{
"NDC": [
{
"NDCCode": "67684-3001-2",
"PackageDescription": "10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-2) / 15 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "67684-3001-02",
"ProductNDC": "67684-3001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dotarem",
"NonProprietaryName": "Gadoterate Meglumine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190918",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204781",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOTERATE MEGLUMINE",
"StrengthNumber": "376.9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.",
"Description": "DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively."
},
{
"NDCCode": "67684-3001-1",
"PackageDescription": "10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-1) / 10 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "67684-3001-01",
"ProductNDC": "67684-3001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dotarem",
"NonProprietaryName": "Gadoterate Meglumine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190918",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204781",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOTERATE MEGLUMINE",
"StrengthNumber": "376.9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20190918",
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"IndicationAndUsage": "DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.",
"Description": "DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively."
},
{
"NDCCode": "67684-3001-3",
"PackageDescription": "10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-3) / 20 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "67684-3001-03",
"ProductNDC": "67684-3001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dotarem",
"NonProprietaryName": "Gadoterate Meglumine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190918",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204781",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOTERATE MEGLUMINE",
"StrengthNumber": "376.9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20190918",
"SamplePackage": "N",
"IndicationAndUsage": "DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.",
"Description": "DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively."
},
{
"NDCCode": "67684-1000-2",
"PackageDescription": "10 BOTTLE in 1 CARTON (67684-1000-2) > 100 mL in 1 BOTTLE",
"NDC11Code": "67684-1000-02",
"ProductNDC": "67684-1000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxilan",
"NonProprietaryName": "Ioxilan Injection",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20020318",
"EndMarketingDate": "20171031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020316",
"LabelerName": "Guerbet LLC",
"SubstanceName": "IOXILAN",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "67684-1001-2",
"PackageDescription": "10 BOTTLE in 1 CARTON (67684-1001-2) > 100 mL in 1 BOTTLE",
"NDC11Code": "67684-1001-02",
"ProductNDC": "67684-1001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxilan",
"NonProprietaryName": "Ioxilan Injection",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20020318",
"EndMarketingDate": "20171031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020316",
"LabelerName": "Guerbet LLC",
"SubstanceName": "IOXILAN",
"StrengthNumber": "350",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "67684-1901-2",
"PackageDescription": "1 VIAL in 1 CARTON (67684-1901-2) / 10 mL in 1 VIAL",
"NDC11Code": "67684-1901-02",
"ProductNDC": "67684-1901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipiodol",
"NonProprietaryName": "Ethiodized Oil",
"DosageFormName": "INJECTION",
"RouteName": "INTRA-ARTERIAL; INTRALYMPHATIC; INTRAUTERINE",
"StartMarketingDate": "20140321",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009190",
"LabelerName": "Guerbet LLC",
"SubstanceName": "ETHIODIZED OIL",
"StrengthNumber": "480",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180928",
"SamplePackage": "N",
"IndicationAndUsage": "Lipiodol is an oil-based radio-opaque contrast agent indicated for: 1 hysterosalpingography in adults, 2 lymphography in adult and pediatric patients, 3 selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC).",
"Description": "Lipiodol, ethiodized oil injection, is a sterile injectable radio-opaque agent. Each milliliter contains 480 mg of Iodine organically combined with ethyl esters of fatty acids of poppy seed oil. The precise structure of Lipiodol is unknown. Lipiodol is a sterile, clear, pale yellow to amber colored oil. Lipiodol has a viscosity of 34 – 70 mPa·s at 20°C, and a density of 1.28 g/cm 3at 20°C."
},
{
"NDCCode": "67684-2000-2",
"PackageDescription": "10 VIAL in 1 PACKAGE (67684-2000-2) / 15 mL in 1 VIAL",
"NDC11Code": "67684-2000-02",
"ProductNDC": "67684-2000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dotarem",
"NonProprietaryName": "Gadoterate Meglumine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130320",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204781",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOTERATE MEGLUMINE",
"StrengthNumber": "376.9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130320",
"SamplePackage": "N",
"IndicationAndUsage": "DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.",
"Description": "DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively."
},
{
"NDCCode": "67684-2001-2",
"PackageDescription": "10 VIAL in 1 PACKAGE (67684-2001-2) / 15 mL in 1 VIAL",
"NDC11Code": "67684-2001-02",
"ProductNDC": "67684-2001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dotarem",
"NonProprietaryName": "Gadoterate Meglumine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130320",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204781",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOTERATE MEGLUMINE",
"StrengthNumber": "376.9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191024",
"SamplePackage": "N",
"IndicationAndUsage": "DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.",
"Description": "DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively."
},
{
"NDCCode": "67684-4230-2",
"PackageDescription": "10 VIAL in 1 CARTON (67684-4230-2) / 3 mL in 1 VIAL",
"NDC11Code": "67684-4230-02",
"ProductNDC": "67684-4230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM 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": "ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-4231-2",
"PackageDescription": "10 VIAL in 1 CARTON (67684-4231-2) / 7.5 mL in 1 VIAL",
"NDC11Code": "67684-4231-02",
"ProductNDC": "67684-4231",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM 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": "ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-4232-2",
"PackageDescription": "10 VIAL in 1 CARTON (67684-4232-2) / 10 mL in 1 VIAL",
"NDC11Code": "67684-4232-02",
"ProductNDC": "67684-4232",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM 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": "ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-4233-2",
"PackageDescription": "10 VIAL in 1 CARTON (67684-4233-2) / 15 mL in 1 VIAL",
"NDC11Code": "67684-4233-02",
"ProductNDC": "67684-4233",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM 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": "ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-4240-2",
"PackageDescription": "10 SYRINGE in 1 CARTON (67684-4240-2) / 7.5 mL in 1 SYRINGE",
"NDC11Code": "67684-4240-02",
"ProductNDC": "67684-4240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM 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": "ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-4241-2",
"PackageDescription": "10 SYRINGE in 1 CARTON (67684-4241-2) / 10 mL in 1 SYRINGE",
"NDC11Code": "67684-4241-02",
"ProductNDC": "67684-4241",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM 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": "ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-4242-2",
"PackageDescription": "10 SYRINGE in 1 CARTON (67684-4242-2) / 15 mL in 1 SYRINGE",
"NDC11Code": "67684-4242-02",
"ProductNDC": "67684-4242",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM 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": "ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-4250-2",
"PackageDescription": "25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-2) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "67684-4250-02",
"ProductNDC": "67684-4250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220921",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM 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": "ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-4251-2",
"PackageDescription": "25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-2) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "67684-4251-02",
"ProductNDC": "67684-4251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elucirem",
"NonProprietaryName": "Gadopiclenol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216986",
"LabelerName": "Guerbet LLC",
"SubstanceName": "GADOPICLENOL",
"StrengthNumber": "485.1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251114",
"SamplePackage": "N",
"IndicationAndUsage": "ELUCIREM 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": "ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2."
},
{
"NDCCode": "67684-5505-2",
"PackageDescription": "25 VIAL, GLASS in 1 CASE (67684-5505-2) > 50 mL in 1 VIAL, GLASS",
"NDC11Code": "67684-5505-02",
"ProductNDC": "67684-5505",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hexabrix",
"NonProprietaryName": "Ioxaglate Meglumine And Ioxaglate Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20090409",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018905",
"LabelerName": "Guerbet LLC",
"SubstanceName": "IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM",
"StrengthNumber": "393; 196",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "10511-3001-2",
"PackageDescription": "1 KIT in 1 CARTON (10511-3001-2) * 50 mL in 1 SYRINGE, PLASTIC * 50 mL in 1 VIAL, GLASS",
"NDC11Code": "10511-3001-02",
"ProductNDC": "10511-3001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cysview",
"NonProprietaryName": "Hexaminolevulinate Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20180501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022555",
"LabelerName": "Photocure Inc.",
"Status": "Active",
"LastUpdate": "2026-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180501",
"SamplePackage": "N",
"IndicationAndUsage": "CYSVIEW is indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: : 1 With suspected or known lesion(s) based on a prior cystoscopy, 2 Undergoing surveillance cystoscopy for bladder cancer .",
"Description": "CYSVIEW (hexaminolevulinate hydrochloride) for intravesical solution is an optical imaging agent. The chemical name of hexaminolevulinate hydrochloride is hexyl 5-amino-4-oxopentanoate hydrochloride, and it has a molecular formula of C11H21NO3∙HCl. Its molecular weight is 251.76, and it has the following structural formula. CYSVIEW and DILUENT for CYSVIEW are supplied together as a kit: : 1 CYSVIEW is a sterile, non-pyrogenic, freeze-dried, white to off-white or pale yellow powder provided in a clear glass vial. Each vial contains 100 mg hexaminolevulinate hydrochloride (equivalent to 85 mg hexaminolevulinate). , 2 The DILUENT for CYSVIEW is a sterile, non-pyrogenic, clear, colorless solution (pH 6) free from visible particles provided in a 50 mL plastic prefilled syringe. Each mL contains 0.61 mg disodium hydrogen phosphate, 0.58 mg potassium dihydrogen phosphate, 7.02 mg sodium chloride, hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. ."
},
{
"NDCCode": "14222-3001-2",
"PackageDescription": "1 TUBE in 1 CARTON (14222-3001-2) / 7 mL in 1 TUBE",
"NDC11Code": "14222-3001-02",
"ProductNDC": "14222-3001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rodan And Fields Reverse Brightening Defense Broad Spectrum Spf 50 Mineral Sunscreen",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250221",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Rodan & Fields Beauty, LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "5.2; 5.15",
"StrengthUnit": "g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250221",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "14799-3001-2",
"PackageDescription": "500 g in 1 BAG (14799-3001-2) ",
"NDC11Code": "14799-3001-02",
"ProductNDC": "14799-3001",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Vasopressin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zhejiang Supor Pharmaceuticals Co., Ltd",
"SubstanceName": "VASOPRESSIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2025-10-15",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "17-APR-14"
},
{
"NDCCode": "33992-3001-2",
"PackageDescription": "2 BOTTLE in 1 PACKAGE (33992-3001-2) > 36.7 mL in 1 BOTTLE (33992-3001-1) ",
"NDC11Code": "33992-3001-02",
"ProductNDC": "33992-3001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "2-pack Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130524",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Greenbrier International, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "36.7",
"StrengthUnit": "mL/59.2mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130524",
"SamplePackage": "N",
"IndicationAndUsage": "Other information: 1 store at 20oC to 25oC (68o to 77oF), 2 may discolor certain fabrics."
},
{
"NDCCode": "34690-3001-2",
"PackageDescription": "4 g in 1 BOX (34690-3001-2)",
"NDC11Code": "34690-3001-02",
"ProductNDC": "34690-3001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Slimming Sap Patch",
"NonProprietaryName": "Topical Starch",
"DosageFormName": "POULTICE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100115",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "KJI Industrial Co Ltd",
"SubstanceName": "STARCH, CORN",
"StrengthNumber": "1.27",
"StrengthUnit": "g/4g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "36987-3001-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-3001-2)",
"NDC11Code": "36987-3001-02",
"ProductNDC": "36987-3001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yellow Pine",
"NonProprietaryName": "Yellow Pine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "PINUS ECHINATA POLLEN",
"StrengthNumber": "40000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-3001-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-3001-2) ",
"NDC11Code": "37662-3001-02",
"ProductNDC": "37662-3001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scandium Iodatum",
"NonProprietaryName": "Scandium Iodatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230420",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "SCANDIUM IODIDE",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230420",
"SamplePackage": "N"
},
{
"NDCCode": "41167-3001-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (41167-3001-2) > 20 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "41167-3001-02",
"ProductNDC": "41167-3001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pamprin Multisymptom Menstrual Pain Relief",
"NonProprietaryName": "Acetaminophen And Pamabrom And Pyrilamine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Chattem, Inc.",
"SubstanceName": "ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE",
"StrengthNumber": "500; 25; 15",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-10-09",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "42707-3001-2",
"PackageDescription": "30 POUCH in 1 BOX (42707-3001-2) > 80 mL in 1 POUCH (42707-3001-1)",
"NDC11Code": "42707-3001-02",
"ProductNDC": "42707-3001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ginseng Khan",
"NonProprietaryName": "Panax Ginseng Fruit",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120215",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Korea Genetic Pharm Co., Ltd",
"SubstanceName": "PANAX GINSENG FRUIT",
"StrengthNumber": "90",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "48951-3001-2",
"PackageDescription": "1350 PELLET in 1 BOTTLE, GLASS (48951-3001-2) ",
"NDC11Code": "48951-3001-02",
"ProductNDC": "48951-3001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cactus Cinis Avenae",
"NonProprietaryName": "Cactus Cinis Avenae",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "ARNICA MONTANA; HAWTHORN LEAF WITH FLOWER; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; SELENICEREUS GRANDIFLORUS STEM",
"StrengthNumber": "20; 3; 6; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
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"LabelerName": "Bonogen Co., Ltd",
"SubstanceName": "BIOTIN",
"StrengthNumber": ".002",
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"ProductNdcExcludeFlag": "E",
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{
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl Alcohol",
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"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For preparation of the skin prior to injection."
}
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<?xml version="1.0" encoding="utf-8"?>
<NDCList>
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<PackageDescription>10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-2) / 15 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>67684-3001-02</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>INTRAVENOUS</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
<StrengthNumber>376.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
</NDC>
<NDC>
<NDCCode>67684-3001-1</NDCCode>
<PackageDescription>10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-1) / 10 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>67684-3001-01</NDC11Code>
<ProductNDC>67684-3001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
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<LastUpdate>2025-03-24</LastUpdate>
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<IndicationAndUsage>DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
</NDC>
<NDC>
<NDCCode>67684-3001-3</NDCCode>
<PackageDescription>10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-3) / 20 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>67684-3001-03</NDC11Code>
<ProductNDC>67684-3001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dotarem</ProprietaryName>
<NonProprietaryName>Gadoterate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190918</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204781</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
<StrengthNumber>376.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
</NDC>
<NDC>
<NDCCode>67684-1000-2</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (67684-1000-2) > 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>67684-1000-02</NDC11Code>
<ProductNDC>67684-1000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxilan</ProprietaryName>
<NonProprietaryName>Ioxilan Injection</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20020318</StartMarketingDate>
<EndMarketingDate>20171031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020316</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>IOXILAN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>67684-1001-2</NDCCode>
<PackageDescription>10 BOTTLE in 1 CARTON (67684-1001-2) > 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>67684-1001-02</NDC11Code>
<ProductNDC>67684-1001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxilan</ProprietaryName>
<NonProprietaryName>Ioxilan Injection</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20020318</StartMarketingDate>
<EndMarketingDate>20171031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020316</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>IOXILAN</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>67684-1901-2</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (67684-1901-2) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>67684-1901-02</NDC11Code>
<ProductNDC>67684-1901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lipiodol</ProprietaryName>
<NonProprietaryName>Ethiodized Oil</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRA-ARTERIAL; INTRALYMPHATIC; INTRAUTERINE</RouteName>
<StartMarketingDate>20140321</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009190</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>ETHIODIZED OIL</SubstanceName>
<StrengthNumber>480</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lipiodol is an oil-based radio-opaque contrast agent indicated for: 1 hysterosalpingography in adults, 2 lymphography in adult and pediatric patients, 3 selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC).</IndicationAndUsage>
<Description>Lipiodol, ethiodized oil injection, is a sterile injectable radio-opaque agent. Each milliliter contains 480 mg of Iodine organically combined with ethyl esters of fatty acids of poppy seed oil. The precise structure of Lipiodol is unknown. Lipiodol is a sterile, clear, pale yellow to amber colored oil. Lipiodol has a viscosity of 34 – 70 mPa·s at 20°C, and a density of 1.28 g/cm 3at 20°C.</Description>
</NDC>
<NDC>
<NDCCode>67684-2000-2</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (67684-2000-2) / 15 mL in 1 VIAL</PackageDescription>
<NDC11Code>67684-2000-02</NDC11Code>
<ProductNDC>67684-2000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dotarem</ProprietaryName>
<NonProprietaryName>Gadoterate Meglumine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130320</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204781</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
<StrengthNumber>376.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
</NDC>
<NDC>
<NDCCode>67684-2001-2</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (67684-2001-2) / 15 mL in 1 VIAL</PackageDescription>
<NDC11Code>67684-2001-02</NDC11Code>
<ProductNDC>67684-2001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dotarem</ProprietaryName>
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<StartMarketingDate>20130320</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204781</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOTERATE MEGLUMINE</SubstanceName>
<StrengthNumber>376.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.</IndicationAndUsage>
<Description>DOTAREM (gadoterate meglumine) is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging. The chemical name for gadoterate meglumine is D-glucitol, 1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, .kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1); it has a formula weight of 753.9 g/mol and empirical formula of C 23H 42O 13N 5Gd (anhydrous basis). The structural formula of gadoterate meglumine in solution is as follows. CAS Registry No. 92943-93-6. DOTAREM Injection is a sterile, nonpyrogenic, clear, colorless to yellow, aqueous solution of 0.5 mmol/mL of gadoterate meglumine. No preservative is added. Each mL of DOTAREM contains 376.9 mg of gadoterate meglumine, 0.25 mg of DOTA and water for injection. DOTAREM has a pH of 6.5 to 8.0. The main physiochemical properties of DOTAREM are provided below. The thermodynamic stability constants for gadoterate (log K therm and log K cond at pH 7.4) are 25.6 and 19.3, respectively.</Description>
</NDC>
<NDC>
<NDCCode>67684-4230-2</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (67684-4230-2) / 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>67684-4230-02</NDC11Code>
<ProductNDC>67684-4230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elucirem</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELUCIREM 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>ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>67684-4231-2</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (67684-4231-2) / 7.5 mL in 1 VIAL</PackageDescription>
<NDC11Code>67684-4231-02</NDC11Code>
<ProductNDC>67684-4231</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elucirem</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELUCIREM 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>ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>67684-4232-2</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (67684-4232-2) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>67684-4232-02</NDC11Code>
<ProductNDC>67684-4232</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elucirem</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELUCIREM 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>ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>67684-4233-2</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (67684-4233-2) / 15 mL in 1 VIAL</PackageDescription>
<NDC11Code>67684-4233-02</NDC11Code>
<ProductNDC>67684-4233</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elucirem</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELUCIREM 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>ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>67684-4240-2</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (67684-4240-2) / 7.5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>67684-4240-02</NDC11Code>
<ProductNDC>67684-4240</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elucirem</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELUCIREM 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>ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>67684-4241-2</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (67684-4241-2) / 10 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>67684-4241-02</NDC11Code>
<ProductNDC>67684-4241</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elucirem</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELUCIREM 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>ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>67684-4242-2</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (67684-4242-2) / 15 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>67684-4242-02</NDC11Code>
<ProductNDC>67684-4242</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elucirem</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELUCIREM 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>ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>67684-4250-2</NDCCode>
<PackageDescription>25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-2) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
<NDC11Code>67684-4250-02</NDC11Code>
<ProductNDC>67684-4250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elucirem</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELUCIREM 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>ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>67684-4251-2</NDCCode>
<PackageDescription>25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-2) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
<NDC11Code>67684-4251-02</NDC11Code>
<ProductNDC>67684-4251</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elucirem</ProprietaryName>
<NonProprietaryName>Gadopiclenol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216986</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>GADOPICLENOL</SubstanceName>
<StrengthNumber>485.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELUCIREM 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>ELUCIREM (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 970.11 g/mol and a molecular formula of C35H54GdN7O15. ELUCIREM 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 ELUCIREM are provided in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>67684-5505-2</NDCCode>
<PackageDescription>25 VIAL, GLASS in 1 CASE (67684-5505-2) > 50 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>67684-5505-02</NDC11Code>
<ProductNDC>67684-5505</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hexabrix</ProprietaryName>
<NonProprietaryName>Ioxaglate Meglumine And Ioxaglate Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20090409</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018905</ApplicationNumber>
<LabelerName>Guerbet LLC</LabelerName>
<SubstanceName>IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM</SubstanceName>
<StrengthNumber>393; 196</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>10511-3001-2</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (10511-3001-2) * 50 mL in 1 SYRINGE, PLASTIC * 50 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>10511-3001-02</NDC11Code>
<ProductNDC>10511-3001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cysview</ProprietaryName>
<NonProprietaryName>Hexaminolevulinate Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022555</ApplicationNumber>
<LabelerName>Photocure Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CYSVIEW is indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: : 1 With suspected or known lesion(s) based on a prior cystoscopy, 2 Undergoing surveillance cystoscopy for bladder cancer .</IndicationAndUsage>
<Description>CYSVIEW (hexaminolevulinate hydrochloride) for intravesical solution is an optical imaging agent. The chemical name of hexaminolevulinate hydrochloride is hexyl 5-amino-4-oxopentanoate hydrochloride, and it has a molecular formula of C11H21NO3∙HCl. Its molecular weight is 251.76, and it has the following structural formula. CYSVIEW and DILUENT for CYSVIEW are supplied together as a kit: : 1 CYSVIEW is a sterile, non-pyrogenic, freeze-dried, white to off-white or pale yellow powder provided in a clear glass vial. Each vial contains 100 mg hexaminolevulinate hydrochloride (equivalent to 85 mg hexaminolevulinate). , 2 The DILUENT for CYSVIEW is a sterile, non-pyrogenic, clear, colorless solution (pH 6) free from visible particles provided in a 50 mL plastic prefilled syringe. Each mL contains 0.61 mg disodium hydrogen phosphate, 0.58 mg potassium dihydrogen phosphate, 7.02 mg sodium chloride, hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. .</Description>
</NDC>
<NDC>
<NDCCode>14222-3001-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (14222-3001-2) / 7 mL in 1 TUBE</PackageDescription>
<NDC11Code>14222-3001-02</NDC11Code>
<ProductNDC>14222-3001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rodan And Fields Reverse Brightening Defense Broad Spectrum Spf 50 Mineral Sunscreen</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250221</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Rodan & Fields Beauty, LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>5.2; 5.15</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14799-3001-2</NDCCode>
<PackageDescription>500 g in 1 BAG (14799-3001-2) </PackageDescription>
<NDC11Code>14799-3001-02</NDC11Code>
<ProductNDC>14799-3001</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Vasopressin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zhejiang Supor Pharmaceuticals Co., Ltd</LabelerName>
<SubstanceName>VASOPRESSIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-10-15</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>17-APR-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>33992-3001-2</NDCCode>
<PackageDescription>2 BOTTLE in 1 PACKAGE (33992-3001-2) > 36.7 mL in 1 BOTTLE (33992-3001-1) </PackageDescription>
<NDC11Code>33992-3001-02</NDC11Code>
<ProductNDC>33992-3001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>2-pack Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130524</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Greenbrier International, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>36.7</StrengthNumber>
<StrengthUnit>mL/59.2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Other information: 1 store at 20oC to 25oC (68o to 77oF), 2 may discolor certain fabrics.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>34690-3001-2</NDCCode>
<PackageDescription>4 g in 1 BOX (34690-3001-2)</PackageDescription>
<NDC11Code>34690-3001-02</NDC11Code>
<ProductNDC>34690-3001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Slimming Sap Patch</ProprietaryName>
<NonProprietaryName>Topical Starch</NonProprietaryName>
<DosageFormName>POULTICE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>KJI Industrial Co Ltd</LabelerName>
<SubstanceName>STARCH, CORN</SubstanceName>
<StrengthNumber>1.27</StrengthNumber>
<StrengthUnit>g/4g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>36987-3001-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-3001-2)</PackageDescription>
<NDC11Code>36987-3001-02</NDC11Code>
<ProductNDC>36987-3001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yellow Pine</ProprietaryName>
<NonProprietaryName>Yellow Pine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>PINUS ECHINATA POLLEN</SubstanceName>
<StrengthNumber>40000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-3001-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-3001-2) </PackageDescription>
<NDC11Code>37662-3001-02</NDC11Code>
<ProductNDC>37662-3001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Scandium Iodatum</ProprietaryName>
<NonProprietaryName>Scandium Iodatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230420</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>SCANDIUM IODIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41167-3001-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (41167-3001-2) > 20 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>41167-3001-02</NDC11Code>
<ProductNDC>41167-3001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pamprin Multisymptom Menstrual Pain Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen And Pamabrom And Pyrilamine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Chattem, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>500; 25; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-09</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42707-3001-2</NDCCode>
<PackageDescription>30 POUCH in 1 BOX (42707-3001-2) > 80 mL in 1 POUCH (42707-3001-1)</PackageDescription>
<NDC11Code>42707-3001-02</NDC11Code>
<ProductNDC>42707-3001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ginseng Khan</ProprietaryName>
<NonProprietaryName>Panax Ginseng Fruit</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Korea Genetic Pharm Co., Ltd</LabelerName>
<SubstanceName>PANAX GINSENG FRUIT</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>48951-3001-2</NDCCode>
<PackageDescription>1350 PELLET in 1 BOTTLE, GLASS (48951-3001-2) </PackageDescription>
<NDC11Code>48951-3001-02</NDC11Code>
<ProductNDC>48951-3001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cactus Cinis Avenae</ProprietaryName>
<NonProprietaryName>Cactus Cinis Avenae</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; HAWTHORN LEAF WITH FLOWER; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; SELENICEREUS GRANDIFLORUS STEM</SubstanceName>
<StrengthNumber>20; 3; 6; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: FOR ORAL USE ONLY.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50653-3001-2</NDCCode>
<PackageDescription>150 mL in 1 BOTTLE, WITH APPLICATOR (50653-3001-2)</PackageDescription>
<NDC11Code>50653-3001-02</NDC11Code>
<ProductNDC>50653-3001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bonogen Activator</ProprietaryName>
<ProprietaryNameSuffix>Hair Loss Treatment</ProprietaryNameSuffix>
<NonProprietaryName>Biotin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100425</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Bonogen Co., Ltd</LabelerName>
<SubstanceName>BIOTIN</SubstanceName>
<StrengthNumber>.002</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50730-3001-2</NDCCode>
<PackageDescription>3000 PACKET in 1 CASE (50730-3001-2) > 1 SWAB in 1 PACKET</PackageDescription>
<NDC11Code>50730-3001-02</NDC11Code>
<ProductNDC>50730-3001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopropyl Alcohol</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19860501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>H and P Industries, Inc. dba Triad Group</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For preparation of the skin prior to injection.</IndicationAndUsage>
</NDC>
</NDCList>