{
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"IndicationAndUsage": "Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2."
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"ProductTypeName": "HUMAN OTC DRUG",
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{
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"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; BETA-ENDORPHIN HUMAN",
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"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
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"SamplePackage": "N"
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{
"NDCCode": "0270-7015-38",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CASE (0270-7015-38) > 3 mL in 1 VIAL, SINGLE-DOSE",
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"ProductNDC": "0270-7015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vueway",
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"LastUpdate": "2022-11-05",
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"StartMarketingDatePackage": "20220921",
"SamplePackage": "N"
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{
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"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CASE (0270-7015-40) > 7.5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00270-7015-40",
"ProductNDC": "0270-7015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vueway",
"NonProprietaryName": "Gadopiclenol",
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"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "GADOPICLENOL",
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"Status": "Deprecated",
"LastUpdate": "2022-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N"
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{
"NDCCode": "0270-7015-44",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CASE (0270-7015-44) > 15 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00270-7015-44",
"ProductNDC": "0270-7015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vueway",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "GADOPICLENOL",
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"Status": "Deprecated",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20220921",
"SamplePackage": "N"
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"NDCCode": "0270-7015-46",
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"ProductNDC": "0270-7015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vueway",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2."
},
{
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"ProductNDC": "0270-7015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vueway",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2."
},
{
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"PackageDescription": "6 CARTON in 1 CASE (0270-7015-64) / 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "00270-7015-64",
"ProductNDC": "0270-7015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vueway",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2."
},
{
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"ProductNDC": "0270-7015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vueway",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"IndicationAndUsage": "Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2."
},
{
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"PackageDescription": "10 VIAL in 1 CASE (0270-7015-75) / 30 mL in 1 VIAL",
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"ProductNDC": "0270-7015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vueway",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"IndicationAndUsage": "Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2."
},
{
"NDCCode": "0270-7015-76",
"PackageDescription": "10 VIAL in 1 CASE (0270-7015-76) / 50 mL in 1 VIAL",
"NDC11Code": "00270-7015-76",
"ProductNDC": "0270-7015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vueway",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"IndicationAndUsage": "Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2."
},
{
"NDCCode": "0270-7015-77",
"PackageDescription": "10 VIAL in 1 CASE (0270-7015-77) / 100 mL in 1 VIAL",
"NDC11Code": "00270-7015-77",
"ProductNDC": "0270-7015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vueway",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"IndicationAndUsage": "Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2."
},
{
"NDCCode": "0270-7015-81",
"PackageDescription": "10 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0270-7015-81) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "00270-7015-81",
"ProductNDC": "0270-7015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vueway",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"IndicationAndUsage": "Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2."
},
{
"NDCCode": "0270-7015-91",
"PackageDescription": "10 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0270-7015-91) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "00270-7015-91",
"ProductNDC": "0270-7015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vueway",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"IndicationAndUsage": "Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).",
"Description": "Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2."
},
{
"NDCCode": "43547-270-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-270-10) ",
"NDC11Code": "43547-0270-10",
"ProductNDC": "43547-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078110",
"LabelerName": "SOLCO HEALTHCARE US, LLC",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110920",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).",
"Description": "Ropinirole tablets contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243oC to 250°C and a solubility of 133 mg/mL in water. Each round biconvex film-coated ropinirole tablet contains 0.29, 0.57, 1.14, 2.28, 3.42, 4.56, or 5.70 mg of ropinirole hydrochloride equivalent to ropinirole 0.25, 0.5, 1, 2, 3, 4, or 5 mg, respectively. Inactive ingredients of the core tablets consist of croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Inactive ingredients of the film coats are slightly different among the 7 strengths of tablets and are tabulated below. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "43547-270-50",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-270-50) ",
"NDC11Code": "43547-0270-50",
"ProductNDC": "43547-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole Hydrochloride",
"NonProprietaryName": "Ropinirole Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078110",
"LabelerName": "SOLCO HEALTHCARE US, LLC",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110920",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).",
"Description": "Ropinirole tablets contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243oC to 250°C and a solubility of 133 mg/mL in water. Each round biconvex film-coated ropinirole tablet contains 0.29, 0.57, 1.14, 2.28, 3.42, 4.56, or 5.70 mg of ropinirole hydrochloride equivalent to ropinirole 0.25, 0.5, 1, 2, 3, 4, or 5 mg, respectively. Inactive ingredients of the core tablets consist of croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Inactive ingredients of the film coats are slightly different among the 7 strengths of tablets and are tabulated below. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "66993-270-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (66993-270-30) ",
"NDC11Code": "66993-0270-30",
"ProductNDC": "66993-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Atorvastatin",
"NonProprietaryName": "Amlodipine And Atorvastatin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220314",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021540",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220314",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.",
"Description": "Amlodipine and atorvastatin tablets combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5∙C6H6O3S. Atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-β, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Its empirical formula is (C33H34FN2O5)2Ca3H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate, a white to off-white crystalline powder, and atorvastatin calcium, also a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 2.5mg amlodipine equivalent to 3.47mg amlodipine besylate and 10mg atorvastatin equivalent to 10.4mg atorvastatin calcium., 2 2.5mg amlodipine equivalent to 3.47mg amlodipine besylate and 20mg atorvastatin equivalent to 20.7mg atorvastatin calcium., 3 2.5mg amlodipine equivalent to 3.47mg amlodipine besylate and 40mg atorvastatin equivalent to 41.4mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium."
},
{
"NDCCode": "0169-7205-01",
"PackageDescription": "1 KIT in 1 KIT (0169-7205-01) * 5 mL in 1 VIAL, GLASS (0169-7215-11) * 5 mL in 1 SYRINGE, GLASS (0169-7015-98) ",
"NDC11Code": "00169-7205-01",
"ProductNDC": "0169-7205",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Novoseven",
"ProprietaryNameSuffix": "Rt",
"NonProprietaryName": "Coagulation Factor Viia (recombinant)",
"DosageFormName": "KIT",
"StartMarketingDate": "20121029",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103665",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2022-11-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121029",
"SamplePackage": "N",
"IndicationAndUsage": "NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant), is indicated for: 1 Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets., 2 Treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia.",
"Description": "NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant) is a sterile, white lyophilized powder of recombinant human coagulation factor VIIa (rFVIIa) for reconstitution for intravenous injection. The product is supplied as single‑dose vials containing the following. NOVOSEVEN RT also contains trace amounts of proteins derived from the manufacturing and purification processes such as mouse IgG (maximum of 1.2 ng/mg), bovine IgG (maximum of 30 ng/mg), and protein from BHK-cells and media (maximum of 19 ng/mg). The diluent for reconstitution of NOVOSEVEN RT is a 10 mmol solution of histidine in water for injection and is supplied as a clear colorless solution in a vial or pre-filled diluent syringe. After reconstitution with the appropriate volume of histidine diluent, each vial contains approximately 1 mg/mL NOVOSEVEN RT (corresponding to 1000 micrograms/mL). The reconstituted solution is a clear colorless solution with a pH of approximately 6.0 and contains no preservatives. Recombinant coagulation Factor VIIa (rFVIIa), the active ingredient in NOVOSEVEN RT, is a vitamin K‑dependent glycoprotein consisting of 406 amino acid residues with an approximate molecular mass of 50 kDa). It is structurally similar to endogenous human coagulation factor VIIa. The gene for human coagulation factor VII (FVII) is cloned and expressed in baby hamster kidney cells (BHK cells). Recombinant FVII is secreted into the culture media (containing newborn calf serum) in its single-chain form and then proteolytically converted by autocatalysis to the active two-chain form, rFVIIa, during a chromatographic purification process. The purification process has been demonstrated to remove exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus). No human serum or other proteins are used in the production or formulation of NOVOSEVEN RT."
},
{
"NDCCode": "0338-7015-04",
"PackageDescription": "4 BAG in 1 CARTON (0338-7015-04) / 2000 mL in 1 BAG (0338-7015-01) ",
"NDC11Code": "00338-7015-04",
"ProductNDC": "0338-7015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clinimix",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020734",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE",
"StrengthNumber": "365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 20",
"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; g/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240715",
"SamplePackage": "N",
"IndicationAndUsage": "CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients.",
"Description": "CLINIMIX sulfite-free (amino acids in dextrose) 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. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. 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 contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0363-7015-04",
"PackageDescription": "1 BOTTLE in 1 BOX (0363-7015-04) / 60 mL in 1 BOTTLE",
"NDC11Code": "00363-7015-04",
"ProductNDC": "0363-7015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dye Free Infants Pain And Fever",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20240410",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "WALGREENS",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2024-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240410",
"SamplePackage": "N",
"IndicationAndUsage": "Uses temporarily:. reduces fever relieves minor aches and pains due to: : 1 the common cold, 2 flu, 3 headache, 4 sore throat, 5 toothache."
},
{
"NDCCode": "10888-7015-1",
"PackageDescription": "150000 TABLET, COATED in 1 CARTON (10888-7015-1)",
"NDC11Code": "10888-7015-01",
"ProductNDC": "10888-7015",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, COATED",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Banner Pharmacaps Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "41595-7015-1",
"PackageDescription": "56 g in 1 CANISTER (41595-7015-1) ",
"NDC11Code": "41595-7015-01",
"ProductNDC": "41595-7015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Brut Arctic Force",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161116",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Idelle Labs, Ltd",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "19",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20161116",
"SamplePackage": "N",
"IndicationAndUsage": "Reduces underarm wetness."
},
{
"NDCCode": "44385-7015-0",
"PackageDescription": "208197 mL in 1 DRUM (44385-7015-0) ",
"NDC11Code": "44385-7015-00",
"ProductNDC": "44385-7015",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20201227",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Nice-Pak Products, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "65.9",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "27-DEC-20"
},
{
"NDCCode": "48951-7015-1",
"PackageDescription": "10 AMPULE in 1 BOX (48951-7015-1) / 1 mL in 1 AMPULE",
"NDC11Code": "48951-7015-01",
"ProductNDC": "48951-7015",
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{
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},
{
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},
{
"NDCCode": "52731-7015-2",
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"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For oral use only."
}
]
}
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<NDCList>
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<Description>Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2.</Description>
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<StartMarketingDate>20201223</StartMarketingDate>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<ProductNDC>73069-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ithurts</ProprietaryName>
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<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
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<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; BETA-ENDORPHIN HUMAN</SubstanceName>
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<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0270-7015-38</NDCCode>
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<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0270-7015-40</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CASE (0270-7015-40) > 7.5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00270-7015-40</NDC11Code>
<ProductNDC>0270-7015</ProductNDC>
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<ProprietaryName>Vueway</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
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<RouteName>INTRAVENOUS</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0270-7015-44</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CASE (0270-7015-44) > 15 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00270-7015-44</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vueway</ProprietaryName>
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<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2.</Description>
</NDC>
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<NDCCode>0270-7015-48</NDCCode>
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<NDC11Code>00270-7015-48</NDC11Code>
<ProductNDC>0270-7015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vueway</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>0270-7015-64</NDCCode>
<PackageDescription>6 CARTON in 1 CASE (0270-7015-64) / 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
<NDC11Code>00270-7015-64</NDC11Code>
<ProductNDC>0270-7015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vueway</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2.</Description>
</NDC>
<NDC>
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<PackageDescription>10 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0270-7015-66) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
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<ProductNDC>0270-7015</ProductNDC>
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<ProprietaryName>Vueway</ProprietaryName>
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<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
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<StrengthUnit>mg/mL</StrengthUnit>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2.</Description>
</NDC>
<NDC>
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<PackageDescription>10 VIAL in 1 CASE (0270-7015-75) / 30 mL in 1 VIAL</PackageDescription>
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<ProductNDC>0270-7015</ProductNDC>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
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<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2.</Description>
</NDC>
<NDC>
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<PackageDescription>10 VIAL in 1 CASE (0270-7015-76) / 50 mL in 1 VIAL</PackageDescription>
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<ProductNDC>0270-7015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vueway</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2.</Description>
</NDC>
<NDC>
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<PackageDescription>10 VIAL in 1 CASE (0270-7015-77) / 100 mL in 1 VIAL</PackageDescription>
<NDC11Code>00270-7015-77</NDC11Code>
<ProductNDC>0270-7015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vueway</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2.</Description>
</NDC>
<NDC>
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<ProductNDC>0270-7015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vueway</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>0270-7015-91</NDCCode>
<PackageDescription>10 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0270-7015-91) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
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<ProductNDC>0270-7015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vueway</ProprietaryName>
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<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vueway® is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: 1 the central nervous system (brain, spine, and associated tissues), 2 the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).</IndicationAndUsage>
<Description>Vueway (gadopiclenol) injection is a paramagnetic macrocyclic non-ionic gadolinium-based contrast agent for intravenous use. The chemical name for gadopiclenol is rac-[(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ3N3,N6,N9-1(2,6)-pyridina-κN1-cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ3O1,O1',O1'')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C35H54GdN7O15. Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution. Each mL contains 485.1 mg (0.5 mmol) of gadopiclenol (containing 0.5 mmol of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2.</Description>
</NDC>
<NDC>
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<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-270-10) </PackageDescription>
<NDC11Code>43547-0270-10</NDC11Code>
<ProductNDC>43547-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropinirole Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110920</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078110</ApplicationNumber>
<LabelerName>SOLCO HEALTHCARE US, LLC</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole tablets contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243oC to 250°C and a solubility of 133 mg/mL in water. Each round biconvex film-coated ropinirole tablet contains 0.29, 0.57, 1.14, 2.28, 3.42, 4.56, or 5.70 mg of ropinirole hydrochloride equivalent to ropinirole 0.25, 0.5, 1, 2, 3, 4, or 5 mg, respectively. Inactive ingredients of the core tablets consist of croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Inactive ingredients of the film coats are slightly different among the 7 strengths of tablets and are tabulated below. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
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<ProductNDC>43547-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole Hydrochloride</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20110920</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078110</ApplicationNumber>
<LabelerName>SOLCO HEALTHCARE US, LLC</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole tablets contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243oC to 250°C and a solubility of 133 mg/mL in water. Each round biconvex film-coated ropinirole tablet contains 0.29, 0.57, 1.14, 2.28, 3.42, 4.56, or 5.70 mg of ropinirole hydrochloride equivalent to ropinirole 0.25, 0.5, 1, 2, 3, 4, or 5 mg, respectively. Inactive ingredients of the core tablets consist of croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Inactive ingredients of the film coats are slightly different among the 7 strengths of tablets and are tabulated below. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
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<PackageDescription>30 TABLET, COATED in 1 BOTTLE (66993-270-30) </PackageDescription>
<NDC11Code>66993-0270-30</NDC11Code>
<ProductNDC>66993-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Atorvastatin</ProprietaryName>
<NonProprietaryName>Amlodipine And Atorvastatin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220314</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021540</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: : 1 To reduce the risk of:oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDoMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDoNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:oAdults with primary hyperlipidemia.oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:oPrimary dysbetalipoproteinemiaoHypertriglyceridemia.</IndicationAndUsage>
<Description>Amlodipine and atorvastatin tablets combine the calcium channel blocker amlodipine besylate with the HMG-CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5∙C6H6O3S. Atorvastatin calcium is chemically described as [R-(R*, R*)]-2-(4-fluorophenyl)-β, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. Its empirical formula is (C33H34FN2O5)2Ca3H2O. The structural formulae for amlodipine besylate and atorvastatin calcium are shown below. Amlodipine and atorvastatin tablets contain amlodipine besylate, a white to off-white crystalline powder, and atorvastatin calcium, also a white to off-white crystalline powder. Amlodipine besylate has a molecular weight of 567.1 and atorvastatin calcium has a molecular weight of 1209.42. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Amlodipine and atorvastatin tablets are available as film-coated tablets containing: 1 2.5mg amlodipine equivalent to 3.47mg amlodipine besylate and 10mg atorvastatin equivalent to 10.4mg atorvastatin calcium., 2 2.5mg amlodipine equivalent to 3.47mg amlodipine besylate and 20mg atorvastatin equivalent to 20.7mg atorvastatin calcium., 3 2.5mg amlodipine equivalent to 3.47mg amlodipine besylate and 40mg atorvastatin equivalent to 41.4mg atorvastatin calcium., 4 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 5 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 6 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 7 5 mg amlodipine equivalent to 6.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium., 8 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 10 mg atorvastatin equivalent to 10.4 mg atorvastatin calcium., 9 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 20 mg atorvastatin equivalent to 20.7 mg atorvastatin calcium., 10 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 40 mg atorvastatin equivalent to 41.4 mg atorvastatin calcium., 11 10 mg amlodipine equivalent to 13.9 mg amlodipine besylate and 80 mg atorvastatin equivalent to 82.9 mg atorvastatin calcium.</Description>
</NDC>
<NDC>
<NDCCode>0169-7205-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7205-01) * 5 mL in 1 VIAL, GLASS (0169-7215-11) * 5 mL in 1 SYRINGE, GLASS (0169-7015-98) </PackageDescription>
<NDC11Code>00169-7205-01</NDC11Code>
<ProductNDC>0169-7205</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Novoseven</ProprietaryName>
<ProprietaryNameSuffix>Rt</ProprietaryNameSuffix>
<NonProprietaryName>Coagulation Factor Viia (recombinant)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20121029</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103665</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2022-11-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant), is indicated for: 1 Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets., 2 Treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia.</IndicationAndUsage>
<Description>NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant) is a sterile, white lyophilized powder of recombinant human coagulation factor VIIa (rFVIIa) for reconstitution for intravenous injection. The product is supplied as single‑dose vials containing the following. NOVOSEVEN RT also contains trace amounts of proteins derived from the manufacturing and purification processes such as mouse IgG (maximum of 1.2 ng/mg), bovine IgG (maximum of 30 ng/mg), and protein from BHK-cells and media (maximum of 19 ng/mg). The diluent for reconstitution of NOVOSEVEN RT is a 10 mmol solution of histidine in water for injection and is supplied as a clear colorless solution in a vial or pre-filled diluent syringe. After reconstitution with the appropriate volume of histidine diluent, each vial contains approximately 1 mg/mL NOVOSEVEN RT (corresponding to 1000 micrograms/mL). The reconstituted solution is a clear colorless solution with a pH of approximately 6.0 and contains no preservatives. Recombinant coagulation Factor VIIa (rFVIIa), the active ingredient in NOVOSEVEN RT, is a vitamin K‑dependent glycoprotein consisting of 406 amino acid residues with an approximate molecular mass of 50 kDa). It is structurally similar to endogenous human coagulation factor VIIa. The gene for human coagulation factor VII (FVII) is cloned and expressed in baby hamster kidney cells (BHK cells). Recombinant FVII is secreted into the culture media (containing newborn calf serum) in its single-chain form and then proteolytically converted by autocatalysis to the active two-chain form, rFVIIa, during a chromatographic purification process. The purification process has been demonstrated to remove exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus). No human serum or other proteins are used in the production or formulation of NOVOSEVEN RT.</Description>
</NDC>
<NDC>
<NDCCode>0338-7015-04</NDCCode>
<PackageDescription>4 BAG in 1 CARTON (0338-7015-04) / 2000 mL in 1 BAG (0338-7015-01) </PackageDescription>
<NDC11Code>00338-7015-04</NDC11Code>
<ProductNDC>0338-7015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clinimix</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020734</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE</SubstanceName>
<StrengthNumber>365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 20</StrengthNumber>
<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; g/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>CLINIMIX sulfite-free (amino acids in dextrose) 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. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8. The injection port chamber contains dextrose. 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 contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0363-7015-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (0363-7015-04) / 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00363-7015-04</NDC11Code>
<ProductNDC>0363-7015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dye Free Infants Pain And Fever</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240410</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>WALGREENS</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses temporarily:. reduces fever relieves minor aches and pains due to: : 1 the common cold, 2 flu, 3 headache, 4 sore throat, 5 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10888-7015-1</NDCCode>
<PackageDescription>150000 TABLET, COATED in 1 CARTON (10888-7015-1)</PackageDescription>
<NDC11Code>10888-7015-01</NDC11Code>
<ProductNDC>10888-7015</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Banner Pharmacaps Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>41595-7015-1</NDCCode>
<PackageDescription>56 g in 1 CANISTER (41595-7015-1) </PackageDescription>
<NDC11Code>41595-7015-01</NDC11Code>
<ProductNDC>41595-7015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Brut Arctic Force</ProprietaryName>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161116</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Idelle Labs, Ltd</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>19</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>44385-7015-0</NDCCode>
<PackageDescription>208197 mL in 1 DRUM (44385-7015-0) </PackageDescription>
<NDC11Code>44385-7015-00</NDC11Code>
<ProductNDC>44385-7015</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20201227</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Nice-Pak Products, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>65.9</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-DEC-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>48951-7015-1</NDCCode>
<PackageDescription>10 AMPULE in 1 BOX (48951-7015-1) / 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>48951-7015-01</NDC11Code>
<ProductNDC>48951-7015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mandragora Rheum</ProprietaryName>
<NonProprietaryName>Mandragora Rheum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>MANDRAGORA OFFICINARUM ROOT; TARAXACUM PALUSTRE ROOT; SILVER; BOVINE TYPE I COLLAGEN; FORMICA RUFA; SUS SCROFA PANCREAS; BOS TAURUS BONE</SubstanceName>
<StrengthNumber>3; 3; 6; 6; 6; 6; 8</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allogeneic Cultured Cell Scaffold [EPC], Collagen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50114-7015-1</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (50114-7015-1) > 1.1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>50114-7015-01</NDC11Code>
<ProductNDC>50114-7015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Engystol</ProprietaryName>
<NonProprietaryName>Cynanchum Vincetoxicum Root And Sulfur</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20140531</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura</LabelerName>
<SubstanceName>CYNANCHUM VINCETOXICUM ROOT; SULFUR</SubstanceName>
<StrengthNumber>6; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1.1mL; [hp_X]/1.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140531</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Engystol® Injection Solution is a homeopathic drug product indicated for the support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50114-7015-2</NDCCode>
<PackageDescription>3 AMPULE in 1 CARTON (50114-7015-2) > 1.1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>50114-7015-02</NDC11Code>
<ProductNDC>50114-7015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Engystol</ProprietaryName>
<NonProprietaryName>Cynanchum Vincetoxicum Root And Sulfur</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20140531</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura</LabelerName>
<SubstanceName>CYNANCHUM VINCETOXICUM ROOT; SULFUR</SubstanceName>
<StrengthNumber>6; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1.1mL; [hp_X]/1.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140531</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Engystol® Injection Solution is a homeopathic drug product indicated for the support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51885-7015-1</NDCCode>
<PackageDescription>1000 AMPULE in 1 BOX (51885-7015-1) > 1.1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>51885-7015-01</NDC11Code>
<ProductNDC>51885-7015</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Cynanchum Vincetoxicum Root And Sulfur</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<StartMarketingDate>20180331</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Biologische Heilmittel Heel</LabelerName>
<SubstanceName>CYNANCHUM VINCETOXICUM ROOT; SULFUR</SubstanceName>
<StrengthNumber>6; 4</StrengthNumber>
<StrengthUnit>[hp_X]/1.1mL; [hp_X]/1.1mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>31-MAR-18</StartMarketingDatePackage>
<EndMarketingDatePackage>31-MAY-24</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>52731-7015-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (52731-7015-2) > 50 mL in 1 BOTTLE (52731-7015-1) (52731-7015-1)</PackageDescription>
<NDC11Code>52731-7015-02</NDC11Code>
<ProductNDC>52731-7015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diarrhea Complex</ProprietaryName>
<NonProprietaryName>Aloe Socotrina, Arsenicum Album, Bryonia, Collinsonia Canadensis, Colocynthis, Croton Tiglium, Cuprum Aceticum, Echinacea Angustifolia, Mercurius Sub. Corros, Rheum Officinale, Sulfur, Veratrum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nova Homeopathic Therapeutics, Inc.</LabelerName>
<SubstanceName>ALOE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ACETATE; ECHINACEA ANGUSTIFOLIA; MERCURIC CHLORIDE; RHEUM OFFICINALE ROOT; SULFUR; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>4; 6; 4; 3; 4; 4; 4; 3; 6; 3; 8; 4</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For oral use only.</IndicationAndUsage>
</NDC>
</NDCList>