{
"NDC": [
{
"NDCCode": "68462-131-49",
"PackageDescription": "1 TUBE in 1 CARTON (68462-131-49) / 80 g in 1 TUBE",
"NDC11Code": "68462-0131-49",
"ProductNDC": "68462-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207117",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160805",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide USP is designated chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. Graphic Formula:. C24H31FO6 M.W. 434.50. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerine, lactic acid, benzyl alcohol and purified water."
},
{
"NDCCode": "68462-184-49",
"PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (68462-184-49) / 70 g in 1 TUBE, WITH APPLICATOR",
"NDC11Code": "68462-0184-49",
"ProductNDC": "68462-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "GEL",
"RouteName": "VAGINAL",
"StartMarketingDate": "20220127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215794",
"LabelerName": "GLENMARK PHARMACEUTICALS INC., USA",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220127",
"SamplePackage": "N"
},
{
"NDCCode": "68462-797-49",
"PackageDescription": "1 TUBE in 1 CARTON (68462-797-49) / 80 g in 1 TUBE",
"NDC11Code": "68462-0797-49",
"ProductNDC": "68462-797",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208320",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170822",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Ointment 0.1% and 0.5% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide USP is designated chemically as 9-Fluoro-11, 16, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Structural Formula:. C24H31FO6, MW 434.50. Each gram of 0.1% and 0.5% Triamcinolone Acetonide Ointment USP contains 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum."
},
{
"NDCCode": "68462-131-17",
"PackageDescription": "1 TUBE in 1 CARTON (68462-131-17) / 15 g in 1 TUBE",
"NDC11Code": "68462-0131-17",
"ProductNDC": "68462-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207117",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160805",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide USP is designated chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. Graphic Formula:. C24H31FO6 M.W. 434.50. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerine, lactic acid, benzyl alcohol and purified water."
},
{
"NDCCode": "68462-131-35",
"PackageDescription": "1 TUBE in 1 CARTON (68462-131-35) / 30 g in 1 TUBE",
"NDC11Code": "68462-0131-35",
"ProductNDC": "68462-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207117",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160805",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide USP is designated chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. Graphic Formula:. C24H31FO6 M.W. 434.50. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerine, lactic acid, benzyl alcohol and purified water."
},
{
"NDCCode": "68462-131-59",
"PackageDescription": "454 g in 1 JAR (68462-131-59) ",
"NDC11Code": "68462-0131-59",
"ProductNDC": "68462-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207117",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160805",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide USP is designated chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. Graphic Formula:. C24H31FO6 M.W. 434.50. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerine, lactic acid, benzyl alcohol and purified water."
},
{
"NDCCode": "42507-131-49",
"PackageDescription": "1 BOTTLE in 1 BOX (42507-131-49) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "42507-0131-49",
"ProductNDC": "42507-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20130413",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078682",
"LabelerName": "Hy-Vee",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130413",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "55316-131-49",
"PackageDescription": "1 BOTTLE in 1 BOX (55316-131-49) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "55316-0131-49",
"ProductNDC": "55316-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20121211",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078682",
"LabelerName": "Healthy Accents (DZA Brands, LLC)",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121211",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "59779-131-49",
"PackageDescription": "1 BOTTLE in 1 CARTON (59779-131-49) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "59779-0131-49",
"ProductNDC": "59779-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Pharmacy Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20091204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079205",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "62207-131-49",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-131-49) ",
"NDC11Code": "62207-0131-49",
"ProductNDC": "62207-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216509",
"LabelerName": "Granules India Ltd",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240816",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate is a beta-adrenergic blocker indicated for the treatment of. : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .",
"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 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, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 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; soluble in methanol; sparingly soluble in alcohol; slightly soluble in isopropyl alcohol. Inactive ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, d-mannitol, ethylcellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "53041-688-03",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (53041-688-03) ",
"NDC11Code": "53041-0688-03",
"ProductNDC": "53041-688",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diatrizoate Meglumine And Diatrizoate Sodium",
"NonProprietaryName": "Diatrizoate Meglumine And Diatrizoate Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "20191218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214201",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM",
"StrengthNumber": "660; 100",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2022-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191218",
"SamplePackage": "N",
"IndicationAndUsage": "Diatrizoate Meglumine and Diatrizoate Sodium Solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous.Diatrizoate Meglumine and Diatrizoate Sodium Solution may also be used as an adjunct to contrast enhancement is computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology.",
"Description": "Diatrizoate Meglumine and Diatrizoate Sodium Solution USP is a palatable lemon-flavored water-soluble iodinated radiopaque contrast medium for oral or rectal administration only. Each mL contains 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium; pH has been adjusted to 6.0 to 7.6 with sodium hydroxide. Each mL contains approximately 4.8 mg (0.21 mEq) sodium and 367 mg organically bound iodine. Inactive ingredients: edetate disodium, flavor, hydrochloric acid, polysorbate 80, purified water, saccharin sodium, simethicone, sodium citrate and sodium hydroxide. Diatrizoate meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitol 3,5-diacetamido-2,4,6-triiodo-benzoate (salt); diatrizoate sodium is monosodium 3, 5-diacetamido-2,4,6-triiodobenzoate. Structural formulas. Diatrizoate Meglumine C11H9I3N2O4.C7H17NO5MW 809.13Organically Bound Iodine: 47.1%CAS – 131-49-7. Diatrizoate SodiumC11H8I3N2NaO4MW 635.90Organically Bound Iodine: 59.9%CAS – 737-31-5."
},
{
"NDCCode": "53041-690-03",
"PackageDescription": "120 mL in 1 BOTTLE, GLASS (53041-690-03) ",
"NDC11Code": "53041-0690-03",
"ProductNDC": "53041-690",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diatrizoate Meglumine And Diatrizoate Sodium",
"NonProprietaryName": "Diatrizoate Meglumine And Diatrizoate Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "20191218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214201",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM",
"StrengthNumber": "660; 100",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2022-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191218",
"SamplePackage": "N",
"IndicationAndUsage": "Diatrizoate Meglumine and Diatrizoate Sodium Solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous.Diatrizoate Meglumine and Diatrizoate Sodium Solution may also be used as an adjunct to contrast enhancement is computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology.",
"Description": "Diatrizoate Meglumine and Diatrizoate Sodium Solution USP is a palatable lemon-flavored water-soluble iodinated radiopaque contrast medium for oral or rectal administration only. Each mL contains 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium; pH has been adjusted to 6.0 to 7.6 with sodium hydroxide. Each mL contains approximately 4.8 mg (0.21 mEq) sodium and 367 mg organically bound iodine. Inactive ingredients: edetate disodium, flavor, hydrochloric acid, polysorbate 80, purified water, saccharin sodium, simethicone, sodium citrate and sodium hydroxide. Diatrizoate meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitol 3,5-diacetamido-2,4,6-triiodo-benzoate (salt); diatrizoate sodium is monosodium 3, 5-diacetamido-2,4,6-triiodobenzoate. Structural formulas. Diatrizoate Meglumine C11H9I3N2O4.C7H17NO5MW 809.13Organically Bound Iodine: 47.1%CAS – 131-49-7. Diatrizoate SodiumC11H8I3N2NaO4MW 635.90Organically Bound Iodine: 59.9%CAS – 737-31-5."
},
{
"NDCCode": "53041-690-09",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (53041-690-09) ",
"NDC11Code": "53041-0690-09",
"ProductNDC": "53041-690",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diatrizoate Meglumine And Diatrizoate Sodium",
"NonProprietaryName": "Diatrizoate Meglumine And Diatrizoate Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "20191218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214201",
"LabelerName": "Guardian Drug Company",
"SubstanceName": "DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM",
"StrengthNumber": "660; 100",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2022-07-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191218",
"SamplePackage": "N",
"IndicationAndUsage": "Diatrizoate Meglumine and Diatrizoate Sodium Solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous.Diatrizoate Meglumine and Diatrizoate Sodium Solution may also be used as an adjunct to contrast enhancement is computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology.",
"Description": "Diatrizoate Meglumine and Diatrizoate Sodium Solution USP is a palatable lemon-flavored water-soluble iodinated radiopaque contrast medium for oral or rectal administration only. Each mL contains 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium; pH has been adjusted to 6.0 to 7.6 with sodium hydroxide. Each mL contains approximately 4.8 mg (0.21 mEq) sodium and 367 mg organically bound iodine. Inactive ingredients: edetate disodium, flavor, hydrochloric acid, polysorbate 80, purified water, saccharin sodium, simethicone, sodium citrate and sodium hydroxide. Diatrizoate meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitol 3,5-diacetamido-2,4,6-triiodo-benzoate (salt); diatrizoate sodium is monosodium 3, 5-diacetamido-2,4,6-triiodobenzoate. Structural formulas. Diatrizoate Meglumine C11H9I3N2O4.C7H17NO5MW 809.13Organically Bound Iodine: 47.1%CAS – 131-49-7. Diatrizoate SodiumC11H8I3N2NaO4MW 635.90Organically Bound Iodine: 59.9%CAS – 737-31-5."
},
{
"NDCCode": "61314-543-94",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61314-543-94) / 15 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "61314-0543-94",
"ProductNDC": "61314-543",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tyruko",
"NonProprietaryName": "Natalizumab-sztn",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251117",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761322",
"LabelerName": "Sandoz Inc",
"SubstanceName": "NATALIZUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Integrin Receptor Antagonist [EPC], Integrin Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251117",
"SamplePackage": "N",
"IndicationAndUsage": "TYRUKO is an integrin receptor antagonist indicated for treatment of:. Multiple Sclerosis (MS). TYRUKO is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Natalizumab products increase the risk of PML [see Warnings and Precautions (5.1)]. When initiating and continuing treatment with TYRUKO, physicians should consider whether the expected benefit of TYRUKO is sufficient to offset this risk. (1.1). Crohn's Disease (CD): 1 TYRUKO is indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α. (1.2) .",
"Description": "Natalizumab-sztn is a recombinant humanized IgG4ĸ monoclonal antibody produced in a Chinese hamster ovary (CHO) mammalian cell expression system. Natalizumab-sztn contains human framework regions and the complementarity-determining regions of an antibody that binds to α4-integrin. The molecular weight of natalizumab-sztn is 149 kilodaltons. TYRUKO (natalizumab-sztn) injection is supplied as a sterile, preservative-free, colorless, and clear to slightly opalescent solution for intravenous infusion. Each 15 mL of solution contains 300 mg natalizumab-sztn; histidine (6.36 mg); L-histidine hydrochloride monohydrate (22.86 mg); polysorbate 80, USP/NF (3 mg); sodium chloride, USP (131.49 mg); and Water for Injection, USP at pH 5.7."
},
{
"NDCCode": "62032-131-70",
"PackageDescription": "1 TUBE in 1 CARTON (62032-131-70) > 50 g in 1 TUBE",
"NDC11Code": "62032-0131-70",
"ProductNDC": "62032-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gentle Rejuvenation Ultra Light Repair Spf 30",
"ProprietaryNameSuffix": "Sunscreen",
"NonProprietaryName": "Homosalate, Octinoxate, Octocrylene, And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131015",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC.",
"SubstanceName": "HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE",
"StrengthNumber": "120; 75; 20; 49",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "69269-131-70",
"PackageDescription": "1 TUBE in 1 CARTON (69269-131-70) > 50 g in 1 TUBE",
"NDC11Code": "69269-0131-70",
"ProductNDC": "69269-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Obagi",
"NonProprietaryName": "Homosalate, Octinoxate, Octocrylene, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "YS PLUS CORPORATION",
"SubstanceName": "HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE",
"StrengthNumber": "120; 75; 20; 49",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2017-06-14"
},
{
"NDCCode": "83831-131-01",
"PackageDescription": "1 VIAL in 1 CARTON (83831-131-01) / 4 mL in 1 VIAL",
"NDC11Code": "83831-0131-01",
"ProductNDC": "83831-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Axtle",
"NonProprietaryName": "Pemetrexed",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210661",
"LabelerName": "Avyxa Pharma, LLC",
"SubstanceName": "PEMETREXED",
"StrengthNumber": "100",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "AXTLE is a folate analog metabolic inhibitor indicated: : 1 in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. (1.1), 2 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. (1.1), 3 as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 4 as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1).",
"Description": "Pemetrexed is a folate analog metabolic inhibitor. The drug substance is pemetrexed dipotassium heptahydrate, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, dipotassium salt, heptahydrate. It is a white to off-white powder having blue or green tinge with a molecular formula of C20H19K2N5O6 .7 H2O and a molecular weight of 629.49. Pemetrexed dipotassium is freely soluble in water. The reported pKaS are 3.6 and 4.5. The structural formula of pemetrexed dipotassium heptahydrate is as follows. AXTLE is supplied as a sterile white to light-yellow or green-yellow lyophilized powder or cake for intravenous infusion available in single-dose vials. Each 100-mg or 500-mg vial of AXTLE contains 100 mg pemetrexed equivalent to 118.3 mg pemetrexed dipotassium and 106 mg mannitol or 500 mg pemetrexed equivalent to 591.5 mg pemetrexed dipotassium and 500 mg mannitol, respectively. Hydrochloric acid may have been added to adjust the pH."
},
{
"NDCCode": "68462-185-56",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) / 20 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "68462-0185-56",
"ProductNDC": "68462-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OIL",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20181218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211815",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".11",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181218",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone acetonide oil, 0.01% (ear drops) is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.",
"Description": "Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contain fluocinolone acetonide, USP {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. Chemically, fluocinolone acetonide, USP is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide, USP in Fluocinolone Acetonide Oil, 0.01% (Ear Drops) has a molecular weight of 452.49. It is a white or almost white, crystalline powder and melts at 270°C with decomposition; practically insoluble in water and heptane, soluble in methanol, anhydrous ethanol and acetone, slightly soluble in ether and chloroform. Each gram of Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contains approximately 0.11 mg of fluocinolone acetonide, USP in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF."
},
{
"NDCCode": "68462-281-32",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "68462-0281-32",
"ProductNDC": "68462-281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brimonidine Tartrate/timolol Maleate",
"NonProprietaryName": "Brimonidine Tartrate And Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214987",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "BRIMONIDINE TARTRATE; TIMOLOL MALEATE",
"StrengthNumber": "2; 5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240516",
"SamplePackage": "N",
"IndicationAndUsage": "Brimonidine tartrate and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The IOP-lowering of brimonidine tartrate and timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.",
"Description": "Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution 0.2%/0.5%, sterile, contains brimonidine tartrate, a relatively selective alpha-2 adrenergic receptor agonist, and timolol maleate, a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent) for topical ophthalmic use. The structural formulae are. Brimonidine tartrate. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.22. Timolol maleate. (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.49 as the maleate salt. In solution, Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3. Brimonidine tartrate appears as a white, or slightly yellowish, or slightly brownish powder and is soluble in water and practically insoluble in anhydrous ethanol and toluene. Timolol maleate appears as a white to practically white powder and is soluble in water, methanol, and alcohol, sparingly soluble in chloroform and propylene glycol and insoluble in ether and cyclohexane. Each mL of Brimonidine Tartrate and Timolol Maleate Ophthalmic Solutioncontains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% (6.8 mg/mL timolol maleate) with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, monobasic; sodium phosphate, dibasic; water for injection; and hydrochloric acid and/or sodium hydroxide to adjust pH."
},
{
"NDCCode": "68462-281-69",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "68462-0281-69",
"ProductNDC": "68462-281",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brimonidine Tartrate/timolol Maleate",
"NonProprietaryName": "Brimonidine Tartrate And Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214987",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "BRIMONIDINE TARTRATE; TIMOLOL MALEATE",
"StrengthNumber": "2; 5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240516",
"SamplePackage": "N",
"IndicationAndUsage": "Brimonidine tartrate and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The IOP-lowering of brimonidine tartrate and timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.",
"Description": "Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution 0.2%/0.5%, sterile, contains brimonidine tartrate, a relatively selective alpha-2 adrenergic receptor agonist, and timolol maleate, a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent) for topical ophthalmic use. The structural formulae are. Brimonidine tartrate. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.22. Timolol maleate. (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.49 as the maleate salt. In solution, Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3. Brimonidine tartrate appears as a white, or slightly yellowish, or slightly brownish powder and is soluble in water and practically insoluble in anhydrous ethanol and toluene. Timolol maleate appears as a white to practically white powder and is soluble in water, methanol, and alcohol, sparingly soluble in chloroform and propylene glycol and insoluble in ether and cyclohexane. Each mL of Brimonidine Tartrate and Timolol Maleate Ophthalmic Solutioncontains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% (6.8 mg/mL timolol maleate) with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, monobasic; sodium phosphate, dibasic; water for injection; and hydrochloric acid and/or sodium hydroxide to adjust pH."
},
{
"NDCCode": "68462-297-17",
"PackageDescription": "15 g in 1 CARTON (68462-297-17) ",
"NDC11Code": "68462-0297-17",
"ProductNDC": "68462-297",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox Olamine",
"NonProprietaryName": "Ciclopirox Olamine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090273",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CICLOPIROX OLAMINE",
"StrengthNumber": "7.7",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091113",
"SamplePackage": "N",
"IndicationAndUsage": "Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.",
"Description": "Ciclopirox olamine cream, USP, 0.77% is for topical use. Each gram of ciclopirox olamine cream, USP contains 7.70 mg of ciclopirox (as ciclopirox olamine USP) in a water miscible vanishing cream base consisting of benzyl alcohol (1%) as preservative, cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate and stearyl alcohol. Ciclopirox olamine cream, USP contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine USP). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2 -aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is."
},
{
"NDCCode": "68462-297-35",
"PackageDescription": "30 g in 1 CARTON (68462-297-35) ",
"NDC11Code": "68462-0297-35",
"ProductNDC": "68462-297",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox Olamine",
"NonProprietaryName": "Ciclopirox Olamine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090273",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CICLOPIROX OLAMINE",
"StrengthNumber": "7.7",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091113",
"SamplePackage": "N",
"IndicationAndUsage": "Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.",
"Description": "Ciclopirox olamine cream, USP, 0.77% is for topical use. Each gram of ciclopirox olamine cream, USP contains 7.70 mg of ciclopirox (as ciclopirox olamine USP) in a water miscible vanishing cream base consisting of benzyl alcohol (1%) as preservative, cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate and stearyl alcohol. Ciclopirox olamine cream, USP contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine USP). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2 -aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is."
},
{
"NDCCode": "68462-297-92",
"PackageDescription": "90 g in 1 CARTON (68462-297-92) ",
"NDC11Code": "68462-0297-92",
"ProductNDC": "68462-297",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox Olamine",
"NonProprietaryName": "Ciclopirox Olamine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090273",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "CICLOPIROX OLAMINE",
"StrengthNumber": "7.7",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091113",
"SamplePackage": "N",
"IndicationAndUsage": "Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.",
"Description": "Ciclopirox olamine cream, USP, 0.77% is for topical use. Each gram of ciclopirox olamine cream, USP contains 7.70 mg of ciclopirox (as ciclopirox olamine USP) in a water miscible vanishing cream base consisting of benzyl alcohol (1%) as preservative, cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate and stearyl alcohol. Ciclopirox olamine cream, USP contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine USP). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2 -aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is."
},
{
"NDCCode": "68462-590-89",
"PackageDescription": "1 BOTTLE in 1 CARTON (68462-590-89) / 118.28 mL in 1 BOTTLE",
"NDC11Code": "68462-0590-89",
"ProductNDC": "68462-590",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210539",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".11",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181030",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone acetonide topical oil, 0.01% is a low to medium potency corticosteroid indicated. In adult patients for the treatment of psoriasis of the scalp (Scalp Oil).",
"Description": "Fluocinolone Acetonide Topical Oil, 0.01% contains fluocinolone acetonide, USP (6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene) bis-(oxy)]-pregna-1,4-diene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as Fluocinolone Acetonide Topical Oil, 0.01%, fluocinolone acetonide for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older and as fluocinolone acetonide oil, 0.01% for chronic eczematous external otitis. Chemically, fluocinolone acetonide, USP is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide, USP in Fluocinolone Acetonide Topical Oil, 0.01% has a molecular weight of 452.49. It is a white to almost white, crystalline powder and melts at about 270°C with decomposition; practically insoluble in water and heptane, soluble in methanol, anhydrous ethanol and acetone, slightly soluble in ether and chloroform. Each gram of Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide, USP in a blend of oils, which contains anhydrous citric acid, isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic."
},
{
"NDCCode": "68462-591-89",
"PackageDescription": "1 BOTTLE in 1 CARTON (68462-591-89) / 118.28 mL in 1 BOTTLE",
"NDC11Code": "68462-0591-89",
"ProductNDC": "68462-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210556",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".11",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-22",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20181026",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone acetonide body oil is a corticosteroid indicated for the topical treatment of: 1 atopic dermatitis in adults (1), 2 moderate to severe atopic dermatitis in pediatric patients 3 months of age and older (1).",
"Description": "Fluocinolone Acetonide body oil, 0.01% (fluocinolone acetonide), topical oil, 0.01% contains fluocinolone acetonide, USP (6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17 [(1-methylethylidene)bis-(oxy)]-pregna-1,4-diene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide, USP is C24 H30 F2 O6. It has the following structural formula. Fluocinolone acetonide, USP has a molecular weight of 452.49. It is a white to almost white, crystalline powder and melts at 270°C with decomposition; practically insoluble in water and heptane; soluble in methanol, anhydrous ethanol and acetone; slightly soluble in ether and chloroform. Each gram of Fluocinolone Acetonide Topical Oil contains approximately 0.11 mg of fluocinolone acetonide, USP in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil. Fluocinolone Acetonide body oil is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in fluocinolone acetonide body oil is heated at 246°C (475°F) for at least 15 minutes. The refined peanut oil used in fluocinolone acetonide body oil is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million (ppm)."
},
{
"NDCCode": "68462-720-29",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (68462-720-29) / 1 KIT in 1 BLISTER PACK (68462-720-84) ",
"NDC11Code": "68462-0720-29",
"ProductNDC": "68462-720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Drospirenone And Ethinyl Estradiol",
"NonProprietaryName": "Drospirenone And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20150817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204296",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150817",
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"IndicationAndUsage": "Drospirenone and ethinyl estradiol tablets are a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2) , 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).",
"Description": "Drospirenone and Ethinyl Estradiol Tablets, USP provide an oral contraceptive regimen consisting of 24 brown to reddish brown active film-coated tablets each containing 3 mg of drospirenone, USP and 0.02 mg of ethinyl estradiol, USP and 4 white to off-white inert film-coated tablets. The inactive ingredients in the brown to reddish brown tablets are corn starch, crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, povidone, talc, titanium dioxide. The white to off-white inert film-coated tablets contain anhydrous lactose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80, titanium dioxide. Drospirenone, USP (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5’H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.49 and a molecular formula of C24H30O3. Ethinyl estradiol, USP (19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows:. Drospirenone, USP. Ethinyl Estradiol, USP."
},
{
"NDCCode": "0007-3261-01",
"PackageDescription": "20 mL in 1 VIAL, SINGLE-USE (0007-3261-01)",
"NDC11Code": "00007-3261-01",
"ProductNDC": "0007-3261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bexxar",
"ProprietaryNameSuffix": "Dosimetric",
"NonProprietaryName": "Tositumomab I-131",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090715",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125011",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "TOSITUMOMAB I-131",
"StrengthNumber": ".61",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "CD20-directed Antibody Interactions [MoA],CD20-directed Radiotherapeutic Antibody [EPC],Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "0007-3262-01",
"PackageDescription": "20 mL in 1 VIAL, SINGLE-USE (0007-3262-01)",
"NDC11Code": "00007-3262-01",
"ProductNDC": "0007-3262",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bexxar",
"ProprietaryNameSuffix": "Therapeutic",
"NonProprietaryName": "Tositumomab I-131",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20090715",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125011",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "TOSITUMOMAB I-131",
"StrengthNumber": "5.6",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "CD20-directed Antibody Interactions [MoA],CD20-directed Radiotherapeutic Antibody [EPC],Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-03-05"
},
{
"NDCCode": "0019-9450-01",
"PackageDescription": "1 VIAL in 1 CAN (0019-9450-01) > 1 mL in 1 VIAL",
"NDC11Code": "00019-9450-01",
"ProductNDC": "0019-9450",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Iodide I-131",
"ProprietaryNameSuffix": "Therapeutic",
"NonProprietaryName": "Sodium Iodide, I-131",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20110822",
"EndMarketingDate": "20170701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016515",
"LabelerName": "Mallinckrodt Inc.",
"SubstanceName": "SODIUM IODIDE I-131",
"StrengthNumber": "5",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
},
{
"NDCCode": "0019-9450-02",
"PackageDescription": "1 VIAL in 1 CAN (0019-9450-02) > 2 mL in 1 VIAL",
"NDC11Code": "00019-9450-02",
"ProductNDC": "0019-9450",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Iodide I-131",
"ProprietaryNameSuffix": "Therapeutic",
"NonProprietaryName": "Sodium Iodide, I-131",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20110822",
"EndMarketingDate": "20170701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016515",
"LabelerName": "Mallinckrodt Inc.",
"SubstanceName": "SODIUM IODIDE I-131",
"StrengthNumber": "5",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
}
]
}
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<IndicationAndUsage>Triamcinolone Acetonide Cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide USP is designated chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. Graphic Formula:. C24H31FO6 M.W. 434.50. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerine, lactic acid, benzyl alcohol and purified water.</Description>
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<PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (68462-184-49) / 70 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
<NDC11Code>68462-0184-49</NDC11Code>
<ProductNDC>68462-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
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<DosageFormName>GEL</DosageFormName>
<RouteName>VAGINAL</RouteName>
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<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
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<PackageDescription>1 TUBE in 1 CARTON (68462-797-49) / 80 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0797-49</NDC11Code>
<ProductNDC>68462-797</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208320</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone Acetonide Ointment 0.1% and 0.5% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide USP is designated chemically as 9-Fluoro-11, 16, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Structural Formula:. C24H31FO6, MW 434.50. Each gram of 0.1% and 0.5% Triamcinolone Acetonide Ointment USP contains 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum.</Description>
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<PackageDescription>1 TUBE in 1 CARTON (68462-131-17) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>68462-0131-17</NDC11Code>
<ProductNDC>68462-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
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<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone Acetonide Cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide USP is designated chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. Graphic Formula:. C24H31FO6 M.W. 434.50. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerine, lactic acid, benzyl alcohol and purified water.</Description>
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<Status>Active</Status>
<LastUpdate>2024-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone Acetonide Cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide USP is designated chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. Graphic Formula:. C24H31FO6 M.W. 434.50. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerine, lactic acid, benzyl alcohol and purified water.</Description>
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<PackageDescription>454 g in 1 JAR (68462-131-59) </PackageDescription>
<NDC11Code>68462-0131-59</NDC11Code>
<ProductNDC>68462-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
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<DosageFormName>CREAM</DosageFormName>
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<StrengthUnit>mg/g</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2024-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone Acetonide Cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide USP is designated chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. Graphic Formula:. C24H31FO6 M.W. 434.50. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerine, lactic acid, benzyl alcohol and purified water.</Description>
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<NDC11Code>42507-0131-49</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130413</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078682</ApplicationNumber>
<LabelerName>Hy-Vee</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130413</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC11Code>55316-0131-49</NDC11Code>
<ProductNDC>55316-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
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<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121211</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078682</ApplicationNumber>
<LabelerName>Healthy Accents (DZA Brands, LLC)</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20121211</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>59779-131-49</NDCCode>
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<ProprietaryName>Cvs Pharmacy Ibuprofen</ProprietaryName>
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<StartMarketingDate>20091204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079205</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216509</ApplicationNumber>
<LabelerName>Granules India Ltd</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate is a beta-adrenergic blocker indicated for the treatment of. : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .</IndicationAndUsage>
<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 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, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 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; soluble in methanol; sparingly soluble in alcohol; slightly soluble in isopropyl alcohol. Inactive ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, d-mannitol, ethylcellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
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<NDCCode>53041-688-03</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (53041-688-03) </PackageDescription>
<NDC11Code>53041-0688-03</NDC11Code>
<ProductNDC>53041-688</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diatrizoate Meglumine And Diatrizoate Sodium</ProprietaryName>
<NonProprietaryName>Diatrizoate Meglumine And Diatrizoate Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; RECTAL</RouteName>
<StartMarketingDate>20191218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214201</ApplicationNumber>
<LabelerName>Guardian Drug Company</LabelerName>
<SubstanceName>DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM</SubstanceName>
<StrengthNumber>660; 100</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-07</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20191218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diatrizoate Meglumine and Diatrizoate Sodium Solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous.Diatrizoate Meglumine and Diatrizoate Sodium Solution may also be used as an adjunct to contrast enhancement is computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology.</IndicationAndUsage>
<Description>Diatrizoate Meglumine and Diatrizoate Sodium Solution USP is a palatable lemon-flavored water-soluble iodinated radiopaque contrast medium for oral or rectal administration only. Each mL contains 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium; pH has been adjusted to 6.0 to 7.6 with sodium hydroxide. Each mL contains approximately 4.8 mg (0.21 mEq) sodium and 367 mg organically bound iodine. Inactive ingredients: edetate disodium, flavor, hydrochloric acid, polysorbate 80, purified water, saccharin sodium, simethicone, sodium citrate and sodium hydroxide. Diatrizoate meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitol 3,5-diacetamido-2,4,6-triiodo-benzoate (salt); diatrizoate sodium is monosodium 3, 5-diacetamido-2,4,6-triiodobenzoate. Structural formulas. Diatrizoate Meglumine C11H9I3N2O4.C7H17NO5MW 809.13Organically Bound Iodine: 47.1%CAS – 131-49-7. Diatrizoate SodiumC11H8I3N2NaO4MW 635.90Organically Bound Iodine: 59.9%CAS – 737-31-5.</Description>
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<NDC>
<NDCCode>53041-690-03</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, GLASS (53041-690-03) </PackageDescription>
<NDC11Code>53041-0690-03</NDC11Code>
<ProductNDC>53041-690</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diatrizoate Meglumine And Diatrizoate Sodium</ProprietaryName>
<NonProprietaryName>Diatrizoate Meglumine And Diatrizoate Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; RECTAL</RouteName>
<StartMarketingDate>20191218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214201</ApplicationNumber>
<LabelerName>Guardian Drug Company</LabelerName>
<SubstanceName>DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM</SubstanceName>
<StrengthNumber>660; 100</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diatrizoate Meglumine and Diatrizoate Sodium Solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous.Diatrizoate Meglumine and Diatrizoate Sodium Solution may also be used as an adjunct to contrast enhancement is computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology.</IndicationAndUsage>
<Description>Diatrizoate Meglumine and Diatrizoate Sodium Solution USP is a palatable lemon-flavored water-soluble iodinated radiopaque contrast medium for oral or rectal administration only. Each mL contains 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium; pH has been adjusted to 6.0 to 7.6 with sodium hydroxide. Each mL contains approximately 4.8 mg (0.21 mEq) sodium and 367 mg organically bound iodine. Inactive ingredients: edetate disodium, flavor, hydrochloric acid, polysorbate 80, purified water, saccharin sodium, simethicone, sodium citrate and sodium hydroxide. Diatrizoate meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitol 3,5-diacetamido-2,4,6-triiodo-benzoate (salt); diatrizoate sodium is monosodium 3, 5-diacetamido-2,4,6-triiodobenzoate. Structural formulas. Diatrizoate Meglumine C11H9I3N2O4.C7H17NO5MW 809.13Organically Bound Iodine: 47.1%CAS – 131-49-7. Diatrizoate SodiumC11H8I3N2NaO4MW 635.90Organically Bound Iodine: 59.9%CAS – 737-31-5.</Description>
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<NDC>
<NDCCode>53041-690-09</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (53041-690-09) </PackageDescription>
<NDC11Code>53041-0690-09</NDC11Code>
<ProductNDC>53041-690</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diatrizoate Meglumine And Diatrizoate Sodium</ProprietaryName>
<NonProprietaryName>Diatrizoate Meglumine And Diatrizoate Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; RECTAL</RouteName>
<StartMarketingDate>20191218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214201</ApplicationNumber>
<LabelerName>Guardian Drug Company</LabelerName>
<SubstanceName>DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM</SubstanceName>
<StrengthNumber>660; 100</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diatrizoate Meglumine and Diatrizoate Sodium Solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous.Diatrizoate Meglumine and Diatrizoate Sodium Solution may also be used as an adjunct to contrast enhancement is computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology.</IndicationAndUsage>
<Description>Diatrizoate Meglumine and Diatrizoate Sodium Solution USP is a palatable lemon-flavored water-soluble iodinated radiopaque contrast medium for oral or rectal administration only. Each mL contains 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium; pH has been adjusted to 6.0 to 7.6 with sodium hydroxide. Each mL contains approximately 4.8 mg (0.21 mEq) sodium and 367 mg organically bound iodine. Inactive ingredients: edetate disodium, flavor, hydrochloric acid, polysorbate 80, purified water, saccharin sodium, simethicone, sodium citrate and sodium hydroxide. Diatrizoate meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitol 3,5-diacetamido-2,4,6-triiodo-benzoate (salt); diatrizoate sodium is monosodium 3, 5-diacetamido-2,4,6-triiodobenzoate. Structural formulas. Diatrizoate Meglumine C11H9I3N2O4.C7H17NO5MW 809.13Organically Bound Iodine: 47.1%CAS – 131-49-7. Diatrizoate SodiumC11H8I3N2NaO4MW 635.90Organically Bound Iodine: 59.9%CAS – 737-31-5.</Description>
</NDC>
<NDC>
<NDCCode>61314-543-94</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61314-543-94) / 15 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>61314-0543-94</NDC11Code>
<ProductNDC>61314-543</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tyruko</ProprietaryName>
<NonProprietaryName>Natalizumab-sztn</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251117</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761322</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>NATALIZUMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Integrin Receptor Antagonist [EPC], Integrin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TYRUKO is an integrin receptor antagonist indicated for treatment of:. Multiple Sclerosis (MS). TYRUKO is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Natalizumab products increase the risk of PML [see Warnings and Precautions (5.1)]. When initiating and continuing treatment with TYRUKO, physicians should consider whether the expected benefit of TYRUKO is sufficient to offset this risk. (1.1). Crohn's Disease (CD): 1 TYRUKO is indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α. (1.2) .</IndicationAndUsage>
<Description>Natalizumab-sztn is a recombinant humanized IgG4ĸ monoclonal antibody produced in a Chinese hamster ovary (CHO) mammalian cell expression system. Natalizumab-sztn contains human framework regions and the complementarity-determining regions of an antibody that binds to α4-integrin. The molecular weight of natalizumab-sztn is 149 kilodaltons. TYRUKO (natalizumab-sztn) injection is supplied as a sterile, preservative-free, colorless, and clear to slightly opalescent solution for intravenous infusion. Each 15 mL of solution contains 300 mg natalizumab-sztn; histidine (6.36 mg); L-histidine hydrochloride monohydrate (22.86 mg); polysorbate 80, USP/NF (3 mg); sodium chloride, USP (131.49 mg); and Water for Injection, USP at pH 5.7.</Description>
</NDC>
<NDC>
<NDCCode>62032-131-70</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62032-131-70) > 50 g in 1 TUBE</PackageDescription>
<NDC11Code>62032-0131-70</NDC11Code>
<ProductNDC>62032-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gentle Rejuvenation Ultra Light Repair Spf 30</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Homosalate, Octinoxate, Octocrylene, And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131015</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC.</LabelerName>
<SubstanceName>HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE</SubstanceName>
<StrengthNumber>120; 75; 20; 49</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69269-131-70</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69269-131-70) > 50 g in 1 TUBE</PackageDescription>
<NDC11Code>69269-0131-70</NDC11Code>
<ProductNDC>69269-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Obagi</ProprietaryName>
<NonProprietaryName>Homosalate, Octinoxate, Octocrylene, Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>YS PLUS CORPORATION</LabelerName>
<SubstanceName>HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE</SubstanceName>
<StrengthNumber>120; 75; 20; 49</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-06-14</LastUpdate>
</NDC>
<NDC>
<NDCCode>83831-131-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (83831-131-01) / 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>83831-0131-01</NDC11Code>
<ProductNDC>83831-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Axtle</ProprietaryName>
<NonProprietaryName>Pemetrexed</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210661</ApplicationNumber>
<LabelerName>Avyxa Pharma, LLC</LabelerName>
<SubstanceName>PEMETREXED</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AXTLE is a folate analog metabolic inhibitor indicated: : 1 in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. (1.1), 2 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. (1.1), 3 as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 4 as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1).</IndicationAndUsage>
<Description>Pemetrexed is a folate analog metabolic inhibitor. The drug substance is pemetrexed dipotassium heptahydrate, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, dipotassium salt, heptahydrate. It is a white to off-white powder having blue or green tinge with a molecular formula of C20H19K2N5O6 .7 H2O and a molecular weight of 629.49. Pemetrexed dipotassium is freely soluble in water. The reported pKaS are 3.6 and 4.5. The structural formula of pemetrexed dipotassium heptahydrate is as follows. AXTLE is supplied as a sterile white to light-yellow or green-yellow lyophilized powder or cake for intravenous infusion available in single-dose vials. Each 100-mg or 500-mg vial of AXTLE contains 100 mg pemetrexed equivalent to 118.3 mg pemetrexed dipotassium and 106 mg mannitol or 500 mg pemetrexed equivalent to 591.5 mg pemetrexed dipotassium and 500 mg mannitol, respectively. Hydrochloric acid may have been added to adjust the pH.</Description>
</NDC>
<NDC>
<NDCCode>68462-185-56</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) / 20 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>68462-0185-56</NDC11Code>
<ProductNDC>68462-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20181218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211815</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.11</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone acetonide oil, 0.01% (ear drops) is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contain fluocinolone acetonide, USP {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. Chemically, fluocinolone acetonide, USP is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide, USP in Fluocinolone Acetonide Oil, 0.01% (Ear Drops) has a molecular weight of 452.49. It is a white or almost white, crystalline powder and melts at 270°C with decomposition; practically insoluble in water and heptane, soluble in methanol, anhydrous ethanol and acetone, slightly soluble in ether and chloroform. Each gram of Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contains approximately 0.11 mg of fluocinolone acetonide, USP in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF.</Description>
</NDC>
<NDC>
<NDCCode>68462-281-32</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (68462-281-32) / 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>68462-0281-32</NDC11Code>
<ProductNDC>68462-281</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brimonidine Tartrate/timolol Maleate</ProprietaryName>
<NonProprietaryName>Brimonidine Tartrate And Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214987</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>BRIMONIDINE TARTRATE; TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>2; 5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Brimonidine tartrate and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The IOP-lowering of brimonidine tartrate and timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.</IndicationAndUsage>
<Description>Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution 0.2%/0.5%, sterile, contains brimonidine tartrate, a relatively selective alpha-2 adrenergic receptor agonist, and timolol maleate, a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent) for topical ophthalmic use. The structural formulae are. Brimonidine tartrate. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.22. Timolol maleate. (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.49 as the maleate salt. In solution, Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3. Brimonidine tartrate appears as a white, or slightly yellowish, or slightly brownish powder and is soluble in water and practically insoluble in anhydrous ethanol and toluene. Timolol maleate appears as a white to practically white powder and is soluble in water, methanol, and alcohol, sparingly soluble in chloroform and propylene glycol and insoluble in ether and cyclohexane. Each mL of Brimonidine Tartrate and Timolol Maleate Ophthalmic Solutioncontains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% (6.8 mg/mL timolol maleate) with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, monobasic; sodium phosphate, dibasic; water for injection; and hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>68462-281-69</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (68462-281-69) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>68462-0281-69</NDC11Code>
<ProductNDC>68462-281</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brimonidine Tartrate/timolol Maleate</ProprietaryName>
<NonProprietaryName>Brimonidine Tartrate And Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214987</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>BRIMONIDINE TARTRATE; TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>2; 5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Brimonidine tartrate and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The IOP-lowering of brimonidine tartrate and timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.</IndicationAndUsage>
<Description>Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution 0.2%/0.5%, sterile, contains brimonidine tartrate, a relatively selective alpha-2 adrenergic receptor agonist, and timolol maleate, a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent) for topical ophthalmic use. The structural formulae are. Brimonidine tartrate. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.22. Timolol maleate. (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.49 as the maleate salt. In solution, Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3. Brimonidine tartrate appears as a white, or slightly yellowish, or slightly brownish powder and is soluble in water and practically insoluble in anhydrous ethanol and toluene. Timolol maleate appears as a white to practically white powder and is soluble in water, methanol, and alcohol, sparingly soluble in chloroform and propylene glycol and insoluble in ether and cyclohexane. Each mL of Brimonidine Tartrate and Timolol Maleate Ophthalmic Solutioncontains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% (6.8 mg/mL timolol maleate) with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, monobasic; sodium phosphate, dibasic; water for injection; and hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>68462-297-17</NDCCode>
<PackageDescription>15 g in 1 CARTON (68462-297-17) </PackageDescription>
<NDC11Code>68462-0297-17</NDC11Code>
<ProductNDC>68462-297</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox Olamine</ProprietaryName>
<NonProprietaryName>Ciclopirox Olamine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090273</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CICLOPIROX OLAMINE</SubstanceName>
<StrengthNumber>7.7</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.</IndicationAndUsage>
<Description>Ciclopirox olamine cream, USP, 0.77% is for topical use. Each gram of ciclopirox olamine cream, USP contains 7.70 mg of ciclopirox (as ciclopirox olamine USP) in a water miscible vanishing cream base consisting of benzyl alcohol (1%) as preservative, cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate and stearyl alcohol. Ciclopirox olamine cream, USP contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine USP). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2 -aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>68462-297-35</NDCCode>
<PackageDescription>30 g in 1 CARTON (68462-297-35) </PackageDescription>
<NDC11Code>68462-0297-35</NDC11Code>
<ProductNDC>68462-297</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox Olamine</ProprietaryName>
<NonProprietaryName>Ciclopirox Olamine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090273</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CICLOPIROX OLAMINE</SubstanceName>
<StrengthNumber>7.7</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.</IndicationAndUsage>
<Description>Ciclopirox olamine cream, USP, 0.77% is for topical use. Each gram of ciclopirox olamine cream, USP contains 7.70 mg of ciclopirox (as ciclopirox olamine USP) in a water miscible vanishing cream base consisting of benzyl alcohol (1%) as preservative, cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate and stearyl alcohol. Ciclopirox olamine cream, USP contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine USP). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2 -aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>68462-297-92</NDCCode>
<PackageDescription>90 g in 1 CARTON (68462-297-92) </PackageDescription>
<NDC11Code>68462-0297-92</NDC11Code>
<ProductNDC>68462-297</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox Olamine</ProprietaryName>
<NonProprietaryName>Ciclopirox Olamine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090273</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>CICLOPIROX OLAMINE</SubstanceName>
<StrengthNumber>7.7</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.</IndicationAndUsage>
<Description>Ciclopirox olamine cream, USP, 0.77% is for topical use. Each gram of ciclopirox olamine cream, USP contains 7.70 mg of ciclopirox (as ciclopirox olamine USP) in a water miscible vanishing cream base consisting of benzyl alcohol (1%) as preservative, cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate and stearyl alcohol. Ciclopirox olamine cream, USP contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine USP). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2 -aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>68462-590-89</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68462-590-89) / 118.28 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68462-0590-89</NDC11Code>
<ProductNDC>68462-590</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210539</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.11</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone acetonide topical oil, 0.01% is a low to medium potency corticosteroid indicated. In adult patients for the treatment of psoriasis of the scalp (Scalp Oil).</IndicationAndUsage>
<Description>Fluocinolone Acetonide Topical Oil, 0.01% contains fluocinolone acetonide, USP (6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene) bis-(oxy)]-pregna-1,4-diene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as Fluocinolone Acetonide Topical Oil, 0.01%, fluocinolone acetonide for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older and as fluocinolone acetonide oil, 0.01% for chronic eczematous external otitis. Chemically, fluocinolone acetonide, USP is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide, USP in Fluocinolone Acetonide Topical Oil, 0.01% has a molecular weight of 452.49. It is a white to almost white, crystalline powder and melts at about 270°C with decomposition; practically insoluble in water and heptane, soluble in methanol, anhydrous ethanol and acetone, slightly soluble in ether and chloroform. Each gram of Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide, USP in a blend of oils, which contains anhydrous citric acid, isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.</Description>
</NDC>
<NDC>
<NDCCode>68462-591-89</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68462-591-89) / 118.28 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>68462-0591-89</NDC11Code>
<ProductNDC>68462-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210556</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.11</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone acetonide body oil is a corticosteroid indicated for the topical treatment of: 1 atopic dermatitis in adults (1), 2 moderate to severe atopic dermatitis in pediatric patients 3 months of age and older (1).</IndicationAndUsage>
<Description>Fluocinolone Acetonide body oil, 0.01% (fluocinolone acetonide), topical oil, 0.01% contains fluocinolone acetonide, USP (6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17 [(1-methylethylidene)bis-(oxy)]-pregna-1,4-diene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide, USP is C24 H30 F2 O6. It has the following structural formula. Fluocinolone acetonide, USP has a molecular weight of 452.49. It is a white to almost white, crystalline powder and melts at 270°C with decomposition; practically insoluble in water and heptane; soluble in methanol, anhydrous ethanol and acetone; slightly soluble in ether and chloroform. Each gram of Fluocinolone Acetonide Topical Oil contains approximately 0.11 mg of fluocinolone acetonide, USP in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil. Fluocinolone Acetonide body oil is formulated with 48% refined peanut oil. The bulk refined peanut oil, used in fluocinolone acetonide body oil is heated at 246°C (475°F) for at least 15 minutes. The refined peanut oil used in fluocinolone acetonide body oil is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million (ppm).</Description>
</NDC>
<NDC>
<NDCCode>68462-720-29</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (68462-720-29) / 1 KIT in 1 BLISTER PACK (68462-720-84) </PackageDescription>
<NDC11Code>68462-0720-29</NDC11Code>
<ProductNDC>68462-720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Drospirenone And Ethinyl Estradiol</ProprietaryName>
<NonProprietaryName>Drospirenone And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204296</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Drospirenone and ethinyl estradiol tablets are a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: 1 Prevent pregnancy. (1.1), 2 Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. (1.2) , 3 Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3).</IndicationAndUsage>
<Description>Drospirenone and Ethinyl Estradiol Tablets, USP provide an oral contraceptive regimen consisting of 24 brown to reddish brown active film-coated tablets each containing 3 mg of drospirenone, USP and 0.02 mg of ethinyl estradiol, USP and 4 white to off-white inert film-coated tablets. The inactive ingredients in the brown to reddish brown tablets are corn starch, crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, povidone, talc, titanium dioxide. The white to off-white inert film-coated tablets contain anhydrous lactose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80, titanium dioxide. Drospirenone, USP (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5’H)-furan]-3,5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.49 and a molecular formula of C24H30O3. Ethinyl estradiol, USP (19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows:. Drospirenone, USP. Ethinyl Estradiol, USP.</Description>
</NDC>
<NDC>
<NDCCode>0007-3261-01</NDCCode>
<PackageDescription>20 mL in 1 VIAL, SINGLE-USE (0007-3261-01)</PackageDescription>
<NDC11Code>00007-3261-01</NDC11Code>
<ProductNDC>0007-3261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bexxar</ProprietaryName>
<ProprietaryNameSuffix>Dosimetric</ProprietaryNameSuffix>
<NonProprietaryName>Tositumomab I-131</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090715</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125011</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>TOSITUMOMAB I-131</SubstanceName>
<StrengthNumber>.61</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>CD20-directed Antibody Interactions [MoA],CD20-directed Radiotherapeutic Antibody [EPC],Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0007-3262-01</NDCCode>
<PackageDescription>20 mL in 1 VIAL, SINGLE-USE (0007-3262-01)</PackageDescription>
<NDC11Code>00007-3262-01</NDC11Code>
<ProductNDC>0007-3262</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bexxar</ProprietaryName>
<ProprietaryNameSuffix>Therapeutic</ProprietaryNameSuffix>
<NonProprietaryName>Tositumomab I-131</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20090715</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125011</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>TOSITUMOMAB I-131</SubstanceName>
<StrengthNumber>5.6</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>CD20-directed Antibody Interactions [MoA],CD20-directed Radiotherapeutic Antibody [EPC],Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-03-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0019-9450-01</NDCCode>
<PackageDescription>1 VIAL in 1 CAN (0019-9450-01) > 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>00019-9450-01</NDC11Code>
<ProductNDC>0019-9450</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Iodide I-131</ProprietaryName>
<ProprietaryNameSuffix>Therapeutic</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Iodide, I-131</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110822</StartMarketingDate>
<EndMarketingDate>20170701</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016515</ApplicationNumber>
<LabelerName>Mallinckrodt Inc.</LabelerName>
<SubstanceName>SODIUM IODIDE I-131</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0019-9450-02</NDCCode>
<PackageDescription>1 VIAL in 1 CAN (0019-9450-02) > 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>00019-9450-02</NDC11Code>
<ProductNDC>0019-9450</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Iodide I-131</ProprietaryName>
<ProprietaryNameSuffix>Therapeutic</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Iodide, I-131</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110822</StartMarketingDate>
<EndMarketingDate>20170701</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016515</ApplicationNumber>
<LabelerName>Mallinckrodt Inc.</LabelerName>
<SubstanceName>SODIUM IODIDE I-131</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
</NDC>
</NDCList>