{
"NDC": [
{
"NDCCode": "68428-446-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-446-06) ",
"NDC11Code": "68428-0446-06",
"ProductNDC": "68428-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Juglans Regia",
"NonProprietaryName": "Juglans Regia Fruit Rind, Immature, Juglans Regia Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF",
"StrengthNumber": "30; 30",
"StrengthUnit": "[hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N"
},
{
"NDCCode": "13537-446-06",
"PackageDescription": "1 BOTTLE, GLASS in 1 BOX (13537-446-06) > 50 g in 1 BOTTLE, GLASS (13537-446-05)",
"NDC11Code": "13537-0446-06",
"ProductNDC": "13537-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Lederm 45plus Jour",
"ProprietaryNameSuffix": "Spf 15 Facial Treatment Against Noticeable Signs Of Aging Day - Oily Skin",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD.",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": ".03; .05; .03; .05",
"StrengthUnit": "g/g; g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "41250-446-06",
"PackageDescription": "180 mL in 1 BOTTLE, PLASTIC (41250-446-06) ",
"NDC11Code": "41250-0446-06",
"ProductNDC": "41250-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meijer Maximum Strength Severe Congestion And Cough",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "MEIJER, INC.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "20; 400; 10",
"StrengthUnit": "mg/20mL; mg/20mL; mg/20mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200420",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves:cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleepnasal congestion due to a cold."
},
{
"NDCCode": "61037-446-06",
"PackageDescription": "946 mL in 1 BOTTLE, PLASTIC (61037-446-06) ",
"NDC11Code": "61037-0446-06",
"ProductNDC": "61037-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Gel",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200316",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bajaj Medical, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200316",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "68428-446-03",
"PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-446-03) ",
"NDC11Code": "68428-0446-03",
"ProductNDC": "68428-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Juglans Regia",
"NonProprietaryName": "Juglans Regia Fruit Rind, Immature, Juglans Regia Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF",
"StrengthNumber": "30; 30",
"StrengthUnit": "[hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N"
},
{
"NDCCode": "68428-446-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-446-05) ",
"NDC11Code": "68428-0446-05",
"ProductNDC": "68428-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Juglans Regia",
"NonProprietaryName": "Juglans Regia Fruit Rind, Immature, Juglans Regia Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF",
"StrengthNumber": "30; 30",
"StrengthUnit": "[hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N"
},
{
"NDCCode": "68428-446-11",
"PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-446-11) ",
"NDC11Code": "68428-0446-11",
"ProductNDC": "68428-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Juglans Regia",
"NonProprietaryName": "Juglans Regia Fruit Rind, Immature, Juglans Regia Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF",
"StrengthNumber": "30; 30",
"StrengthUnit": "[hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N"
},
{
"NDCCode": "68428-446-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-446-12) ",
"NDC11Code": "68428-0446-12",
"ProductNDC": "68428-446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Juglans Regia",
"NonProprietaryName": "Juglans Regia Fruit Rind, Immature, Juglans Regia Leaf",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF",
"StrengthNumber": "30; 30",
"StrengthUnit": "[hp_C]/1; [hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N"
},
{
"NDCCode": "0615-8029-05",
"PackageDescription": "15 TABLET in 1 BLISTER PACK (0615-8029-05) ",
"NDC11Code": "00615-8029-05",
"ProductNDC": "0615-8029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070511",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077987",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200325",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "Pravastatin sodium tablets, USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. C23H35NaO7MW 446.52. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, mannitol, meglumine, microcrystalline cellulose and starch. The 10 mg, 20 mg and 80 mg tablets also contain D&C yellow no. 10 aluminum lake and the 40 mg tablet also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake."
},
{
"NDCCode": "0615-8029-39",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (0615-8029-39) ",
"NDC11Code": "00615-8029-39",
"ProductNDC": "0615-8029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070511",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077987",
"LabelerName": "NCS HealthCare of KY, LLC dba Vangard Labs",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160518",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.",
"Description": "Pravastatin sodium tablets, USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. C23H35NaO7MW 446.52. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, mannitol, meglumine, microcrystalline cellulose and starch. The 10 mg, 20 mg and 80 mg tablets also contain D&C yellow no. 10 aluminum lake and the 40 mg tablet also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake."
},
{
"NDCCode": "21922-007-06",
"PackageDescription": "1 TUBE in 1 CARTON (21922-007-06) / 45 g in 1 TUBE",
"NDC11Code": "21922-0007-06",
"ProductNDC": "21922-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Valerate Cream",
"NonProprietaryName": "Hydrocortisone Valerate Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211047",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "HYDROCORTISONE VALERATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221231",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone valerate cream USP, 0.2% is medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.",
"Description": "Hydrocortisone valerate cream USP, 0.2% contain hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate is C26H38O6. It has the following structural formula. Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water.Each gram of hydrocortisone valerate cream USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type C, dibasic sodium phosphate, methylparaben, sodium lauryl sulfate, polyoxyethylene (100) stearyl ether, stearyl alcohol, white petrolatum, polyoxyl 2 stearyl ether, purified water and propylene glycol."
},
{
"NDCCode": "49643-446-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-446-05) ",
"NDC11Code": "49643-0446-05",
"ProductNDC": "49643-446",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Calif. Black Walnut Pollen",
"NonProprietaryName": "Juglans Californica",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "JUGLANS CALIFORNICA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-446-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (49643-446-10) ",
"NDC11Code": "49643-0446-10",
"ProductNDC": "49643-446",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Calif. Black Walnut Pollen",
"NonProprietaryName": "Juglans Californica",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "JUGLANS CALIFORNICA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-446-30",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49643-446-30) ",
"NDC11Code": "49643-0446-30",
"ProductNDC": "49643-446",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Calif. Black Walnut Pollen",
"NonProprietaryName": "Juglans Californica",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "JUGLANS CALIFORNICA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49643-446-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (49643-446-50) ",
"NDC11Code": "49643-0446-50",
"ProductNDC": "49643-446",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Calif. Black Walnut Pollen",
"NonProprietaryName": "Juglans Californica",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "JUGLANS CALIFORNICA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "50228-446-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-05) ",
"NDC11Code": "50228-0446-05",
"ProductNDC": "50228-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride Extended-release Tablets",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210416",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213334",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2021-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210416",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride extended-release tablets, USP contain the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol and is practically insoluble in acetone and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets contain 500 mg or 1,000 mg of metformin hydrochloride, USP which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. Each tablet contains ammonio methacrylate copolymer, crospovidone, hypromellose, magnesium stearate, pregelatinized starch (maize), povidone, polyethylene glycol, silicon dioxide, talc, titanium dioxide and triethyl citrate. Metformin hydrochloride extended-release tablets USP meets USP Dissolution Test 12."
},
{
"NDCCode": "50228-446-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-30) ",
"NDC11Code": "50228-0446-30",
"ProductNDC": "50228-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride Extended-release Tablets",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210416",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213334",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2021-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210416",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride extended-release tablets, USP contain the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol and is practically insoluble in acetone and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets contain 500 mg or 1,000 mg of metformin hydrochloride, USP which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. Each tablet contains ammonio methacrylate copolymer, crospovidone, hypromellose, magnesium stearate, pregelatinized starch (maize), povidone, polyethylene glycol, silicon dioxide, talc, titanium dioxide and triethyl citrate. Metformin hydrochloride extended-release tablets USP meets USP Dissolution Test 12."
},
{
"NDCCode": "50228-446-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-90) ",
"NDC11Code": "50228-0446-90",
"ProductNDC": "50228-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride Extended-release Tablets",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210416",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213334",
"LabelerName": "ScieGen Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2021-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210416",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride extended-release tablets, USP contain the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol and is practically insoluble in acetone and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets contain 500 mg or 1,000 mg of metformin hydrochloride, USP which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. Each tablet contains ammonio methacrylate copolymer, crospovidone, hypromellose, magnesium stearate, pregelatinized starch (maize), povidone, polyethylene glycol, silicon dioxide, talc, titanium dioxide and triethyl citrate. Metformin hydrochloride extended-release tablets USP meets USP Dissolution Test 12."
},
{
"NDCCode": "51167-446-01",
"PackageDescription": "4 PACKAGE in 1 CARTON (51167-446-01) / 1 KIT in 1 PACKAGE * 1 GRANULE in 1 PACKET (51167-746-07) * 1 GRANULE in 1 PACKET (51167-846-07) ",
"NDC11Code": "51167-0446-01",
"ProductNDC": "51167-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trikafta",
"NonProprietaryName": "Elexacaftor, Tezacaftor, And Ivacaftor",
"DosageFormName": "KIT",
"StartMarketingDate": "20230426",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217660",
"LabelerName": "Vertex Pharmaceuticals Incorporated",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230426",
"SamplePackage": "N",
"IndicationAndUsage": "TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients aged 2 years and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data (see Table 6) or results in production of CFTR protein [see Clinical Pharmacology (12.1)]. If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein.",
"Description": "TRIKAFTA is a co-package of elexacaftor, tezacaftor and ivacaftor fixed-dose combination tablets or granules and ivacaftor tablets or granules. Both tablets and granules are for oral administration. The elexacaftor, tezacaftor and ivacaftor fixed-dose combination tablets are available as: orange, oblong-shaped, film-coated tablet containing 100 mg of elexacaftor, 50 mg of tezacaftor, 75 mg of ivacaftor, or light orange, oblong-shaped, film-coated tablet containing 50 mg of elexacaftor, 25 mg of tezacaftor, 37.5 mg of ivacaftor. The fixed-dose combination tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablet film coat contains hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, talc, and titanium dioxide. The ivacaftor tablet is available as a light blue, oblong-shaped, film-coated tablet containing 150 mg or 75 mg of ivacaftor and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The tablet film coat contains carnauba wax, FD&C Blue #2, PEG 3350, polyvinyl alcohol, talc, and titanium dioxide. The printing ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. The elexacaftor, tezacaftor and ivacaftor fixed-dose combination oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter enclosed in unit-dose packets. Each unit-dose packet contains 100 mg of elexacaftor, 50 mg of tezacaftor, 75 mg of ivacaftor or 80 mg of elexacaftor, 40 mg of tezacaftor, 60 mg of ivacaftor and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sodium lauryl sulfate, and sucralose. The ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter enclosed in unit-dose packets. Each unit-dose packet contains 75 mg or 59.5 mg of ivacaftor and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sodium lauryl sulfate, and sucralose. The active ingredients of TRIKAFTA are described below."
},
{
"NDCCode": "51672-1290-6",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1290-6) / 45 g in 1 TUBE",
"NDC11Code": "51672-1290-06",
"ProductNDC": "51672-1290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Valerate",
"NonProprietaryName": "Hydrocortisone Valerate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19980825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075042",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "HYDROCORTISONE VALERATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980825",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone valerate cream, 0.2% and hydrocortisone valerate ointment, 0.2% are medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.",
"Description": "Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate ointment USP, 0.2%, contain hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate is C 26H 38O 6. It has the following structural formula:. Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water. Each gram of hydrocortisone valerate cream USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type C, dibasic sodium phosphate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum. Each gram of hydrocortisone valerate ointment USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type B, dibasic sodium phosphate, methylparaben, mineral oil, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum."
},
{
"NDCCode": "51672-1292-6",
"PackageDescription": "1 TUBE in 1 CARTON (51672-1292-6) / 45 g in 1 TUBE",
"NDC11Code": "51672-1292-06",
"ProductNDC": "51672-1292",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone Valerate",
"NonProprietaryName": "Hydrocortisone Valerate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19980825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075043",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "HYDROCORTISONE VALERATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980825",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone valerate cream, 0.2% and hydrocortisone valerate ointment, 0.2% are medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.",
"Description": "Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate ointment USP, 0.2%, contain hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate is C 26H 38O 6. It has the following structural formula:. Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water. Each gram of hydrocortisone valerate cream USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type C, dibasic sodium phosphate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum. Each gram of hydrocortisone valerate ointment USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type B, dibasic sodium phosphate, methylparaben, mineral oil, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum."
},
{
"NDCCode": "52493-446-89",
"PackageDescription": "24 kg in 1 DRUM (52493-446-89) ",
"NDC11Code": "52493-0446-89",
"ProductNDC": "52493-446",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Entecavir",
"DosageFormName": "GRANULE",
"StartMarketingDate": "20230920",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Amneal Pharmaceuticals Co. (I) Pvt. Ltd.",
"SubstanceName": "ENTECAVIR",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-06",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20-SEP-23"
},
{
"NDCCode": "67457-446-10",
"PackageDescription": "1 VIAL in 1 CARTON (67457-446-10) / 10 mL in 1 VIAL",
"NDC11Code": "67457-0446-10",
"ProductNDC": "67457-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pamidronate Disodium",
"NonProprietaryName": "Pamidronate Disodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078520",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "PAMIDRONATE DISODIUM",
"StrengthNumber": "9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Bisphosphonate [EPC], Diphosphonates [CS]",
"Status": "Active",
"LastUpdate": "2026-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110510",
"SamplePackage": "N",
"IndicationAndUsage": "Pamidronate disodium is a bisphosphonate indicated for the treatment of: 1 moderate or severe hypercalcemia associated with malignancy, with or without bone metastases (1.1), 2 patients with moderate to severe Paget’s disease of bone (1.2), 3 osteolytic bone metastases of breast cancer or osteolytic lesions of multiple myeloma, in conjunction with standard antineoplastic therapy (1.3).",
"Description": "Pamidronate Disodium Injection is a bisphosphonate available in 30 mg and 90 mg vials for intravenous administration. Each mL of the 30 mg/10 mL vial contains 3 mg pamidronate disodium, 47 mg mannitol; water for injection, q.s.; and phosphoric acid to adjust pH 6.0 to 7.0. Each mL of the 90 mg/10 mL vial contains, 9 mg pamidronate disodium, 37.5 mg mannitol; water for injection, q.s.; and phosphoric acid to adjust pH 6.0 to 7.0. The pH of a 1% solution of pamidronate disodium in distilled water is approximately 8.3. Pamidronate disodium, a member of the group of chemical compounds known as bisphosphonates, is an analog of pyrophosphate. Pamidronate disodium is designated chemically as phosphonic acid (3-amino-1-hydroxypropylidene) bis-, disodium salt, and its structural formula is. Pamidronate disodium is a white powder. It is soluble in water and in 2N sodium hydroxide, sparingly soluble in 0.1N hydrochloric acid and in 0.1N acetic acid, and practically insoluble in organic solvents. Its molecular formula is C3H9NO7P2Na2 and its molecular weight is 279.1 (calculated as the anhydrous form)."
},
{
"NDCCode": "68180-446-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (68180-446-01) ",
"NDC11Code": "68180-0446-01",
"ProductNDC": "68180-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201109",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120327",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2) .",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2.C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP are supplied for oral administration as 25 mg (quetiapine) round, pink tablets, 50 mg (quetiapine) round, white tablets, 100 mg (quetiapine) round, yellow tablets, 200 mg (quetiapine) round, white tablets, 300 mg (quetiapine) capsule-shaped, white tablets and 400 mg (quetiapine) capsule-shaped, yellow tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide black; and the 100 mg and 400 mg tablets contain iron oxide yellow. Each 25 mg film-coated tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg film-coated tablet contains. 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg film-coated tablet contains 115.12 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg film-coated tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg film-coated tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg film-coated tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "68180-446-03",
"PackageDescription": "1000 TABLET in 1 BOTTLE (68180-446-03) ",
"NDC11Code": "68180-0446-03",
"ProductNDC": "68180-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201109",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120327",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2) .",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2.C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP are supplied for oral administration as 25 mg (quetiapine) round, pink tablets, 50 mg (quetiapine) round, white tablets, 100 mg (quetiapine) round, yellow tablets, 200 mg (quetiapine) round, white tablets, 300 mg (quetiapine) capsule-shaped, white tablets and 400 mg (quetiapine) capsule-shaped, yellow tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide black; and the 100 mg and 400 mg tablets contain iron oxide yellow. Each 25 mg film-coated tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg film-coated tablet contains. 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg film-coated tablet contains 115.12 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg film-coated tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg film-coated tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg film-coated tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine."
},
{
"NDCCode": "68382-446-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE (68382-446-01) ",
"NDC11Code": "68382-0446-01",
"ProductNDC": "68382-446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bosentan",
"NonProprietaryName": "Bosentan",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207760",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "BOSENTAN",
"StrengthNumber": "62.5",
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"Description": "Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan."
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{
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"Description": "Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan."
},
{
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"Description": "Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan."
},
{
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"Description": "Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan."
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{
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"Description": "Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan."
}
]
}
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<ApplicationNumber>ANDA077987</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200325</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>Pravastatin sodium tablets, USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. C23H35NaO7MW 446.52. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, mannitol, meglumine, microcrystalline cellulose and starch. The 10 mg, 20 mg and 80 mg tablets also contain D&C yellow no. 10 aluminum lake and the 40 mg tablet also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>0615-8029-39</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (0615-8029-39) </PackageDescription>
<NDC11Code>00615-8029-39</NDC11Code>
<ProductNDC>0615-8029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070511</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077987</ApplicationNumber>
<LabelerName>NCS HealthCare of KY, LLC dba Vangard Labs</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160518</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.</IndicationAndUsage>
<Description>Pravastatin sodium tablets, USP are one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate. Pravastatin sodium, USP is designated chemically as 1-Naphthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. C23H35NaO7MW 446.52. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets, USP are available for oral administration as 10 mg, 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients include: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, mannitol, meglumine, microcrystalline cellulose and starch. The 10 mg, 20 mg and 80 mg tablets also contain D&C yellow no. 10 aluminum lake and the 40 mg tablet also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>21922-007-06</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-007-06) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0007-06</NDC11Code>
<ProductNDC>21922-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Valerate Cream</ProprietaryName>
<NonProprietaryName>Hydrocortisone Valerate Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211047</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE VALERATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone valerate cream USP, 0.2% is medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.</IndicationAndUsage>
<Description>Hydrocortisone valerate cream USP, 0.2% contain hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate is C26H38O6. It has the following structural formula. Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water.Each gram of hydrocortisone valerate cream USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type C, dibasic sodium phosphate, methylparaben, sodium lauryl sulfate, polyoxyethylene (100) stearyl ether, stearyl alcohol, white petrolatum, polyoxyl 2 stearyl ether, purified water and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>49643-446-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-446-05) </PackageDescription>
<NDC11Code>49643-0446-05</NDC11Code>
<ProductNDC>49643-446</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Calif. Black Walnut Pollen</ProprietaryName>
<NonProprietaryName>Juglans Californica</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>JUGLANS CALIFORNICA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49643-446-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49643-446-10) </PackageDescription>
<NDC11Code>49643-0446-10</NDC11Code>
<ProductNDC>49643-446</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Calif. Black Walnut Pollen</ProprietaryName>
<NonProprietaryName>Juglans Californica</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>JUGLANS CALIFORNICA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49643-446-30</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49643-446-30) </PackageDescription>
<NDC11Code>49643-0446-30</NDC11Code>
<ProductNDC>49643-446</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Calif. Black Walnut Pollen</ProprietaryName>
<NonProprietaryName>Juglans Californica</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>JUGLANS CALIFORNICA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49643-446-50</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49643-446-50) </PackageDescription>
<NDC11Code>49643-0446-50</NDC11Code>
<ProductNDC>49643-446</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Calif. Black Walnut Pollen</ProprietaryName>
<NonProprietaryName>Juglans Californica</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>JUGLANS CALIFORNICA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>50228-446-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-05) </PackageDescription>
<NDC11Code>50228-0446-05</NDC11Code>
<ProductNDC>50228-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride Extended-release Tablets</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210416</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213334</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets, USP contain the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol and is practically insoluble in acetone and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets contain 500 mg or 1,000 mg of metformin hydrochloride, USP which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. Each tablet contains ammonio methacrylate copolymer, crospovidone, hypromellose, magnesium stearate, pregelatinized starch (maize), povidone, polyethylene glycol, silicon dioxide, talc, titanium dioxide and triethyl citrate. Metformin hydrochloride extended-release tablets USP meets USP Dissolution Test 12.</Description>
</NDC>
<NDC>
<NDCCode>50228-446-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-30) </PackageDescription>
<NDC11Code>50228-0446-30</NDC11Code>
<ProductNDC>50228-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride Extended-release Tablets</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210416</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213334</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets, USP contain the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol and is practically insoluble in acetone and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets contain 500 mg or 1,000 mg of metformin hydrochloride, USP which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. Each tablet contains ammonio methacrylate copolymer, crospovidone, hypromellose, magnesium stearate, pregelatinized starch (maize), povidone, polyethylene glycol, silicon dioxide, talc, titanium dioxide and triethyl citrate. Metformin hydrochloride extended-release tablets USP meets USP Dissolution Test 12.</Description>
</NDC>
<NDC>
<NDCCode>50228-446-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-90) </PackageDescription>
<NDC11Code>50228-0446-90</NDC11Code>
<ProductNDC>50228-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride Extended-release Tablets</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210416</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213334</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets, USP contain the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol and is practically insoluble in acetone and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets contain 500 mg or 1,000 mg of metformin hydrochloride, USP which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. Each tablet contains ammonio methacrylate copolymer, crospovidone, hypromellose, magnesium stearate, pregelatinized starch (maize), povidone, polyethylene glycol, silicon dioxide, talc, titanium dioxide and triethyl citrate. Metformin hydrochloride extended-release tablets USP meets USP Dissolution Test 12.</Description>
</NDC>
<NDC>
<NDCCode>51167-446-01</NDCCode>
<PackageDescription>4 PACKAGE in 1 CARTON (51167-446-01) / 1 KIT in 1 PACKAGE * 1 GRANULE in 1 PACKET (51167-746-07) * 1 GRANULE in 1 PACKET (51167-846-07) </PackageDescription>
<NDC11Code>51167-0446-01</NDC11Code>
<ProductNDC>51167-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trikafta</ProprietaryName>
<NonProprietaryName>Elexacaftor, Tezacaftor, And Ivacaftor</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230426</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217660</ApplicationNumber>
<LabelerName>Vertex Pharmaceuticals Incorporated</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients aged 2 years and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data (see Table 6) or results in production of CFTR protein [see Clinical Pharmacology (12.1)]. If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein.</IndicationAndUsage>
<Description>TRIKAFTA is a co-package of elexacaftor, tezacaftor and ivacaftor fixed-dose combination tablets or granules and ivacaftor tablets or granules. Both tablets and granules are for oral administration. The elexacaftor, tezacaftor and ivacaftor fixed-dose combination tablets are available as: orange, oblong-shaped, film-coated tablet containing 100 mg of elexacaftor, 50 mg of tezacaftor, 75 mg of ivacaftor, or light orange, oblong-shaped, film-coated tablet containing 50 mg of elexacaftor, 25 mg of tezacaftor, 37.5 mg of ivacaftor. The fixed-dose combination tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablet film coat contains hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, talc, and titanium dioxide. The ivacaftor tablet is available as a light blue, oblong-shaped, film-coated tablet containing 150 mg or 75 mg of ivacaftor and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The tablet film coat contains carnauba wax, FD&C Blue #2, PEG 3350, polyvinyl alcohol, talc, and titanium dioxide. The printing ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. The elexacaftor, tezacaftor and ivacaftor fixed-dose combination oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter enclosed in unit-dose packets. Each unit-dose packet contains 100 mg of elexacaftor, 50 mg of tezacaftor, 75 mg of ivacaftor or 80 mg of elexacaftor, 40 mg of tezacaftor, 60 mg of ivacaftor and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sodium lauryl sulfate, and sucralose. The ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter enclosed in unit-dose packets. Each unit-dose packet contains 75 mg or 59.5 mg of ivacaftor and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sodium lauryl sulfate, and sucralose. The active ingredients of TRIKAFTA are described below.</Description>
</NDC>
<NDC>
<NDCCode>51672-1290-6</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1290-6) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1290-06</NDC11Code>
<ProductNDC>51672-1290</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Valerate</ProprietaryName>
<NonProprietaryName>Hydrocortisone Valerate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19980825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075042</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE VALERATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone valerate cream, 0.2% and hydrocortisone valerate ointment, 0.2% are medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.</IndicationAndUsage>
<Description>Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate ointment USP, 0.2%, contain hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate is C 26H 38O 6. It has the following structural formula:. Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water. Each gram of hydrocortisone valerate cream USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type C, dibasic sodium phosphate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum. Each gram of hydrocortisone valerate ointment USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type B, dibasic sodium phosphate, methylparaben, mineral oil, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>51672-1292-6</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51672-1292-6) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>51672-1292-06</NDC11Code>
<ProductNDC>51672-1292</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone Valerate</ProprietaryName>
<NonProprietaryName>Hydrocortisone Valerate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19980825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075043</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE VALERATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone valerate cream, 0.2% and hydrocortisone valerate ointment, 0.2% are medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.</IndicationAndUsage>
<Description>Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate ointment USP, 0.2%, contain hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate is C 26H 38O 6. It has the following structural formula:. Hydrocortisone valerate has a molecular weight of 446.58. It is a white, crystalline solid, soluble in ethanol and methanol, sparingly soluble in propylene glycol and insoluble in water. Each gram of hydrocortisone valerate cream USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type C, dibasic sodium phosphate, methylparaben, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum. Each gram of hydrocortisone valerate ointment USP, 0.2% contains 2 mg hydrocortisone valerate in a hydrophilic base composed of carbomer homopolymer type B, dibasic sodium phosphate, methylparaben, mineral oil, polyoxyl 2 stearyl ether, propylene glycol, purified water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>52493-446-89</NDCCode>
<PackageDescription>24 kg in 1 DRUM (52493-446-89) </PackageDescription>
<NDC11Code>52493-0446-89</NDC11Code>
<ProductNDC>52493-446</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Entecavir</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<StartMarketingDate>20230920</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Amneal Pharmaceuticals Co. (I) Pvt. Ltd.</LabelerName>
<SubstanceName>ENTECAVIR</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-06</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-SEP-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>67457-446-10</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (67457-446-10) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>67457-0446-10</NDC11Code>
<ProductNDC>67457-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pamidronate Disodium</ProprietaryName>
<NonProprietaryName>Pamidronate Disodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078520</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>PAMIDRONATE DISODIUM</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pamidronate disodium is a bisphosphonate indicated for the treatment of: 1 moderate or severe hypercalcemia associated with malignancy, with or without bone metastases (1.1), 2 patients with moderate to severe Paget’s disease of bone (1.2), 3 osteolytic bone metastases of breast cancer or osteolytic lesions of multiple myeloma, in conjunction with standard antineoplastic therapy (1.3).</IndicationAndUsage>
<Description>Pamidronate Disodium Injection is a bisphosphonate available in 30 mg and 90 mg vials for intravenous administration. Each mL of the 30 mg/10 mL vial contains 3 mg pamidronate disodium, 47 mg mannitol; water for injection, q.s.; and phosphoric acid to adjust pH 6.0 to 7.0. Each mL of the 90 mg/10 mL vial contains, 9 mg pamidronate disodium, 37.5 mg mannitol; water for injection, q.s.; and phosphoric acid to adjust pH 6.0 to 7.0. The pH of a 1% solution of pamidronate disodium in distilled water is approximately 8.3. Pamidronate disodium, a member of the group of chemical compounds known as bisphosphonates, is an analog of pyrophosphate. Pamidronate disodium is designated chemically as phosphonic acid (3-amino-1-hydroxypropylidene) bis-, disodium salt, and its structural formula is. Pamidronate disodium is a white powder. It is soluble in water and in 2N sodium hydroxide, sparingly soluble in 0.1N hydrochloric acid and in 0.1N acetic acid, and practically insoluble in organic solvents. Its molecular formula is C3H9NO7P2Na2 and its molecular weight is 279.1 (calculated as the anhydrous form).</Description>
</NDC>
<NDC>
<NDCCode>68180-446-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68180-446-01) </PackageDescription>
<NDC11Code>68180-0446-01</NDC11Code>
<ProductNDC>68180-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201109</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2) .</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2.C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP are supplied for oral administration as 25 mg (quetiapine) round, pink tablets, 50 mg (quetiapine) round, white tablets, 100 mg (quetiapine) round, yellow tablets, 200 mg (quetiapine) round, white tablets, 300 mg (quetiapine) capsule-shaped, white tablets and 400 mg (quetiapine) capsule-shaped, yellow tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide black; and the 100 mg and 400 mg tablets contain iron oxide yellow. Each 25 mg film-coated tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg film-coated tablet contains. 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg film-coated tablet contains 115.12 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg film-coated tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg film-coated tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg film-coated tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>68180-446-03</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (68180-446-03) </PackageDescription>
<NDC11Code>68180-0446-03</NDC11Code>
<ProductNDC>68180-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201109</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder manic episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2) .</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2.C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets USP are supplied for oral administration as 25 mg (quetiapine) round, pink tablets, 50 mg (quetiapine) round, white tablets, 100 mg (quetiapine) round, yellow tablets, 200 mg (quetiapine) round, white tablets, 300 mg (quetiapine) capsule-shaped, white tablets and 400 mg (quetiapine) capsule-shaped, yellow tablets. Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. The 25 mg tablets contain iron oxide red and iron oxide black; and the 100 mg and 400 mg tablets contain iron oxide yellow. Each 25 mg film-coated tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg film-coated tablet contains. 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg film-coated tablet contains 115.12 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 200 mg film-coated tablet contains 230.24 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg film-coated tablet contains 345.36 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg film-coated tablet contains 460.48 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>68382-446-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE (68382-446-01) </PackageDescription>
<NDC11Code>68382-0446-01</NDC11Code>
<ProductNDC>68382-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bosentan</ProprietaryName>
<NonProprietaryName>Bosentan</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207760</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>BOSENTAN</SubstanceName>
<StrengthNumber>62.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
<Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan.</Description>
</NDC>
<NDC>
<NDCCode>68382-446-05</NDCCode>
<PackageDescription>500 TABLET, COATED in 1 BOTTLE (68382-446-05) </PackageDescription>
<NDC11Code>68382-0446-05</NDC11Code>
<ProductNDC>68382-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bosentan</ProprietaryName>
<NonProprietaryName>Bosentan</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207760</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>BOSENTAN</SubstanceName>
<StrengthNumber>62.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
<Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan.</Description>
</NDC>
<NDC>
<NDCCode>68382-446-14</NDCCode>
<PackageDescription>60 TABLET, COATED in 1 BOTTLE (68382-446-14) </PackageDescription>
<NDC11Code>68382-0446-14</NDC11Code>
<ProductNDC>68382-446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bosentan</ProprietaryName>
<NonProprietaryName>Bosentan</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207760</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>BOSENTAN</SubstanceName>
<StrengthNumber>62.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
<Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan.</Description>
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<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
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<IndicationAndUsage>Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
<Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan.</Description>
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<ApplicationNumber>ANDA207760</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
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<Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
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<IndicationAndUsage>Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
<Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan.</Description>
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