{
"NDC": [
{
"NDCCode": "72709-821-78",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (72709-821-78) > 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "72709-0821-78",
"ProductNDC": "72709-821",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lutesol Homeopathic Medicine Sterile Eye Drops",
"NonProprietaryName": "Calendula Officinalis",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20181128",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Yokina Inc.",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/15mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181128",
"SamplePackage": "N",
"IndicationAndUsage": "According to homeopathic indications these ingredients provide temporary relief from symptoms such as Dryness, redness and promote corneal health, after a serious causes have been ruled out by physician. *These statements are based on traditional homeopathic practice. They have not been reviewed by Food and Drug Administration."
},
{
"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",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204805",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"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."
},
{
"NDCCode": "10135-821-14",
"PackageDescription": "14 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-14) ",
"NDC11Code": "10135-0821-14",
"ProductNDC": "10135-821",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204805",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"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."
},
{
"NDCCode": "10135-821-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-30) ",
"NDC11Code": "10135-0821-30",
"ProductNDC": "10135-821",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204805",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"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."
},
{
"NDCCode": "10135-821-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-90) ",
"NDC11Code": "10135-0821-90",
"ProductNDC": "10135-821",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204805",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "DESVENLAFAXINE SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"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."
},
{
"NDCCode": "10356-821-25",
"PackageDescription": "4.8 g in 1 TUBE (10356-821-25)",
"NDC11Code": "10356-0821-25",
"ProductNDC": "10356-821",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nivea A Kiss Of Recovery Medicated Lip Care",
"NonProprietaryName": "Dimethicone, Avobenzone, Octinoxate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110214",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Beiersdorf Inc",
"SubstanceName": "DIMETHICONE; AVOBENZONE; OCTINOXATE",
"StrengthNumber": ".012; .01; .067",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "11071-821-01",
"PackageDescription": "15 kg in 1 DRUM (11071-821-01)",
"NDC11Code": "11071-0821-01",
"ProductNDC": "11071-821",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Rabeprazole Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "19990819",
"EndMarketingDate": "20161021",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Eisai Co., Ltd.",
"SubstanceName": "RABEPRAZOLE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20161021"
},
{
"NDCCode": "11344-821-99",
"PackageDescription": "124 mL in 1 TUBE (11344-821-99) ",
"NDC11Code": "11344-0821-99",
"ProductNDC": "11344-821",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acne Scrub",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161027",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "21",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-02-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161027",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of acne."
},
{
"NDCCode": "11673-821-90",
"PackageDescription": "1 KIT in 1 CARTON (11673-821-90) * 2 TABLET, FILM COATED in 1 BLISTER PACK * 2 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "11673-0821-90",
"ProductNDC": "11673-821",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Daytime Vapor Ice Cold And Flu Nighttime Vapor Ice Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Doxylamine Succinate",
"DosageFormName": "KIT",
"StartMarketingDate": "20190815",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Target Corporation",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190815",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N"
},
{
"NDCCode": "13537-821-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-821-02) > 4 g in 1 TUBE (13537-821-01)",
"NDC11Code": "13537-0821-02",
"ProductNDC": "13537-821",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25",
"ProprietaryNameSuffix": "(marron Topacio) - Brown",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".0664; .0151",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14783-821-02",
"PackageDescription": "1 TUBE in 1 BOX (14783-821-02) > 30 mL in 1 TUBE (14783-821-01) ",
"NDC11Code": "14783-0821-02",
"ProductNDC": "14783-821",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pro Hydro-nutritive Foundation Spf 15/ Base De Maquillaje Hidro - Nutritiva Fps 15",
"ProprietaryNameSuffix": "(beige 5) - Brown",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150824",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".05; .02",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "15127-821-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (15127-821-01) ",
"NDC11Code": "15127-0821-01",
"ProductNDC": "15127-821",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chlorpheniramine",
"NonProprietaryName": "Chlorpheniramine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19921219",
"EndMarketingDate": "20210910",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "L&R Distributors, Inc.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19921219",
"EndMarketingDatePackage": "20210910",
"SamplePackage": "N"
},
{
"NDCCode": "15127-821-09",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (15127-821-09) > 12 TABLET in 1 BLISTER PACK",
"NDC11Code": "15127-0821-09",
"ProductNDC": "15127-821",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chlorpheniramine",
"NonProprietaryName": "Chlorpheniramine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19921219",
"EndMarketingDate": "20210910",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "L&R Distributors, Inc.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19921219",
"EndMarketingDatePackage": "20210910",
"SamplePackage": "N"
},
{
"NDCCode": "16571-821-02",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (16571-821-02) ",
"NDC11Code": "16571-0821-02",
"ProductNDC": "16571-821",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20221004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206309",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221004",
"SamplePackage": "N",
"IndicationAndUsage": "Temozolomide is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2) Treatment of adults with refractory anaplastic astrocytoma. (1.2) .",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence temozolomide can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for Temozolomide Capsules, USP are as follows. Temozolomide Capsules 5 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 20 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 100 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 140 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 180 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 250 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. Temozolomide Capsules 5 mg: The green cap contains gelatin, titanium dioxide, yellow iron oxide, and FD&C Blue 2.Temozolomide Capsules 20 mg: The yellow cap contains gelatin, titanium dioxide, and yellow iron oxide.Temozolomide Capsules 100 mg: The pink cap contains gelatin, titanium dioxide, and yellow iron oxide, and red iron oxide.Temozolomide Capsules 140 mg: The blue cap contains gelatin, titanium dioxide, yellow iron oxide and FD&C Blue #2.Temozolomide Capsules 180 mg: The orange cap contains gelatin, titanium dioxide and red iron oxide.Temozolomide Capsules 250 mg: The white cap contains gelatin, titanium dioxide. FDA approved dissolution test specifications differ from USP."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>72709-821-78</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (72709-821-78) > 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>72709-0821-78</NDC11Code>
<ProductNDC>72709-821</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lutesol Homeopathic Medicine Sterile Eye Drops</ProprietaryName>
<NonProprietaryName>Calendula Officinalis</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20181128</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Yokina Inc.</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>According to homeopathic indications these ingredients provide temporary relief from symptoms such as Dryness, redness and promote corneal health, after a serious causes have been ruled out by physician. *These statements are based on traditional homeopathic practice. They have not been reviewed by Food and Drug Administration.</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>
<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>10135-821-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-30) </PackageDescription>
<NDC11Code>10135-0821-30</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>10135-821-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-90) </PackageDescription>
<NDC11Code>10135-0821-90</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>
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<StrengthNumber>.012; .01; .067</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
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<EndMarketingDate>20161021</EndMarketingDate>
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<LabelerName>Eisai Co., Ltd.</LabelerName>
<SubstanceName>RABEPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20161021</ListingRecordCertifiedThrough>
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<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>21</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-09</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of acne.</IndicationAndUsage>
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<PackageDescription>1 KIT in 1 CARTON (11673-821-90) * 2 TABLET, FILM COATED in 1 BLISTER PACK * 2 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11673-0821-90</NDC11Code>
<ProductNDC>11673-821</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Daytime Vapor Ice Cold And Flu Nighttime Vapor Ice Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Doxylamine Succinate</NonProprietaryName>
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<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190815</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<NDCCode>13537-821-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-821-02) > 4 g in 1 TUBE (13537-821-01)</PackageDescription>
<NDC11Code>13537-0821-02</NDC11Code>
<ProductNDC>13537-821</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(marron Topacio) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.0664; .0151</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
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<PackageDescription>1 TUBE in 1 BOX (14783-821-02) > 30 mL in 1 TUBE (14783-821-01) </PackageDescription>
<NDC11Code>14783-0821-02</NDC11Code>
<ProductNDC>14783-821</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pro Hydro-nutritive Foundation Spf 15/ Base De Maquillaje Hidro - Nutritiva Fps 15</ProprietaryName>
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<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
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<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.05; .02</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
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<NDCCode>15127-821-01</NDCCode>
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<NDC11Code>15127-0821-01</NDC11Code>
<ProductNDC>15127-821</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chlorpheniramine</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName>
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<EndMarketingDate>20210910</EndMarketingDate>
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<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>L&R Distributors, Inc.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19921219</StartMarketingDatePackage>
<EndMarketingDatePackage>20210910</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>15127-821-09</NDCCode>
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<NDC11Code>15127-0821-09</NDC11Code>
<ProductNDC>15127-821</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chlorpheniramine</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
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<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>L&R Distributors, Inc.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19921219</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>16571-821-02</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (16571-821-02) </PackageDescription>
<NDC11Code>16571-0821-02</NDC11Code>
<ProductNDC>16571-821</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206309</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temozolomide is an alkylating drug indicated for the treatment of adults with: 1 Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1), 2 Anaplastic astrocytoma. (1.2) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. (1.2) Treatment of adults with refractory anaplastic astrocytoma. (1.2) .</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula of temozolomide is. The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence temozolomide can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP. Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for Temozolomide Capsules, USP are as follows. Temozolomide Capsules 5 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 20 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 100 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 140 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 180 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid.Temozolomide Capsules 250 mg: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, and stearic acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. Temozolomide Capsules 5 mg: The green cap contains gelatin, titanium dioxide, yellow iron oxide, and FD&C Blue 2.Temozolomide Capsules 20 mg: The yellow cap contains gelatin, titanium dioxide, and yellow iron oxide.Temozolomide Capsules 100 mg: The pink cap contains gelatin, titanium dioxide, and yellow iron oxide, and red iron oxide.Temozolomide Capsules 140 mg: The blue cap contains gelatin, titanium dioxide, yellow iron oxide and FD&C Blue #2.Temozolomide Capsules 180 mg: The orange cap contains gelatin, titanium dioxide and red iron oxide.Temozolomide Capsules 250 mg: The white cap contains gelatin, titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
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