{
"NDC": [
{
"NDCCode": "59088-685-52",
"PackageDescription": "85 g in 1 PACKAGE (59088-685-52) ",
"NDC11Code": "59088-0685-52",
"ProductNDC": "59088-685",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Maximum Strength Feminine Anti-itch Wipes",
"NonProprietaryName": "Pramoxine Hydrochloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190603",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "PureTek Corporation",
"SubstanceName": "PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190603",
"SamplePackage": "N"
},
{
"NDCCode": "76348-685-02",
"PackageDescription": "52 mL in 1 BOTTLE, PUMP (76348-685-02) ",
"NDC11Code": "76348-0685-02",
"ProductNDC": "76348-685",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clear Reflection Complexion Acne Treatment Serum",
"NonProprietaryName": "Salicylic Acid 2%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231030",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Renu Laboratories, Inc.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "1.04",
"StrengthUnit": "g/52mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231030",
"SamplePackage": "N",
"IndicationAndUsage": "Recommended use is in the morning after cleansing and before applying any makeup."
},
{
"NDCCode": "0143-9168-01",
"PackageDescription": ".5 mL in 1 SYRINGE (0143-9168-01) ",
"NDC11Code": "00143-9168-01",
"ProductNDC": "0143-9168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Starjemza",
"NonProprietaryName": "Ustekinumab-hmny",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251027",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761419",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251027",
"SamplePackage": "N",
"IndicationAndUsage": "STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "0143-9169-01",
"PackageDescription": ".5 mL in 1 VIAL (0143-9169-01) ",
"NDC11Code": "00143-9169-01",
"ProductNDC": "0143-9169",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Starjemza",
"NonProprietaryName": "Ustekinumab-hmny",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251027",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761419",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251027",
"SamplePackage": "N",
"IndicationAndUsage": "STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "0143-9170-01",
"PackageDescription": "1 mL in 1 SYRINGE (0143-9170-01) ",
"NDC11Code": "00143-9170-01",
"ProductNDC": "0143-9170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Starjemza",
"NonProprietaryName": "Ustekinumab-hmny",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251027",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761419",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "90",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251027",
"SamplePackage": "N",
"IndicationAndUsage": "STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "0143-9171-01",
"PackageDescription": "26 mL in 1 VIAL (0143-9171-01) ",
"NDC11Code": "00143-9171-01",
"ProductNDC": "0143-9171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Starjemza",
"NonProprietaryName": "Ustekinumab-hmny",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251027",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761419",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "130",
"StrengthUnit": "mg/26mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251027",
"SamplePackage": "N",
"IndicationAndUsage": "STARJEMZA is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-hmny, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-hmny is produced in a Chinese hamster ovary cell line (CHO-BAT). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-hmny is comprised of 1326 amino acids and has an estimated molecular mass of approximately 145,000 Daltons (the polypeptide part only). STARJEMZA (ustekinumab-hmny) injection is a sterile, preservative-free, clear, colorless to light yellow solution with pH of 5.7-6.3. STARJEMZA for Subcutaneous Use. Available as 45 mg of ustekinumab-hmny in 0.5 mL and 90 mg of ustekinumab-hmny in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed 1/2 inch needle and as 45 mg of ustekinumab-hmny in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-hmny, histidine (0.265 mg), L-histidine hydrochloride monohydrate (0.685 mg), polysorbate 80 (0.05 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-hmny, histidine (0.53 mg), L-histidine hydrochloride monohydrate (1.37 mg), polysorbate 80 (0.1 mg), and sucrose (76 mg). STARJEMZA for Intravenous Infusion. Available as 130 mg of ustekinumab-hmny in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-hmny, edetate disodium (0.52 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "64980-685-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (64980-685-01) ",
"NDC11Code": "64980-0685-01",
"ProductNDC": "64980-685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218531",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250224",
"SamplePackage": "N",
"IndicationAndUsage": "Enalapril maleate tablets, USP is indicated for the treatment of hypertension. Enalapril maleate tablets, USP is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.",
"Description": "Enalapril maleate, USP is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as L–Proline, 1–[N-[1-(ethoxycarbonyl)–3–phenylpropyl]–L–alanyl]-,(S)-,(Z)-2-butenedioate(1:1). Its empirical formula is C20H28N2O5●C4H4O4, and its structural formula is. Enalapril maleate, USP is an off-white, crystalline powder with a molecular weight of 492.52. It is practically insoluble in n-Heptane (non-polar organic solvents), slightly soluble in Acetone (semi polar organic solvents), sparingly soluble in water, soluble in alcohol, freely soluble in methanol and in dimethyl formamide. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate, USP is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 4000, pregelatinised starch, sodium bicarbonate and sodium stearate. The 10 mg tablets also contain red iron oxide, and 20 mg tablets also contain yellow iron oxide and red iron oxide. FDA approved dissolution test specifications differs from the USP."
},
{
"NDCCode": "64980-685-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (64980-685-10) ",
"NDC11Code": "64980-0685-10",
"ProductNDC": "64980-685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218531",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250224",
"SamplePackage": "N",
"IndicationAndUsage": "Enalapril maleate tablets, USP is indicated for the treatment of hypertension. Enalapril maleate tablets, USP is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.",
"Description": "Enalapril maleate, USP is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as L–Proline, 1–[N-[1-(ethoxycarbonyl)–3–phenylpropyl]–L–alanyl]-,(S)-,(Z)-2-butenedioate(1:1). Its empirical formula is C20H28N2O5●C4H4O4, and its structural formula is. Enalapril maleate, USP is an off-white, crystalline powder with a molecular weight of 492.52. It is practically insoluble in n-Heptane (non-polar organic solvents), slightly soluble in Acetone (semi polar organic solvents), sparingly soluble in water, soluble in alcohol, freely soluble in methanol and in dimethyl formamide. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate, USP is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 4000, pregelatinised starch, sodium bicarbonate and sodium stearate. The 10 mg tablets also contain red iron oxide, and 20 mg tablets also contain yellow iron oxide and red iron oxide. FDA approved dissolution test specifications differs from the USP."
},
{
"NDCCode": "59088-754-00",
"PackageDescription": "1 KIT in 1 KIT (59088-754-00) * 1 TUBE in 1 CARTON (45802-151-94) / 30 g in 1 TUBE * 118 mL in 1 TUBE (59088-333-08) ",
"NDC11Code": "59088-0754-00",
"ProductNDC": "59088-754",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluopar",
"NonProprietaryName": "Fluocinonide, Dimethicone",
"DosageFormName": "KIT",
"StartMarketingDate": "20140114",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200303",
"SamplePackage": "N",
"Description": "Fluocinonide Cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6α, 9-Difluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione, cyclic 16, 17-acetal with acetone, 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.52. It has the following chemical structure. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of Fluocinonide Cream USP, 0.1% contains 1 mg fluocinonide in a cream base of carbopol 980, citric acid, diisopropanolamine, glycerin, glyceryl monostearate, glyceryl stearate, isostearic acid, PEG-100 stearate, polyethylene glycol monomethyl ether, propylene glycol, and water."
},
{
"NDCCode": "59088-755-00",
"PackageDescription": "1 KIT in 1 KIT (59088-755-00) * 1 TUBE in 1 CARTON (45802-151-94) > 30 g in 1 TUBE",
"NDC11Code": "59088-0755-00",
"ProductNDC": "59088-755",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinol Pak",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "KIT",
"StartMarketingDate": "20200702",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200702",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. Limitation of Use: 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea.",
"Description": "Fluocinonide Cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6α, 9-Difluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione, cyclic 16, 17-acetal with acetone, 21-acetate. Its chemical formula is C 26H 32F 2O 7 and it has a molecular weight of 494.52. It has the following chemical structure. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of Fluocinonide Cream USP, 0.1% contains 1 mg fluocinonide in a cream base of carbopol 980, citric acid, diisopropanolamine, glycerin, glyceryl monostearate, glyceryl stearate, isostearic acid, PEG-100 stearate, polyethylene glycol monomethyl ether, propylene glycol, and water."
},
{
"NDCCode": "10135-685-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (10135-685-10) ",
"NDC11Code": "10135-0685-10",
"ProductNDC": "10135-685",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "650",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200301",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves: 1 acid indigestion heartburn, 2 sour stomach, 3 upset stomach associated with these symptoms."
},
{
"NDCCode": "10967-685-61",
"PackageDescription": "15 g in 1 JAR (10967-685-61) ",
"NDC11Code": "10967-0685-61",
"ProductNDC": "10967-685",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prevage Anti-aging Eye Cream Spf 15",
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"ApplicationNumber": "ANDA074937",
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},
{
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"ProductNDC": "13533-685",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Plasbumin",
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"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
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"Pharm_Classes": "Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]",
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"LabelerName": "GRIFOLS USA, LLC",
"SubstanceName": "ALBUMIN HUMAN",
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"PackageDescription": "1 VIAL in 1 CARTON (13533-685-27) > 500 mL in 1 VIAL (13533-685-28) ",
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"ProductNDC": "13533-685",
"ProductTypeName": "PLASMA DERIVATIVE",
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"RouteName": "INTRAVENOUS",
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"LabelerName": "GRIFOLS USA, LLC",
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"Pharm_Classes": "Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N"
},
{
"NDCCode": "13537-685-02",
"PackageDescription": "1 BOTTLE in 1 BOX (13537-685-02) > 30 mL in 1 BOTTLE (13537-685-01)",
"NDC11Code": "13537-0685-02",
"ProductNDC": "13537-685",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Signs Of Age Appearance Minimizer Foundation Spf 20 Fm",
"ProprietaryNameSuffix": "Medium 5 - Beige",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151123",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".07; .0244",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
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"ProductNDC": "13811-685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202713",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
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"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "13811-685-10",
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"NDC11Code": "13811-0685-10",
"ProductNDC": "13811-685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
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"RouteName": "ORAL",
"StartMarketingDate": "20101228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202713",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
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"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "13811-685-30",
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"ProductNDC": "13811-685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
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"RouteName": "ORAL",
"StartMarketingDate": "20101228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202713",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
"StrengthNumber": "5; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "13811-685-50",
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"ProductNDC": "13811-685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Valsartan",
"NonProprietaryName": "Amlodipine And Valsartan",
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"RouteName": "ORAL",
"StartMarketingDate": "20101228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202713",
"LabelerName": "Trigen Laboratories, LLC",
"SubstanceName": "AMLODIPINE BESYLATE; VALSARTAN",
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"StrengthUnit": "mg/1; mg/1",
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"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "14141-685-02",
"PackageDescription": "1 BOTTLE in 1 BOX (14141-685-02) / 30 mL in 1 BOTTLE (14141-685-01) ",
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"ProductNDC": "14141-685",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Effet Parfait Signs Of Age Appearance Minimizer Foundation Spf 20 Fm",
"ProprietaryNameSuffix": "Medium 5 - Beige",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
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"EndMarketingDate": "20240315",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Bel Star S.A. (Colombia)",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": ".07; .0244",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2024-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20240315",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
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"ProductNDC": "16571-685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212285",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Clomipramine hydrochloride capsules USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/ day (up to 200 mg) for all children and adolescents. The effectiveness of Clomipramine hydrochloride capsules for long term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
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},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Rising Pharma Holdings, Inc.",
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"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
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"LastUpdate": "2025-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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},
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"MarketingCategoryName": "ANDA",
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"Status": "Active",
"LastUpdate": "2025-08-14",
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"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Clomipramine hydrochloride capsules USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/ day (up to 200 mg) for all children and adolescents. The effectiveness of Clomipramine hydrochloride capsules for long term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clomipramine hydrochloride capsules USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride USP is a white or slightly yellow, crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients. D&C Yellow 10, FD&C Red 40, FD&C Blue 1 (50 mg capsules only), gelatin, magnesium stearate, pregelatinized starch, and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ammonia solution, butyl alcohol, dehydrated alcohol, black iron oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP."
},
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"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue # 2 Lake of indigo carmine. 500 mg tablets: Ferric oxide yellow. 750 mg tablets: Ferric oxide red and FD&C # 6 lake of sunset yellow."
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"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue # 2 Lake of indigo carmine. 500 mg tablets: Ferric oxide yellow. 750 mg tablets: Ferric oxide red and FD&C # 6 lake of sunset yellow."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue # 2 Lake of indigo carmine. 500 mg tablets: Ferric oxide yellow. 750 mg tablets: Ferric oxide red and FD&C # 6 lake of sunset yellow."
}
]
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<StartMarketingDatePackage>20250224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enalapril maleate tablets, USP is indicated for the treatment of hypertension. Enalapril maleate tablets, USP is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.</IndicationAndUsage>
<Description>Enalapril maleate, USP is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as L–Proline, 1–[N-[1-(ethoxycarbonyl)–3–phenylpropyl]–L–alanyl]-,(S)-,(Z)-2-butenedioate(1:1). Its empirical formula is C20H28N2O5●C4H4O4, and its structural formula is. Enalapril maleate, USP is an off-white, crystalline powder with a molecular weight of 492.52. It is practically insoluble in n-Heptane (non-polar organic solvents), slightly soluble in Acetone (semi polar organic solvents), sparingly soluble in water, soluble in alcohol, freely soluble in methanol and in dimethyl formamide. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate, USP is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 4000, pregelatinised starch, sodium bicarbonate and sodium stearate. The 10 mg tablets also contain red iron oxide, and 20 mg tablets also contain yellow iron oxide and red iron oxide. FDA approved dissolution test specifications differs from the USP.</Description>
</NDC>
<NDC>
<NDCCode>64980-685-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (64980-685-10) </PackageDescription>
<NDC11Code>64980-0685-10</NDC11Code>
<ProductNDC>64980-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218531</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enalapril maleate tablets, USP is indicated for the treatment of hypertension. Enalapril maleate tablets, USP is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.</IndicationAndUsage>
<Description>Enalapril maleate, USP is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as L–Proline, 1–[N-[1-(ethoxycarbonyl)–3–phenylpropyl]–L–alanyl]-,(S)-,(Z)-2-butenedioate(1:1). Its empirical formula is C20H28N2O5●C4H4O4, and its structural formula is. Enalapril maleate, USP is an off-white, crystalline powder with a molecular weight of 492.52. It is practically insoluble in n-Heptane (non-polar organic solvents), slightly soluble in Acetone (semi polar organic solvents), sparingly soluble in water, soluble in alcohol, freely soluble in methanol and in dimethyl formamide. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate, USP is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 4000, pregelatinised starch, sodium bicarbonate and sodium stearate. The 10 mg tablets also contain red iron oxide, and 20 mg tablets also contain yellow iron oxide and red iron oxide. FDA approved dissolution test specifications differs from the USP.</Description>
</NDC>
<NDC>
<NDCCode>59088-754-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-754-00) * 1 TUBE in 1 CARTON (45802-151-94) / 30 g in 1 TUBE * 118 mL in 1 TUBE (59088-333-08) </PackageDescription>
<NDC11Code>59088-0754-00</NDC11Code>
<ProductNDC>59088-754</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluopar</ProprietaryName>
<NonProprietaryName>Fluocinonide, Dimethicone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140114</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Fluocinonide Cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6α, 9-Difluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione, cyclic 16, 17-acetal with acetone, 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.52. It has the following chemical structure. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of Fluocinonide Cream USP, 0.1% contains 1 mg fluocinonide in a cream base of carbopol 980, citric acid, diisopropanolamine, glycerin, glyceryl monostearate, glyceryl stearate, isostearic acid, PEG-100 stearate, polyethylene glycol monomethyl ether, propylene glycol, and water.</Description>
</NDC>
<NDC>
<NDCCode>59088-755-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-755-00) * 1 TUBE in 1 CARTON (45802-151-94) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0755-00</NDC11Code>
<ProductNDC>59088-755</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinol Pak</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20200702</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. Limitation of Use: 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1), 2 Avoid use on the face, groin, or axillae. (1.2), 3 Avoid use in perioral dermatitis or rosacea.</IndicationAndUsage>
<Description>Fluocinonide Cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6α, 9-Difluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione, cyclic 16, 17-acetal with acetone, 21-acetate. Its chemical formula is C 26H 32F 2O 7 and it has a molecular weight of 494.52. It has the following chemical structure. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of Fluocinonide Cream USP, 0.1% contains 1 mg fluocinonide in a cream base of carbopol 980, citric acid, diisopropanolamine, glycerin, glyceryl monostearate, glyceryl stearate, isostearic acid, PEG-100 stearate, polyethylene glycol monomethyl ether, propylene glycol, and water.</Description>
</NDC>
<NDC>
<NDCCode>10135-685-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (10135-685-10) </PackageDescription>
<NDC11Code>10135-0685-10</NDC11Code>
<ProductNDC>10135-685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>650</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves: 1 acid indigestion heartburn, 2 sour stomach, 3 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10967-685-61</NDCCode>
<PackageDescription>15 g in 1 JAR (10967-685-61) </PackageDescription>
<NDC11Code>10967-0685-61</NDC11Code>
<ProductNDC>10967-685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prevage Anti-aging Eye Cream Spf 15</ProprietaryName>
<NonProprietaryName>Octinoxate, Oxybenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Revlon</LabelerName>
<SubstanceName>OXYBENZONE; OCTINOXATE</SubstanceName>
<StrengthNumber>1.4; 4.1</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-685-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-685-26) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0685-26</NDC11Code>
<ProductNDC>11673-685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074937</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: : 1 relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache, 2 reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-685-28</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-685-28) > 148 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0685-28</NDC11Code>
<ProductNDC>11673-685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074937</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>11673-685-34</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-685-34) / 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0685-34</NDC11Code>
<ProductNDC>11673-685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074937</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: : 1 relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache, 2 reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13533-685-20</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (13533-685-20) > 50 mL in 1 VIAL (13533-685-21) </PackageDescription>
<NDC11Code>13533-0685-20</NDC11Code>
<ProductNDC>13533-685</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Plasbumin</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19760826</StartMarketingDate>
<EndMarketingDate>20181108</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101138</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19760826</StartMarketingDatePackage>
<EndMarketingDatePackage>20181108</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13533-685-25</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (13533-685-25) > 250 mL in 1 VIAL (13533-685-26) </PackageDescription>
<NDC11Code>13533-0685-25</NDC11Code>
<ProductNDC>13533-685</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Plasbumin</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19760826</StartMarketingDate>
<EndMarketingDate>20181108</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101138</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19760826</StartMarketingDatePackage>
<EndMarketingDatePackage>20181108</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13533-685-27</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (13533-685-27) > 500 mL in 1 VIAL (13533-685-28) </PackageDescription>
<NDC11Code>13533-0685-27</NDC11Code>
<ProductNDC>13533-685</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Plasbumin</ProprietaryName>
<NonProprietaryName>Albumin (human)</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19760826</StartMarketingDate>
<EndMarketingDate>20181108</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101138</ApplicationNumber>
<LabelerName>GRIFOLS USA, LLC</LabelerName>
<SubstanceName>ALBUMIN HUMAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19760826</StartMarketingDatePackage>
<EndMarketingDatePackage>20181108</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13537-685-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (13537-685-02) > 30 mL in 1 BOTTLE (13537-685-01)</PackageDescription>
<NDC11Code>13537-0685-02</NDC11Code>
<ProductNDC>13537-685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Signs Of Age Appearance Minimizer Foundation Spf 20 Fm</ProprietaryName>
<ProprietaryNameSuffix>Medium 5 - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151123</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.07; .0244</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13811-685-01</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (13811-685-01)</PackageDescription>
<NDC11Code>13811-0685-01</NDC11Code>
<ProductNDC>13811-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202713</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>5; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>13811-685-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (13811-685-10)</PackageDescription>
<NDC11Code>13811-0685-10</NDC11Code>
<ProductNDC>13811-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202713</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>5; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>13811-685-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (13811-685-30)</PackageDescription>
<NDC11Code>13811-0685-30</NDC11Code>
<ProductNDC>13811-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202713</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>5; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>13811-685-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (13811-685-50)</PackageDescription>
<NDC11Code>13811-0685-50</NDC11Code>
<ProductNDC>13811-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Valsartan</ProprietaryName>
<NonProprietaryName>Amlodipine And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202713</ApplicationNumber>
<LabelerName>Trigen Laboratories, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; VALSARTAN</SubstanceName>
<StrengthNumber>5; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>14141-685-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (14141-685-02) / 30 mL in 1 BOTTLE (14141-685-01) </PackageDescription>
<NDC11Code>14141-0685-02</NDC11Code>
<ProductNDC>14141-685</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Effet Parfait Signs Of Age Appearance Minimizer Foundation Spf 20 Fm</ProprietaryName>
<ProprietaryNameSuffix>Medium 5 - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191202</StartMarketingDate>
<EndMarketingDate>20240315</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Bel Star S.A. (Colombia)</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.07; .0244</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-03-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191202</StartMarketingDatePackage>
<EndMarketingDatePackage>20240315</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16571-685-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (16571-685-01) </PackageDescription>
<NDC11Code>16571-0685-01</NDC11Code>
<ProductNDC>16571-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212285</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/ day (up to 200 mg) for all children and adolescents. The effectiveness of Clomipramine hydrochloride capsules for long term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride USP is a white or slightly yellow, crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients. D&C Yellow 10, FD&C Red 40, FD&C Blue 1 (50 mg capsules only), gelatin, magnesium stearate, pregelatinized starch, and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ammonia solution, butyl alcohol, dehydrated alcohol, black iron oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>16571-685-03</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (16571-685-03) </PackageDescription>
<NDC11Code>16571-0685-03</NDC11Code>
<ProductNDC>16571-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212285</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/ day (up to 200 mg) for all children and adolescents. The effectiveness of Clomipramine hydrochloride capsules for long term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride USP is a white or slightly yellow, crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients. D&C Yellow 10, FD&C Red 40, FD&C Blue 1 (50 mg capsules only), gelatin, magnesium stearate, pregelatinized starch, and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ammonia solution, butyl alcohol, dehydrated alcohol, black iron oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>16571-685-09</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (16571-685-09) </PackageDescription>
<NDC11Code>16571-0685-09</NDC11Code>
<ProductNDC>16571-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212285</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clomipramine hydrochloride capsules USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of Clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/ day (up to 200 mg) for all children and adolescents. The effectiveness of Clomipramine hydrochloride capsules for long term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clomipramine hydrochloride capsules USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine hydrochloride is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro-5H-dibenz[b,f] azepine monohydrochloride, and its structural formula is. Clomipramine hydrochloride USP is a white or slightly yellow, crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Inactive Ingredients. D&C Yellow 10, FD&C Red 40, FD&C Blue 1 (50 mg capsules only), gelatin, magnesium stearate, pregelatinized starch, and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ammonia solution, butyl alcohol, dehydrated alcohol, black iron oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>16590-685-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (16590-685-30)</PackageDescription>
<NDC11Code>16590-0685-30</NDC11Code>
<ProductNDC>16590-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078858</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue # 2 Lake of indigo carmine. 500 mg tablets: Ferric oxide yellow. 750 mg tablets: Ferric oxide red and FD&C # 6 lake of sunset yellow.</Description>
</NDC>
<NDC>
<NDCCode>16590-685-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (16590-685-60)</PackageDescription>
<NDC11Code>16590-0685-60</NDC11Code>
<ProductNDC>16590-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078858</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue # 2 Lake of indigo carmine. 500 mg tablets: Ferric oxide yellow. 750 mg tablets: Ferric oxide red and FD&C # 6 lake of sunset yellow.</Description>
</NDC>
<NDC>
<NDCCode>16590-685-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (16590-685-90)</PackageDescription>
<NDC11Code>16590-0685-90</NDC11Code>
<ProductNDC>16590-685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078858</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue # 2 Lake of indigo carmine. 500 mg tablets: Ferric oxide yellow. 750 mg tablets: Ferric oxide red and FD&C # 6 lake of sunset yellow.</Description>
</NDC>
</NDCList>