RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "50458-584-51",
      "PackageDescription": "1 KIT in 1 CARTON (50458-584-51)  *  42 TABLET, FILM COATED in 1 BLISTER PACK *  9 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "50458-0584-51",
      "ProductNDC": "50458-584",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Xarelto",
      "NonProprietaryName": "Rivaroxaban",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20140916",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022406",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "Status": "Active",
      "LastUpdate": "2026-09-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140916",
      "SamplePackage": "N",
      "IndicationAndUsage": "XARELTO is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6), 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
      "Description": "Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in XARELTO® Tablets and XARELTO® for oral suspension with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each XARELTO tablet contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of XARELTO are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for XARELTO 2.5 mg is Opadry® Light Yellow, containing ferric oxide yellow, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 10 mg tablets is Opadry® Pink and for XARELTO 15 mg tablets is Opadry® Red, both containing ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 20 mg tablets is Opadry® II Dark Red, containing ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. XARELTO for oral suspension is supplied as granules in bottles containing 155 mg of rivaroxaban (1 mg of rivaroxaban per mL after reconstitution). The inactive ingredients are: anhydrous citric acid, hypromellose, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sucralose, sweet and creamy flavor and xanthan gum."
    },
    {
      "NDCCode": "50458-584-52",
      "PackageDescription": "1 KIT in 1 CARTON (50458-584-52)  *  42 TABLET, FILM COATED in 1 BLISTER PACK *  9 TABLET, FILM COATED in 1 BLISTER PACK",
      "NDC11Code": "50458-0584-52",
      "ProductNDC": "50458-584",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Xarelto",
      "NonProprietaryName": "Rivaroxaban",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20140916",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022406",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "Status": "Active",
      "LastUpdate": "2026-09-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20161101",
      "SamplePackage": "N",
      "IndicationAndUsage": "XARELTO is a factor Xa inhibitor indicated: 1 to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1), 2 for treatment of deep vein thrombosis (DVT) (1.2), 3 for treatment of pulmonary embolism (PE) (1.3), 4 for reduction in the risk of recurrence of DVT or PE (1.4), 5 for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5), 6 for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6), 7 to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7), 8 to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8), 9 for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9), 10 for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
      "Description": "Rivaroxaban, a factor Xa (FXa) inhibitor, is the active ingredient in XARELTO® Tablets and XARELTO® for oral suspension with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is. Rivaroxaban is a pure (S)-enantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media. Each XARELTO tablet contains 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of XARELTO are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for XARELTO 2.5 mg is Opadry® Light Yellow, containing ferric oxide yellow, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 10 mg tablets is Opadry® Pink and for XARELTO 15 mg tablets is Opadry® Red, both containing ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 20 mg tablets is Opadry® II Dark Red, containing ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. XARELTO for oral suspension is supplied as granules in bottles containing 155 mg of rivaroxaban (1 mg of rivaroxaban per mL after reconstitution). The inactive ingredients are: anhydrous citric acid, hypromellose, mannitol, microcrystalline cellulose and carboxymethylcellulose sodium, sodium benzoate, sucralose, sweet and creamy flavor and xanthan gum."
    },
    {
      "NDCCode": "50458-540-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50458-540-60) ",
      "NDC11Code": "50458-0540-60",
      "ProductNDC": "50458-540",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Invokamet",
      "NonProprietaryName": "Canagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140808",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204353",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "50; 500",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140808",
      "SamplePackage": "N",
      "IndicationAndUsage": "INVOKAMET. INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR. INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin. Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 2 End-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.",
      "Description": "INVOKAMET® (canagliflozin and metformin HCl immediate-release tablets) and INVOKAMET® XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. Canagliflozin. Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C24H25FO5S∙1/2 H2O and 453.53, respectively. The structural formula for canagliflozin is. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. Metformin HCl. Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C4H11N5 ∙ HCl and 165.62, respectively. The structural formula for metformin HCl is. INVOKAMET and INVOKAMET XR. INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). INVOKAMET contains the following inactive ingredients: croscarmellose sodium (E468), hypromellose, magnesium stearate (E572), and microcrystalline cellulose (E460[i]). The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (E172) (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (E172) (150 mg/1,000 mg tablets only). INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium (E468), hydroxypropyl cellulose (E463), hypromellose, lactose anhydrous, magnesium stearate (E572) (vegetable-sourced), microcrystalline cellulose (E460[i]), polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172) (50 mg/1,000 mg and 150 mg/1,000 mg tablets only). INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion."
    },
    {
      "NDCCode": "50458-541-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50458-541-60) ",
      "NDC11Code": "50458-0541-60",
      "ProductNDC": "50458-541",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Invokamet",
      "NonProprietaryName": "Canagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140808",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204353",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "50; 1000",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140808",
      "SamplePackage": "N",
      "IndicationAndUsage": "INVOKAMET. INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR. INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin. Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 2 End-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.",
      "Description": "INVOKAMET® (canagliflozin and metformin HCl immediate-release tablets) and INVOKAMET® XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. Canagliflozin. Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C24H25FO5S∙1/2 H2O and 453.53, respectively. The structural formula for canagliflozin is. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. Metformin HCl. Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C4H11N5 ∙ HCl and 165.62, respectively. The structural formula for metformin HCl is. INVOKAMET and INVOKAMET XR. INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). INVOKAMET contains the following inactive ingredients: croscarmellose sodium (E468), hypromellose, magnesium stearate (E572), and microcrystalline cellulose (E460[i]). The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (E172) (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (E172) (150 mg/1,000 mg tablets only). INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium (E468), hydroxypropyl cellulose (E463), hypromellose, lactose anhydrous, magnesium stearate (E572) (vegetable-sourced), microcrystalline cellulose (E460[i]), polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172) (50 mg/1,000 mg and 150 mg/1,000 mg tablets only). INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion."
    },
    {
      "NDCCode": "50458-542-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50458-542-60) ",
      "NDC11Code": "50458-0542-60",
      "ProductNDC": "50458-542",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Invokamet",
      "NonProprietaryName": "Canagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140808",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204353",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "150; 500",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140808",
      "SamplePackage": "N",
      "IndicationAndUsage": "INVOKAMET. INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR. INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin. Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 2 End-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.",
      "Description": "INVOKAMET® (canagliflozin and metformin HCl immediate-release tablets) and INVOKAMET® XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. Canagliflozin. Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C24H25FO5S∙1/2 H2O and 453.53, respectively. The structural formula for canagliflozin is. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. Metformin HCl. Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C4H11N5 ∙ HCl and 165.62, respectively. The structural formula for metformin HCl is. INVOKAMET and INVOKAMET XR. INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). INVOKAMET contains the following inactive ingredients: croscarmellose sodium (E468), hypromellose, magnesium stearate (E572), and microcrystalline cellulose (E460[i]). The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (E172) (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (E172) (150 mg/1,000 mg tablets only). INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium (E468), hydroxypropyl cellulose (E463), hypromellose, lactose anhydrous, magnesium stearate (E572) (vegetable-sourced), microcrystalline cellulose (E460[i]), polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172) (50 mg/1,000 mg and 150 mg/1,000 mg tablets only). INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion."
    },
    {
      "NDCCode": "50458-543-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50458-543-60) ",
      "NDC11Code": "50458-0543-60",
      "ProductNDC": "50458-543",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Invokamet",
      "NonProprietaryName": "Canagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140808",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA204353",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "150; 1000",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140808",
      "SamplePackage": "N",
      "IndicationAndUsage": "INVOKAMET. INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR. INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin. Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 2 End-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.",
      "Description": "INVOKAMET® (canagliflozin and metformin HCl immediate-release tablets) and INVOKAMET® XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. Canagliflozin. Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C24H25FO5S∙1/2 H2O and 453.53, respectively. The structural formula for canagliflozin is. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. Metformin HCl. Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C4H11N5 ∙ HCl and 165.62, respectively. The structural formula for metformin HCl is. INVOKAMET and INVOKAMET XR. INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). INVOKAMET contains the following inactive ingredients: croscarmellose sodium (E468), hypromellose, magnesium stearate (E572), and microcrystalline cellulose (E460[i]). The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (E172) (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (E172) (150 mg/1,000 mg tablets only). INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium (E468), hydroxypropyl cellulose (E463), hypromellose, lactose anhydrous, magnesium stearate (E572) (vegetable-sourced), microcrystalline cellulose (E460[i]), polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172) (50 mg/1,000 mg and 150 mg/1,000 mg tablets only). INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion."
    },
    {
      "NDCCode": "50458-940-01",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-940-01) ",
      "NDC11Code": "50458-0940-01",
      "ProductNDC": "50458-940",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Invokamet Xr",
      "NonProprietaryName": "Canagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160920",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205879",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "50; 500",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-26",
      "PackageNdcExcludeFlag": "N",
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      "StartMarketingDatePackage": "20160920",
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      "IndicationAndUsage": "INVOKAMET. INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR. INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin. Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 2 End-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.",
      "Description": "INVOKAMET® (canagliflozin and metformin HCl immediate-release tablets) and INVOKAMET® XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. Canagliflozin. Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C24H25FO5S∙1/2 H2O and 453.53, respectively. The structural formula for canagliflozin is. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. Metformin HCl. Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C4H11N5 ∙ HCl and 165.62, respectively. The structural formula for metformin HCl is. INVOKAMET and INVOKAMET XR. INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). INVOKAMET contains the following inactive ingredients: croscarmellose sodium (E468), hypromellose, magnesium stearate (E572), and microcrystalline cellulose (E460[i]). The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (E172) (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (E172) (150 mg/1,000 mg tablets only). INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium (E468), hydroxypropyl cellulose (E463), hypromellose, lactose anhydrous, magnesium stearate (E572) (vegetable-sourced), microcrystalline cellulose (E460[i]), polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172) (50 mg/1,000 mg and 150 mg/1,000 mg tablets only). INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion."
    },
    {
      "NDCCode": "50458-941-01",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-941-01) ",
      "NDC11Code": "50458-0941-01",
      "ProductNDC": "50458-941",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Invokamet Xr",
      "NonProprietaryName": "Canagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160920",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205879",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "50; 1000",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-26",
      "PackageNdcExcludeFlag": "N",
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      "StartMarketingDatePackage": "20160920",
      "SamplePackage": "N",
      "IndicationAndUsage": "INVOKAMET. INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR. INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin. Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 2 End-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.",
      "Description": "INVOKAMET® (canagliflozin and metformin HCl immediate-release tablets) and INVOKAMET® XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. Canagliflozin. Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C24H25FO5S∙1/2 H2O and 453.53, respectively. The structural formula for canagliflozin is. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. Metformin HCl. Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C4H11N5 ∙ HCl and 165.62, respectively. The structural formula for metformin HCl is. INVOKAMET and INVOKAMET XR. INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). INVOKAMET contains the following inactive ingredients: croscarmellose sodium (E468), hypromellose, magnesium stearate (E572), and microcrystalline cellulose (E460[i]). The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (E172) (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (E172) (150 mg/1,000 mg tablets only). INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium (E468), hydroxypropyl cellulose (E463), hypromellose, lactose anhydrous, magnesium stearate (E572) (vegetable-sourced), microcrystalline cellulose (E460[i]), polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172) (50 mg/1,000 mg and 150 mg/1,000 mg tablets only). INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion."
    },
    {
      "NDCCode": "50458-942-01",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-942-01) ",
      "NDC11Code": "50458-0942-01",
      "ProductNDC": "50458-942",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Invokamet Xr",
      "NonProprietaryName": "Canagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160920",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205879",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "150; 500",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
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      "StartMarketingDatePackage": "20160920",
      "SamplePackage": "N",
      "IndicationAndUsage": "INVOKAMET. INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR. INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin. Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 2 End-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.",
      "Description": "INVOKAMET® (canagliflozin and metformin HCl immediate-release tablets) and INVOKAMET® XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. Canagliflozin. Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C24H25FO5S∙1/2 H2O and 453.53, respectively. The structural formula for canagliflozin is. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. Metformin HCl. Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C4H11N5 ∙ HCl and 165.62, respectively. The structural formula for metformin HCl is. INVOKAMET and INVOKAMET XR. INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). INVOKAMET contains the following inactive ingredients: croscarmellose sodium (E468), hypromellose, magnesium stearate (E572), and microcrystalline cellulose (E460[i]). The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (E172) (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (E172) (150 mg/1,000 mg tablets only). INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium (E468), hydroxypropyl cellulose (E463), hypromellose, lactose anhydrous, magnesium stearate (E572) (vegetable-sourced), microcrystalline cellulose (E460[i]), polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172) (50 mg/1,000 mg and 150 mg/1,000 mg tablets only). INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion."
    },
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      "NDCCode": "50458-943-01",
      "PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-943-01) ",
      "NDC11Code": "50458-0943-01",
      "ProductNDC": "50458-943",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Invokamet Xr",
      "NonProprietaryName": "Canagliflozin And Metformin Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160920",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA205879",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
      "StrengthNumber": "150; 1000",
      "StrengthUnit": "mg/1; mg/1",
      "Pharm_Classes": "Biguanide [EPC], Biguanides [CS], P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-08-26",
      "PackageNdcExcludeFlag": "N",
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      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160920",
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      "IndicationAndUsage": "INVOKAMET. INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR. INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin. Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD)., 2 End-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.",
      "Description": "INVOKAMET® (canagliflozin and metformin HCl immediate-release tablets) and INVOKAMET® XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. Canagliflozin. Canagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C24H25FO5S∙1/2 H2O and 453.53, respectively. The structural formula for canagliflozin is. Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9. Metformin HCl. Metformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C4H11N5 ∙ HCl and 165.62, respectively. The structural formula for metformin HCl is. INVOKAMET and INVOKAMET XR. INVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively). INVOKAMET contains the following inactive ingredients: croscarmellose sodium (E468), hypromellose, magnesium stearate (E572), and microcrystalline cellulose (E460[i]). The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (E172) (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (E172) (150 mg/1,000 mg tablets only). INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium (E468), hydroxypropyl cellulose (E463), hypromellose, lactose anhydrous, magnesium stearate (E572) (vegetable-sourced), microcrystalline cellulose (E460[i]), polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350 (E1521), polyvinyl alcohol (E1203) (partially hydrolyzed), talc (E553b), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and iron oxide black (E172) (50 mg/1,000 mg and 150 mg/1,000 mg tablets only). INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion."
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      "NDCCode": "0078-0526-51",
      "PackageDescription": "28 CAPSULE in 1 BLISTER PACK (0078-0526-51) ",
      "NDC11Code": "00078-0526-51",
      "ProductNDC": "0078-0526",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tasigna",
      "NonProprietaryName": "Nilotinib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20071029",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022068",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "NILOTINIB HYDROCHLORIDE MONOHYDRATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20071029",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tasigna is a kinase inhibitor indicated for the treatment of: 1 Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2) , 3 Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. (1.3) .",
      "Description": "Tasigna contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to slightly yellowish to slightly greenish yellow powder with the molecular formula and weight, respectively, of C28H22F3N7OHCl  H2O and 584 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pKa1 was determined to be 2.1; pKa2 was estimated to be 5.4. The chemical name of nilotinib monohydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below. Tasigna (nilotinib) capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55 mg, 166 mg, and 221 mg nilotinib monohydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and poloxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow), iron oxide (black), and titanium dioxide."
    },
    {
      "NDCCode": "0078-0592-51",
      "PackageDescription": "28 CAPSULE in 1 BLISTER PACK (0078-0592-51) ",
      "NDC11Code": "00078-0592-51",
      "ProductNDC": "0078-0592",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Tasigna",
      "NonProprietaryName": "Nilotinib",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20071029",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022068",
      "LabelerName": "Novartis Pharmaceuticals Corporation",
      "SubstanceName": "NILOTINIB HYDROCHLORIDE MONOHYDRATE",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-12-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20071029",
      "SamplePackage": "N",
      "IndicationAndUsage": "Tasigna is a kinase inhibitor indicated for the treatment of: 1 Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2) , 3 Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. (1.3) .",
      "Description": "Tasigna contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to slightly yellowish to slightly greenish yellow powder with the molecular formula and weight, respectively, of C28H22F3N7OHCl  H2O and 584 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pKa1 was determined to be 2.1; pKa2 was estimated to be 5.4. The chemical name of nilotinib monohydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below. Tasigna (nilotinib) capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55 mg, 166 mg, and 221 mg nilotinib monohydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and poloxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow), iron oxide (black), and titanium dioxide."
    },
    {
      "NDCCode": "0338-0202-06",
      "PackageDescription": "6 BAG in 1 CARTON (0338-0202-06)  / 1000 mL in 1 BAG (0338-0202-01) ",
      "NDC11Code": "00338-0202-06",
      "ProductNDC": "0338-0202",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200921",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 14",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200921",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
      "Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "0338-0206-04",
      "PackageDescription": "4 BAG in 1 CARTON (0338-0206-04)  / 2000 mL in 1 BAG (0338-0206-01) ",
      "NDC11Code": "00338-0206-04",
      "ProductNDC": "0338-0206",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200921",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 14",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200921",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
      "Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "0338-0210-06",
      "PackageDescription": "6 BAG in 1 CARTON (0338-0210-06)  / 1000 mL in 1 BAG (0338-0210-01) ",
      "NDC11Code": "00338-0210-06",
      "ProductNDC": "0338-0210",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200921",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 10",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200921",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
      "Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "0338-0214-04",
      "PackageDescription": "4 BAG in 1 CARTON (0338-0214-04)  / 2000 mL in 1 BAG (0338-0214-01) ",
      "NDC11Code": "00338-0214-04",
      "ProductNDC": "0338-0214",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clinimix E",
      "NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20200921",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020678",
      "LabelerName": "Baxter Healthcare Company",
      "SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE",
      "StrengthNumber": "584; 448; 464; 320; 480; 464; 384; 336; 144; 1656; 824; 920; 544; 400; 32; 261; 51; 205; 33; 10",
      "StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL",
      "Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Active",
      "LastUpdate": "2026-06-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20200921",
      "SamplePackage": "N",
      "IndicationAndUsage": "CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.",
      "Description": "CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8. The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl22H2O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C6H12O6  H2O) and has the following structure. Dextrose is derived from corn. See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)]. The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic). CLINIMIX E contains no more than 25 mcg/L of aluminum."
    },
    {
      "NDCCode": "31722-584-60",
      "PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (31722-584-60) ",
      "NDC11Code": "31722-0584-60",
      "ProductNDC": "31722-584",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Raltegravir",
      "NonProprietaryName": "Raltegravir",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20241219",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203540",
      "LabelerName": "Camber Pharmaceuticals, Inc.",
      "SubstanceName": "RALTEGRAVIR POTASSIUM",
      "StrengthNumber": "400",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20241219",
      "SamplePackage": "N",
      "IndicationAndUsage": "Adult Patients: Raltegravir tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients. Pediatric Patients: Raltegravir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg.",
      "Description": "Raltegravir tablets, USP contain raltegravir potassium USP, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorobenzyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide monopotassium salt. The molecular formula is C 20H 20FKN 6O 5and the molecular weight is 482.51. The structural formula is:. Raltegravir potassium, USP is white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in acetonitrile and ethanol, insoluble in isopropyl alcohol. Each 400 mg film-coated tablet of raltegravir for oral administration contains 434.4 mg of raltegravir potassium USP, equivalent to 400 mg of raltegravir and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene oxide, sodium stearyl fumarate. The tablets are coated with opadry II white containing polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP."
    },
    {
      "NDCCode": "50458-028-02",
      "PackageDescription": "2 BLISTER PACK in 1 KIT (50458-028-02)  / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00) ",
      "NDC11Code": "50458-0028-02",
      "ProductNDC": "50458-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Spravato",
      "NonProprietaryName": "Esketamine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "NASAL",
      "StartMarketingDate": "20190305",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA211243",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "ESKETAMINE HYDROCHLORIDE",
      "StrengthNumber": "28",
      "StrengthUnit": "mg/.2mL",
      "DEASchedule": "CIII",
      "Status": "Active",
      "LastUpdate": "2026-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190305",
      "SamplePackage": "N",
      "IndicationAndUsage": "SPRAVATO is indicated for the treatment of: 1 Treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant, 2 Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant.",
      "Description": "SPRAVATO ®contains esketamine hydrochloride, a non-competitive N-methyl- D-aspartate (NMDA) receptor antagonist. Esketamine is the S-enantiomer of racemic ketamine. The chemical name is (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. Its molecular formula is C13H16ClNO.HCl and its molecular weight is 274.2. The structural formula is:. Esketamine hydrochloride is a white or almost white crystalline powder that is freely soluble in water and in methanol, and soluble in ethanol. SPRAVATO nasal spray is intended for nasal administration. Esketamine hydrochloride is contained as a solution in a stoppered glass vial within the nasal spray device. Each device delivers two sprays with a total of 32.3 mg of esketamine hydrochloride (equivalent to 28 mg of esketamine) in 0.2 mL of a clear, colorless aqueous solution with a pH of 4.5. The inactive ingredients are citric acid monohydrate, edetate disodium, sodium hydroxide, and water for injection."
    },
    {
      "NDCCode": "50458-028-03",
      "PackageDescription": "3 BLISTER PACK in 1 KIT (50458-028-03)  / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00) ",
      "NDC11Code": "50458-0028-03",
      "ProductNDC": "50458-028",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Spravato",
      "NonProprietaryName": "Esketamine Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "NASAL",
      "StartMarketingDate": "20190305",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA211243",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "ESKETAMINE HYDROCHLORIDE",
      "StrengthNumber": "28",
      "StrengthUnit": "mg/.2mL",
      "DEASchedule": "CIII",
      "Status": "Active",
      "LastUpdate": "2026-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20190305",
      "SamplePackage": "N",
      "IndicationAndUsage": "SPRAVATO is indicated for the treatment of: 1 Treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant, 2 Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant.",
      "Description": "SPRAVATO ®contains esketamine hydrochloride, a non-competitive N-methyl- D-aspartate (NMDA) receptor antagonist. Esketamine is the S-enantiomer of racemic ketamine. The chemical name is (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. Its molecular formula is C13H16ClNO.HCl and its molecular weight is 274.2. The structural formula is:. Esketamine hydrochloride is a white or almost white crystalline powder that is freely soluble in water and in methanol, and soluble in ethanol. SPRAVATO nasal spray is intended for nasal administration. Esketamine hydrochloride is contained as a solution in a stoppered glass vial within the nasal spray device. Each device delivers two sprays with a total of 32.3 mg of esketamine hydrochloride (equivalent to 28 mg of esketamine) in 0.2 mL of a clear, colorless aqueous solution with a pH of 4.5. The inactive ingredients are citric acid monohydrate, edetate disodium, sodium hydroxide, and water for injection."
    },
    {
      "NDCCode": "50458-090-05",
      "PackageDescription": "5 POUCH in 1 BOX (50458-090-05)  > 1 PATCH in 1 POUCH > 72 h in 1 PATCH",
      "NDC11Code": "50458-0090-05",
      "ProductNDC": "50458-090",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duragesic",
      "NonProprietaryName": "Fentanyl",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "19900807",
      "EndMarketingDate": "20200331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019813",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "FENTANYL",
      "StrengthNumber": "12.5",
      "StrengthUnit": "ug/h",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2020-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19900807",
      "EndMarketingDatePackage": "20200331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50458-091-05",
      "PackageDescription": "5 POUCH in 1 BOX (50458-091-05)  > 1 PATCH in 1 POUCH > 72 h in 1 PATCH",
      "NDC11Code": "50458-0091-05",
      "ProductNDC": "50458-091",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duragesic",
      "NonProprietaryName": "Fentanyl",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "19900807",
      "EndMarketingDate": "20191031",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019813",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "FENTANYL",
      "StrengthNumber": "25",
      "StrengthUnit": "ug/h",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2019-11-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19900807",
      "EndMarketingDatePackage": "20191031",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50458-092-05",
      "PackageDescription": "5 POUCH in 1 BOX (50458-092-05)  > 1 PATCH in 1 POUCH > 72 h in 1 PATCH",
      "NDC11Code": "50458-0092-05",
      "ProductNDC": "50458-092",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duragesic",
      "NonProprietaryName": "Fentanyl",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "19900807",
      "EndMarketingDate": "20200331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019813",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "FENTANYL",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/h",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2020-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19900807",
      "EndMarketingDatePackage": "20200331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50458-093-05",
      "PackageDescription": "5 POUCH in 1 BOX (50458-093-05)  > 1 PATCH in 1 POUCH > 72 h in 1 PATCH",
      "NDC11Code": "50458-0093-05",
      "ProductNDC": "50458-093",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duragesic",
      "NonProprietaryName": "Fentanyl",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "19900807",
      "EndMarketingDate": "20200331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019813",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "FENTANYL",
      "StrengthNumber": "75",
      "StrengthUnit": "ug/h",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2020-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19900807",
      "EndMarketingDatePackage": "20200331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50458-094-05",
      "PackageDescription": "5 POUCH in 1 BOX (50458-094-05)  > 1 PATCH in 1 POUCH > 72 h in 1 PATCH",
      "NDC11Code": "50458-0094-05",
      "ProductNDC": "50458-094",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duragesic",
      "NonProprietaryName": "Fentanyl",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "19900807",
      "EndMarketingDate": "20200331",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019813",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "FENTANYL",
      "StrengthNumber": "100",
      "StrengthUnit": "ug/h",
      "Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2020-04-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "19900807",
      "EndMarketingDatePackage": "20200331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50458-098-01",
      "PackageDescription": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01) ",
      "NDC11Code": "50458-0098-01",
      "ProductNDC": "50458-098",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Elmiron",
      "NonProprietaryName": "Pentosan Polysulfate Sodium",
      "DosageFormName": "CAPSULE, GELATIN COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "19960926",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020193",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "PENTOSAN POLYSULFATE SODIUM",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Glycosaminoglycan [EPC], Glycosaminoglycans [CS]",
      "Status": "Active",
      "LastUpdate": "2024-09-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19960926",
      "SamplePackage": "N",
      "IndicationAndUsage": "ELMIRON ®(pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.",
      "Description": "Pentosan polysulfate sodium is a semi-synthetically produced heparin-like macromolecular carbohydrate derivative, which chemically and structurally resembles glycosaminoglycans. It is a white odorless powder, slightly hygroscopic and soluble in water to 50% at pH 6. It has a molecular weight of 4000 to 6000 Dalton with the following structural formula. ELMIRON ®is supplied in white, opaque hard gelatin capsules containing 100 mg pentosan polysulfate sodium, microcrystalline cellulose, and magnesium stearate. It also contains pharmaceutical glaze (modified) in SD-45, synthetic black iron oxide, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, FD&C Blue No. 1 aluminum lake, D&C Yellow No. 10 aluminum lake, n-butyl alcohol, propylene glycol, SDA-3A alcohol, and titanium dioxide. It is formulated for oral use."
    },
    {
      "NDCCode": "50458-101-05",
      "PackageDescription": "5 POUCH in 1 BOX (50458-101-05)  > 1 PATCH in 1 POUCH",
      "NDC11Code": "50458-0101-05",
      "ProductNDC": "50458-101",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duragesic",
      "ProprietaryNameSuffix": "(fentanyl System)",
      "NonProprietaryName": "Fentanyl",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20181105",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019813",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "FENTANYL",
      "StrengthNumber": "12.5",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20181115",
      "EndMarketingDatePackage": "20210730",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50458-102-05",
      "PackageDescription": "5 POUCH in 1 BOX (50458-102-05)  > 1 PATCH in 1 POUCH",
      "NDC11Code": "50458-0102-05",
      "ProductNDC": "50458-102",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duragesic",
      "ProprietaryNameSuffix": "(fentanyl System)",
      "NonProprietaryName": "Fentanyl",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20181105",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019813",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "FENTANYL",
      "StrengthNumber": "25",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20181105",
      "EndMarketingDatePackage": "20210730",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50458-104-05",
      "PackageDescription": "5 POUCH in 1 BOX (50458-104-05)  > 1 PATCH in 1 POUCH",
      "NDC11Code": "50458-0104-05",
      "ProductNDC": "50458-104",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duragesic",
      "ProprietaryNameSuffix": "(fentanyl System)",
      "NonProprietaryName": "Fentanyl",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20181105",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019813",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "FENTANYL",
      "StrengthNumber": "50",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20181115",
      "EndMarketingDatePackage": "20210730",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50458-105-05",
      "PackageDescription": "5 POUCH in 1 BOX (50458-105-05)  > 1 PATCH in 1 POUCH",
      "NDC11Code": "50458-0105-05",
      "ProductNDC": "50458-105",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duragesic",
      "ProprietaryNameSuffix": "(fentanyl System)",
      "NonProprietaryName": "Fentanyl",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20181105",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019813",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "FENTANYL",
      "StrengthNumber": "75",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20181115",
      "EndMarketingDatePackage": "20210730",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "50458-106-05",
      "PackageDescription": "5 POUCH in 1 BOX (50458-106-05)  > 1 PATCH in 1 POUCH",
      "NDC11Code": "50458-0106-05",
      "ProductNDC": "50458-106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duragesic",
      "ProprietaryNameSuffix": "(fentanyl System)",
      "NonProprietaryName": "Fentanyl",
      "DosageFormName": "PATCH",
      "RouteName": "TRANSDERMAL",
      "StartMarketingDate": "20181105",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019813",
      "LabelerName": "Janssen Pharmaceuticals, Inc.",
      "SubstanceName": "FENTANYL",
      "StrengthNumber": "100",
      "StrengthUnit": "ug/1",
      "Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
      "DEASchedule": "CII",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-31",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20181115",
      "EndMarketingDatePackage": "20210730",
      "SamplePackage": "N"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"50458-584-51","ProprietaryName":"Xarelto","NonProprietaryName":"Rivaroxaban"},{"NDCCode":"50458-584-52","ProprietaryName":"Xarelto","NonProprietaryName":"Rivaroxaban"},{"NDCCode":"50458-540-60","ProprietaryName":"Invokamet","NonProprietaryName":"Canagliflozin And Metformin Hydrochloride"},{"NDCCode":"50458-541-60","ProprietaryName":"Invokamet","NonProprietaryName":"Canagliflozin And Metformin Hydrochloride"},{"NDCCode":"50458-542-60","ProprietaryName":"Invokamet","NonProprietaryName":"Canagliflozin And Metformin Hydrochloride"},{"NDCCode":"50458-543-60","ProprietaryName":"Invokamet","NonProprietaryName":"Canagliflozin And Metformin Hydrochloride"},{"NDCCode":"50458-940-01","ProprietaryName":"Invokamet Xr","NonProprietaryName":"Canagliflozin And Metformin Hydrochloride"},{"NDCCode":"50458-941-01","ProprietaryName":"Invokamet Xr","NonProprietaryName":"Canagliflozin And Metformin Hydrochloride"},{"NDCCode":"50458-942-01","ProprietaryName":"Invokamet Xr","NonProprietaryName":"Canagliflozin And Metformin Hydrochloride"},{"NDCCode":"50458-943-01","ProprietaryName":"Invokamet Xr","NonProprietaryName":"Canagliflozin And Metformin Hydrochloride"},{"NDCCode":"0078-0526-51","ProprietaryName":"Tasigna","NonProprietaryName":"Nilotinib"},{"NDCCode":"0078-0592-51","ProprietaryName":"Tasigna","NonProprietaryName":"Nilotinib"},{"NDCCode":"0338-0202-06","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-0206-04","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-0210-06","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"0338-0214-04","ProprietaryName":"Clinimix E","NonProprietaryName":"Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose"},{"NDCCode":"31722-584-60","ProprietaryName":"Raltegravir","NonProprietaryName":"Raltegravir"},{"NDCCode":"50458-028-02","ProprietaryName":"Spravato","NonProprietaryName":"Esketamine Hydrochloride"},{"NDCCode":"50458-028-03","ProprietaryName":"Spravato","NonProprietaryName":"Esketamine Hydrochloride"},{"NDCCode":"50458-090-05","ProprietaryName":"Duragesic","NonProprietaryName":"Fentanyl"},{"NDCCode":"50458-091-05","ProprietaryName":"Duragesic","NonProprietaryName":"Fentanyl"},{"NDCCode":"50458-092-05","ProprietaryName":"Duragesic","NonProprietaryName":"Fentanyl"},{"NDCCode":"50458-093-05","ProprietaryName":"Duragesic","NonProprietaryName":"Fentanyl"},{"NDCCode":"50458-094-05","ProprietaryName":"Duragesic","NonProprietaryName":"Fentanyl"},{"NDCCode":"50458-098-01","ProprietaryName":"Elmiron","NonProprietaryName":"Pentosan Polysulfate Sodium"},{"NDCCode":"50458-101-05","ProprietaryName":"Duragesic","NonProprietaryName":"Fentanyl"},{"NDCCode":"50458-102-05","ProprietaryName":"Duragesic","NonProprietaryName":"Fentanyl"},{"NDCCode":"50458-104-05","ProprietaryName":"Duragesic","NonProprietaryName":"Fentanyl"},{"NDCCode":"50458-105-05","ProprietaryName":"Duragesic","NonProprietaryName":"Fentanyl"},{"NDCCode":"50458-106-05","ProprietaryName":"Duragesic","NonProprietaryName":"Fentanyl"}]}
                    

<NDCList><NDC><NDCCode>50458-584-51</NDCCode><ProprietaryName>Xarelto</ProprietaryName><NonProprietaryName>Rivaroxaban</NonProprietaryName></NDC><NDC><NDCCode>50458-584-52</NDCCode><ProprietaryName>Xarelto</ProprietaryName><NonProprietaryName>Rivaroxaban</NonProprietaryName></NDC><NDC><NDCCode>50458-540-60</NDCCode><ProprietaryName>Invokamet</ProprietaryName><NonProprietaryName>Canagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50458-541-60</NDCCode><ProprietaryName>Invokamet</ProprietaryName><NonProprietaryName>Canagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50458-542-60</NDCCode><ProprietaryName>Invokamet</ProprietaryName><NonProprietaryName>Canagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50458-543-60</NDCCode><ProprietaryName>Invokamet</ProprietaryName><NonProprietaryName>Canagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50458-940-01</NDCCode><ProprietaryName>Invokamet Xr</ProprietaryName><NonProprietaryName>Canagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50458-941-01</NDCCode><ProprietaryName>Invokamet Xr</ProprietaryName><NonProprietaryName>Canagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50458-942-01</NDCCode><ProprietaryName>Invokamet Xr</ProprietaryName><NonProprietaryName>Canagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50458-943-01</NDCCode><ProprietaryName>Invokamet Xr</ProprietaryName><NonProprietaryName>Canagliflozin And Metformin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>0078-0526-51</NDCCode><ProprietaryName>Tasigna</ProprietaryName><NonProprietaryName>Nilotinib</NonProprietaryName></NDC><NDC><NDCCode>0078-0592-51</NDCCode><ProprietaryName>Tasigna</ProprietaryName><NonProprietaryName>Nilotinib</NonProprietaryName></NDC><NDC><NDCCode>0338-0202-06</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0338-0206-04</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0338-0210-06</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>0338-0214-04</NDCCode><ProprietaryName>Clinimix E</ProprietaryName><NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose</NonProprietaryName></NDC><NDC><NDCCode>31722-584-60</NDCCode><ProprietaryName>Raltegravir</ProprietaryName><NonProprietaryName>Raltegravir</NonProprietaryName></NDC><NDC><NDCCode>50458-028-02</NDCCode><ProprietaryName>Spravato</ProprietaryName><NonProprietaryName>Esketamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50458-028-03</NDCCode><ProprietaryName>Spravato</ProprietaryName><NonProprietaryName>Esketamine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>50458-090-05</NDCCode><ProprietaryName>Duragesic</ProprietaryName><NonProprietaryName>Fentanyl</NonProprietaryName></NDC><NDC><NDCCode>50458-091-05</NDCCode><ProprietaryName>Duragesic</ProprietaryName><NonProprietaryName>Fentanyl</NonProprietaryName></NDC><NDC><NDCCode>50458-092-05</NDCCode><ProprietaryName>Duragesic</ProprietaryName><NonProprietaryName>Fentanyl</NonProprietaryName></NDC><NDC><NDCCode>50458-093-05</NDCCode><ProprietaryName>Duragesic</ProprietaryName><NonProprietaryName>Fentanyl</NonProprietaryName></NDC><NDC><NDCCode>50458-094-05</NDCCode><ProprietaryName>Duragesic</ProprietaryName><NonProprietaryName>Fentanyl</NonProprietaryName></NDC><NDC><NDCCode>50458-098-01</NDCCode><ProprietaryName>Elmiron</ProprietaryName><NonProprietaryName>Pentosan Polysulfate 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