{
"NDC": [
{
"NDCCode": "72865-151-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-151-30) ",
"NDC11Code": "72865-0151-30",
"ProductNDC": "72865-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209403",
"LabelerName": "XLCare 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": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210216",
"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 C 22H 22F 3N⋅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": "72865-151-31",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (72865-151-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "72865-0151-31",
"ProductNDC": "72865-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209403",
"LabelerName": "XLCare 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": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210216",
"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 C 22H 22F 3N⋅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": "72865-101-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-101-30) ",
"NDC11Code": "72865-0101-30",
"ProductNDC": "72865-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202659",
"LabelerName": "XLCARE Pharmaceuticals INC.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil Tablet, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablet, USP is formulated as white, film-coated round-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
},
{
"NDCCode": "72865-102-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-102-30) ",
"NDC11Code": "72865-0102-30",
"ProductNDC": "72865-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202659",
"LabelerName": "XLCARE Pharmaceuticals INC.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil Tablet, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablet, USP is formulated as white, film-coated round-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
},
{
"NDCCode": "72865-103-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-103-30) ",
"NDC11Code": "72865-0103-30",
"ProductNDC": "72865-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202659",
"LabelerName": "XLCARE Pharmaceuticals INC.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190801",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil Tablet, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablet, USP is formulated as white, film-coated round-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
},
{
"NDCCode": "72865-104-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-104-30) ",
"NDC11Code": "72865-0104-30",
"ProductNDC": "72865-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209908",
"LabelerName": "XLCare Pharmaceuticals Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241210",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) If tadalafil tablet is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4).",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-(6R-12aR)-. Tadalafil USP is a white or almost white powder that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as round (2.5 mg and 5 mg) and capsule (10 mg and 20 mg) shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil, talc, titanium dioxide and triacetin. In addition, 2.5 mg contains FD&C blue #2/indigo carmine aluminum lake."
},
{
"NDCCode": "72865-106-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-106-30) ",
"NDC11Code": "72865-0106-30",
"ProductNDC": "72865-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209908",
"LabelerName": "XLCare Pharmaceuticals Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241210",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) If tadalafil tablet is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4).",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-(6R-12aR)-. Tadalafil USP is a white or almost white powder that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as round (2.5 mg and 5 mg) and capsule (10 mg and 20 mg) shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil, talc, titanium dioxide and triacetin. In addition, 2.5 mg contains FD&C blue #2/indigo carmine aluminum lake."
},
{
"NDCCode": "72865-107-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-107-30) ",
"NDC11Code": "72865-0107-30",
"ProductNDC": "72865-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209908",
"LabelerName": "XLCare Pharmaceuticals Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241210",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) If tadalafil tablet is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4).",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-(6R-12aR)-. Tadalafil USP is a white or almost white powder that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as round (2.5 mg and 5 mg) and capsule (10 mg and 20 mg) shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil, talc, titanium dioxide and triacetin. In addition, 2.5 mg contains FD&C blue #2/indigo carmine aluminum lake."
},
{
"NDCCode": "72865-108-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-108-30) ",
"NDC11Code": "72865-0108-30",
"ProductNDC": "72865-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209908",
"LabelerName": "XLCare Pharmaceuticals Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241210",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) If tadalafil tablet is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4).",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-(6R-12aR)-. Tadalafil USP is a white or almost white powder that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as round (2.5 mg and 5 mg) and capsule (10 mg and 20 mg) shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil, talc, titanium dioxide and triacetin. In addition, 2.5 mg contains FD&C blue #2/indigo carmine aluminum lake."
},
{
"NDCCode": "72865-117-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (72865-117-30) ",
"NDC11Code": "72865-0117-30",
"ProductNDC": "72865-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211518",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200217",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Each benzonatate capsule USP contains. Benzonatate, USP 200 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg and 200 mg capsules also contain D&C Yellow No. 10. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink."
},
{
"NDCCode": "72865-118-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (72865-118-30) ",
"NDC11Code": "72865-0118-30",
"ProductNDC": "72865-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211518",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200217",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Each benzonatate capsule USP contains. Benzonatate, USP 150 mg. Each benzonatate capsule USP contains. Benzonatate, USP 200 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg and 200 mg capsules also contain D&C Yellow No. 10. 150 mg capsules also contain FD&C Yellow No. 6 powder. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink."
},
{
"NDCCode": "72865-119-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (72865-119-30) ",
"NDC11Code": "72865-0119-30",
"ProductNDC": "72865-119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211518",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200217",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Each benzonatate capsule USP contains. Benzonatate, USP 200 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg and 200 mg capsules also contain D&C Yellow No. 10. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink."
},
{
"NDCCode": "72865-140-30",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-140-30) ",
"NDC11Code": "72865-0140-30",
"ProductNDC": "72865-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dutasteride",
"NonProprietaryName": "Dutasteride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20200309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206574",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "DUTASTERIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200309",
"SamplePackage": "N",
"Description": "Dutasteride is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5 with the following structural formula. Dutasteride is a white to pale yellow powder with a melting point of 242° to 250°C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water. Each dutasteride capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium dioxide. The capsules are printed with edible black ink containing black iron oxide, hypromellose and propylene glycol."
},
{
"NDCCode": "72865-141-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-141-30) ",
"NDC11Code": "72865-0141-30",
"ProductNDC": "72865-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203835",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200313",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2’-(lH-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "72865-142-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-142-30) ",
"NDC11Code": "72865-0142-30",
"ProductNDC": "72865-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203835",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200313",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2’-(lH-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "72865-143-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-143-30) ",
"NDC11Code": "72865-0143-30",
"ProductNDC": "72865-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203835",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200313",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2’-(lH-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "72865-148-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (72865-148-30) ",
"NDC11Code": "72865-0148-30",
"ProductNDC": "72865-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091240",
"LabelerName": "XLCare Pharmaceuticals Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210727",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin capsules are indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis.",
"Description": "Indomethacin capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 25 mg or 50 mg of indomethacin USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.79. Its molecular formula is C 19H 16ClNO 4, and it has the following chemical structure. Indomethacin USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol, in chloroform and in ether. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin capsules USP, 25 mg or 50 mg include: lactose monohydrate, sodium lauryl sulfate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. The hard gelatin shell consists of gelatin, titanium dioxide, FD & C Blue 1, D & C Yellow 10. The capsules are printed with black ink containing black iron oxide E172 dye."
},
{
"NDCCode": "72865-149-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (72865-149-30) ",
"NDC11Code": "72865-0149-30",
"ProductNDC": "72865-149",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091240",
"LabelerName": "XLCare Pharmaceuticals Inc.",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210727",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin capsules are indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis.",
"Description": "Indomethacin capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 25 mg or 50 mg of indomethacin USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.79. Its molecular formula is C 19H 16ClNO 4, and it has the following chemical structure. Indomethacin USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol, in chloroform and in ether. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin capsules USP, 25 mg or 50 mg include: lactose monohydrate, sodium lauryl sulfate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. The hard gelatin shell consists of gelatin, titanium dioxide, FD & C Blue 1, D & C Yellow 10. The capsules are printed with black ink containing black iron oxide E172 dye."
},
{
"NDCCode": "72865-150-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-150-30) ",
"NDC11Code": "72865-0150-30",
"ProductNDC": "72865-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209403",
"LabelerName": "XLCare Pharmaceuticals Inc.",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210216",
"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 C 22H 22F 3N⋅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": "72865-152-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-152-30) ",
"NDC11Code": "72865-0152-30",
"ProductNDC": "72865-152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209403",
"LabelerName": "XLCare Pharmaceuticals Inc.",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210216",
"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 C 22H 22F 3N⋅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": "72865-153-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (72865-153-30) ",
"NDC11Code": "72865-0153-30",
"ProductNDC": "72865-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205064",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201120",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)].",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23H 27Cl 2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72865-154-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (72865-154-30) ",
"NDC11Code": "72865-0154-30",
"ProductNDC": "72865-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205064",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201120",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)].",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23H 27Cl 2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72865-155-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (72865-155-30) ",
"NDC11Code": "72865-0155-30",
"ProductNDC": "72865-155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205064",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
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"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)].",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23H 27Cl 2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
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"LabelerName": "XLCare Pharmaceuticals, Inc.",
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"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)].",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23H 27Cl 2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72865-157-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (72865-157-30) ",
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"ProductNDC": "72865-157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
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"StartMarketingDate": "20201120",
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"LabelerName": "XLCare Pharmaceuticals, Inc.",
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"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)].",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23H 27Cl 2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72865-158-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (72865-158-30) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"StartMarketingDate": "20201120",
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"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
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"StartMarketingDatePackage": "20201120",
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"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)].",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23H 27Cl 2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72865-172-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-172-30) ",
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"ProductNDC": "72865-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz",
"NonProprietaryName": "Efavirenz",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078886",
"LabelerName": "XLCare Pharmaceuticals Inc.",
"SubstanceName": "EFAVIRENZ",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]",
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"IndicationAndUsage": "Efavirenz tablets in combination with other antiretroviral agents are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.",
"Description": "Efavirenz is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C 14H 9ClF 3NO 2 and its structural formula is:. Efavirenz USP is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 microgram/mL). Tablets: Efavirenz is available as film-coated tablets for oral administration containing 600 mg of efavirenz USP and the following inactive ingredients: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate. The film coating contains Opadry ® Yellow (hypromellose, titanium dioxide, iron oxide yellow and polyethylene glycol)."
},
{
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"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (72865-175-30) ",
"NDC11Code": "72865-0175-30",
"ProductNDC": "72865-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Montelukast",
"NonProprietaryName": "Montelukast",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202843",
"LabelerName": "XLCare Pharmaceuticals Inc.",
"SubstanceName": "MONTELUKAST SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-18",
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"IndicationAndUsage": "Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 15 years of age and older (1.1). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1.2). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (1.3).",
"Description": "Montelukast sodium USP, the active ingredient in montelukast sodium tablets, USP is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium USP is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl] cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35CINNaO 3S, and its molecular weight is 608.17. The structural formula is:. Montelukast sodium USP is a hygroscopic, optically active, white or almost white powder. Montelukast sodium USP is freely soluble in water and methylene chloride, freely soluble to very soluble in alcohol. Each 10 mg film-coated montelukast sodium tablet USP contains 10.4 mg montelukast sodium USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose. The tablets are coated with opadry yellow which contains carnauba wax, hydroxypropyl cellulose, hypromellose, red iron oxide, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "72865-180-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (72865-180-30) ",
"NDC11Code": "72865-0180-30",
"ProductNDC": "72865-180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205064",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
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"LastUpdate": "2023-10-03",
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"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder.",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C23H27Cl2N3O2, and molecular weight is 448.39. The chemical structure is as follows. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72865-181-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (72865-181-30) ",
"NDC11Code": "72865-0181-30",
"ProductNDC": "72865-181",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205064",
"LabelerName": "XLCare Pharmaceuticals, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder.",
"Description": "Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C23H27Cl2N3O2, and molecular weight is 448.39. The chemical structure is as follows. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
}
]
}
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<NDCList>
<NDC>
<NDCCode>72865-151-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72865-151-30) </PackageDescription>
<NDC11Code>72865-0151-30</NDC11Code>
<ProductNDC>72865-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209403</ApplicationNumber>
<LabelerName>XLCare 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>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<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 C 22H 22F 3N⋅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>
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<NDCCode>72865-151-31</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (72865-151-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>72865-0151-31</NDC11Code>
<ProductNDC>72865-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209403</ApplicationNumber>
<LabelerName>XLCare 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>2023-01-18</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<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 C 22H 22F 3N⋅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>
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<NDC>
<NDCCode>72865-101-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72865-101-30) </PackageDescription>
<NDC11Code>72865-0101-30</NDC11Code>
<ProductNDC>72865-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202659</ApplicationNumber>
<LabelerName>XLCARE Pharmaceuticals INC.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil Tablet, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablet, USP is formulated as white, film-coated round-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>72865-102-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72865-102-30) </PackageDescription>
<NDC11Code>72865-0102-30</NDC11Code>
<ProductNDC>72865-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202659</ApplicationNumber>
<LabelerName>XLCARE Pharmaceuticals INC.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil Tablet, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablet, USP is formulated as white, film-coated round-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
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<NDC>
<NDCCode>72865-103-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72865-103-30) </PackageDescription>
<NDC11Code>72865-0103-30</NDC11Code>
<ProductNDC>72865-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202659</ApplicationNumber>
<LabelerName>XLCARE Pharmaceuticals INC.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil Tablet, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablet, USP is formulated as white, film-coated round-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>72865-104-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72865-104-30) </PackageDescription>
<NDC11Code>72865-0104-30</NDC11Code>
<ProductNDC>72865-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209908</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) If tadalafil tablet is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4).</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-(6R-12aR)-. Tadalafil USP is a white or almost white powder that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as round (2.5 mg and 5 mg) and capsule (10 mg and 20 mg) shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil, talc, titanium dioxide and triacetin. In addition, 2.5 mg contains FD&C blue #2/indigo carmine aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>72865-106-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72865-106-30) </PackageDescription>
<NDC11Code>72865-0106-30</NDC11Code>
<ProductNDC>72865-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209908</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) If tadalafil tablet is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4).</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-(6R-12aR)-. Tadalafil USP is a white or almost white powder that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as round (2.5 mg and 5 mg) and capsule (10 mg and 20 mg) shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil, talc, titanium dioxide and triacetin. In addition, 2.5 mg contains FD&C blue #2/indigo carmine aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>72865-107-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72865-107-30) </PackageDescription>
<NDC11Code>72865-0107-30</NDC11Code>
<ProductNDC>72865-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209908</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) If tadalafil tablet is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4).</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-(6R-12aR)-. Tadalafil USP is a white or almost white powder that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as round (2.5 mg and 5 mg) and capsule (10 mg and 20 mg) shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil, talc, titanium dioxide and triacetin. In addition, 2.5 mg contains FD&C blue #2/indigo carmine aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>72865-108-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72865-108-30) </PackageDescription>
<NDC11Code>72865-0108-30</NDC11Code>
<ProductNDC>72865-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209908</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) If tadalafil tablet is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4).</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22H 19N 3O 4representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-(6R-12aR)-. Tadalafil USP is a white or almost white powder that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as round (2.5 mg and 5 mg) and capsule (10 mg and 20 mg) shaped tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil, talc, titanium dioxide and triacetin. In addition, 2.5 mg contains FD&C blue #2/indigo carmine aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>72865-117-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (72865-117-30) </PackageDescription>
<NDC11Code>72865-0117-30</NDC11Code>
<ProductNDC>72865-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211518</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Each benzonatate capsule USP contains. Benzonatate, USP 200 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg and 200 mg capsules also contain D&C Yellow No. 10. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink.</Description>
</NDC>
<NDC>
<NDCCode>72865-118-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (72865-118-30) </PackageDescription>
<NDC11Code>72865-0118-30</NDC11Code>
<ProductNDC>72865-118</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211518</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Each benzonatate capsule USP contains. Benzonatate, USP 150 mg. Each benzonatate capsule USP contains. Benzonatate, USP 200 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg and 200 mg capsules also contain D&C Yellow No. 10. 150 mg capsules also contain FD&C Yellow No. 6 powder. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink.</Description>
</NDC>
<NDC>
<NDCCode>72865-119-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (72865-119-30) </PackageDescription>
<NDC11Code>72865-0119-30</NDC11Code>
<ProductNDC>72865-119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211518</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsule USP contains. Benzonatate, USP 100 mg. Each benzonatate capsule USP contains. Benzonatate, USP 200 mg. Benzonatate capsules USP also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg and 200 mg capsules also contain D&C Yellow No. 10. Each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink.</Description>
</NDC>
<NDC>
<NDCCode>72865-140-30</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 BOTTLE (72865-140-30) </PackageDescription>
<NDC11Code>72865-0140-30</NDC11Code>
<ProductNDC>72865-140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dutasteride</ProprietaryName>
<NonProprietaryName>Dutasteride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206574</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DUTASTERIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Dutasteride is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT. Dutasteride is chemically designated as (5α,17β)-N-{2,5 bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5 with the following structural formula. Dutasteride is a white to pale yellow powder with a melting point of 242° to 250°C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water. Each dutasteride capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium dioxide. The capsules are printed with edible black ink containing black iron oxide, hypromellose and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>72865-141-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72865-141-30) </PackageDescription>
<NDC11Code>72865-0141-30</NDC11Code>
<ProductNDC>72865-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203835</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2’-(lH-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20200313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203835</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2’-(lH-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch.</Description>
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<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72865-143-30) </PackageDescription>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20200313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203835</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1), 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2), 3 Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2’-(lH-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch.</Description>
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<NDC>
<NDCCode>72865-148-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (72865-148-30) </PackageDescription>
<NDC11Code>72865-0148-30</NDC11Code>
<ProductNDC>72865-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091240</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin capsules are indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 25 mg or 50 mg of indomethacin USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.79. Its molecular formula is C 19H 16ClNO 4, and it has the following chemical structure. Indomethacin USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol, in chloroform and in ether. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin capsules USP, 25 mg or 50 mg include: lactose monohydrate, sodium lauryl sulfate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. The hard gelatin shell consists of gelatin, titanium dioxide, FD & C Blue 1, D & C Yellow 10. The capsules are printed with black ink containing black iron oxide E172 dye.</Description>
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<NDC>
<NDCCode>72865-149-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (72865-149-30) </PackageDescription>
<NDC11Code>72865-0149-30</NDC11Code>
<ProductNDC>72865-149</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091240</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin capsules are indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis.</IndicationAndUsage>
<Description>Indomethacin capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 25 mg or 50 mg of indomethacin USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.79. Its molecular formula is C 19H 16ClNO 4, and it has the following chemical structure. Indomethacin USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol, in chloroform and in ether. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin capsules USP, 25 mg or 50 mg include: lactose monohydrate, sodium lauryl sulfate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. The hard gelatin shell consists of gelatin, titanium dioxide, FD & C Blue 1, D & C Yellow 10. The capsules are printed with black ink containing black iron oxide E172 dye.</Description>
</NDC>
<NDC>
<NDCCode>72865-150-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72865-150-30) </PackageDescription>
<NDC11Code>72865-0150-30</NDC11Code>
<ProductNDC>72865-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209403</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210216</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 C 22H 22F 3N⋅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>
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<NDC>
<NDCCode>72865-152-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72865-152-30) </PackageDescription>
<NDC11Code>72865-0152-30</NDC11Code>
<ProductNDC>72865-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209403</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210216</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 C 22H 22F 3N⋅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>
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<NDC>
<NDCCode>72865-153-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72865-153-30) </PackageDescription>
<NDC11Code>72865-0153-30</NDC11Code>
<ProductNDC>72865-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23H 27Cl 2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>72865-154-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72865-154-30) </PackageDescription>
<NDC11Code>72865-0154-30</NDC11Code>
<ProductNDC>72865-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23H 27Cl 2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>72865-155-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72865-155-30) </PackageDescription>
<NDC11Code>72865-0155-30</NDC11Code>
<ProductNDC>72865-155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23H 27Cl 2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>72865-156-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72865-156-30) </PackageDescription>
<NDC11Code>72865-0156-30</NDC11Code>
<ProductNDC>72865-156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23H 27Cl 2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
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<PackageDescription>30 TABLET in 1 BOTTLE (72865-157-30) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
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<StartMarketingDate>20201120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
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<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23H 27Cl 2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
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<NDCCode>72865-158-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72865-158-30) </PackageDescription>
<NDC11Code>72865-0158-30</NDC11Code>
<ProductNDC>72865-158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
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<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23H 27Cl 2N 3O 2, and molecular weight is 448.39. The chemical structure is as follows:. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
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<NDC>
<NDCCode>72865-172-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72865-172-30) </PackageDescription>
<NDC11Code>72865-0172-30</NDC11Code>
<ProductNDC>72865-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Efavirenz</ProprietaryName>
<NonProprietaryName>Efavirenz</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078886</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>EFAVIRENZ</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-14</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz tablets in combination with other antiretroviral agents are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.</IndicationAndUsage>
<Description>Efavirenz is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C 14H 9ClF 3NO 2 and its structural formula is:. Efavirenz USP is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 microgram/mL). Tablets: Efavirenz is available as film-coated tablets for oral administration containing 600 mg of efavirenz USP and the following inactive ingredients: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate. The film coating contains Opadry ® Yellow (hypromellose, titanium dioxide, iron oxide yellow and polyethylene glycol).</Description>
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<NDC>
<NDCCode>72865-175-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (72865-175-30) </PackageDescription>
<NDC11Code>72865-0175-30</NDC11Code>
<ProductNDC>72865-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Montelukast</ProprietaryName>
<NonProprietaryName>Montelukast</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202843</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MONTELUKAST SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-18</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 15 years of age and older (1.1). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1.2). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (1.3).</IndicationAndUsage>
<Description>Montelukast sodium USP, the active ingredient in montelukast sodium tablets, USP is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium USP is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl] cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35H 35CINNaO 3S, and its molecular weight is 608.17. The structural formula is:. Montelukast sodium USP is a hygroscopic, optically active, white or almost white powder. Montelukast sodium USP is freely soluble in water and methylene chloride, freely soluble to very soluble in alcohol. Each 10 mg film-coated montelukast sodium tablet USP contains 10.4 mg montelukast sodium USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose. The tablets are coated with opadry yellow which contains carnauba wax, hydroxypropyl cellulose, hypromellose, red iron oxide, titanium dioxide and yellow iron oxide.</Description>
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<NDC>
<NDCCode>72865-180-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72865-180-30) </PackageDescription>
<NDC11Code>72865-0180-30</NDC11Code>
<ProductNDC>72865-180</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder.</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C23H27Cl2N3O2, and molecular weight is 448.39. The chemical structure is as follows. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
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<NDCCode>72865-181-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72865-181-30) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205064</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole oral tablets are indicated for the treatment of: 1 Schizophrenia , 2 Treatment of Tourette’s Disorder.</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets, USP are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The molecular formula is C23H27Cl2N3O2, and molecular weight is 448.39. The chemical structure is as follows. Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
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