{
"NDC": [
{
"NDCCode": "10967-652-11",
"PackageDescription": "26.6 mL in 1 BOTTLE, PLASTIC (10967-652-11) ",
"NDC11Code": "10967-0652-11",
"ProductNDC": "10967-652",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Revlon Colorstay Preo And Protect Primer",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide, Octinoxate Primer",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Revlon Consumer Products Corp",
"SubstanceName": "ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "9; 7.5; 3.6",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunbunrs. If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "15071-652-11",
"PackageDescription": "56 g in 1 BOTTLE (15071-652-11)",
"NDC11Code": "15071-0652-11",
"ProductNDC": "15071-652",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rash Relief Silver",
"NonProprietaryName": "Dimethicone Zinc Oxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Touchless Care Concepts LLC",
"SubstanceName": "DIMETHICONE; ZINC OXIDE",
"StrengthNumber": "20; 25",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Manage moisture, friction, and inflammation: skin folds, incontinence dermatitis, venous stasis/pressure ulcers, wounds."
},
{
"NDCCode": "50268-652-12",
"PackageDescription": "20 BLISTER PACK in 1 BOX (50268-652-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-652-11) ",
"NDC11Code": "50268-0652-12",
"ProductNDC": "50268-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pilocarpine Hydrochloride",
"NonProprietaryName": "Pilocarpine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077220",
"LabelerName": "AvPAK",
"SubstanceName": "PILOCARPINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210107",
"SamplePackage": "N"
},
{
"NDCCode": "60687-652-21",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (60687-652-21) / 1 TABLET in 1 BLISTER PACK (60687-652-11) ",
"NDC11Code": "60687-0652-21",
"ProductNDC": "60687-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220907",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203828",
"LabelerName": "American Health Packaging",
"SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220907",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets is (1RS, 1’RS)-1, 1’-[(2RS, 2’SR)-bis (6-fluoro-3, 4-dihydro-2H-1-benzopyran-2-yl)]- 2, 2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS] - nebivolol, respectively. Nebivolol's molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Nebivolol hydrochloride is a white to off white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1 M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 (for 10 mg strength), FD&C Blue #2 (for 2.5 mg, 10 mg and 20 mg strengths), FD&C Yellow #6 (for 5 mg strength), polyethylene glycol 6000, hypromellose 15cps, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and maize starch."
},
{
"NDCCode": "68084-652-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-652-01) > 1 TABLET in 1 BLISTER PACK (68084-652-11)",
"NDC11Code": "68084-0652-01",
"ProductNDC": "68084-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078670",
"LabelerName": "American Health Packaging",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-01-01"
},
{
"NDCCode": "68428-652-11",
"PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-652-11) ",
"NDC11Code": "68428-0652-11",
"ProductNDC": "68428-652",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Strontium Carbonicum",
"NonProprietaryName": "Strontium Carbonate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101011",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "STRONTIUM CARBONATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20101011",
"SamplePackage": "N"
},
{
"NDCCode": "0407-2222-16",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2222-16) / 50 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2222-16",
"ProductNDC": "0407-2222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20021213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020351",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "270",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021213",
"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-2222-17",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2222-17) / 100 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2222-17",
"ProductNDC": "0407-2222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20021213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020351",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "270",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021213",
"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-2222-19",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2222-19) / 150 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2222-19",
"ProductNDC": "0407-2222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20021213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020351",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "270",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021213",
"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-2222-21",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2222-21) / 200 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2222-21",
"ProductNDC": "0407-2222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20021213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020351",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "270",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021213",
"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-2223-16",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-16) / 50 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2223-16",
"ProductNDC": "0407-2223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20030909",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020351",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "320",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030909",
"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-2223-17",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-17) / 100 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2223-17",
"ProductNDC": "0407-2223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20030909",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020351",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "320",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030909",
"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-2223-19",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-19) / 150 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2223-19",
"ProductNDC": "0407-2223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20030909",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020351",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "320",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030909",
"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-2223-21",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-21) / 200 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2223-21",
"ProductNDC": "0407-2223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20030909",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020351",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "320",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030909",
"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-2223-23",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-23) / 500 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2223-23",
"ProductNDC": "0407-2223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020808",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "320",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
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"IndicationAndUsage": "VISIPAQUE is indicated for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo- 1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium."
},
{
"NDCCode": "0407-2223-62",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-62) / 50 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2223-62",
"ProductNDC": "0407-2223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020808",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "320",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20100601",
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"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated in for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo- 1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C 35H 44I 6N 6O 15) has the following structural formula:. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL(550 mg Iodixanol/mL), 0.074 mg calcium chloride dehydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium. , 2 VISIPAQUE 320 mg Iodine/mL(652 mg Iodixanol/mL), 0.044 mg calcium chloride dehydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. ."
},
{
"NDCCode": "0407-2223-64",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-64) / 100 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2223-64",
"ProductNDC": "0407-2223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20100601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020808",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "320",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20100601",
"EndMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated in for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo- 1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C 35H 44I 6N 6O 15) has the following structural formula:. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL(550 mg Iodixanol/mL), 0.074 mg calcium chloride dehydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium. , 2 VISIPAQUE 320 mg Iodine/mL(652 mg Iodixanol/mL), 0.044 mg calcium chloride dehydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. ."
},
{
"NDCCode": "0407-2223-66",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-66) / 150 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2223-66",
"ProductNDC": "0407-2223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20100601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020808",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "320",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-11-13",
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"StartMarketingDatePackage": "20100601",
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"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated in for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo- 1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C 35H 44I 6N 6O 15) has the following structural formula:. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL(550 mg Iodixanol/mL), 0.074 mg calcium chloride dehydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium. , 2 VISIPAQUE 320 mg Iodine/mL(652 mg Iodixanol/mL), 0.044 mg calcium chloride dehydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. ."
},
{
"NDCCode": "0407-2223-67",
"PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-67) / 200 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00407-2223-67",
"ProductNDC": "0407-2223",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Visipaque",
"NonProprietaryName": "Iodixanol",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20100601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020808",
"LabelerName": "GE Healthcare Inc.",
"SubstanceName": "IODIXANOL",
"StrengthNumber": "320",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20100601",
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"SamplePackage": "N",
"IndicationAndUsage": "VISIPAQUE is indicated in for.",
"Description": "VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo- 1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C 35H 44I 6N 6O 15) has the following structural formula:. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL(550 mg Iodixanol/mL), 0.074 mg calcium chloride dehydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium. , 2 VISIPAQUE 320 mg Iodine/mL(652 mg Iodixanol/mL), 0.044 mg calcium chloride dehydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. ."
},
{
"NDCCode": "11673-652-06",
"PackageDescription": "160 BLISTER PACK in 1 CARTON (11673-652-06) > 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "11673-0652-06",
"ProductNDC": "11673-652",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20160318",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078968",
"LabelerName": "Target Corporation",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-11-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "16714-652-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16714-652-01) ",
"NDC11Code": "16714-0652-01",
"ProductNDC": "16714-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070426",
"EndMarketingDatePackage": "20270427",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "16714-652-03",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (16714-652-03) ",
"NDC11Code": "16714-0652-03",
"ProductNDC": "16714-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"EndMarketingDate": "20270427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20070426",
"EndMarketingDatePackage": "20270427",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "43063-624-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-624-30) ",
"NDC11Code": "43063-0624-30",
"ProductNDC": "43063-624",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090617",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151026",
"SamplePackage": "N",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "43063-624-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-624-60) ",
"NDC11Code": "43063-0624-60",
"ProductNDC": "43063-624",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090617",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230111",
"SamplePackage": "N",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "43063-624-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-624-90) ",
"NDC11Code": "43063-0624-90",
"ProductNDC": "43063-624",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120910",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090617",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200729",
"SamplePackage": "N",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "43063-652-02",
"PackageDescription": "2 TABLET in 1 BOTTLE, PLASTIC (43063-652-02) ",
"NDC11Code": "43063-0652-02",
"ProductNDC": "43063-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077903",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
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"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160128",
"SamplePackage": "N"
},
{
"NDCCode": "43063-652-10",
"PackageDescription": "10 TABLET in 1 BOTTLE, PLASTIC (43063-652-10) ",
"NDC11Code": "43063-0652-10",
"ProductNDC": "43063-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077903",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160125",
"SamplePackage": "N"
},
{
"NDCCode": "43063-652-14",
"PackageDescription": "14 TABLET in 1 BOTTLE, PLASTIC (43063-652-14) ",
"NDC11Code": "43063-0652-14",
"ProductNDC": "43063-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077903",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160616",
"SamplePackage": "N"
},
{
"NDCCode": "43063-652-21",
"PackageDescription": "21 TABLET in 1 BOTTLE, PLASTIC (43063-652-21) ",
"NDC11Code": "43063-0652-21",
"ProductNDC": "43063-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077903",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210317",
"SamplePackage": "N"
},
{
"NDCCode": "43063-652-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43063-652-30) ",
"NDC11Code": "43063-0652-30",
"ProductNDC": "43063-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077903",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160801",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>10967-652-11</NDCCode>
<PackageDescription>26.6 mL in 1 BOTTLE, PLASTIC (10967-652-11) </PackageDescription>
<NDC11Code>10967-0652-11</NDC11Code>
<ProductNDC>10967-652</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Revlon Colorstay Preo And Protect Primer</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Zinc Oxide, Octinoxate Primer</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Revlon Consumer Products Corp</LabelerName>
<SubstanceName>ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>9; 7.5; 3.6</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunbunrs. If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15071-652-11</NDCCode>
<PackageDescription>56 g in 1 BOTTLE (15071-652-11)</PackageDescription>
<NDC11Code>15071-0652-11</NDC11Code>
<ProductNDC>15071-652</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rash Relief Silver</ProprietaryName>
<NonProprietaryName>Dimethicone Zinc Oxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Touchless Care Concepts LLC</LabelerName>
<SubstanceName>DIMETHICONE; ZINC OXIDE</SubstanceName>
<StrengthNumber>20; 25</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Manage moisture, friction, and inflammation: skin folds, incontinence dermatitis, venous stasis/pressure ulcers, wounds.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50268-652-12</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 BOX (50268-652-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-652-11) </PackageDescription>
<NDC11Code>50268-0652-12</NDC11Code>
<ProductNDC>50268-652</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pilocarpine Hydrochloride</ProprietaryName>
<NonProprietaryName>Pilocarpine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077220</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>PILOCARPINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60687-652-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (60687-652-21) / 1 TABLET in 1 BLISTER PACK (60687-652-11) </PackageDescription>
<NDC11Code>60687-0652-21</NDC11Code>
<ProductNDC>60687-652</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220907</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203828</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220907</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets is (1RS, 1’RS)-1, 1’-[(2RS, 2’SR)-bis (6-fluoro-3, 4-dihydro-2H-1-benzopyran-2-yl)]- 2, 2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS] - nebivolol, respectively. Nebivolol's molecular formula is (C 22H 25F 2NO 4HCl) with the following structural formula:. Nebivolol hydrochloride is a white to off white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1 M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 (for 10 mg strength), FD&C Blue #2 (for 2.5 mg, 10 mg and 20 mg strengths), FD&C Yellow #6 (for 5 mg strength), polyethylene glycol 6000, hypromellose 15cps, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and maize starch.</Description>
</NDC>
<NDC>
<NDCCode>68084-652-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-652-01) > 1 TABLET in 1 BLISTER PACK (68084-652-11)</PackageDescription>
<NDC11Code>68084-0652-01</NDC11Code>
<ProductNDC>68084-652</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078670</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>68428-652-11</NDCCode>
<PackageDescription>300 PELLET in 1 BOTTLE, GLASS (68428-652-11) </PackageDescription>
<NDC11Code>68428-0652-11</NDC11Code>
<ProductNDC>68428-652</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Strontium Carbonicum</ProprietaryName>
<NonProprietaryName>Strontium Carbonate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101011</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>STRONTIUM CARBONATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0407-2222-16</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2222-16) / 50 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2222-16</NDC11Code>
<ProductNDC>0407-2222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20021213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020351</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>270</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-2222-17</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2222-17) / 100 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2222-17</NDC11Code>
<ProductNDC>0407-2222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20021213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020351</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>270</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-2222-19</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2222-19) / 150 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2222-19</NDC11Code>
<ProductNDC>0407-2222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20021213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020351</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>270</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-2222-21</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2222-21) / 200 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2222-21</NDC11Code>
<ProductNDC>0407-2222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20021213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020351</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>270</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-2223-16</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2223-16) / 50 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2223-16</NDC11Code>
<ProductNDC>0407-2223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20030909</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020351</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-2223-17</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2223-17) / 100 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2223-17</NDC11Code>
<ProductNDC>0407-2223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20030909</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020351</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-2223-19</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2223-19) / 150 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2223-19</NDC11Code>
<ProductNDC>0407-2223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20030909</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020351</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-2223-21</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2223-21) / 200 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2223-21</NDC11Code>
<ProductNDC>0407-2223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20030909</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020351</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-2223-23</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2223-23) / 500 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2223-23</NDC11Code>
<ProductNDC>0407-2223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20060501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020808</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo- 1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C35H44I6N6O15) has the following structural formula. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL (550 mg Iodixanol/mL), 0.074 mg calcium chloride dihydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium., 2 VISIPAQUE 320 mg Iodine/mL (652 mg Iodixanol/mL), 0.044 mg calcium chloride dihydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium.</Description>
</NDC>
<NDC>
<NDCCode>0407-2223-62</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2223-62) / 50 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2223-62</NDC11Code>
<ProductNDC>0407-2223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020808</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100601</StartMarketingDatePackage>
<EndMarketingDatePackage>20240821</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated in for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo- 1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C 35H 44I 6N 6O 15) has the following structural formula:. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL(550 mg Iodixanol/mL), 0.074 mg calcium chloride dehydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium. , 2 VISIPAQUE 320 mg Iodine/mL(652 mg Iodixanol/mL), 0.044 mg calcium chloride dehydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. .</Description>
</NDC>
<NDC>
<NDCCode>0407-2223-64</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2223-64) / 100 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2223-64</NDC11Code>
<ProductNDC>0407-2223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020808</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100601</StartMarketingDatePackage>
<EndMarketingDatePackage>20241101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated in for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo- 1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C 35H 44I 6N 6O 15) has the following structural formula:. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL(550 mg Iodixanol/mL), 0.074 mg calcium chloride dehydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium. , 2 VISIPAQUE 320 mg Iodine/mL(652 mg Iodixanol/mL), 0.044 mg calcium chloride dehydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. .</Description>
</NDC>
<NDC>
<NDCCode>0407-2223-66</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2223-66) / 150 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2223-66</NDC11Code>
<ProductNDC>0407-2223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020808</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>320</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>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100601</StartMarketingDatePackage>
<EndMarketingDatePackage>20241109</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated in for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo- 1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C 35H 44I 6N 6O 15) has the following structural formula:. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL(550 mg Iodixanol/mL), 0.074 mg calcium chloride dehydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium. , 2 VISIPAQUE 320 mg Iodine/mL(652 mg Iodixanol/mL), 0.044 mg calcium chloride dehydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. .</Description>
</NDC>
<NDC>
<NDCCode>0407-2223-67</NDCCode>
<PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-2223-67) / 200 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00407-2223-67</NDC11Code>
<ProductNDC>0407-2223</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Visipaque</ProprietaryName>
<NonProprietaryName>Iodixanol</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020808</ApplicationNumber>
<LabelerName>GE Healthcare Inc.</LabelerName>
<SubstanceName>IODIXANOL</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100601</StartMarketingDatePackage>
<EndMarketingDatePackage>20241015</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VISIPAQUE is indicated in for.</IndicationAndUsage>
<Description>VISIPAQUE (iodixanol) injection is a dimeric, iso-osmolar, nonionic, water-soluble, radiographic contrast medium for intravascular (intravenous and intra-arterial) use. It is provided as a ready-to-use sterile, pyrogen-free, and preservative free, colorless to pale yellow solution. The chemical formula is 5,5´-[(2-hydroxy-1,3-propanediyl) bis(acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6-triiodo- 1,3- benzenedicarboxamide] with a molecular weight of 1550.20 (iodine content 49.1%). VISIPAQUE (C 35H 44I 6N 6O 15) has the following structural formula:. VISIPAQUE is available in two strengths: 1 VISIPAQUE 270 mg Iodine/mL(550 mg Iodixanol/mL), 0.074 mg calcium chloride dehydrate, 1.87 mg sodium chloride, 1.2 mg tromethamine, and 0.1 mg edetate calcium disodium. , 2 VISIPAQUE 320 mg Iodine/mL(652 mg Iodixanol/mL), 0.044 mg calcium chloride dehydrate, 1.11 mg sodium chloride, 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. .</Description>
</NDC>
<NDC>
<NDCCode>11673-652-06</NDCCode>
<PackageDescription>160 BLISTER PACK in 1 CARTON (11673-652-06) > 1 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11673-0652-06</NDC11Code>
<ProductNDC>11673-652</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160318</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078968</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16714-652-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16714-652-01) </PackageDescription>
<NDC11Code>16714-0652-01</NDC11Code>
<ProductNDC>16714-652</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<EndMarketingDate>20270427</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070426</StartMarketingDatePackage>
<EndMarketingDatePackage>20270427</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
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<NDCCode>16714-652-03</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (16714-652-03) </PackageDescription>
<NDC11Code>16714-0652-03</NDC11Code>
<ProductNDC>16714-652</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<EndMarketingDate>20270427</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20070426</StartMarketingDatePackage>
<EndMarketingDatePackage>20270427</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
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<NDC>
<NDCCode>43063-624-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-624-30) </PackageDescription>
<NDC11Code>43063-0624-30</NDC11Code>
<ProductNDC>43063-624</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090617</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide.</Description>
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<NDCCode>43063-624-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-624-60) </PackageDescription>
<NDC11Code>43063-0624-60</NDC11Code>
<ProductNDC>43063-624</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090617</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide.</Description>
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<NDC>
<NDCCode>43063-624-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-624-90) </PackageDescription>
<NDC11Code>43063-0624-90</NDC11Code>
<ProductNDC>43063-624</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120910</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090617</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide.</Description>
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<NDCCode>43063-652-02</NDCCode>
<PackageDescription>2 TABLET in 1 BOTTLE, PLASTIC (43063-652-02) </PackageDescription>
<NDC11Code>43063-0652-02</NDC11Code>
<ProductNDC>43063-652</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077903</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>43063-652-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE, PLASTIC (43063-652-10) </PackageDescription>
<NDC11Code>43063-0652-10</NDC11Code>
<ProductNDC>43063-652</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077903</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077903</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077903</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
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<ApplicationNumber>ANDA077903</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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