaryName>Coagulation Factor Ix (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19970201</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103677</ApplicationNumber>
<LabelerName>Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BeneFIX®, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: 1 oOn-demand treatment and control of bleeding episodes, 2 oPerioperative management of bleeding, 3 oRoutine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>BeneFIX, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA technology. The product is formulated as a sterile, non-pyrogenic, lyophilized powder preparation intended to be reconstituted for intravenous injection. It is available in single-use vials containing the labeled amount of factor IX activity, expressed in International Units (IU). Each vial contains nominally 250, 500, 1000, 2000, or 3000 IU of recombinant coagulation factor IX. The potency (in IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One IU is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. After reconstitution of the lyophilized drug product, the concentrations of excipients are 0.234% sodium chloride, 8 mM L-histidine, 0.8% sucrose, 208 mM glycine, 0.004% polysorbate 80. The specific activity of BeneFIX is greater than or equal to 200 IU per milligram of protein. BeneFIX contains no preservatives and all dosage strengths yield a clear, colorless solution upon reconstitution. Coagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. BeneFIX is not derived from human blood. It is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized. No additives of animal or human origin are used during the cell culture, purification, and formulation processes of BeneFIX. The stored cell banks are free of human blood or plasma products. The CHO cell line secretes recombinant factor IX into a defined cell culture medium, and the recombinant factor IX is purified by a four-step chromatography purification process that does not require a monoclonal antibody step. The process also includes a membrane nanofiltration step that has the ability to retain molecules with apparent molecular weights >70,000 Da (such as large proteins and viral particles). BeneFIX is a single component by SDS-polyacrylamide gel electrophoresis evaluation.</Description>
</NDC>
<NDC>
<NDCCode>58394-636-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58394-636-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-136-03) </PackageDescription>
<NDC11Code>58394-0636-03</NDC11Code>
<ProductNDC>58394-636</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Benefix</ProprietaryName>
<NonProprietaryName>Coagulation Factor Ix (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20070706</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103677</ApplicationNumber>
<LabelerName>Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BeneFIX®, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: 1 oOn-demand treatment and control of bleeding episodes, 2 oPerioperative management of bleeding, 3 oRoutine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>BeneFIX, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA technology. The product is formulated as a sterile, non-pyrogenic, lyophilized powder preparation intended to be reconstituted for intravenous injection. It is available in single-use vials containing the labeled amount of factor IX activity, expressed in International Units (IU). Each vial contains nominally 250, 500, 1000, 2000, or 3000 IU of recombinant coagulation factor IX. The potency (in IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One IU is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. After reconstitution of the lyophilized drug product, the concentrations of excipients are 0.234% sodium chloride, 8 mM L-histidine, 0.8% sucrose, 208 mM glycine, 0.004% polysorbate 80. The specific activity of BeneFIX is greater than or equal to 200 IU per milligram of protein. BeneFIX contains no preservatives and all dosage strengths yield a clear, colorless solution upon reconstitution. Coagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. BeneFIX is not derived from human blood. It is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized. No additives of animal or human origin are used during the cell culture, purification, and formulation processes of BeneFIX. The stored cell banks are free of human blood or plasma products. The CHO cell line secretes recombinant factor IX into a defined cell culture medium, and the recombinant factor IX is purified by a four-step chromatography purification process that does not require a monoclonal antibody step. The process also includes a membrane nanofiltration step that has the ability to retain molecules with apparent molecular weights >70,000 Da (such as large proteins and viral particles). BeneFIX is a single component by SDS-polyacrylamide gel electrophoresis evaluation.</Description>
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<NDC>
<NDCCode>58394-637-03</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (58394-637-03) * 5 mL in 1 VIAL, SINGLE-USE (58394-137-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) </PackageDescription>
<NDC11Code>58394-0637-03</NDC11Code>
<ProductNDC>58394-637</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Benefix</ProprietaryName>
<NonProprietaryName>Coagulation Factor Ix (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120201</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103677</ApplicationNumber>
<LabelerName>Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-26</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BeneFIX®, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: 1 oOn-demand treatment and control of bleeding episodes, 2 oPerioperative management of bleeding, 3 oRoutine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>BeneFIX, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA technology. The product is formulated as a sterile, non-pyrogenic, lyophilized powder preparation intended to be reconstituted for intravenous injection. It is available in single-use vials containing the labeled amount of factor IX activity, expressed in International Units (IU). Each vial contains nominally 250, 500, 1000, 2000, or 3000 IU of recombinant coagulation factor IX. The potency (in IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One IU is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. After reconstitution of the lyophilized drug product, the concentrations of excipients are 0.234% sodium chloride, 8 mM L-histidine, 0.8% sucrose, 208 mM glycine, 0.004% polysorbate 80. The specific activity of BeneFIX is greater than or equal to 200 IU per milligram of protein. BeneFIX contains no preservatives and all dosage strengths yield a clear, colorless solution upon reconstitution. Coagulation factor IX is the active ingredient in BeneFIX. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. BeneFIX is not derived from human blood. It is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized. No additives of animal or human origin are used during the cell culture, purification, and formulation processes of BeneFIX. The stored cell banks are free of human blood or plasma products. The CHO cell line secretes recombinant factor IX into a defined cell culture medium, and the recombinant factor IX is purified by a four-step chromatography purification process that does not require a monoclonal antibody step. The process also includes a membrane nanofiltration step that has the ability to retain molecules with apparent molecular weights >70,000 Da (such as large proteins and viral particles). BeneFIX is a single component by SDS-polyacrylamide gel electrophoresis evaluation.</Description>
</NDC>
<NDC>
<NDCCode>60290-041-01</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (60290-041-01) </PackageDescription>
<NDC11Code>60290-0041-01</NDC11Code>
<ProductNDC>60290-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213853</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>ATORVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets is indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H- pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is C 66H 68CaF 2N 4O 10.3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium is a white to off-white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.359 mg, 20.718 mg, 41.436 mg, or 82.872 mg atorvastatin calcium trihydrate) and the following inactive ingredients: Croscarmellose sodium, NF; Hydroxy propyl cellulose, NF; Lactose monohydrate, NF; Magnesium stearate, NF;, Microcrystalline cellulose, NF; Polysorbate 80, NF; Precipitated calcium carbonate, NF; Hypromellose; Macrogol; Talc and Titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>60290-041-02</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (60290-041-02) </PackageDescription>
<NDC11Code>60290-0041-02</NDC11Code>
<ProductNDC>60290-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213853</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>ATORVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets is indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H- pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is C 66H 68CaF 2N 4O 10.3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium is a white to off-white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.359 mg, 20.718 mg, 41.436 mg, or 82.872 mg atorvastatin calcium trihydrate) and the following inactive ingredients: Croscarmellose sodium, NF; Hydroxy propyl cellulose, NF; Lactose monohydrate, NF; Magnesium stearate, NF;, Microcrystalline cellulose, NF; Polysorbate 80, NF; Precipitated calcium carbonate, NF; Hypromellose; Macrogol; Talc and Titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>60290-041-03</NDCCode>
<PackageDescription>2500 TABLET in 1 BOTTLE (60290-041-03) </PackageDescription>
<NDC11Code>60290-0041-03</NDC11Code>
<ProductNDC>60290-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213853</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>ATORVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets is indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H- pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is C 66H 68CaF 2N 4O 10.3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium is a white to off-white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.359 mg, 20.718 mg, 41.436 mg, or 82.872 mg atorvastatin calcium trihydrate) and the following inactive ingredients: Croscarmellose sodium, NF; Hydroxy propyl cellulose, NF; Lactose monohydrate, NF; Magnesium stearate, NF;, Microcrystalline cellulose, NF; Polysorbate 80, NF; Precipitated calcium carbonate, NF; Hypromellose; Macrogol; Talc and Titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>60290-041-04</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (60290-041-04) </PackageDescription>
<NDC11Code>60290-0041-04</NDC11Code>
<ProductNDC>60290-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213853</ApplicationNumber>
<LabelerName>Umedica Laboratories USA Inc.</LabelerName>
<SubstanceName>ATORVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets is indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H- pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is C 66H 68CaF 2N 4O 10.3H 2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium is a white to off-white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is soluble to freely soluble in methanol, slightly soluble in alcohol, insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer and in acetonitrile. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.359 mg, 20.718 mg, 41.436 mg, or 82.872 mg atorvastatin calcium trihydrate) and the following inactive ingredients: Croscarmellose sodium, NF; Hydroxy propyl cellulose, NF; Lactose monohydrate, NF; Magnesium stearate, NF;, Microcrystalline cellulose, NF; Polysorbate 80, NF; Precipitated calcium carbonate, NF; Hypromellose; Macrogol; Talc and Titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70436-041-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-041-01) </PackageDescription>
<NDC11Code>70436-0041-01</NDC11Code>
<ProductNDC>70436-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Guanfacine</ProprietaryName>
<NonProprietaryName>Guanfacine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213428</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals, LLC</LabelerName>
<SubstanceName>GUANFACINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Guanfacine Extended-Release Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Guanfacine Extended-Release Tablets, USP are a once-daily, extended-release formulation of guanfacine hydrochloride (HCl) in a matrix tablet formulation for oral administration only. The chemical designation is N-amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride. The molecular formula is C 9H 9Cl 2N 3OHCl corresponding to a molecular weight of 282.55 g/mol. The chemical structure is:. Guanfacine HCl is a white to off-white crystalline powder, sparingly soluble in water (approximately 1 mg/mL) and alcohol and slightly soluble in acetone. The only organic solvent in which it has relatively high solubility is methanol (>30 mg/mL). Each tablet contains guanfacine HCl equivalent to 1 mg, 2 mg, 3 mg, or 4 mg of guanfacine base. The tablets also contain copovidone, fumaric acid, glyceryl dibehenate, hypromellose, lactose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80 and sodium lauryl sulfate. In addition, the 3-mg and 4-mg tablets also contain FD&C Yellow #6 Aluminum Lake. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>72578-041-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (72578-041-01) </PackageDescription>
<NDC11Code>72578-0041-01</NDC11Code>
<ProductNDC>72578-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220704</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077625</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220704</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
<Description>Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide, USP is a white to off white crystalline powder, pKa=10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is. Zonisamide capsules, USP contain 25 mg or 50 mg or 100 mg zonisamide. Each capsule contains the inactive ingredients FD&C Blue #1, FD&C Red #4, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive. ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>72578-041-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (72578-041-05) </PackageDescription>
<NDC11Code>72578-0041-05</NDC11Code>
<ProductNDC>72578-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220704</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077625</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220704</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.</IndicationAndUsage>
<Description>Zonisamide is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. The active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. The molecular formula is C8H8N2O3S with a molecular weight of 212.23. Zonisamide, USP is a white to off white crystalline powder, pKa=10.2, and is moderately soluble in water (0.80 mg/mL) and 0.1 N HCl (0.50 mg/mL). The chemical structure is. Zonisamide capsules, USP contain 25 mg or 50 mg or 100 mg zonisamide. Each capsule contains the inactive ingredients FD&C Blue #1, FD&C Red #4, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive. ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>72606-041-01</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (72606-041-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .2 mL in 1 SYRINGE * 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>72606-0041-01</NDC11Code>
<ProductNDC>72606-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adalimumab</ProprietaryName>
<NonProprietaryName>Adalimumab-aaty</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231130</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761219</ApplicationNumber>
<LabelerName>CELLTRION USA, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
<Description>Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-aaty injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (Adalimumab-aaty AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of Adalimumab-aaty is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of Adalimumab-aaty contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-aaty contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of Adalimumab-aaty contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>73746-041-01</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (73746-041-01) </PackageDescription>
<NDC11Code>73746-0041-01</NDC11Code>
<ProductNDC>73746-041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Savon De Provence Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200805</StartMarketingDate>
<EndMarketingDate>20221012</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>HOME & BODY COMPANY</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200805</StartMarketingDatePackage>
<EndMarketingDatePackage>20221012</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>82009-041-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (82009-041-90) </PackageDescription>
<NDC11Code>82009-0041-90</NDC11Code>
<ProductNDC>82009-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir</ProprietaryName>
<NonProprietaryName>Valacyclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221014</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203047</ApplicationNumber>
<LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir tablet is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients( 1.1) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1−infected patients Reduction of transmission Herpes Zoster Pediatric Patients ( 1.2) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use ( 1.3) The efficacy and safety of valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1−infected patients.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 556.0 mg or 1.112 grams of valacyclovir hydrochloride USP equivalent to 500 mg or 1 gm of valacyclovir, respectively, and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. In addition to this 500 mg contains FD&C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L-valine2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula:. Valacyclovir hydrochloride USP (monohydrate) is a white or almost white powder with the molecular formula C 13H 23N 6O 5Cl and a molecular weight of 378.81. Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>82293-041-10</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (82293-041-10) / 15 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>82293-0041-10</NDC11Code>
<ProductNDC>82293-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Macitentan</ProprietaryName>
<NonProprietaryName>Macitentan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260507</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211026</ApplicationNumber>
<LabelerName>Novugen Pharma (USA) LLC</LabelerName>
<SubstanceName>MACITENTAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Macitentan is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH ( 1.1).</IndicationAndUsage>
<Description>Macitentan is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C 19H 20Br 2N 6O 4S and a molecular weight of 588.27. Macitentan is achiral and has the following structural formula:. Macitentan is a crystalline powder that is insoluble in water. In the solid state macitentan is very stable, is not hygroscopic, and is not light sensitive. Macitentan is available as a 10 mg film-coated tablet for once daily oral administration. The tablets include the following inactive ingredients: mannitol, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone, and sodium starch glycolate Type A. The tablets are film-coated with a coating material containing polyvinyl alcohol, soya lecithin, talc, titanium dioxide, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>82293-041-20</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (82293-041-20) </PackageDescription>
<NDC11Code>82293-0041-20</NDC11Code>
<ProductNDC>82293-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Macitentan</ProprietaryName>
<NonProprietaryName>Macitentan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260507</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211026</ApplicationNumber>
<LabelerName>Novugen Pharma (USA) LLC</LabelerName>
<SubstanceName>MACITENTAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Macitentan is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH ( 1.1).</IndicationAndUsage>
<Description>Macitentan is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C 19H 20Br 2N 6O 4S and a molecular weight of 588.27. Macitentan is achiral and has the following structural formula:. Macitentan is a crystalline powder that is insoluble in water. In the solid state macitentan is very stable, is not hygroscopic, and is not light sensitive. Macitentan is available as a 10 mg film-coated tablet for once daily oral administration. The tablets include the following inactive ingredients: mannitol, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone, and sodium starch glycolate Type A. The tablets are film-coated with a coating material containing polyvinyl alcohol, soya lecithin, talc, titanium dioxide, and xanthan gum.</Description>
</NDC>
</NDCList>