{
"NDC": [
{
"NDCCode": "21130-526-13",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-526-13) > 120 TABLET in 1 BOTTLE",
"NDC11Code": "21130-0526-13",
"ProductNDC": "21130-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076134",
"LabelerName": "SAFEWAY INC.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090606",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "21130-235-13",
"PackageDescription": "250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (21130-235-13)",
"NDC11Code": "21130-0235-13",
"ProductNDC": "21130-235",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Pain Relief Pm",
"NonProprietaryName": "Acetaminophen And Diphenhydramine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19940515",
"EndMarketingDate": "20181110",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Better Living Brands, LLC",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-11-14",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "21130-270-13",
"PackageDescription": "225 TABLET, COATED in 1 BOTTLE, PLASTIC (21130-270-13) ",
"NDC11Code": "21130-0270-13",
"ProductNDC": "21130-270",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Relief Rapid Release Gelcaps",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150805",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Safeway",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180417",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: the common coldheadachebackacheminor pain of arthritistoothachemuscular achespremenstrual and menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "21130-921-13",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (21130-921-13) > 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "21130-0921-13",
"ProductNDC": "21130-921",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19880524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075010",
"LabelerName": "Better Living Brands, LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "19880524",
"SamplePackage": "N"
},
{
"NDCCode": "21130-526-31",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (21130-526-31) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "21130-0526-31",
"ProductNDC": "21130-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076134",
"LabelerName": "SAFEWAY INC.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090606",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "21130-526-38",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-526-38) > 365 TABLET in 1 BOTTLE",
"NDC11Code": "21130-0526-38",
"ProductNDC": "21130-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076134",
"LabelerName": "SAFEWAY INC.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090606",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "21130-526-43",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-526-43) > 45 TABLET in 1 BOTTLE",
"NDC11Code": "21130-0526-43",
"ProductNDC": "21130-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076134",
"LabelerName": "SAFEWAY INC.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090606",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "21130-526-69",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (21130-526-69) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "21130-0526-69",
"ProductNDC": "21130-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076134",
"LabelerName": "SAFEWAY INC.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090606",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "0143-9288-01",
"PackageDescription": "1 VIAL in 1 CARTON (0143-9288-01) / 2.5 mL in 1 VIAL",
"NDC11Code": "00143-9288-01",
"ProductNDC": "0143-9288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Argatroban",
"NonProprietaryName": "Argatroban",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120105",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203049",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ARGATROBAN",
"StrengthNumber": "250",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-04-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120105",
"SamplePackage": "N",
"IndicationAndUsage": "Argatroban is a direct thrombin inhibitor indicated: 1 For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1) , 2 As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2).",
"Description": "Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8- quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C23H36N6O5SH2O. Its molecular weight is 526.66 g/mol. The structural formula is shown below. Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is a sterile clear, colorless to pale yellow, slightly viscous solution. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is available in 250-mg (in 2.5-mL) single-dose amber vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 100 mg Argatroban. Inert ingredients (per vial): 1300 mg Propylene glycol, 760 mg Dehydrated alcohol."
},
{
"NDCCode": "0143-9377-01",
"PackageDescription": "1 VIAL in 1 CARTON (0143-9377-01) / 50 mL in 1 VIAL",
"NDC11Code": "00143-9377-01",
"ProductNDC": "0143-9377",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Argatroban",
"NonProprietaryName": "Argatroban",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200325",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203049",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "ARGATROBAN",
"StrengthNumber": "50",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-04-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200325",
"SamplePackage": "N",
"IndicationAndUsage": "Argatroban is a direct thrombin inhibitor indicated: 1 For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1) , 2 As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2).",
"Description": "Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8- quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C23H36N6O5SH2O. Its molecular weight is 526.66 g/mol. The structural formula is shown below. Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection 50 mg/50 mL (1 mg/mL) is a sterile clear, colorless to pale yellow, solution. Argatroban Injection 50 mg/50 mL (1 mg/mL) is available in 50-mg (in 50-mL) single-dose vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 1 mg Argatroban. Inert ingredients (per vial): 260 mg Propylene glycol, 152 mg Dehydrated alcohol, and 450 mg Sodium Chloride."
},
{
"NDCCode": "0409-1140-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1140-01) > 2.5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-1140-01",
"ProductNDC": "0409-1140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Argatroban",
"NonProprietaryName": "Argatroban",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204120",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ARGATROBAN",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170306",
"SamplePackage": "N",
"IndicationAndUsage": "Argatroban is a direct thrombin inhibitor indicated: 1 For prophylaxis or treatment of thrombosis in adult patients with heparin induced thrombocytopenia (HIT). (1.1), 2 As an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI). (1.2).",
"Description": "Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino] 1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C23H36N6O5SH2O. Its molecular weight is 526.66 g/mol. The structural formula is. Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection is a sterile clear, colorless to pale yellow, slightly viscous solution in a single-dose amber vial containing 250 mg/2.5 mL of argatroban. Each mL of sterile, nonpyrogenic solution contains 100 mg argatroban, 300 mg D-sorbitol, and 400 mg dehydrated alcohol in water for injection."
},
{
"NDCCode": "50157-526-23",
"PackageDescription": "236 mL in 1 BOTTLE, PUMP (50157-526-23) ",
"NDC11Code": "50157-0526-23",
"ProductNDC": "50157-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Germs Be Gone Sanitizer",
"ProprietaryNameSuffix": "Scented",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210814",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Brands International Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210814",
"SamplePackage": "N",
"IndicationAndUsage": "Effective in destroying harmful bacteria to provide antiseptic cleaning."
},
{
"NDCCode": "55111-526-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (55111-526-01) / 100 CAPSULE in 1 BOTTLE",
"NDC11Code": "55111-0526-01",
"ProductNDC": "55111-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090509",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N",
"Description": "Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2."
},
{
"NDCCode": "55111-526-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (55111-526-05) / 500 CAPSULE in 1 BOTTLE",
"NDC11Code": "55111-0526-05",
"ProductNDC": "55111-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090509",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N",
"Description": "Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2."
},
{
"NDCCode": "55111-526-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (55111-526-30) / 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "55111-0526-30",
"ProductNDC": "55111-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090509",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N",
"Description": "Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2."
},
{
"NDCCode": "55111-526-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55111-526-78) / 10 CAPSULE in 1 BLISTER PACK (55111-526-79) ",
"NDC11Code": "55111-0526-78",
"ProductNDC": "55111-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090509",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100514",
"SamplePackage": "N",
"Description": "Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2."
},
{
"NDCCode": "55700-526-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (55700-526-30) ",
"NDC11Code": "55700-0526-30",
"ProductNDC": "55700-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078888",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170602",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension:. Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity:. Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation:. Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning:. Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet)."
},
{
"NDCCode": "55700-526-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (55700-526-90) ",
"NDC11Code": "55700-0526-90",
"ProductNDC": "55700-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078888",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191206",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension:. Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity:. Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation:. Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning:. Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet)."
},
{
"NDCCode": "58575-526-01",
"PackageDescription": "1000 mL in 1 POUCH (58575-526-01) ",
"NDC11Code": "58575-0526-01",
"ProductNDC": "58575-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Inofoam Antibacterial",
"ProprietaryNameSuffix": "Foaming Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220629",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Inopak, Ltd",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220629",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 Handwash to help reduce bacteria on the skin that potentially can cause disease., 2 recommended for repeated use."
},
{
"NDCCode": "58575-526-42",
"PackageDescription": "3785 mL in 1 JUG (58575-526-42) ",
"NDC11Code": "58575-0526-42",
"ProductNDC": "58575-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Inofoam Antibacterial",
"ProprietaryNameSuffix": "Foaming Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220629",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Inopak, Ltd",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220629",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 Handwash to help reduce bacteria on the skin that potentially can cause disease., 2 recommended for repeated use."
},
{
"NDCCode": "60687-526-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-526-01) / 1 TABLET in 1 BLISTER PACK (60687-526-11) ",
"NDC11Code": "60687-0526-01",
"ProductNDC": "60687-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200409",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070772",
"LabelerName": "American Health Packaging",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200409",
"SamplePackage": "N"
},
{
"NDCCode": "60923-526-35",
"PackageDescription": "1 KIT in 1 CARTON (60923-526-35) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 35 POUCH in 1 BOX / 1 SWAB in 1 POUCH",
"NDC11Code": "60923-0526-35",
"ProductNDC": "60923-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elevidys",
"NonProprietaryName": "Delandistrogene Moxeparvovec-rokl",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230622",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125781",
"LabelerName": "Sarepta Therapeutics, Inc.",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230622",
"SamplePackage": "N",
"IndicationAndUsage": "ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)].",
"Description": "ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells. ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 ×1013 vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188, with a pH of 8.0 ± 0.3."
},
{
"NDCCode": "61077-001-11",
"PackageDescription": "11 mL in 1 BOTTLE, DROPPER (61077-001-11) ",
"NDC11Code": "61077-0001-11",
"ProductNDC": "61077-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "H-warts Formula",
"NonProprietaryName": "Phytolacca Decandra, Thuja Occidentalis",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Healing Natural Oils",
"SubstanceName": "PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "12; 12",
"StrengthUnit": "[hp_C]/11mL; [hp_C]/11mL",
"Status": "Active",
"LastUpdate": "2017-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131106",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of wart symptoms associated with common warts (cauliflower like appearance), plantar warts (under the feet) and flat warts.",
"Description": "Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA."
},
{
"NDCCode": "61077-001-33",
"PackageDescription": "33 mL in 1 BOTTLE, DROPPER (61077-001-33) ",
"NDC11Code": "61077-0001-33",
"ProductNDC": "61077-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "H-warts Formula",
"NonProprietaryName": "Phytolacca Decandra, Thuja Occidentalis",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Healing Natural Oils",
"SubstanceName": "PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "12; 12",
"StrengthUnit": "[hp_C]/11mL; [hp_C]/11mL",
"Status": "Active",
"LastUpdate": "2017-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131106",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of wart symptoms associated with common warts (cauliflower like appearance), plantar warts (under the feet) and flat warts.",
"Description": "Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA."
},
{
"NDCCode": "61077-003-11",
"PackageDescription": "11 mL in 1 BOTTLE, DROPPER (61077-003-11) ",
"NDC11Code": "61077-0003-11",
"ProductNDC": "61077-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "H-hemorrhoids Formula",
"NonProprietaryName": "Aesculus Hippocastanum, Collinsonia Canadensis",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Healing Natural Oils",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; COLLINSONIA CANADENSIS ROOT",
"StrengthNumber": "12; 12",
"StrengthUnit": "[hp_C]/11mL; [hp_C]/11mL",
"Status": "Active",
"LastUpdate": "2017-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20131106",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of hemorrhoid symptoms such as itching, discomfort and inflammation.",
"Description": "Dist. by Healing Natural Oils 3830 Valley Ctr Dr. #705-526, San Diego, CA 92130, USA."
},
{
"NDCCode": "63029-526-11",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 BOX (63029-526-11) > 9 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "63029-0526-11",
"ProductNDC": "63029-526",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Outgro",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Medtech Products Inc.",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": ".009",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "64980-526-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (64980-526-03) ",
"NDC11Code": "64980-0526-03",
"ProductNDC": "64980-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitazoxanide",
"NonProprietaryName": "Nitazoxanide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213820",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "NITAZOXANIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiprotozoal [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201127",
"SamplePackage": "N",
"IndicationAndUsage": "Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2)].",
"Description": "Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a pale yellow to yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy-N-(5-nitro-2-thiazolyl) benzamide. The molecular formula is C12H9N3O5S and the molecular weight is 307.3. The structural formula is. Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, partially pregelatinized maize starch, sodium starch glycolate, hypromellose, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No.2 Aluminum Lake."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "NITAZOXANIDE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiprotozoal [EPC]",
"Status": "Active",
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"StartMarketingDatePackage": "20201127",
"SamplePackage": "N",
"IndicationAndUsage": "Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2)].",
"Description": "Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a pale yellow to yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy-N-(5-nitro-2-thiazolyl) benzamide. The molecular formula is C12H9N3O5S and the molecular weight is 307.3. The structural formula is. Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, partially pregelatinized maize starch, sodium starch glycolate, hypromellose, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No.2 Aluminum Lake."
},
{
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"ProductNDC": "64980-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"StartMarketingDatePackage": "20201127",
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"IndicationAndUsage": "Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2)].",
"Description": "Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a pale yellow to yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy-N-(5-nitro-2-thiazolyl) benzamide. The molecular formula is C12H9N3O5S and the molecular weight is 307.3. The structural formula is. Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, partially pregelatinized maize starch, sodium starch glycolate, hypromellose, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No.2 Aluminum Lake."
},
{
"NDCCode": "64980-526-81",
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"NDC11Code": "64980-0526-81",
"ProductNDC": "64980-526",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2)].",
"Description": "Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a pale yellow to yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy-N-(5-nitro-2-thiazolyl) benzamide. The molecular formula is C12H9N3O5S and the molecular weight is 307.3. The structural formula is. Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, partially pregelatinized maize starch, sodium starch glycolate, hypromellose, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No.2 Aluminum Lake."
}
]
}
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<SubstanceName>IBUPROFEN</SubstanceName>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
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<LabelerName>SAFEWAY INC.</LabelerName>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
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<NDC>
<NDCCode>0143-9288-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0143-9288-01) / 2.5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9288-01</NDC11Code>
<ProductNDC>0143-9288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Argatroban</ProprietaryName>
<NonProprietaryName>Argatroban</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120105</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203049</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ARGATROBAN</SubstanceName>
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<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Argatroban is a direct thrombin inhibitor indicated: 1 For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1) , 2 As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2).</IndicationAndUsage>
<Description>Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8- quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C23H36N6O5SH2O. Its molecular weight is 526.66 g/mol. The structural formula is shown below. Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is a sterile clear, colorless to pale yellow, slightly viscous solution. Argatroban Injection 250 mg/2.5 mL (100 mg/mL) is available in 250-mg (in 2.5-mL) single-dose amber vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 100 mg Argatroban. Inert ingredients (per vial): 1300 mg Propylene glycol, 760 mg Dehydrated alcohol.</Description>
</NDC>
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<PackageDescription>1 VIAL in 1 CARTON (0143-9377-01) / 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9377-01</NDC11Code>
<ProductNDC>0143-9377</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Argatroban</ProprietaryName>
<NonProprietaryName>Argatroban</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200325</StartMarketingDate>
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<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ARGATROBAN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Argatroban is a direct thrombin inhibitor indicated: 1 For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) (1.1) , 2 As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2).</IndicationAndUsage>
<Description>Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8- quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C23H36N6O5SH2O. Its molecular weight is 526.66 g/mol. The structural formula is shown below. Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection 50 mg/50 mL (1 mg/mL) is a sterile clear, colorless to pale yellow, solution. Argatroban Injection 50 mg/50 mL (1 mg/mL) is available in 50-mg (in 50-mL) single-dose vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 1 mg Argatroban. Inert ingredients (per vial): 260 mg Propylene glycol, 152 mg Dehydrated alcohol, and 450 mg Sodium Chloride.</Description>
</NDC>
<NDC>
<NDCCode>0409-1140-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1140-01) > 2.5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00409-1140-01</NDC11Code>
<ProductNDC>0409-1140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Argatroban</ProprietaryName>
<NonProprietaryName>Argatroban</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204120</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ARGATROBAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Argatroban is a direct thrombin inhibitor indicated: 1 For prophylaxis or treatment of thrombosis in adult patients with heparin induced thrombocytopenia (HIT). (1.1), 2 As an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI). (1.2).</IndicationAndUsage>
<Description>Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl)amino] 1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C23H36N6O5SH2O. Its molecular weight is 526.66 g/mol. The structural formula is. Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection is a sterile clear, colorless to pale yellow, slightly viscous solution in a single-dose amber vial containing 250 mg/2.5 mL of argatroban. Each mL of sterile, nonpyrogenic solution contains 100 mg argatroban, 300 mg D-sorbitol, and 400 mg dehydrated alcohol in water for injection.</Description>
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<IndicationAndUsage>Effective in destroying harmful bacteria to provide antiseptic cleaning.</IndicationAndUsage>
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<NDC>
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<PackageDescription>1 BOTTLE in 1 CARTON (55111-526-01) / 100 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>55111-0526-01</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090509</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
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<Description>Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2.</Description>
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<PackageDescription>1 BOTTLE in 1 CARTON (55111-526-05) / 500 CAPSULE in 1 BOTTLE</PackageDescription>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090509</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-20</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-526-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55111-526-30) / 30 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>55111-0526-30</NDC11Code>
<ProductNDC>55111-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090509</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-526-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55111-526-78) / 10 CAPSULE in 1 BLISTER PACK (55111-526-79) </PackageDescription>
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<ProductNDC>55111-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Tacrolimus</NonProprietaryName>
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<ApplicationNumber>ANDA090509</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-20</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20100514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus USP, previously known as FK506, is the active ingredient in tacrolimus capsules USP. Tacrolimus USP is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as [3S-[3R*[E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] -5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus is. Tacrolimus USP has an molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus USP appears as white to off white granular powder. It is practically insoluble in water, freely soluble in methanol, ethanol, acetone, ehyl acetate, chloroform. Tacrolimus USP is available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus, USP. Inactive ingredients include croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide. Tacrolimus Capsules meets USP Organic Impurities Test Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>55700-526-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (55700-526-30) </PackageDescription>
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<ProductNDC>55700-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078888</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
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<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension:. Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity:. Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation:. Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning:. Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet).</Description>
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<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. 1. Motor tension:. Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity:. Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation:. Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning:. Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline powder. It is very soluble in water; freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate and practically insoluble in hexanes. Its molecular weight is 422. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Each buspirone hydrochloride tablet intended for oral administration contains 5 mg or 10 mg or 15 mg or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet).</Description>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Inopak, Ltd</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
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<IndicationAndUsage>Uses: 1 Handwash to help reduce bacteria on the skin that potentially can cause disease., 2 recommended for repeated use.</IndicationAndUsage>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220629</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Inopak, Ltd</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 Handwash to help reduce bacteria on the skin that potentially can cause disease., 2 recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60687-526-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-526-01) / 1 TABLET in 1 BLISTER PACK (60687-526-11) </PackageDescription>
<NDC11Code>60687-0526-01</NDC11Code>
<ProductNDC>60687-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200409</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070772</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60923-526-35</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (60923-526-35) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 35 POUCH in 1 BOX / 1 SWAB in 1 POUCH</PackageDescription>
<NDC11Code>60923-0526-35</NDC11Code>
<ProductNDC>60923-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elevidys</ProprietaryName>
<NonProprietaryName>Delandistrogene Moxeparvovec-rokl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230622</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125781</ApplicationNumber>
<LabelerName>Sarepta Therapeutics, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)].</IndicationAndUsage>
<Description>ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells. ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 ×1013 vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188, with a pH of 8.0 ± 0.3.</Description>
</NDC>
<NDC>
<NDCCode>61077-001-11</NDCCode>
<PackageDescription>11 mL in 1 BOTTLE, DROPPER (61077-001-11) </PackageDescription>
<NDC11Code>61077-0001-11</NDC11Code>
<ProductNDC>61077-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>H-warts Formula</ProprietaryName>
<NonProprietaryName>Phytolacca Decandra, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Healing Natural Oils</LabelerName>
<SubstanceName>PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>12; 12</StrengthNumber>
<StrengthUnit>[hp_C]/11mL; [hp_C]/11mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2017-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of wart symptoms associated with common warts (cauliflower like appearance), plantar warts (under the feet) and flat warts.</IndicationAndUsage>
<Description>Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA.</Description>
</NDC>
<NDC>
<NDCCode>61077-001-33</NDCCode>
<PackageDescription>33 mL in 1 BOTTLE, DROPPER (61077-001-33) </PackageDescription>
<NDC11Code>61077-0001-33</NDC11Code>
<ProductNDC>61077-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>H-warts Formula</ProprietaryName>
<NonProprietaryName>Phytolacca Decandra, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Healing Natural Oils</LabelerName>
<SubstanceName>PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>12; 12</StrengthNumber>
<StrengthUnit>[hp_C]/11mL; [hp_C]/11mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2017-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of wart symptoms associated with common warts (cauliflower like appearance), plantar warts (under the feet) and flat warts.</IndicationAndUsage>
<Description>Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA.</Description>
</NDC>
<NDC>
<NDCCode>61077-003-11</NDCCode>
<PackageDescription>11 mL in 1 BOTTLE, DROPPER (61077-003-11) </PackageDescription>
<NDC11Code>61077-0003-11</NDC11Code>
<ProductNDC>61077-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>H-hemorrhoids Formula</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Collinsonia Canadensis</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Healing Natural Oils</LabelerName>
<SubstanceName>AESCULUS HIPPOCASTANUM FLOWER; COLLINSONIA CANADENSIS ROOT</SubstanceName>
<StrengthNumber>12; 12</StrengthNumber>
<StrengthUnit>[hp_C]/11mL; [hp_C]/11mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2017-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of hemorrhoid symptoms such as itching, discomfort and inflammation.</IndicationAndUsage>
<Description>Dist. by Healing Natural Oils 3830 Valley Ctr Dr. #705-526, San Diego, CA 92130, USA.</Description>
</NDC>
<NDC>
<NDCCode>63029-526-11</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 BOX (63029-526-11) > 9 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>63029-0526-11</NDC11Code>
<ProductNDC>63029-526</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Outgro</ProprietaryName>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Medtech Products Inc.</LabelerName>
<SubstanceName>BENZOCAINE</SubstanceName>
<StrengthNumber>.009</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64980-526-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (64980-526-03) </PackageDescription>
<NDC11Code>64980-0526-03</NDC11Code>
<ProductNDC>64980-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitazoxanide</ProprietaryName>
<NonProprietaryName>Nitazoxanide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213820</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>NITAZOXANIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiprotozoal [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a pale yellow to yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy-N-(5-nitro-2-thiazolyl) benzamide. The molecular formula is C12H9N3O5S and the molecular weight is 307.3. The structural formula is. Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, partially pregelatinized maize starch, sodium starch glycolate, hypromellose, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No.2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>64980-526-21</NDCCode>
<PackageDescription>12 TABLET, FILM COATED in 1 BOTTLE (64980-526-21) </PackageDescription>
<NDC11Code>64980-0526-21</NDC11Code>
<ProductNDC>64980-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitazoxanide</ProprietaryName>
<NonProprietaryName>Nitazoxanide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213820</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>NITAZOXANIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiprotozoal [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a pale yellow to yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy-N-(5-nitro-2-thiazolyl) benzamide. The molecular formula is C12H9N3O5S and the molecular weight is 307.3. The structural formula is. Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, partially pregelatinized maize starch, sodium starch glycolate, hypromellose, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No.2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>64980-526-60</NDCCode>
<PackageDescription>6 TABLET, FILM COATED in 1 BOTTLE (64980-526-60) </PackageDescription>
<NDC11Code>64980-0526-60</NDC11Code>
<ProductNDC>64980-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitazoxanide</ProprietaryName>
<NonProprietaryName>Nitazoxanide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213820</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>NITAZOXANIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiprotozoal [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a pale yellow to yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy-N-(5-nitro-2-thiazolyl) benzamide. The molecular formula is C12H9N3O5S and the molecular weight is 307.3. The structural formula is. Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, partially pregelatinized maize starch, sodium starch glycolate, hypromellose, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No.2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>64980-526-81</NDCCode>
<PackageDescription>18 TABLET, FILM COATED in 1 BOTTLE (64980-526-81) </PackageDescription>
<NDC11Code>64980-0526-81</NDC11Code>
<ProductNDC>64980-526</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitazoxanide</ProprietaryName>
<NonProprietaryName>Nitazoxanide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213820</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>NITAZOXANIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiprotozoal [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide is a pale yellow to yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy-N-(5-nitro-2-thiazolyl) benzamide. The molecular formula is C12H9N3O5S and the molecular weight is 307.3. The structural formula is. Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, partially pregelatinized maize starch, sodium starch glycolate, hypromellose, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No.2 Aluminum Lake.</Description>
</NDC>
</NDCList>