{
"NDC": [
{
"NDCCode": "47335-038-64",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (47335-038-64) / 3 TABLET, FILM COATED in 1 BLISTER PACK (47335-038-60) ",
"NDC11Code": "47335-0038-64",
"ProductNDC": "47335-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bosentan",
"NonProprietaryName": "Bosentan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209324",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "BOSENTAN",
"StrengthNumber": "62.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20190426",
"SamplePackage": "N",
"IndicationAndUsage": "Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.",
"Description": "Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2’]-bipyrimidin-4-yl]-benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.63 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white to off-white crystalline powder. It is poorly soluble in water. In the solid state, bosentan is very stable, is not hygroscopic and is not light sensitive. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hydroxypropylmethylcellulose, iron oxide red, iron oxide yellow, magnesium stearate, povidone, pregelatinized maize starch, sodium starch glycolate, talc, titanium dioxide, and triacetin. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of anhydrous bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of anhydrous bosentan."
},
{
"NDCCode": "47335-038-86",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (47335-038-86) ",
"NDC11Code": "47335-0038-86",
"ProductNDC": "47335-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bosentan",
"NonProprietaryName": "Bosentan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209324",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "BOSENTAN",
"StrengthNumber": "62.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20190426",
"SamplePackage": "N",
"IndicationAndUsage": "Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.",
"Description": "Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2’]-bipyrimidin-4-yl]-benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.63 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white to off-white crystalline powder. It is poorly soluble in water. In the solid state, bosentan is very stable, is not hygroscopic and is not light sensitive. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hydroxypropylmethylcellulose, iron oxide red, iron oxide yellow, magnesium stearate, povidone, pregelatinized maize starch, sodium starch glycolate, talc, titanium dioxide, and triacetin. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of anhydrous bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of anhydrous bosentan."
},
{
"NDCCode": "47682-038-64",
"PackageDescription": "24 PACKET in 1 BOX (47682-038-64) / 1 TABLET, CHEWABLE in 1 PACKET",
"NDC11Code": "47682-0038-64",
"ProductNDC": "47682-038",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medique Products Chewable Low Dose Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20240426",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Unifirst First Aid Corporation",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240426",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. for the temporary relief of minor aches and pains or as recommended by your doctor."
},
{
"NDCCode": "60432-038-64",
"PackageDescription": "1892 mL in 1 BOTTLE, PLASTIC (60432-038-64) ",
"NDC11Code": "60432-0038-64",
"ProductNDC": "60432-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Generlac",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "19961031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074603",
"LabelerName": "Morton Grove Pharmaceuticals, Inc.",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19961031",
"SamplePackage": "N",
"IndicationAndUsage": "For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by an improvement in the patients' mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients' protein tolerance is also frequently observed with lactulose solution therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose solution has been given for over 2 years in controlled studies.",
"Description": "Generlac Solution (Lactulose Solution, USP) is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of Generlac Solution contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, less than 0.8 g epilactose and 0.1 g or less of fructose). The pH range is between 2.5 and 6.5. Generlac Solution is a colonic acidifier for treatment and prevention of portal-systemic encephalopathy. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula. C12H22O11. The molecular weight is 342.30. It is freely soluble in water."
},
{
"NDCCode": "65222-038-64",
"PackageDescription": "1863 g in 1 BOTTLE, PLASTIC (65222-038-64) ",
"NDC11Code": "65222-0038-64",
"ProductNDC": "65222-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nupro Fluorides",
"ProprietaryNameSuffix": "Berry Cherry",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "RINSE",
"RouteName": "DENTAL",
"StartMarketingDate": "19740101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Dentsply LLC. Professional Division Trading as \"DENTSPLY Professional\"",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19740101",
"SamplePackage": "N"
},
{
"NDCCode": "47335-009-64",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (47335-009-64) / 15 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "47335-0009-64",
"ProductNDC": "47335-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208934",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190326",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing 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)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as round shaped (2.5 mg) and oval shaped (5 mg, 10 mg, and 20 mg) tablets for oral administration. Each tadalafil tablet, USP contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, talc, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "47335-010-64",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (47335-010-64) / 15 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "47335-0010-64",
"ProductNDC": "47335-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208934",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190326",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing 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)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as round shaped (2.5 mg) and oval shaped (5 mg, 10 mg, and 20 mg) tablets for oral administration. Each tadalafil tablet, USP contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, talc, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "47335-039-64",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (47335-039-64) / 3 TABLET, FILM COATED in 1 BLISTER PACK (47335-039-60) ",
"NDC11Code": "47335-0039-64",
"ProductNDC": "47335-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bosentan",
"NonProprietaryName": "Bosentan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209324",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "BOSENTAN",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190426",
"SamplePackage": "N",
"IndicationAndUsage": "Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.",
"Description": "Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2’]-bipyrimidin-4-yl]-benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.63 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white to off-white crystalline powder. It is poorly soluble in water. In the solid state, bosentan is very stable, is not hygroscopic and is not light sensitive. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hydroxypropylmethylcellulose, iron oxide red, iron oxide yellow, magnesium stearate, povidone, pregelatinized maize starch, sodium starch glycolate, talc, titanium dioxide, and triacetin. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of anhydrous bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of anhydrous bosentan."
},
{
"NDCCode": "47335-236-64",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (47335-236-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-236-60) ",
"NDC11Code": "47335-0236-64",
"ProductNDC": "47335-236",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ambrisentan",
"NonProprietaryName": "Ambrisentan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210784",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "AMBRISENTAN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190429",
"SamplePackage": "N",
"IndicationAndUsage": "Ambrisentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).",
"Description": "Ambrisentan is an endothelin receptor antagonist. The chemical name of ambrisentan is (+)-(2S)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid. It has a molecular formula of C22H22N2O4 and a molecular weight of 378.42 and has the following structural formula. Figure 1 Ambrisentan Structural Formula Ambrisentan is a white to off-white, crystalline solid. It is a carboxylic acid with a pKa of 4.0. Ambrisentan is practically insoluble in water and in aqueous solutions at low pH. Solubility increases in aqueous solutions at higher pH. In the solid state ambrisentan is very stable, is not hygroscopic, and is not light sensitive. Ambrisentan is available as 5 mg and 10 mg film-coated tablets for once daily oral administration. The tablets include the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The tablets are film-coated with a coating material containing FD&C Red #40 aluminum lake, lecithin, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Each round, pale pink ambrisentan tablet contains 5 mg of ambrisentan. Each oval, deep pink ambrisentan tablet contains 10 mg of ambrisentan. Ambrisentan tablets are unscored."
},
{
"NDCCode": "47335-237-64",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (47335-237-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-237-60) ",
"NDC11Code": "47335-0237-64",
"ProductNDC": "47335-237",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ambrisentan",
"NonProprietaryName": "Ambrisentan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210784",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "AMBRISENTAN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190429",
"SamplePackage": "N",
"IndicationAndUsage": "Ambrisentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).",
"Description": "Ambrisentan is an endothelin receptor antagonist. The chemical name of ambrisentan is (+)-(2S)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid. It has a molecular formula of C22H22N2O4 and a molecular weight of 378.42 and has the following structural formula. Figure 1 Ambrisentan Structural Formula Ambrisentan is a white to off-white, crystalline solid. It is a carboxylic acid with a pKa of 4.0. Ambrisentan is practically insoluble in water and in aqueous solutions at low pH. Solubility increases in aqueous solutions at higher pH. In the solid state ambrisentan is very stable, is not hygroscopic, and is not light sensitive. Ambrisentan is available as 5 mg and 10 mg film-coated tablets for once daily oral administration. The tablets include the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The tablets are film-coated with a coating material containing FD&C Red #40 aluminum lake, lecithin, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Each round, pale pink ambrisentan tablet contains 5 mg of ambrisentan. Each oval, deep pink ambrisentan tablet contains 10 mg of ambrisentan. Ambrisentan tablets are unscored."
},
{
"NDCCode": "47335-475-64",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (47335-475-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "47335-0475-64",
"ProductNDC": "47335-475",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imatinib Mesylate",
"NonProprietaryName": "Imatinib Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078340",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "IMATINIB MESYLATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160201",
"SamplePackage": "N",
"IndicationAndUsage": "Imatinib mesylate is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1) , 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. ( 1.2) , 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). ( 1.3) , 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. ( 1.5) , 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. ( 1.6) , 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. ( 1.7) , 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). ( 1.8) , 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9), 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).",
"Description": "Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.45 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 477.8 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is:. Imatinib mesylate is an off-white to creamish yellow crystalline powder. Its molecular formula is C 29H 31N 7O CH 4SO 3and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: silicified microcrystalline cellulose, mannitol, copovidone, crospovidone, magnesium stearate, hypromellose, iron oxide yellow, polyethylene glycol, titanium dioxide, FD&C yellow # 6 aluminum lake and iron oxide red."
},
{
"NDCCode": "47335-724-64",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (47335-724-64) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60) ",
"NDC11Code": "47335-0724-64",
"ProductNDC": "47335-724",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride",
"NonProprietaryName": "Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090818",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "60; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180301",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throat. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose."
},
{
"NDCCode": "47335-923-64",
"PackageDescription": "3 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-923-64) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "47335-0923-64",
"ProductNDC": "47335-923",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202637",
"LabelerName": "Sun Pharma Global FZE",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-05-22",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "47335-984-64",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (47335-984-64) / 10 CAPSULE in 1 BLISTER PACK (47335-984-60) ",
"NDC11Code": "47335-0984-64",
"ProductNDC": "47335-984",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezallor Sprinkle",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190504",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208647",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190504",
"SamplePackage": "N",
"IndicationAndUsage": "EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution."
},
{
"NDCCode": "47335-985-64",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (47335-985-64) / 10 CAPSULE in 1 BLISTER PACK (47335-985-60) ",
"NDC11Code": "47335-0985-64",
"ProductNDC": "47335-985",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezallor Sprinkle",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190504",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208647",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190504",
"SamplePackage": "N",
"IndicationAndUsage": "EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution."
},
{
"NDCCode": "47335-986-64",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (47335-986-64) / 10 CAPSULE in 1 BLISTER PACK (47335-986-60) ",
"NDC11Code": "47335-0986-64",
"ProductNDC": "47335-986",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezallor Sprinkle",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190504",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208647",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190504",
"SamplePackage": "N",
"IndicationAndUsage": "EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution."
},
{
"NDCCode": "47335-987-64",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (47335-987-64) / 10 CAPSULE in 1 BLISTER PACK (47335-987-60) ",
"NDC11Code": "47335-0987-64",
"ProductNDC": "47335-987",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezallor Sprinkle",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190504",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208647",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190504",
"SamplePackage": "N",
"IndicationAndUsage": "EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution."
},
{
"NDCCode": "23155-038-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (23155-038-01) ",
"NDC11Code": "23155-0038-01",
"ProductNDC": "23155-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paromomycin Sulfate",
"NonProprietaryName": "Paromomycin Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20091022",
"EndMarketingDate": "20240331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065173",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "PAROMOMYCIN SULFATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiprotozoal [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20091022",
"EndMarketingDatePackage": "20240331",
"SamplePackage": "N",
"IndicationAndUsage": "Paromomycin sulfate is indicated for intestinal amebiasis–acute and chronic (NOTE-It is not effective in extraintestinal amebiasis); management of hepatic coma–as adjunctive therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Paromomycin Sulfate Capsules and other antibacterial drugs, Paromomycin Sulfate Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Paromomycin sulfate is a broad spectrum antibiotic produced by Streptomyces riomosus var. paromomycinus. It is a white, amorphous, stable, water-soluble product. Paromomycin sulfate is designated chemically as 0-2, 6-Diamino-2, 6-dideoxy-β -L-idopyranosyl-(1→3)-0-β -D-ribofuranosyl-(1→5)-0-[2-amino-2-deoxy-α -D-glucopyranosyl-(1→4)]-2-deoxystreptamine sulfate (salt). The molecular formula is C23H45N5O14xH2SO4, with a molecular weight of 615.64 (base). Its structural formula is. Each capsule, for oral administration, contains paromomycin sulfate equivalent to 250 mg paromomycin. Each capsule also contains the following inactive ingredients: FD&C Blue # 1, D&C Red # 28, FD&C Red # 40, gelatin and titanium dioxide. The imprinting ink for the 250 mg capsule contains D&C yellow #10, FD&C blue # 1, FD&C blue # 2, FD&C red # 40, iron oxide black, pharmaceutical shellac glaze, and propylene glycol."
},
{
"NDCCode": "47335-039-86",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (47335-039-86) ",
"NDC11Code": "47335-0039-86",
"ProductNDC": "47335-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bosentan",
"NonProprietaryName": "Bosentan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209324",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "BOSENTAN",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190426",
"SamplePackage": "N",
"IndicationAndUsage": "Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.",
"Description": "Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2’]-bipyrimidin-4-yl]-benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.63 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white to off-white crystalline powder. It is poorly soluble in water. In the solid state, bosentan is very stable, is not hygroscopic and is not light sensitive. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hydroxypropylmethylcellulose, iron oxide red, iron oxide yellow, magnesium stearate, povidone, pregelatinized maize starch, sodium starch glycolate, talc, titanium dioxide, and triacetin. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of anhydrous bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of anhydrous bosentan."
},
{
"NDCCode": "10019-038-67",
"PackageDescription": "10 AMPULE in 1 PACKAGE (10019-038-67) > 2 mL in 1 AMPULE (10019-038-39)",
"NDC11Code": "10019-0038-67",
"ProductNDC": "10019-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl Citrate",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20100625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA019101",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "10129-038-03",
"PackageDescription": "1 TUBE in 1 BOX (10129-038-03) > 86 g in 1 TUBE",
"NDC11Code": "10129-0038-03",
"ProductNDC": "10129-038",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Perio Armor-x",
"NonProprietaryName": "1.7% Hydrogen Peroxide",
"DosageFormName": "GEL",
"RouteName": "DENTAL; PERIODONTAL",
"StartMarketingDate": "20220815",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Gingi-Pak a Division of the Belport",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "1.7",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
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"IndicationAndUsage": "For temporary use in cleansing minor oral wounds and treatment of inflammation resulting from dental procedures or other irritations of the mouth and gums. Perio Armor may be used for decreasing the presence of plaque, a known factor in the development of gingivitis and tooth decay."
},
{
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"ProprietaryName": "Loccitane - Immortelle Precious Bb Broad Spectrum Spf 30 02 Light",
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},
{
"NDCCode": "10578-038-90",
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"IndicationAndUsage": "For the relief of itching, burning and scaly conditions not due to insect or allergy conditions."
},
{
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},
{
"NDCCode": "11084-038-03",
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"IndicationAndUsage": "surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care. healthcare personnel handwash: helps reduce bacteria that potentially can cause disease. patient preoperative skin preparation: preparation of the patient's skin prior to surgery. skin wound and general skin cleansing."
},
{
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"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "USES. HELPS STOP THESE SYMPTOMS OF PSORIASIS, SEBORRHEIC DERMATITIS AND DANDRUFF: 1 FLAKING, 2 SCALING, 3 REDNESS, 4 IRRITATION, 5 ITCHING."
},
{
"NDCCode": "11086-038-11",
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"ProductNDC": "11086-038",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Keralyt",
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"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131030",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Summers Laboratories Inc",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "3",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11410-038-00",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (11410-038-00) > 177.4 mL in 1 BOTTLE, PUMP",
"NDC11Code": "11410-0038-00",
"ProductNDC": "11410-038",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Soothing Shave Gel",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "THE PROACTIV COMPANY LLC",
"SubstanceName": "BENZOYL PEROXIDE",
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"StrengthUnit": "g/100mL",
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"LastUpdate": "2022-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170401",
"SamplePackage": "N"
},
{
"NDCCode": "11559-038-01",
"PackageDescription": "1 TUBE in 1 CARTON (11559-038-01) > 30 mL in 1 TUBE",
"NDC11Code": "11559-0038-01",
"ProductNDC": "11559-038",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Double Wear All Day Glow Bb Moisture Makeup Broad Spectrum Spf 30",
"NonProprietaryName": "Octinoxate, Octisalate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ESTEE LAUDER INC",
"SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".085125; .05675; .05902; .03632",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20131201",
"SamplePackage": "N"
},
{
"NDCCode": "11673-038-32",
"PackageDescription": "32 TABLET, CHEWABLE in 1 BAG (11673-038-32) ",
"NDC11Code": "11673-0038-32",
"ProductNDC": "11673-038",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cherry Antacid Soft Chew",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
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"StartMarketingDate": "20180129",
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"StrengthNumber": "1177",
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"PackageNdcExcludeFlag": "N",
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}
]
}
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<NDCList>
<NDC>
<NDCCode>47335-038-64</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (47335-038-64) / 3 TABLET, FILM COATED in 1 BLISTER PACK (47335-038-60) </PackageDescription>
<NDC11Code>47335-0038-64</NDC11Code>
<ProductNDC>47335-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bosentan</ProprietaryName>
<NonProprietaryName>Bosentan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
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<StartMarketingDate>20190426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209324</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
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<StrengthNumber>62.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2’]-bipyrimidin-4-yl]-benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.63 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white to off-white crystalline powder. It is poorly soluble in water. In the solid state, bosentan is very stable, is not hygroscopic and is not light sensitive. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hydroxypropylmethylcellulose, iron oxide red, iron oxide yellow, magnesium stearate, povidone, pregelatinized maize starch, sodium starch glycolate, talc, titanium dioxide, and triacetin. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of anhydrous bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of anhydrous bosentan.</Description>
</NDC>
<NDC>
<NDCCode>47335-038-86</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (47335-038-86) </PackageDescription>
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<ProductNDC>47335-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bosentan</ProprietaryName>
<NonProprietaryName>Bosentan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
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<StartMarketingDate>20190426</StartMarketingDate>
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<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>BOSENTAN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2’]-bipyrimidin-4-yl]-benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.63 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white to off-white crystalline powder. It is poorly soluble in water. In the solid state, bosentan is very stable, is not hygroscopic and is not light sensitive. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hydroxypropylmethylcellulose, iron oxide red, iron oxide yellow, magnesium stearate, povidone, pregelatinized maize starch, sodium starch glycolate, talc, titanium dioxide, and triacetin. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of anhydrous bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of anhydrous bosentan.</Description>
</NDC>
<NDC>
<NDCCode>47682-038-64</NDCCode>
<PackageDescription>24 PACKET in 1 BOX (47682-038-64) / 1 TABLET, CHEWABLE in 1 PACKET</PackageDescription>
<NDC11Code>47682-0038-64</NDC11Code>
<ProductNDC>47682-038</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medique Products Chewable Low Dose Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240426</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Unifirst First Aid Corporation</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. for the temporary relief of minor aches and pains or as recommended by your doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60432-038-64</NDCCode>
<PackageDescription>1892 mL in 1 BOTTLE, PLASTIC (60432-038-64) </PackageDescription>
<NDC11Code>60432-0038-64</NDC11Code>
<ProductNDC>60432-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Generlac</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; RECTAL</RouteName>
<StartMarketingDate>19961031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074603</ApplicationNumber>
<LabelerName>Morton Grove Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by an improvement in the patients' mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients' protein tolerance is also frequently observed with lactulose solution therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose solution has been given for over 2 years in controlled studies.</IndicationAndUsage>
<Description>Generlac Solution (Lactulose Solution, USP) is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of Generlac Solution contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, less than 0.8 g epilactose and 0.1 g or less of fructose). The pH range is between 2.5 and 6.5. Generlac Solution is a colonic acidifier for treatment and prevention of portal-systemic encephalopathy. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula. C12H22O11. The molecular weight is 342.30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>65222-038-64</NDCCode>
<PackageDescription>1863 g in 1 BOTTLE, PLASTIC (65222-038-64) </PackageDescription>
<NDC11Code>65222-0038-64</NDC11Code>
<ProductNDC>65222-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nupro Fluorides</ProprietaryName>
<ProprietaryNameSuffix>Berry Cherry</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>19740101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Dentsply LLC. Professional Division Trading as "DENTSPLY Professional"</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47335-009-64</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (47335-009-64) / 15 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>47335-0009-64</NDC11Code>
<ProductNDC>47335-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208934</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, 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>2023-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing 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)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as round shaped (2.5 mg) and oval shaped (5 mg, 10 mg, and 20 mg) tablets for oral administration. Each tadalafil tablet, USP contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, talc, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>47335-010-64</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (47335-010-64) / 15 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>47335-0010-64</NDC11Code>
<ProductNDC>47335-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208934</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, 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>2023-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing 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)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as round shaped (2.5 mg) and oval shaped (5 mg, 10 mg, and 20 mg) tablets for oral administration. Each tadalafil tablet, USP contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, talc, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>47335-039-64</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (47335-039-64) / 3 TABLET, FILM COATED in 1 BLISTER PACK (47335-039-60) </PackageDescription>
<NDC11Code>47335-0039-64</NDC11Code>
<ProductNDC>47335-039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bosentan</ProprietaryName>
<NonProprietaryName>Bosentan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209324</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>BOSENTAN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
<Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2’]-bipyrimidin-4-yl]-benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.63 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white to off-white crystalline powder. It is poorly soluble in water. In the solid state, bosentan is very stable, is not hygroscopic and is not light sensitive. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hydroxypropylmethylcellulose, iron oxide red, iron oxide yellow, magnesium stearate, povidone, pregelatinized maize starch, sodium starch glycolate, talc, titanium dioxide, and triacetin. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of anhydrous bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of anhydrous bosentan.</Description>
</NDC>
<NDC>
<NDCCode>47335-236-64</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (47335-236-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-236-60) </PackageDescription>
<NDC11Code>47335-0236-64</NDC11Code>
<ProductNDC>47335-236</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ambrisentan</ProprietaryName>
<NonProprietaryName>Ambrisentan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210784</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>AMBRISENTAN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ambrisentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).</IndicationAndUsage>
<Description>Ambrisentan is an endothelin receptor antagonist. The chemical name of ambrisentan is (+)-(2S)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid. It has a molecular formula of C22H22N2O4 and a molecular weight of 378.42 and has the following structural formula. Figure 1 Ambrisentan Structural Formula Ambrisentan is a white to off-white, crystalline solid. It is a carboxylic acid with a pKa of 4.0. Ambrisentan is practically insoluble in water and in aqueous solutions at low pH. Solubility increases in aqueous solutions at higher pH. In the solid state ambrisentan is very stable, is not hygroscopic, and is not light sensitive. Ambrisentan is available as 5 mg and 10 mg film-coated tablets for once daily oral administration. The tablets include the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The tablets are film-coated with a coating material containing FD&C Red #40 aluminum lake, lecithin, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Each round, pale pink ambrisentan tablet contains 5 mg of ambrisentan. Each oval, deep pink ambrisentan tablet contains 10 mg of ambrisentan. Ambrisentan tablets are unscored.</Description>
</NDC>
<NDC>
<NDCCode>47335-237-64</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (47335-237-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-237-60) </PackageDescription>
<NDC11Code>47335-0237-64</NDC11Code>
<ProductNDC>47335-237</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ambrisentan</ProprietaryName>
<NonProprietaryName>Ambrisentan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210784</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>AMBRISENTAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ambrisentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).</IndicationAndUsage>
<Description>Ambrisentan is an endothelin receptor antagonist. The chemical name of ambrisentan is (+)-(2S)-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid. It has a molecular formula of C22H22N2O4 and a molecular weight of 378.42 and has the following structural formula. Figure 1 Ambrisentan Structural Formula Ambrisentan is a white to off-white, crystalline solid. It is a carboxylic acid with a pKa of 4.0. Ambrisentan is practically insoluble in water and in aqueous solutions at low pH. Solubility increases in aqueous solutions at higher pH. In the solid state ambrisentan is very stable, is not hygroscopic, and is not light sensitive. Ambrisentan is available as 5 mg and 10 mg film-coated tablets for once daily oral administration. The tablets include the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The tablets are film-coated with a coating material containing FD&C Red #40 aluminum lake, lecithin, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Each round, pale pink ambrisentan tablet contains 5 mg of ambrisentan. Each oval, deep pink ambrisentan tablet contains 10 mg of ambrisentan. Ambrisentan tablets are unscored.</Description>
</NDC>
<NDC>
<NDCCode>47335-475-64</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (47335-475-64) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>47335-0475-64</NDC11Code>
<ProductNDC>47335-475</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imatinib Mesylate</ProprietaryName>
<NonProprietaryName>Imatinib Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078340</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>IMATINIB MESYLATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Imatinib mesylate is a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1) , 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. ( 1.2) , 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). ( 1.3) , 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. ( 1.5) , 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. ( 1.6) , 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. ( 1.7) , 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). ( 1.8) , 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9), 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).</IndicationAndUsage>
<Description>Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.45 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 477.8 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is:. Imatinib mesylate is an off-white to creamish yellow crystalline powder. Its molecular formula is C 29H 31N 7O CH 4SO 3and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: silicified microcrystalline cellulose, mannitol, copovidone, crospovidone, magnesium stearate, hypromellose, iron oxide yellow, polyethylene glycol, titanium dioxide, FD&C yellow # 6 aluminum lake and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>47335-724-64</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (47335-724-64) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (47335-724-60) </PackageDescription>
<NDC11Code>47335-0724-64</NDC11Code>
<ProductNDC>47335-724</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090818</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60; 120</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throat. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. reduces swelling of nasal passages. temporarily relieves sinus congestion and pressure. temporarily restores freer breathing through the nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47335-923-64</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-923-64) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>47335-0923-64</NDC11Code>
<ProductNDC>47335-923</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202637</ApplicationNumber>
<LabelerName>Sun Pharma Global FZE</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-05-22</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47335-984-64</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (47335-984-64) / 10 CAPSULE in 1 BLISTER PACK (47335-984-60) </PackageDescription>
<NDC11Code>47335-0984-64</NDC11Code>
<ProductNDC>47335-984</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezallor Sprinkle</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190504</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208647</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>47335-985-64</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (47335-985-64) / 10 CAPSULE in 1 BLISTER PACK (47335-985-60) </PackageDescription>
<NDC11Code>47335-0985-64</NDC11Code>
<ProductNDC>47335-985</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezallor Sprinkle</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190504</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208647</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>47335-986-64</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (47335-986-64) / 10 CAPSULE in 1 BLISTER PACK (47335-986-60) </PackageDescription>
<NDC11Code>47335-0986-64</NDC11Code>
<ProductNDC>47335-986</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezallor Sprinkle</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190504</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208647</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>47335-987-64</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (47335-987-64) / 10 CAPSULE in 1 BLISTER PACK (47335-987-60) </PackageDescription>
<NDC11Code>47335-0987-64</NDC11Code>
<ProductNDC>47335-987</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezallor Sprinkle</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190504</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208647</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EZALLOR SPRINKLE is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl]-(3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular formula for rosuvastatin calcium is (C22H27FN3O6S)2·Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is off-white to light yellow amorphous powder that is slightly soluble in water and methanol, and insoluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7. Each rosuvastatin capsule for oral use contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (present as 5.198 mg, 10.395 mg, 20.790 mg, or 41.580 mg of rosuvastatin calcium) in the form of granules with the following inactive ingredients: crospovidone, ferric oxide, hypromellose, magnesium oxide, mannitol, microcrystalline cellulose, polyethylene glycol 4000, silicon dioxide, and sodium citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate, titanium dioxide, and water. Additionally following colorants are used in capsules: FD&C Red 40 (5 mg), FD&C Blue 1 (5 mg, 10 mg, 20 mg), D&C Red 28 (5 mg, 10 mg), FD&C Red 3 (20 mg), and FD&C Green 3 (40 mg). The imprinting black ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>23155-038-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (23155-038-01) </PackageDescription>
<NDC11Code>23155-0038-01</NDC11Code>
<ProductNDC>23155-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paromomycin Sulfate</ProprietaryName>
<NonProprietaryName>Paromomycin Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091022</StartMarketingDate>
<EndMarketingDate>20240331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065173</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PAROMOMYCIN SULFATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiprotozoal [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20091022</StartMarketingDatePackage>
<EndMarketingDatePackage>20240331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paromomycin sulfate is indicated for intestinal amebiasis–acute and chronic (NOTE-It is not effective in extraintestinal amebiasis); management of hepatic coma–as adjunctive therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Paromomycin Sulfate Capsules and other antibacterial drugs, Paromomycin Sulfate Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Paromomycin sulfate is a broad spectrum antibiotic produced by Streptomyces riomosus var. paromomycinus. It is a white, amorphous, stable, water-soluble product. Paromomycin sulfate is designated chemically as 0-2, 6-Diamino-2, 6-dideoxy-β -L-idopyranosyl-(1→3)-0-β -D-ribofuranosyl-(1→5)-0-[2-amino-2-deoxy-α -D-glucopyranosyl-(1→4)]-2-deoxystreptamine sulfate (salt). The molecular formula is C23H45N5O14xH2SO4, with a molecular weight of 615.64 (base). Its structural formula is. Each capsule, for oral administration, contains paromomycin sulfate equivalent to 250 mg paromomycin. Each capsule also contains the following inactive ingredients: FD&C Blue # 1, D&C Red # 28, FD&C Red # 40, gelatin and titanium dioxide. The imprinting ink for the 250 mg capsule contains D&C yellow #10, FD&C blue # 1, FD&C blue # 2, FD&C red # 40, iron oxide black, pharmaceutical shellac glaze, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>47335-039-86</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (47335-039-86) </PackageDescription>
<NDC11Code>47335-0039-86</NDC11Code>
<ProductNDC>47335-039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bosentan</ProprietaryName>
<NonProprietaryName>Bosentan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209324</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>BOSENTAN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
<Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2’]-bipyrimidin-4-yl]-benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.63 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white to off-white crystalline powder. It is poorly soluble in water. In the solid state, bosentan is very stable, is not hygroscopic and is not light sensitive. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hydroxypropylmethylcellulose, iron oxide red, iron oxide yellow, magnesium stearate, povidone, pregelatinized maize starch, sodium starch glycolate, talc, titanium dioxide, and triacetin. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of anhydrous bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of anhydrous bosentan.</Description>
</NDC>
<NDC>
<NDCCode>10019-038-67</NDCCode>
<PackageDescription>10 AMPULE in 1 PACKAGE (10019-038-67) > 2 mL in 1 AMPULE (10019-038-39)</PackageDescription>
<NDC11Code>10019-0038-67</NDC11Code>
<ProductNDC>10019-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl Citrate</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20100625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA019101</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>10129-038-03</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (10129-038-03) > 86 g in 1 TUBE</PackageDescription>
<NDC11Code>10129-0038-03</NDC11Code>
<ProductNDC>10129-038</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Perio Armor-x</ProprietaryName>
<NonProprietaryName>1.7% Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>DENTAL; PERIODONTAL</RouteName>
<StartMarketingDate>20220815</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Gingi-Pak a Division of the Belport</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>1.7</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary use in cleansing minor oral wounds and treatment of inflammation resulting from dental procedures or other irritations of the mouth and gums. Perio Armor may be used for decreasing the presence of plaque, a known factor in the development of gingivitis and tooth decay.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10345-038-01</NDCCode>
<PackageDescription>40 mL in 1 TUBE (10345-038-01)</PackageDescription>
<NDC11Code>10345-0038-01</NDC11Code>
<ProductNDC>10345-038</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loccitane - Immortelle Precious Bb Broad Spectrum Spf 30 02 Light</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141118</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Laboratoires M&L</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>153.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>10578-038-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (10578-038-90)</PackageDescription>
<NDC11Code>10578-0038-90</NDC11Code>
<ProductNDC>10578-038</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Homeopathic Skin Solutions Formula</ProprietaryName>
<NonProprietaryName>Nux Vomica, Kali Arsenicum, Berberis Vulgaris, Graphites, Arsenicum Album, Hepar Sulphuris Calcareum, Arsenicum Sulphuratum Rubrum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Indiana Botanic Gardens</LabelerName>
<SubstanceName>STRYCHNOS NUX-VOMICA SEED; POTASSIUM ARSENITE ANHYDROUS; BERBERIS VULGARIS ROOT BARK; GRAPHITE; ARSENIC TRIOXIDE; CALCIUM SULFIDE; TETRAARSENIC TETRASULFIDE</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the relief of itching, burning and scaly conditions not due to insect or allergy conditions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10695-038-10</NDCCode>
<PackageDescription>1 kg in 1 BOTTLE (10695-038-10) </PackageDescription>
<NDC11Code>10695-0038-10</NDC11Code>
<ProductNDC>10695-038</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bupivacaine Hcl</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170418</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Willow Birch Pharma, LLC</LabelerName>
<SubstanceName>BUPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-31</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-APR-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>11084-038-03</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (11084-038-03) </PackageDescription>
<NDC11Code>11084-0038-03</NDC11Code>
<ProductNDC>11084-038</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bactoshield Chg</ProprietaryName>
<ProprietaryNameSuffix>Chlorhexidine Gluconate</ProprietaryNameSuffix>
<NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221201</StartMarketingDate>
<EndMarketingDate>20271231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019422</ApplicationNumber>
<LabelerName>SC Johnson Professional USA, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221201</StartMarketingDatePackage>
<EndMarketingDatePackage>20271231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care. healthcare personnel handwash: helps reduce bacteria that potentially can cause disease. patient preoperative skin preparation: preparation of the patient's skin prior to surgery. skin wound and general skin cleansing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11086-038-01</NDCCode>
<PackageDescription>28.4 g in 1 TUBE (11086-038-01) </PackageDescription>
<NDC11Code>11086-0038-01</NDC11Code>
<ProductNDC>11086-038</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Keralyt</ProprietaryName>
<ProprietaryNameSuffix>3 Percent</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131030</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Summers Laboratories Inc</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES. HELPS STOP THESE SYMPTOMS OF PSORIASIS, SEBORRHEIC DERMATITIS AND DANDRUFF: 1 FLAKING, 2 SCALING, 3 REDNESS, 4 IRRITATION, 5 ITCHING.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11086-038-11</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (11086-038-11) > 28.4 g in 1 TUBE (11086-038-01)</PackageDescription>
<NDC11Code>11086-0038-11</NDC11Code>
<ProductNDC>11086-038</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Keralyt</ProprietaryName>
<ProprietaryNameSuffix>3 Percent</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131030</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>Summers Laboratories Inc</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11410-038-00</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (11410-038-00) > 177.4 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>11410-0038-00</NDC11Code>
<ProductNDC>11410-038</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Proactiv Soothing Shave Gel</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>THE PROACTIV COMPANY LLC</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11559-038-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (11559-038-01) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>11559-0038-01</NDC11Code>
<ProductNDC>11559-038</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Double Wear All Day Glow Bb Moisture Makeup Broad Spectrum Spf 30</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ESTEE LAUDER INC</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.085125; .05675; .05902; .03632</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11673-038-32</NDCCode>
<PackageDescription>32 TABLET, CHEWABLE in 1 BAG (11673-038-32) </PackageDescription>
<NDC11Code>11673-0038-32</NDC11Code>
<ProductNDC>11673-038</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cherry Antacid Soft Chew</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180129</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Target</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>1177</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>