{
"NDC": [
{
"NDCCode": "73750-104-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (73750-104-10) ",
"NDC11Code": "73750-0104-10",
"ProductNDC": "73750-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204632",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "VARDENAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "73750-104-11",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (73750-104-11) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "73750-0104-11",
"ProductNDC": "73750-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204632",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "VARDENAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "73750-104-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (73750-104-30) ",
"NDC11Code": "73750-0104-30",
"ProductNDC": "73750-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204632",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "VARDENAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "73750-091-10",
"PackageDescription": "30 g in 1 TUBE (73750-091-10) ",
"NDC11Code": "73750-0091-10",
"ProductNDC": "73750-091",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "1med Clotrimazole 1% Antifungal Cream",
"NonProprietaryName": "Clotrimazole 1% Antifungal Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night). Children under 2 years of age: consult a doctor."
},
{
"NDCCode": "73750-095-10",
"PackageDescription": "30 g in 1 TUBE (73750-095-10) ",
"NDC11Code": "73750-0095-10",
"ProductNDC": "73750-095",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "1med Clotrimazole 1% Antifungal Cream",
"NonProprietaryName": "Clotrimazole 1% Antifungal Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night). Children under 2 years of age: consult a doctor."
},
{
"NDCCode": "73750-099-10",
"PackageDescription": "100 mg in 1 BOTTLE (73750-099-10) ",
"NDC11Code": "73750-0099-10",
"ProductNDC": "73750-099",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamsulosin Hydrochloride",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211885",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/.4mg",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20230203",
"SamplePackage": "N",
"IndicationAndUsage": "Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.",
"Description": "Tamsulosin hydrochloride is an antagonist of alpha 1A adrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-( R)-5-[2-[[2-( o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The empirical formula of tamsulosin hydrochloride is C 20H 28N 2O 5S HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: ethylcellulose, gelatin, methacrylic acid and methyl methacrylate copolymer, polyethylene glycol, sugar spheres (made of sucrose and corn starch), talc, triethyl citrate, titanium dioxide, and trace amounts of black edible ink (contains shellac, potassium hydroxide and black iron oxide). USP dissolution test 2 was used."
},
{
"NDCCode": "73750-102-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (73750-102-10) ",
"NDC11Code": "73750-0102-10",
"ProductNDC": "73750-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204632",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "VARDENAFIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "73750-102-11",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (73750-102-11) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "73750-0102-11",
"ProductNDC": "73750-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204632",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "VARDENAFIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "73750-103-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (73750-103-10) ",
"NDC11Code": "73750-0103-10",
"ProductNDC": "73750-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204632",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "VARDENAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "73750-103-11",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (73750-103-11) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "73750-0103-11",
"ProductNDC": "73750-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204632",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "VARDENAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "73750-105-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (73750-105-10) ",
"NDC11Code": "73750-0105-10",
"ProductNDC": "73750-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204632",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "VARDENAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "73750-105-11",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (73750-105-11) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "73750-0105-11",
"ProductNDC": "73750-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204632",
"LabelerName": "QYK BRANDS LLC",
"SubstanceName": "VARDENAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220301",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide."
},
{
"NDCCode": "73750-459-10",
"PackageDescription": "100 mL in 1 CANISTER (73750-459-10) ",
"NDC11Code": "73750-0459-10",
"ProductNDC": "73750-459",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr Js Natural 75% Alcohol Wipes",
"NonProprietaryName": "Dr Js Natural Alcohol Wipes",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Qyk Brands LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: For handwashing and general cleaning to decrease bacteria on skin whenever soap and water is not readily available."
},
{
"NDCCode": "73750-459-11",
"PackageDescription": "10 mL in 1 POUCH (73750-459-11) ",
"NDC11Code": "73750-0459-11",
"ProductNDC": "73750-459",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr Js Natural 75% Alcohol Wipes",
"NonProprietaryName": "Dr Js Natural Alcohol Wipes",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Qyk Brands LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N"
},
{
"NDCCode": "73750-459-22",
"PackageDescription": "10 PACKAGE in 1 POUCH (73750-459-22) > 6 mL in 1 PACKAGE",
"NDC11Code": "73750-0459-22",
"ProductNDC": "73750-459",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr Js Natural 75% Alcohol Wipes",
"NonProprietaryName": "Dr Js Natural Alcohol Wipes",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Qyk Brands LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200929",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: For handwashing or general cleaning to decrease bacteria on skin or surface whenever soap and water is not readily available."
},
{
"NDCCode": "13668-104-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-10) ",
"NDC11Code": "13668-0104-10",
"ProductNDC": "13668-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Mononitrate",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200270",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110603",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide mononitrate extended-release tablets, USP are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, diethyl phthalate, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. The molecular formula of ISMN is C 6H 9NO 6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane. For 30 mg: Meets USP Dissolution Test 6. For 60 mg and 120 mg: Meets USP Dissolution Test 1."
},
{
"NDCCode": "14789-104-05",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (14789-104-05) / 10 mL in 1 VIAL, MULTI-DOSE (14789-104-07) ",
"NDC11Code": "14789-0104-05",
"ProductNDC": "14789-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Succinylcholine Chloride",
"NonProprietaryName": "Succinylcholine Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20210111",
"EndMarketingDate": "20240721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213552",
"LabelerName": "Nexus Pharmaceuticals Inc",
"SubstanceName": "SUCCINYLCHOLINE CHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210111",
"EndMarketingDatePackage": "20240721",
"SamplePackage": "N",
"IndicationAndUsage": "Succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as an ultra-short-acting, depolarizing, skeletal muscle relaxant. See HOW SUPPLIED for a summary of content and characteristics of the solution. The solution is for intramuscular (IM) or intravenous (IV) use. Succinylcholine Chloride is chemically designated as Ethanaminium, 2,2'-[(1,4-dioxo-1,4-butanediyl) bis(oxy)] bis [N, N, N-trimethyl-, dichloride, its molecular formula is C14H30Cl2N2O4, and its molecular weight is 361.31. It has the following structural formula:. Succinylcholine is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. Succinylcholine Chloride, USP is a white, odorless, crystalline powder. It is freely soluble in water, slightly soluble in alcohol, and practically insoluble in ether. The drug is incompatible with alkaline solutions but relatively stable in acid solutions. Solutions of the drug lose potency unless refrigerated. Solution intended for multiple-dose administration contains methylparaben 0.18% and propylparaben 0.02%, as preservatives. Product not requiring dilution (multiple-dose fliptop vial) contains sodium chloride to render isotonic. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH is 3.6 (3.0 to 4.5). See table in HOW SUPPLIED for characteristics. Sodium Chloride, USP, chemically designated NaCl, is a white crystalline compound freely soluble in water."
},
{
"NDCCode": "16812-104-06",
"PackageDescription": "1 BOTTLE in 1 BAG (16812-104-06) / 10 g in 1 BOTTLE",
"NDC11Code": "16812-0104-06",
"ProductNDC": "16812-104",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tirzepatide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20241016",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Aurisco Pharmaceutical Co.,Ltd",
"SubstanceName": "TIRZEPATIDE",
"StrengthNumber": "10",
"StrengthUnit": "g/10g",
"Status": "Unfinished",
"LastUpdate": "2025-08-15",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "16-OCT-24"
},
{
"NDCCode": "16812-104-10",
"PackageDescription": "1 BOTTLE in 1 BAG (16812-104-10) / 500 g in 1 BOTTLE",
"NDC11Code": "16812-0104-10",
"ProductNDC": "16812-104",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tirzepatide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Aurisco Pharmaceutical Co.,Ltd",
"SubstanceName": "TIRZEPATIDE",
"StrengthNumber": "500",
"StrengthUnit": "g/500g",
"Status": "Unfinished",
"LastUpdate": "2026-07-24",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "01-JUL-26"
},
{
"NDCCode": "17575-104-10",
"PackageDescription": "12352 L in 1 CYLINDER (17575-104-10) ",
"NDC11Code": "17575-0104-10",
"ProductNDC": "17575-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbon Dioxide",
"NonProprietaryName": "Carbon Dioxide",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19660101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205764",
"LabelerName": "AGL Inhalation Therapy Co.",
"SubstanceName": "CARBON DIOXIDE",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19660101",
"SamplePackage": "N"
},
{
"NDCCode": "17772-104-10",
"PackageDescription": "5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-104-10) ",
"NDC11Code": "17772-0104-10",
"ProductNDC": "17772-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trokendi Xr",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201635",
"LabelerName": "Supernus Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130816",
"SamplePackage": "Y",
"IndicationAndUsage": "TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF."
},
{
"NDCCode": "18860-104-10",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (18860-104-10) ",
"NDC11Code": "18860-0104-10",
"ProductNDC": "18860-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fazaclo",
"NonProprietaryName": "Clozapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20080601",
"EndMarketingDate": "20210930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021590",
"LabelerName": "Jazz Pharmaceuticals, Inc.",
"SubstanceName": "CLOZAPINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080601",
"EndMarketingDatePackage": "20210930",
"SamplePackage": "N"
},
{
"NDCCode": "23155-104-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (23155-104-10) ",
"NDC11Code": "23155-0104-10",
"ProductNDC": "23155-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090564",
"LabelerName": "Heritage Pharmaceuticals Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100422",
"SamplePackage": "N"
},
{
"NDCCode": "28955-104-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (28955-104-10) / .8 mL in 1 SYRINGE",
"NDC11Code": "28955-0104-10",
"ProductNDC": "28955-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enoxaparin Sodium",
"NonProprietaryName": "Enoxaparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218775",
"LabelerName": "Hebei Changshan Biochemical Pharmaceutical Co., Ltd.",
"SubstanceName": "ENOXAPARIN SODIUM",
"StrengthNumber": "80",
"StrengthUnit": "mg/.8mL",
"Pharm_Classes": "Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "Enoxaparin sodium injection is a low molecular weight heparin (LMWH) indicated for: Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness ( 1.1) Inpatient treatment of acute DVT with or without pulmonary embolism (1.2) Outpatient treatment of acute DVT without pulmonary embolism (1.2) Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction (MI) (1.3) Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4).",
"Description": "Enoxaparin sodium injection, USP is a sterile aqueous solution containing enoxaparin sodium, USP, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium,USP is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is: <2000 daltons ≤20% 2000 to 8000 daltons ≥68% >8000 daltons ≤18% STRUCTURAL FORMULA. * X = Percent of polysaccharide chain containing 1,6-anhydro derivative on the reducing end. Enoxaparin Sodium Injection, USP 100 mg/mL Concentrationcontains 10 mg enoxaparin sodium, USP (approximate anti-Factor Xa activity of 1000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin Sodium Injection, USP 150 mg/mL Concentrationcontains 15 mg enoxaparin sodium, USP (approximate anti-Factor Xa activity of 1500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The enoxaparin sodium injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection. [ see Dosage and Administration (2)and How Supplied/Storage and Handling (16)]."
},
{
"NDCCode": "31722-104-31",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (31722-104-31) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "31722-0104-31",
"ProductNDC": "31722-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209403",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2020-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201007",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1) Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2) Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (1.3).",
"Description": "Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula of cinacalcet is C22H22F3N⋅HCl with a molecular mass of 393.87. It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is freely soluble in methanol and in ethanol. The hydrochloride salt of cinacalcet is described chemically as (R)-N-(3-(3-(trifluoromethyl) phenyl] propyl]-1-(1-naphthyl) ethylamine hydrochloride and has the following structural formula. Cinacalcet tablets are formulated as light-green, oval, biconvex, film coated tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33.064 mg, 66.127 mg and 99.191 mg as the hydrochloride salt, respectively). Inactive Ingredients The following are the inactive ingredients in cinacalcet tablets: crospovidone, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The coating material contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, FD&C blue #2/indigo carmine AL, iron oxide yellow, polyethylene glycol. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "33261-104-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (33261-104-10)",
"NDC11Code": "33261-0104-10",
"ProductNDC": "33261-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076286",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Tizanidine tablets are a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).",
"Description": "Tizanidine hydrochloride USP, is a centrally acting α2-adrenergic agonist. Tizanidine HCl USP (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride. Tizanidine’s molecular formula is C9H8ClN5S.HCl, its molecular weight is 290.2 and its structural formula is. Tizanidine tablets USP, is supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets USP, are composed of the active ingredient, tizanidine hydrochloride USP (2.29 mg equivalent to 2 mg tizanidine base and 4.58 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, microcrystalline cellulose, colloidal silicon dioxide and stearic acid."
},
{
"NDCCode": "33342-104-39",
"PackageDescription": "9 BLISTER PACK in 1 CARTON (33342-104-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "33342-0104-39",
"ProductNDC": "33342-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203359",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160614",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder manic episodes (1.2) Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with \"F75”), 300 mg (capsule-shaped, white, one side debossed with \"F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "42507-104-10",
"PackageDescription": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (42507-104-10) ",
"NDC11Code": "42507-0104-10",
"ProductNDC": "42507-104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stool Softener Laxative",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20251017",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Hy-Vee",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity) . generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "42543-104-10",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42543-104-10) ",
"NDC11Code": "42543-0104-10",
"ProductNDC": "42543-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205549",
"LabelerName": "Vensun Pharmaceuticals, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20151208",
"SamplePackage": "N"
},
{
"NDCCode": "42571-104-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42571-104-10)",
"NDC11Code": "42571-0104-10",
"ProductNDC": "42571-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glimepiride",
"NonProprietaryName": "Glimepiride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091220",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "GLIMEPIRIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>73750-104-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (73750-104-10) </PackageDescription>
<NDC11Code>73750-0104-10</NDC11Code>
<ProductNDC>73750-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204632</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>VARDENAFIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>73750-104-11</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (73750-104-11) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>73750-0104-11</NDC11Code>
<ProductNDC>73750-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204632</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>VARDENAFIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>73750-104-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (73750-104-30) </PackageDescription>
<NDC11Code>73750-0104-30</NDC11Code>
<ProductNDC>73750-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204632</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>VARDENAFIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>73750-091-10</NDCCode>
<PackageDescription>30 g in 1 TUBE (73750-091-10) </PackageDescription>
<NDC11Code>73750-0091-10</NDC11Code>
<ProductNDC>73750-091</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>1med Clotrimazole 1% Antifungal Cream</ProprietaryName>
<NonProprietaryName>Clotrimazole 1% Antifungal Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night). Children under 2 years of age: consult a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73750-095-10</NDCCode>
<PackageDescription>30 g in 1 TUBE (73750-095-10) </PackageDescription>
<NDC11Code>73750-0095-10</NDC11Code>
<ProductNDC>73750-095</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>1med Clotrimazole 1% Antifungal Cream</ProprietaryName>
<NonProprietaryName>Clotrimazole 1% Antifungal Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night). Children under 2 years of age: consult a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73750-099-10</NDCCode>
<PackageDescription>100 mg in 1 BOTTLE (73750-099-10) </PackageDescription>
<NDC11Code>73750-0099-10</NDC11Code>
<ProductNDC>73750-099</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211885</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/.4mg</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Tamsulosin hydrochloride is an antagonist of alpha 1A adrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-( R)-5-[2-[[2-( o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride is a white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The empirical formula of tamsulosin hydrochloride is C 20H 28N 2O 5S HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is. Each tamsulosin hydrochloride capsule for oral administration contains tamsulosin hydrochloride 0.4 mg, and the following inactive ingredients: ethylcellulose, gelatin, methacrylic acid and methyl methacrylate copolymer, polyethylene glycol, sugar spheres (made of sucrose and corn starch), talc, triethyl citrate, titanium dioxide, and trace amounts of black edible ink (contains shellac, potassium hydroxide and black iron oxide). USP dissolution test 2 was used.</Description>
</NDC>
<NDC>
<NDCCode>73750-102-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (73750-102-10) </PackageDescription>
<NDC11Code>73750-0102-10</NDC11Code>
<ProductNDC>73750-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204632</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>VARDENAFIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>73750-102-11</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (73750-102-11) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>73750-0102-11</NDC11Code>
<ProductNDC>73750-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204632</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>VARDENAFIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>73750-103-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (73750-103-10) </PackageDescription>
<NDC11Code>73750-0103-10</NDC11Code>
<ProductNDC>73750-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204632</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>VARDENAFIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>73750-103-11</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (73750-103-11) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>73750-0103-11</NDC11Code>
<ProductNDC>73750-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204632</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>VARDENAFIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>73750-105-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (73750-105-10) </PackageDescription>
<NDC11Code>73750-0105-10</NDC11Code>
<ProductNDC>73750-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204632</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>VARDENAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>73750-105-11</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (73750-105-11) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>73750-0105-11</NDC11Code>
<ProductNDC>73750-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204632</ApplicationNumber>
<LabelerName>QYK BRANDS LLC</LabelerName>
<SubstanceName>VARDENAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as: 2.5 mg tablets are white to off white, round, film-coated tablets debossed with ‘L 50’ on one side and plain surface on the other side,5 mg tablets are orange, round, film-coated tablets debossed with ‘L 51’ on one side and plain surface on the other side, 10 mg tablets are orange, round, film-coated tablets debossed with ‘L 52’ on one side and plain surface on the other side, 20 mg tablets are orange, round, film-coated tablets debossed with ‘L 53’ on one side and plain surface on the other side. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. In addition 5 mg, 10 mg and 20 mg has yellow ferric oxide and red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>73750-459-10</NDCCode>
<PackageDescription>100 mL in 1 CANISTER (73750-459-10) </PackageDescription>
<NDC11Code>73750-0459-10</NDC11Code>
<ProductNDC>73750-459</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr Js Natural 75% Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Dr Js Natural Alcohol Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Qyk Brands LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: For handwashing and general cleaning to decrease bacteria on skin whenever soap and water is not readily available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73750-459-11</NDCCode>
<PackageDescription>10 mL in 1 POUCH (73750-459-11) </PackageDescription>
<NDC11Code>73750-0459-11</NDC11Code>
<ProductNDC>73750-459</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr Js Natural 75% Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Dr Js Natural Alcohol Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Qyk Brands LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73750-459-22</NDCCode>
<PackageDescription>10 PACKAGE in 1 POUCH (73750-459-22) > 6 mL in 1 PACKAGE</PackageDescription>
<NDC11Code>73750-0459-22</NDC11Code>
<ProductNDC>73750-459</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr Js Natural 75% Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Dr Js Natural Alcohol Wipes</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Qyk Brands LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: For handwashing or general cleaning to decrease bacteria on skin or surface whenever soap and water is not readily available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-104-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-104-10) </PackageDescription>
<NDC11Code>13668-0104-10</NDC11Code>
<ProductNDC>13668-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200270</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide mononitrate extended-release tablets, USP are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, diethyl phthalate, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. The molecular formula of ISMN is C 6H 9NO 6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane. For 30 mg: Meets USP Dissolution Test 6. For 60 mg and 120 mg: Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>14789-104-05</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (14789-104-05) / 10 mL in 1 VIAL, MULTI-DOSE (14789-104-07) </PackageDescription>
<NDC11Code>14789-0104-05</NDC11Code>
<ProductNDC>14789-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Succinylcholine Chloride</ProprietaryName>
<NonProprietaryName>Succinylcholine Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20210111</StartMarketingDate>
<EndMarketingDate>20240721</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213552</ApplicationNumber>
<LabelerName>Nexus Pharmaceuticals Inc</LabelerName>
<SubstanceName>SUCCINYLCHOLINE CHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Depolarizing Neuromuscular Blocker [EPC], Neuromuscular Depolarizing Blockade [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210111</StartMarketingDatePackage>
<EndMarketingDatePackage>20240721</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Succinylcholine Chloride Injection, USP is a sterile, nonpyrogenic solution to be used as an ultra-short-acting, depolarizing, skeletal muscle relaxant. See HOW SUPPLIED for a summary of content and characteristics of the solution. The solution is for intramuscular (IM) or intravenous (IV) use. Succinylcholine Chloride is chemically designated as Ethanaminium, 2,2'-[(1,4-dioxo-1,4-butanediyl) bis(oxy)] bis [N, N, N-trimethyl-, dichloride, its molecular formula is C14H30Cl2N2O4, and its molecular weight is 361.31. It has the following structural formula:. Succinylcholine is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. Succinylcholine Chloride, USP is a white, odorless, crystalline powder. It is freely soluble in water, slightly soluble in alcohol, and practically insoluble in ether. The drug is incompatible with alkaline solutions but relatively stable in acid solutions. Solutions of the drug lose potency unless refrigerated. Solution intended for multiple-dose administration contains methylparaben 0.18% and propylparaben 0.02%, as preservatives. Product not requiring dilution (multiple-dose fliptop vial) contains sodium chloride to render isotonic. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH is 3.6 (3.0 to 4.5). See table in HOW SUPPLIED for characteristics. Sodium Chloride, USP, chemically designated NaCl, is a white crystalline compound freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>16812-104-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 BAG (16812-104-06) / 10 g in 1 BOTTLE</PackageDescription>
<NDC11Code>16812-0104-06</NDC11Code>
<ProductNDC>16812-104</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tirzepatide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20241016</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Aurisco Pharmaceutical Co.,Ltd</LabelerName>
<SubstanceName>TIRZEPATIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/10g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-08-15</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-OCT-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>16812-104-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 BAG (16812-104-10) / 500 g in 1 BOTTLE</PackageDescription>
<NDC11Code>16812-0104-10</NDC11Code>
<ProductNDC>16812-104</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tirzepatide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Aurisco Pharmaceutical Co.,Ltd</LabelerName>
<SubstanceName>TIRZEPATIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>g/500g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-07-24</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JUL-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>17575-104-10</NDCCode>
<PackageDescription>12352 L in 1 CYLINDER (17575-104-10) </PackageDescription>
<NDC11Code>17575-0104-10</NDC11Code>
<ProductNDC>17575-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbon Dioxide</ProprietaryName>
<NonProprietaryName>Carbon Dioxide</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19660101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205764</ApplicationNumber>
<LabelerName>AGL Inhalation Therapy Co.</LabelerName>
<SubstanceName>CARBON DIOXIDE</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19660101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17772-104-10</NDCCode>
<PackageDescription>5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-104-10) </PackageDescription>
<NDC11Code>17772-0104-10</NDC11Code>
<ProductNDC>17772-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trokendi Xr</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201635</ApplicationNumber>
<LabelerName>Supernus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130816</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>TROKENDI XR is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. TROKENDI XR (topiramate) extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. TROKENDI XR (topiramate) is an extended-release capsule. TROKENDI XR capsules contain the following inactive ingredients. Sugar Spheres, NF Hypromellose (Type 2910), USP Mannitol, USP Docusate Sodium, USP Sodium Benzoate, NF Ethylcellulose, NF Oleic Acid, NF Medium Chain Triglycerides, NF Polyethylene Glycol, NF Polyvinyl Alcohol, USP Titanium Dioxide, USP Talc, USP Lecithin, NF Xanthan Gum, NF Glycerin, USP-NF. The capsule shells contain gelatin, USP; Titanium Dioxide, USP; and Colorants. The colorants are. FD&C Blue #1 (all strength capsules) Yellow Iron Oxide, USP (25 mg and 50 mg capsules) FD&C Red #3 (50 mg, 100 mg and 200 mg capsules) FD&C Yellow #6 (50 mg, 100 mg and 200 mg capsules) Riboflavin, USP (25 mg capsules). All capsule shells are imprinted with black print that contains shellac, NF, and black iron oxide, NF.</Description>
</NDC>
<NDC>
<NDCCode>18860-104-10</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (18860-104-10) </PackageDescription>
<NDC11Code>18860-0104-10</NDC11Code>
<ProductNDC>18860-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fazaclo</ProprietaryName>
<NonProprietaryName>Clozapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080601</StartMarketingDate>
<EndMarketingDate>20210930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021590</ApplicationNumber>
<LabelerName>Jazz Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CLOZAPINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20080601</StartMarketingDatePackage>
<EndMarketingDatePackage>20210930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>23155-104-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (23155-104-10) </PackageDescription>
<NDC11Code>23155-0104-10</NDC11Code>
<ProductNDC>23155-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090564</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>28955-104-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (28955-104-10) / .8 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>28955-0104-10</NDC11Code>
<ProductNDC>28955-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enoxaparin Sodium</ProprietaryName>
<NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218775</ApplicationNumber>
<LabelerName>Hebei Changshan Biochemical Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/.8mL</StrengthUnit>
<Pharm_Classes>Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enoxaparin sodium injection is a low molecular weight heparin (LMWH) indicated for: Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness ( 1.1) Inpatient treatment of acute DVT with or without pulmonary embolism (1.2) Outpatient treatment of acute DVT without pulmonary embolism (1.2) Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction (MI) (1.3) Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4).</IndicationAndUsage>
<Description>Enoxaparin sodium injection, USP is a sterile aqueous solution containing enoxaparin sodium, USP, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium,USP is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is: <2000 daltons ≤20% 2000 to 8000 daltons ≥68% >8000 daltons ≤18% STRUCTURAL FORMULA. * X = Percent of polysaccharide chain containing 1,6-anhydro derivative on the reducing end. Enoxaparin Sodium Injection, USP 100 mg/mL Concentrationcontains 10 mg enoxaparin sodium, USP (approximate anti-Factor Xa activity of 1000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin Sodium Injection, USP 150 mg/mL Concentrationcontains 15 mg enoxaparin sodium, USP (approximate anti-Factor Xa activity of 1500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The enoxaparin sodium injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection. [ see Dosage and Administration (2)and How Supplied/Storage and Handling (16)].</Description>
</NDC>
<NDC>
<NDCCode>31722-104-31</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (31722-104-31) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>31722-0104-31</NDC11Code>
<ProductNDC>31722-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209403</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1) Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2) Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (1.3).</IndicationAndUsage>
<Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula of cinacalcet is C22H22F3N⋅HCl with a molecular mass of 393.87. It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is freely soluble in methanol and in ethanol. The hydrochloride salt of cinacalcet is described chemically as (R)-N-(3-(3-(trifluoromethyl) phenyl] propyl]-1-(1-naphthyl) ethylamine hydrochloride and has the following structural formula. Cinacalcet tablets are formulated as light-green, oval, biconvex, film coated tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33.064 mg, 66.127 mg and 99.191 mg as the hydrochloride salt, respectively). Inactive Ingredients The following are the inactive ingredients in cinacalcet tablets: crospovidone, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. The coating material contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, FD&C blue #2/indigo carmine AL, iron oxide yellow, polyethylene glycol. The botanical source for pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>33261-104-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (33261-104-10)</PackageDescription>
<NDC11Code>33261-0104-10</NDC11Code>
<ProductNDC>33261-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076286</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tizanidine tablets are a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Tizanidine hydrochloride USP, is a centrally acting α2-adrenergic agonist. Tizanidine HCl USP (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride. Tizanidine’s molecular formula is C9H8ClN5S.HCl, its molecular weight is 290.2 and its structural formula is. Tizanidine tablets USP, is supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets USP, are composed of the active ingredient, tizanidine hydrochloride USP (2.29 mg equivalent to 2 mg tizanidine base and 4.58 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, microcrystalline cellulose, colloidal silicon dioxide and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>33342-104-39</NDCCode>
<PackageDescription>9 BLISTER PACK in 1 CARTON (33342-104-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0104-39</NDC11Code>
<ProductNDC>33342-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203359</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder manic episodes (1.2) Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with "F75”), 300 mg (capsule-shaped, white, one side debossed with "F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>42507-104-10</NDCCode>
<PackageDescription>100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (42507-104-10) </PackageDescription>
<NDC11Code>42507-0104-10</NDC11Code>
<ProductNDC>42507-104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stool Softener Laxative</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251017</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Hy-Vee</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity) . generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42543-104-10</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42543-104-10) </PackageDescription>
<NDC11Code>42543-0104-10</NDC11Code>
<ProductNDC>42543-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205549</ApplicationNumber>
<LabelerName>Vensun Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42571-104-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42571-104-10)</PackageDescription>
<NDC11Code>42571-0104-10</NDC11Code>
<ProductNDC>42571-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glimepiride</ProprietaryName>
<NonProprietaryName>Glimepiride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091220</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>GLIMEPIRIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
</NDCList>