{
"NDC": [
{
"NDCCode": "77566-821-81",
"PackageDescription": "287 mL in 1 BOTTLE, SPRAY (77566-821-81) ",
"NDC11Code": "77566-0821-81",
"ProductNDC": "77566-821",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wave Hand Sanitizer, 8 Oz",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200729",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Earthlite, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200729",
"SamplePackage": "N"
},
{
"NDCCode": "77566-801-81",
"PackageDescription": "237 mL in 1 BOTTLE, SPRAY (77566-801-81) ",
"NDC11Code": "77566-0801-81",
"ProductNDC": "77566-801",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Earthlite Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Earthlite, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77566-831-81",
"PackageDescription": "287 mL in 1 BOTTLE, SPRAY (77566-831-81) ",
"NDC11Code": "77566-0831-81",
"ProductNDC": "77566-831",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wave Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200729",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Earthlite, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200729",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "55301-821-07",
"PackageDescription": "3 BOTTLE, PLASTIC in 1 CARTON (55301-821-07) / 36 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "55301-0821-07",
"ProductNDC": "55301-821",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"ProprietaryNameSuffix": "Low Dose",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "19900912",
"EndMarketingDate": "20250302",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "ARMY AND AIR FORCE EXCHANGE SERVICE",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19900912",
"EndMarketingDatePackage": "20250302",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor aches and pains or as recommended by your doctor."
},
{
"NDCCode": "77566-801-11",
"PackageDescription": "3780 mL in 1 BOTTLE, PLASTIC (77566-801-11) ",
"NDC11Code": "77566-0801-11",
"ProductNDC": "77566-801",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Earthlite Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Earthlite, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77566-831-11",
"PackageDescription": "3780 mL in 1 BOTTLE, PLASTIC (77566-831-11) ",
"NDC11Code": "77566-0831-11",
"ProductNDC": "77566-831",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wave Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200729",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Earthlite, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200729",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "0407-1412-35",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1412-35) / 200 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1412-35",
"ProductNDC": "0407-1412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL",
"StartMarketingDate": "19851226",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018956",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "240",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19851226",
"EndMarketingDatePackage": "20241024",
"SamplePackage": "N",
"IndicationAndUsage": "OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen (1).",
"Description": "OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula. OMNIPAQUE injection is available in five strengths: : 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-1412-38",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1412-38) / 50 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1412-38",
"ProductNDC": "0407-1412",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL",
"StartMarketingDate": "20050811",
"EndMarketingDate": "20241110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018956",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "240",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050811",
"EndMarketingDatePackage": "20241110",
"SamplePackage": "N",
"IndicationAndUsage": "OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).",
"Description": "OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-1413-48",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1413-48) / 500 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1413-48",
"ProductNDC": "0407-1413",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20161221",
"EndMarketingDate": "20241108",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020608",
"LabelerName": "GE Healthcare",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161221",
"EndMarketingDatePackage": "20241022",
"SamplePackage": "N",
"IndicationAndUsage": "OMNIPAQUE Imaging Bulk Package is indicated for: 1 Computed tomographic (CT) imaging of the head and body by intravenous administration in: adults (300 and 350 mg iodine/mL)pediatric patients (300 mg iodine/mL).",
"Description": "OMNIPAQUE (iohexol) is a nonionic, radiographic contrast agent for intravenous use. OMNIPAQUE is provided as a sterile, pyrogen-free, colorless to pale-yellow solution. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. : 1 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine, 0.1 mg edetate calcium disodium , 2 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine, 0.1 mg edetate calcium disodium ."
},
{
"NDCCode": "0407-1413-86",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1413-86) / 50 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1413-86",
"ProductNDC": "0407-1413",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL",
"StartMarketingDate": "20060921",
"EndMarketingDate": "20241110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020608",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060921",
"EndMarketingDatePackage": "20241009",
"SamplePackage": "N",
"IndicationAndUsage": "OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).",
"Description": "OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-1413-87",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1413-87) / 100 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1413-87",
"ProductNDC": "0407-1413",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL",
"StartMarketingDate": "20060921",
"EndMarketingDate": "20241110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020608",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060921",
"EndMarketingDatePackage": "20241026",
"SamplePackage": "N",
"IndicationAndUsage": "OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).",
"Description": "OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-1413-88",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1413-88) / 150 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1413-88",
"ProductNDC": "0407-1413",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL",
"StartMarketingDate": "20060921",
"EndMarketingDate": "20241110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020608",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060921",
"EndMarketingDatePackage": "20241028",
"SamplePackage": "N",
"IndicationAndUsage": "OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).",
"Description": "OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-1413-89",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1413-89) / 500 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1413-89",
"ProductNDC": "0407-1413",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL",
"StartMarketingDate": "20050803",
"EndMarketingDate": "20241108",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020608",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050803",
"EndMarketingDatePackage": "20241022",
"SamplePackage": "N",
"Description": "Iohexol, N, N´ - Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodoisophthalamide, is a nonionic, water-soluble radiographic contrast medium with a molecular weight of 821.14 (iodine content 46.36%). In aqueous solution each triiodinated molecule remains undissociated. The chemical structure is:. OMNIPAQUE is provided as a sterile, pyrogen-free, colorless to pale-yellow solution, in Pharmacy Bulk Package, in the following iodine concentrations: 300 and 350 mg Iodine/mL. A Pharmacy Bulk Package is used to dispense multiple single doses, utilizing a suitable transfer device. OMNIPAQUE 300 contains 647 mg of iohexol equivalent to 300 mg of organic iodine per mL; and OMNIPAQUE 350 contains 755 mg of iohexol equivalent to 350 mg of organic iodine per mL. Each milliliter of iohexol solution contains 1.21 mg tromethamine and 0.1 mg edetate calcium disodium with the pH adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. All solutions are sterilized by autoclaving and contain no preservatives. Iohexol solution is sensitive to light and therefore should be protected from exposure. The available concentrations have the following physical properties. OMNIPAQUE 300 and OMNIPAQUE 350 have osmolalities from approximately 2.2 to 3 times that of plasma (285 mOsm/kg water) or cerebrospinal fluid (301 mOsm/kg water) as shown in the above table and are hypertonic under conditions of use."
},
{
"NDCCode": "0407-1414-48",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1414-48) / 500 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1414-48",
"ProductNDC": "0407-1414",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20161221",
"EndMarketingDate": "20241108",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020608",
"LabelerName": "GE Healthcare",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161221",
"EndMarketingDatePackage": "20241108",
"SamplePackage": "N",
"IndicationAndUsage": "OMNIPAQUE Imaging Bulk Package is indicated for: 1 Computed tomographic (CT) imaging of the head and body by intravenous administration in: adults (300 and 350 mg iodine/mL)pediatric patients (300 mg iodine/mL).",
"Description": "OMNIPAQUE (iohexol) is a nonionic, radiographic contrast agent for intravenous use. OMNIPAQUE is provided as a sterile, pyrogen-free, colorless to pale-yellow solution. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. : 1 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine, 0.1 mg edetate calcium disodium , 2 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine, 0.1 mg edetate calcium disodium ."
},
{
"NDCCode": "0407-1414-82",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1414-82) / 50 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1414-82",
"ProductNDC": "0407-1414",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR; INTRAVENOUS; ORAL",
"StartMarketingDate": "20060721",
"EndMarketingDate": "20241110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020608",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060721",
"EndMarketingDatePackage": "20240916",
"SamplePackage": "N",
"IndicationAndUsage": "OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).",
"Description": "OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-1414-83",
"PackageDescription": "10 BOTTLE in 1 BOX (0407-1414-83) / 125 mL in 1 BOTTLE",
"NDC11Code": "00407-1414-83",
"ProductNDC": "0407-1414",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR; INTRAVENOUS; ORAL",
"StartMarketingDate": "20060721",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020608",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200323",
"EndMarketingDatePackage": "20240619",
"SamplePackage": "N",
"IndicationAndUsage": "OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).",
"Description": "OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-1414-84",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1414-84) / 100 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1414-84",
"ProductNDC": "0407-1414",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR; INTRAVENOUS; ORAL",
"StartMarketingDate": "20060721",
"EndMarketingDate": "20241110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020608",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060721",
"EndMarketingDatePackage": "20241107",
"SamplePackage": "N",
"IndicationAndUsage": "OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).",
"Description": "OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-1414-85",
"PackageDescription": "10 BOTTLE in 1 BOX (0407-1414-85) > 125 mL in 1 BOTTLE",
"NDC11Code": "00407-1414-85",
"ProductNDC": "0407-1414",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR; INTRAVENOUS; ORAL",
"StartMarketingDate": "20060721",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018956",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-06-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20060721",
"EndMarketingDatePackage": "20230611",
"SamplePackage": "N",
"IndicationAndUsage": "OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).",
"Description": "OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: : 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-1414-86",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1414-86) / 150 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1414-86",
"ProductNDC": "0407-1414",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR; INTRAVENOUS; ORAL",
"StartMarketingDate": "20060721",
"EndMarketingDate": "20241110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020608",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060721",
"EndMarketingDatePackage": "20241106",
"SamplePackage": "N",
"IndicationAndUsage": "OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).",
"Description": "OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-1414-87",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1414-87) / 200 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1414-87",
"ProductNDC": "0407-1414",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR; INTRAVENOUS; ORAL",
"StartMarketingDate": "20060721",
"EndMarketingDate": "20241110",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020608",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20060721",
"EndMarketingDatePackage": "20241008",
"SamplePackage": "N",
"IndicationAndUsage": "OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).",
"Description": "OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-1414-88",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1414-88) / 500 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1414-88",
"ProductNDC": "0407-1414",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL",
"StartMarketingDate": "20050803",
"EndMarketingDate": "20241108",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020608",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050803",
"EndMarketingDatePackage": "20241108",
"SamplePackage": "N",
"Description": "Iohexol, N, N´ - Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodoisophthalamide, is a nonionic, water-soluble radiographic contrast medium with a molecular weight of 821.14 (iodine content 46.36%). In aqueous solution each triiodinated molecule remains undissociated. The chemical structure is:. OMNIPAQUE is provided as a sterile, pyrogen-free, colorless to pale-yellow solution, in Pharmacy Bulk Package, in the following iodine concentrations: 300 and 350 mg Iodine/mL. A Pharmacy Bulk Package is used to dispense multiple single doses, utilizing a suitable transfer device. OMNIPAQUE 300 contains 647 mg of iohexol equivalent to 300 mg of organic iodine per mL; and OMNIPAQUE 350 contains 755 mg of iohexol equivalent to 350 mg of organic iodine per mL. Each milliliter of iohexol solution contains 1.21 mg tromethamine and 0.1 mg edetate calcium disodium with the pH adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. All solutions are sterilized by autoclaving and contain no preservatives. Iohexol solution is sensitive to light and therefore should be protected from exposure. The available concentrations have the following physical properties. OMNIPAQUE 300 and OMNIPAQUE 350 have osmolalities from approximately 2.2 to 3 times that of plasma (285 mOsm/kg water) or cerebrospinal fluid (301 mOsm/kg water) as shown in the above table and are hypertonic under conditions of use."
},
{
"NDCCode": "0407-1414-98",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1414-98) / 500 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-1414-98",
"ProductNDC": "0407-1414",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omnipaque",
"NonProprietaryName": "Iohexol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL",
"StartMarketingDate": "20040903",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020608",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IOHEXOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20040903",
"EndMarketingDatePackage": "20250317",
"SamplePackage": "N",
"Description": "Iohexol,N,N´ - Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodoisophthalamide, is a nonionic, water-soluble radiographic contrast medium with a molecular weight of 821.14 (iodine content 46.36%). In aqueous solution each triiodinated molecule remains undissociated. The chemical structure is. OMNIPAQUE is provided as a sterile, pyrogen-free, colorless to pale-yellow solution, in Pharmacy Bulk Package, in the following iodine concentrations: 300 and 350 mg Iodine/mL. A Pharmacy Bulk Package is used to dispense multiple single doses, utilizing a suitable transfer device. OMNIPAQUE 300 contains 647 mg of iohexol equivalent to 300 mg of organic iodine per mL; and OMNIPAQUE 350 contains 755 mg of iohexol equivalent to 350 mg of organic iodine per mL. Each milliliter of iohexol solution contains 1.21 mg tromethamine and 0.1 mg edetate calcium disodium with the pH adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. All solutions are sterilized by autoclaving and contain no preservatives. Iohexol solution is sensitive to light and therefore should be protected from exposure. The available concentrations have the following physical properties. OMNIPAQUE 300 and OMNIPAQUE 350 have osmolalities from approximately 2.2 to 3 times that of plasma (285 mOsm/kg water) or cerebrospinal fluid (301 mOsm/kg water) as shown in the above table and are hypertonic under conditions of use."
},
{
"NDCCode": "10135-821-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-10) ",
"NDC11Code": "10135-0821-10",
"ProductNDC": "10135-821",
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"LabelerName": "Marlex Pharmaceuticals, Inc.",
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"IndicationAndUsage": "Desvenlafaxine extended-release tablets, is indicated for the treatment of adults with major depressive disorder (MDD) [ seeClinical Studies (14)].",
"Description": "Desvenlafaxine extended-release is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16H 25NO 2(free base) and C 16H 25NO 2C 4H 6O 4H 2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine extended-release is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 50 mg tablet and 100 mg tablet consist of hypromellose, hydroxyethyl cellulose, ethyl cellulose, microcrystalline cellulose, magnesium stearate and film coatings, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides."
},
{
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"Description": "Desvenlafaxine extended-release is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16H 25NO 2(free base) and C 16H 25NO 2C 4H 6O 4H 2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine extended-release is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 50 mg tablet and 100 mg tablet consist of hypromellose, hydroxyethyl cellulose, ethyl cellulose, microcrystalline cellulose, magnesium stearate and film coatings, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides."
},
{
"NDCCode": "10135-821-30",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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},
{
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},
{
"NDCCode": "10356-821-25",
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},
{
"NDCCode": "11071-821-01",
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"LabelerName": "Eisai Co., Ltd.",
"SubstanceName": "RABEPRAZOLE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
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},
{
"NDCCode": "11344-821-99",
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},
{
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}
]
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200729</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Earthlite, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0407-1412-35</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1412-35) / 200 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1412-35</NDC11Code>
<ProductNDC>0407-1412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL</RouteName>
<StartMarketingDate>19851226</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018956</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19851226</StartMarketingDatePackage>
<EndMarketingDatePackage>20241024</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen (1).</IndicationAndUsage>
<Description>OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula. OMNIPAQUE injection is available in five strengths: : 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-1412-38</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1412-38) / 50 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1412-38</NDC11Code>
<ProductNDC>0407-1412</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20050811</StartMarketingDate>
<EndMarketingDate>20241110</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018956</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050811</StartMarketingDatePackage>
<EndMarketingDatePackage>20241110</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).</IndicationAndUsage>
<Description>OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-1413-48</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1413-48) / 500 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1413-48</NDC11Code>
<ProductNDC>0407-1413</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20161221</StartMarketingDate>
<EndMarketingDate>20241108</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020608</ApplicationNumber>
<LabelerName>GE Healthcare</LabelerName>
<SubstanceName>IOHEXOL</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>2024-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161221</StartMarketingDatePackage>
<EndMarketingDatePackage>20241022</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNIPAQUE Imaging Bulk Package is indicated for: 1 Computed tomographic (CT) imaging of the head and body by intravenous administration in: adults (300 and 350 mg iodine/mL)pediatric patients (300 mg iodine/mL).</IndicationAndUsage>
<Description>OMNIPAQUE (iohexol) is a nonionic, radiographic contrast agent for intravenous use. OMNIPAQUE is provided as a sterile, pyrogen-free, colorless to pale-yellow solution. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. : 1 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine, 0.1 mg edetate calcium disodium , 2 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine, 0.1 mg edetate calcium disodium .</Description>
</NDC>
<NDC>
<NDCCode>0407-1413-86</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1413-86) / 50 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1413-86</NDC11Code>
<ProductNDC>0407-1413</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20060921</StartMarketingDate>
<EndMarketingDate>20241110</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020608</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</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>2024-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060921</StartMarketingDatePackage>
<EndMarketingDatePackage>20241009</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).</IndicationAndUsage>
<Description>OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-1413-87</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1413-87) / 100 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1413-87</NDC11Code>
<ProductNDC>0407-1413</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20060921</StartMarketingDate>
<EndMarketingDate>20241110</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020608</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</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>2024-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060921</StartMarketingDatePackage>
<EndMarketingDatePackage>20241026</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).</IndicationAndUsage>
<Description>OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-1413-88</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1413-88) / 150 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1413-88</NDC11Code>
<ProductNDC>0407-1413</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20060921</StartMarketingDate>
<EndMarketingDate>20241110</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020608</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</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>2024-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060921</StartMarketingDatePackage>
<EndMarketingDatePackage>20241028</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).</IndicationAndUsage>
<Description>OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-1413-89</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1413-89) / 500 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1413-89</NDC11Code>
<ProductNDC>0407-1413</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL</RouteName>
<StartMarketingDate>20050803</StartMarketingDate>
<EndMarketingDate>20241108</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020608</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</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>2024-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050803</StartMarketingDatePackage>
<EndMarketingDatePackage>20241022</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Iohexol, N, N´ - Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodoisophthalamide, is a nonionic, water-soluble radiographic contrast medium with a molecular weight of 821.14 (iodine content 46.36%). In aqueous solution each triiodinated molecule remains undissociated. The chemical structure is:. OMNIPAQUE is provided as a sterile, pyrogen-free, colorless to pale-yellow solution, in Pharmacy Bulk Package, in the following iodine concentrations: 300 and 350 mg Iodine/mL. A Pharmacy Bulk Package is used to dispense multiple single doses, utilizing a suitable transfer device. OMNIPAQUE 300 contains 647 mg of iohexol equivalent to 300 mg of organic iodine per mL; and OMNIPAQUE 350 contains 755 mg of iohexol equivalent to 350 mg of organic iodine per mL. Each milliliter of iohexol solution contains 1.21 mg tromethamine and 0.1 mg edetate calcium disodium with the pH adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. All solutions are sterilized by autoclaving and contain no preservatives. Iohexol solution is sensitive to light and therefore should be protected from exposure. The available concentrations have the following physical properties. OMNIPAQUE 300 and OMNIPAQUE 350 have osmolalities from approximately 2.2 to 3 times that of plasma (285 mOsm/kg water) or cerebrospinal fluid (301 mOsm/kg water) as shown in the above table and are hypertonic under conditions of use.</Description>
</NDC>
<NDC>
<NDCCode>0407-1414-48</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1414-48) / 500 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1414-48</NDC11Code>
<ProductNDC>0407-1414</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20161221</StartMarketingDate>
<EndMarketingDate>20241108</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020608</ApplicationNumber>
<LabelerName>GE Healthcare</LabelerName>
<SubstanceName>IOHEXOL</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>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161221</StartMarketingDatePackage>
<EndMarketingDatePackage>20241108</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNIPAQUE Imaging Bulk Package is indicated for: 1 Computed tomographic (CT) imaging of the head and body by intravenous administration in: adults (300 and 350 mg iodine/mL)pediatric patients (300 mg iodine/mL).</IndicationAndUsage>
<Description>OMNIPAQUE (iohexol) is a nonionic, radiographic contrast agent for intravenous use. OMNIPAQUE is provided as a sterile, pyrogen-free, colorless to pale-yellow solution. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. : 1 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine, 0.1 mg edetate calcium disodium , 2 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine, 0.1 mg edetate calcium disodium .</Description>
</NDC>
<NDC>
<NDCCode>0407-1414-82</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1414-82) / 50 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1414-82</NDC11Code>
<ProductNDC>0407-1414</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR; INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20060721</StartMarketingDate>
<EndMarketingDate>20241110</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020608</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</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>2024-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060721</StartMarketingDatePackage>
<EndMarketingDatePackage>20240916</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).</IndicationAndUsage>
<Description>OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-1414-83</NDCCode>
<PackageDescription>10 BOTTLE in 1 BOX (0407-1414-83) / 125 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00407-1414-83</NDC11Code>
<ProductNDC>0407-1414</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR; INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20060721</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020608</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</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>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200323</StartMarketingDatePackage>
<EndMarketingDatePackage>20240619</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).</IndicationAndUsage>
<Description>OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-1414-84</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1414-84) / 100 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1414-84</NDC11Code>
<ProductNDC>0407-1414</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR; INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20060721</StartMarketingDate>
<EndMarketingDate>20241110</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020608</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</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>2024-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060721</StartMarketingDatePackage>
<EndMarketingDatePackage>20241107</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).</IndicationAndUsage>
<Description>OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-1414-85</NDCCode>
<PackageDescription>10 BOTTLE in 1 BOX (0407-1414-85) > 125 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00407-1414-85</NDC11Code>
<ProductNDC>0407-1414</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR; INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20060721</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018956</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</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>2023-06-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060721</StartMarketingDatePackage>
<EndMarketingDatePackage>20230611</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).</IndicationAndUsage>
<Description>OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: : 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-1414-86</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1414-86) / 150 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1414-86</NDC11Code>
<ProductNDC>0407-1414</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR; INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20060721</StartMarketingDate>
<EndMarketingDate>20241110</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020608</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</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>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060721</StartMarketingDatePackage>
<EndMarketingDatePackage>20241106</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).</IndicationAndUsage>
<Description>OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-1414-87</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1414-87) / 200 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1414-87</NDC11Code>
<ProductNDC>0407-1414</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR; INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20060721</StartMarketingDate>
<EndMarketingDate>20241110</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020608</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</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>2024-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20060721</StartMarketingDatePackage>
<EndMarketingDatePackage>20241008</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1).</IndicationAndUsage>
<Description>OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula:. OMNIPAQUE injection is available in five strengths: 1 OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 2 OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 3 OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 4 OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium, 5 OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-1414-88</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1414-88) / 500 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1414-88</NDC11Code>
<ProductNDC>0407-1414</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL</RouteName>
<StartMarketingDate>20050803</StartMarketingDate>
<EndMarketingDate>20241108</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020608</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</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>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050803</StartMarketingDatePackage>
<EndMarketingDatePackage>20241108</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Iohexol, N, N´ - Bis(2,3-dihydroxypropyl)-5-[ N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodoisophthalamide, is a nonionic, water-soluble radiographic contrast medium with a molecular weight of 821.14 (iodine content 46.36%). In aqueous solution each triiodinated molecule remains undissociated. The chemical structure is:. OMNIPAQUE is provided as a sterile, pyrogen-free, colorless to pale-yellow solution, in Pharmacy Bulk Package, in the following iodine concentrations: 300 and 350 mg Iodine/mL. A Pharmacy Bulk Package is used to dispense multiple single doses, utilizing a suitable transfer device. OMNIPAQUE 300 contains 647 mg of iohexol equivalent to 300 mg of organic iodine per mL; and OMNIPAQUE 350 contains 755 mg of iohexol equivalent to 350 mg of organic iodine per mL. Each milliliter of iohexol solution contains 1.21 mg tromethamine and 0.1 mg edetate calcium disodium with the pH adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. All solutions are sterilized by autoclaving and contain no preservatives. Iohexol solution is sensitive to light and therefore should be protected from exposure. The available concentrations have the following physical properties. OMNIPAQUE 300 and OMNIPAQUE 350 have osmolalities from approximately 2.2 to 3 times that of plasma (285 mOsm/kg water) or cerebrospinal fluid (301 mOsm/kg water) as shown in the above table and are hypertonic under conditions of use.</Description>
</NDC>
<NDC>
<NDCCode>0407-1414-98</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1414-98) / 500 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-1414-98</NDC11Code>
<ProductNDC>0407-1414</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omnipaque</ProprietaryName>
<NonProprietaryName>Iohexol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL</RouteName>
<StartMarketingDate>20040903</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020608</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IOHEXOL</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>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040903</StartMarketingDatePackage>
<EndMarketingDatePackage>20250317</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Iohexol,N,N´ - Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodoisophthalamide, is a nonionic, water-soluble radiographic contrast medium with a molecular weight of 821.14 (iodine content 46.36%). In aqueous solution each triiodinated molecule remains undissociated. The chemical structure is. OMNIPAQUE is provided as a sterile, pyrogen-free, colorless to pale-yellow solution, in Pharmacy Bulk Package, in the following iodine concentrations: 300 and 350 mg Iodine/mL. A Pharmacy Bulk Package is used to dispense multiple single doses, utilizing a suitable transfer device. OMNIPAQUE 300 contains 647 mg of iohexol equivalent to 300 mg of organic iodine per mL; and OMNIPAQUE 350 contains 755 mg of iohexol equivalent to 350 mg of organic iodine per mL. Each milliliter of iohexol solution contains 1.21 mg tromethamine and 0.1 mg edetate calcium disodium with the pH adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. All solutions are sterilized by autoclaving and contain no preservatives. Iohexol solution is sensitive to light and therefore should be protected from exposure. The available concentrations have the following physical properties. OMNIPAQUE 300 and OMNIPAQUE 350 have osmolalities from approximately 2.2 to 3 times that of plasma (285 mOsm/kg water) or cerebrospinal fluid (301 mOsm/kg water) as shown in the above table and are hypertonic under conditions of use.</Description>
</NDC>
<NDC>
<NDCCode>10135-821-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-10) </PackageDescription>
<NDC11Code>10135-0821-10</NDC11Code>
<ProductNDC>10135-821</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204805</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine extended-release tablets, is indicated for the treatment of adults with major depressive disorder (MDD) [ seeClinical Studies (14)].</IndicationAndUsage>
<Description>Desvenlafaxine extended-release is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16H 25NO 2(free base) and C 16H 25NO 2C 4H 6O 4H 2O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine extended-release is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 50 mg tablet and 100 mg tablet consist of hypromellose, hydroxyethyl cellulose, ethyl cellulose, microcrystalline cellulose, magnesium stearate and film coatings, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides.</Description>
</NDC>
<NDC>
<NDCCode>10135-821-14</NDCCode>
<PackageDescription>14 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-14) </PackageDescription>
<NDC11Code>10135-0821-14</NDC11Code>
<ProductNDC>10135-821</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204805</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
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<IndicationAndUsage>Desvenlafaxine extended-release tablets, is indicated for the treatment of adults with major depressive disorder (MDD) [ seeClinical Studies (14)].</IndicationAndUsage>
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