{
"NDC": [
{
"NDCCode": "33342-585-07",
"PackageDescription": "30 TABLET in 1 BOTTLE (33342-585-07) ",
"NDC11Code": "33342-0585-07",
"ProductNDC": "33342-585",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211506",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DAPAGLIFLOZIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260406",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin is indicated. To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple. CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. Dapagliflozin is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. Dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Dapagliflozin USP, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.87. The structural formula is. Dapagliflozin USP, is available as a film-coated tablet for oral administration containing 5 mg dapagliflozin USP or 10 mg dapagliflozin USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "33342-585-10",
"PackageDescription": "90 TABLET in 1 BOTTLE (33342-585-10) ",
"NDC11Code": "33342-0585-10",
"ProductNDC": "33342-585",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211506",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DAPAGLIFLOZIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260406",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin is indicated. To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple. CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. Dapagliflozin is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. Dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Dapagliflozin USP, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.87. The structural formula is. Dapagliflozin USP, is available as a film-coated tablet for oral administration containing 5 mg dapagliflozin USP or 10 mg dapagliflozin USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "33342-585-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-585-12) / 10 TABLET in 1 BLISTER PACK (33342-585-66) ",
"NDC11Code": "33342-0585-12",
"ProductNDC": "33342-585",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211506",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DAPAGLIFLOZIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260406",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin is indicated. To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple. CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. Dapagliflozin is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. Dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Dapagliflozin USP, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.87. The structural formula is. Dapagliflozin USP, is available as a film-coated tablet for oral administration containing 5 mg dapagliflozin USP or 10 mg dapagliflozin USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "14209-585-07",
"PackageDescription": "700 mL in 1 BAG (14209-585-07)",
"NDC11Code": "14209-0585-07",
"ProductNDC": "14209-585",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Germ Safe",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Original 7, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin, only when water is not available."
},
{
"NDCCode": "31507-585-07",
"PackageDescription": "700 mL in 1 BAG (31507-585-07)",
"NDC11Code": "31507-0585-07",
"ProductNDC": "31507-585",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Guard Foaming Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120117",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Wechem, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".62",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2018-12-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "42936-585-07",
"PackageDescription": "700 mL in 1 BAG (42936-585-07)",
"NDC11Code": "42936-0585-07",
"ProductNDC": "42936-585",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foam San Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080605",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Hill Manufacturing Co., Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".62",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2018-10-23",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "50491-585-07",
"PackageDescription": "700 mL in 1 BAG (50491-585-07)",
"NDC11Code": "50491-0585-07",
"ProductNDC": "50491-585",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Foam Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Dixie Packing & Seal Company",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "59779-585-07",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (59779-585-07) / 6 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "59779-0585-07",
"ProductNDC": "59779-585",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Allergy Relief",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20090320",
"EndMarketingDate": "20280131",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090320",
"EndMarketingDatePackage": "20280131",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny noseitchy, watery eyessneezingitching of the nose or throat."
},
{
"NDCCode": "62257-585-07",
"PackageDescription": "700 mL in 1 BAG (62257-585-07)",
"NDC11Code": "62257-0585-07",
"ProductNDC": "62257-585",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fast",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20071220",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "ABC Compounding Co., Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63533-585-07",
"PackageDescription": "700 mL in 1 BAG (63533-585-07)",
"NDC11Code": "63533-0585-07",
"ProductNDC": "63533-585",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Han-i-foam",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Momar Incorporated",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin, only when water is not available."
},
{
"NDCCode": "63830-585-07",
"PackageDescription": "700 mL in 1 BAG (63830-585-07)",
"NDC11Code": "63830-0585-07",
"ProductNDC": "63830-585",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prevent",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Pro Chem, Incorporated",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin, only when water is not available."
},
{
"NDCCode": "67147-585-07",
"PackageDescription": "700 mL in 1 BAG (67147-585-07)",
"NDC11Code": "67147-0585-07",
"ProductNDC": "67147-585",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Al Cafoam",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Apple Products, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin, only when water is not available."
},
{
"NDCCode": "68654-585-07",
"PackageDescription": "700 mL in 1 BAG (68654-585-07)",
"NDC11Code": "68654-0585-07",
"ProductNDC": "68654-585",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foamahol",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Share Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin, only when water is not available."
},
{
"NDCCode": "71919-585-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-585-07) ",
"NDC11Code": "71919-0585-07",
"ProductNDC": "71919-585",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rhus Venenata",
"NonProprietaryName": "Toxicodendron Vernix Leafy Twig",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100305",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "TOXICODENDRON VERNIX LEAFY TWIG",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100305",
"SamplePackage": "N"
},
{
"NDCCode": "76463-585-07",
"PackageDescription": "700 mL in 1 BAG (76463-585-07)",
"NDC11Code": "76463-0585-07",
"ProductNDC": "76463-585",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foam Aid",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Gil Manufacturing, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".62",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin, only when water is not available."
},
{
"NDCCode": "33342-002-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-002-07) ",
"NDC11Code": "33342-0002-07",
"ProductNDC": "33342-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamivudine",
"NonProprietaryName": "Lamivudine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090198",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "LAMIVUDINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190502",
"SamplePackage": "N",
"IndicationAndUsage": "Lamivudine is nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV.",
"Description": "Lamivudine USP is a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine USP is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine USP is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine USP has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine USP is a white to off-white crystalline solid with a solubility of approximately 70 mg per mL in water at 20°C. Lamivudine tablets, USP are for oral administration. Each scored 150-mg film-coated tablet contains 150 mg of lamivudine USP and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. Each 300-mg film-coated tablet contains 300 mg of lamivudine USP and the inactive ingredients black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "33342-013-07",
"PackageDescription": "30 TABLET in 1 BOTTLE (33342-013-07) ",
"NDC11Code": "33342-0013-07",
"ProductNDC": "33342-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz",
"NonProprietaryName": "Efavirenz",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091579",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "EFAVIRENZ",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240510",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.",
"Description": "Efavirenz, USP is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as(S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro4(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C14H9ClF3NO2 and its structural formula is: Efavirenz,USP is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 microgram/mL). Tablets: Efavirenz USP is available as film-coated tablets for oral administration containing 600 mg of efavirenz and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating contains Opadry Yellow,consisting of hydroxypropylmethyl cellulose, titanium dioxide, polyethylene glycol and iron oxide yellow."
},
{
"NDCCode": "33342-024-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-024-07) ",
"NDC11Code": "33342-0024-07",
"ProductNDC": "33342-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famciclovir",
"NonProprietaryName": "Famciclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201022",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "FAMCICLOVIR",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120113",
"SamplePackage": "N",
"IndicationAndUsage": "Famciclovir, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients(1.1) Herpes labialis (cold sores) o Treatment of recurrent episodes Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes Herpes zoster (shingles) Human Immunodeficiency Virus (HIV) -Infected Adult Patients(1.2) Treatment of recurrent episodes of orolabial or genital herpesLimitation of Use The efficacy and safety of famciclovir tablets have not been established for: Patients with first episode of genital herpes Patients with ophthalmic zoster Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV- infected patients Black and African American patients with recurrent genital herpes.",
"Description": "The active ingredient in famciclovir tablets, USP is famciclovir, USP an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir,USP is known as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate. Its molecular formula is C14H19N5O4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure. Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08. Famciclovir tablets,USP contain 125 mg, 250 mg, or 500 mg of famciclovir, USP together with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, anhydrous lactose, magnesium stearate, polyethylene glycols, sodium starch glycolate and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "33342-025-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-025-07) ",
"NDC11Code": "33342-0025-07",
"ProductNDC": "33342-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famciclovir",
"NonProprietaryName": "Famciclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201022",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "FAMCICLOVIR",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120113",
"SamplePackage": "N",
"IndicationAndUsage": "Famciclovir, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients(1.1) Herpes labialis (cold sores) o Treatment of recurrent episodes Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes Herpes zoster (shingles) Human Immunodeficiency Virus (HIV) -Infected Adult Patients(1.2) Treatment of recurrent episodes of orolabial or genital herpesLimitation of Use The efficacy and safety of famciclovir tablets have not been established for: Patients with first episode of genital herpes Patients with ophthalmic zoster Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV- infected patients Black and African American patients with recurrent genital herpes.",
"Description": "The active ingredient in famciclovir tablets, USP is famciclovir, USP an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir,USP is known as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate. Its molecular formula is C14H19N5O4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure. Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08. Famciclovir tablets,USP contain 125 mg, 250 mg, or 500 mg of famciclovir, USP together with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, anhydrous lactose, magnesium stearate, polyethylene glycols, sodium starch glycolate and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "33342-026-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-026-07) ",
"NDC11Code": "33342-0026-07",
"ProductNDC": "33342-026",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famciclovir",
"NonProprietaryName": "Famciclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201022",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "FAMCICLOVIR",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120113",
"SamplePackage": "N",
"IndicationAndUsage": "Famciclovir, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients(1.1) Herpes labialis (cold sores) o Treatment of recurrent episodes Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes Herpes zoster (shingles) Human Immunodeficiency Virus (HIV) -Infected Adult Patients(1.2) Treatment of recurrent episodes of orolabial or genital herpesLimitation of Use The efficacy and safety of famciclovir tablets have not been established for: Patients with first episode of genital herpes Patients with ophthalmic zoster Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV- infected patients Black and African American patients with recurrent genital herpes.",
"Description": "The active ingredient in famciclovir tablets, USP is famciclovir, USP an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir,USP is known as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate. Its molecular formula is C14H19N5O4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure. Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08. Famciclovir tablets,USP contain 125 mg, 250 mg, or 500 mg of famciclovir, USP together with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, anhydrous lactose, magnesium stearate, polyethylene glycols, sodium starch glycolate and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "33342-027-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-027-07) ",
"NDC11Code": "33342-0027-07",
"ProductNDC": "33342-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201146",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120817",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.",
"Description": "Donepezil hydrochloride, USP are a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride USP is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride USP is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride USP is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, pregelatinised starch, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate. The film coating contains talc, propylene glycol, hypromellose and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent. Inactive ingredients in 23 mg tablets include hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and hypromellose. The film coating includes ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. USP Dissolution Test pending. Donepezil hydrochloride orally disintegrating tablets USP are available for oral administration. Each donepezil hydrochloride orally disintegrating tablets contains 5 or 10 mg of donepezil hydrochloride USP. Inactive ingredients are mannitol, crospovidone, sucralose, sodium chloride, ferric oxide yellow and magnesium stearate."
},
{
"NDCCode": "33342-028-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-028-07) ",
"NDC11Code": "33342-0028-07",
"ProductNDC": "33342-028",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201146",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120817",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.",
"Description": "Donepezil hydrochloride, USP are a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride USP is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride USP is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride USP is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, pregelatinised starch, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate. The film coating contains talc, propylene glycol, hypromellose and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent. Inactive ingredients in 23 mg tablets include hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and hypromellose. The film coating includes ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. USP Dissolution Test pending. Donepezil hydrochloride orally disintegrating tablets USP are available for oral administration. Each donepezil hydrochloride orally disintegrating tablets contains 5 or 10 mg of donepezil hydrochloride USP. Inactive ingredients are mannitol, crospovidone, sucralose, sodium chloride, ferric oxide yellow and magnesium stearate."
},
{
"NDCCode": "33342-029-07",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (33342-029-07) ",
"NDC11Code": "33342-0029-07",
"ProductNDC": "33342-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20121214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201787",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121214",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.",
"Description": "Donepezil hydrochloride, USP are a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride USP is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride USP is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride USP is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, pregelatinised starch, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate. The film coating contains talc, propylene glycol, hypromellose and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent. Inactive ingredients in 23 mg tablets include hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and hypromellose. The film coating includes ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. USP Dissolution Test pending. Donepezil hydrochloride orally disintegrating tablets USP are available for oral administration. Each donepezil hydrochloride orally disintegrating tablets contains 5 or 10 mg of donepezil hydrochloride USP. Inactive ingredients are mannitol, crospovidone, sucralose, sodium chloride, ferric oxide yellow and magnesium stearate."
},
{
"NDCCode": "33342-030-07",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (33342-030-07) ",
"NDC11Code": "33342-0030-07",
"ProductNDC": "33342-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20121214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201787",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121214",
"SamplePackage": "N",
"IndicationAndUsage": "Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.",
"Description": "Donepezil hydrochloride, USP are a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride USP is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride USP is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride USP is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, pregelatinised starch, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate. The film coating contains talc, propylene glycol, hypromellose and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent. Inactive ingredients in 23 mg tablets include hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and hypromellose. The film coating includes ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. USP Dissolution Test pending. Donepezil hydrochloride orally disintegrating tablets USP are available for oral administration. Each donepezil hydrochloride orally disintegrating tablets contains 5 or 10 mg of donepezil hydrochloride USP. Inactive ingredients are mannitol, crospovidone, sucralose, sodium chloride, ferric oxide yellow and magnesium stearate."
},
{
"NDCCode": "33342-041-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-041-07) ",
"NDC11Code": "33342-0041-07",
"ProductNDC": "33342-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202255",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230419",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil Tablets, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3 d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4 methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets, USP are formulated as white to off-white, diamond shaped film-coated tablets containing sildenafil citrate, USP equivalent to 25 mg, 50 mg, or 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate and microcrystalline cellulose. The film coating ingredient contains: Hypromellose, titanium dioxide, triacetin."
},
{
"NDCCode": "33342-042-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-042-07) ",
"NDC11Code": "33342-0042-07",
"ProductNDC": "33342-042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202255",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230419",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil Tablets, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3 d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4 methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets, USP are formulated as white to off-white, diamond shaped film-coated tablets containing sildenafil citrate, USP equivalent to 25 mg, 50 mg, or 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate and microcrystalline cellulose. The film coating ingredient contains: Hypromellose, titanium dioxide, triacetin."
},
{
"NDCCode": "33342-043-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-043-07) ",
"NDC11Code": "33342-0043-07",
"ProductNDC": "33342-043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202255",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230419",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil Tablets, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3 d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4 methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets, USP are formulated as white to off-white, diamond shaped film-coated tablets containing sildenafil citrate, USP equivalent to 25 mg, 50 mg, or 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate and microcrystalline cellulose. The film coating ingredient contains: Hypromellose, titanium dioxide, triacetin."
},
{
"NDCCode": "33342-044-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-044-07) ",
"NDC11Code": "33342-0044-07",
"ProductNDC": "33342-044",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202230",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120510",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium USP and the following inactive ingredients: silicified microcrystalline cellulose, lactose monohydrate, corn starch, povidone, collodial silicon dioxide, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium USP 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48mg (0.216 mEq), respectively."
},
{
"NDCCode": "33342-045-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-045-07) ",
"NDC11Code": "33342-0045-07",
"ProductNDC": "33342-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202230",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120601",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium USP and the following inactive ingredients: silicified microcrystalline cellulose, lactose monohydrate, corn starch, povidone, collodial silicon dioxide, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium USP 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48mg (0.216 mEq), respectively."
},
{
"NDCCode": "33342-046-07",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (33342-046-07) ",
"NDC11Code": "33342-0046-07",
"ProductNDC": "33342-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202230",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120601",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).",
"Description": "Losartan potassium USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium USP and the following inactive ingredients: silicified microcrystalline cellulose, lactose monohydrate, corn starch, povidone, collodial silicon dioxide, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium USP 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48mg (0.216 mEq), respectively."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>33342-585-07</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (33342-585-07) </PackageDescription>
<NDC11Code>33342-0585-07</NDC11Code>
<ProductNDC>33342-585</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin</ProprietaryName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211506</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DAPAGLIFLOZIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin is indicated. To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple. CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. Dapagliflozin is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. Dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Dapagliflozin USP, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.87. The structural formula is. Dapagliflozin USP, is available as a film-coated tablet for oral administration containing 5 mg dapagliflozin USP or 10 mg dapagliflozin USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>33342-585-10</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (33342-585-10) </PackageDescription>
<NDC11Code>33342-0585-10</NDC11Code>
<ProductNDC>33342-585</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin</ProprietaryName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211506</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DAPAGLIFLOZIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin is indicated. To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple. CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. Dapagliflozin is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. Dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Dapagliflozin USP, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.87. The structural formula is. Dapagliflozin USP, is available as a film-coated tablet for oral administration containing 5 mg dapagliflozin USP or 10 mg dapagliflozin USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>33342-585-12</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-585-12) / 10 TABLET in 1 BLISTER PACK (33342-585-66) </PackageDescription>
<NDC11Code>33342-0585-12</NDC11Code>
<ProductNDC>33342-585</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin</ProprietaryName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211506</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DAPAGLIFLOZIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin is indicated. To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple. CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. Dapagliflozin is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2. Dapagliflozin is likely to be ineffective in this setting based upon its mechanism of action. Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Dapagliflozin USP, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.87. The structural formula is. Dapagliflozin USP, is available as a film-coated tablet for oral administration containing 5 mg dapagliflozin USP or 10 mg dapagliflozin USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>14209-585-07</NDCCode>
<PackageDescription>700 mL in 1 BAG (14209-585-07)</PackageDescription>
<NDC11Code>14209-0585-07</NDC11Code>
<ProductNDC>14209-585</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Germ Safe</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Original 7, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin, only when water is not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>31507-585-07</NDCCode>
<PackageDescription>700 mL in 1 BAG (31507-585-07)</PackageDescription>
<NDC11Code>31507-0585-07</NDC11Code>
<ProductNDC>31507-585</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Guard Foaming Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Wechem, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.62</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42936-585-07</NDCCode>
<PackageDescription>700 mL in 1 BAG (42936-585-07)</PackageDescription>
<NDC11Code>42936-0585-07</NDC11Code>
<ProductNDC>42936-585</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foam San Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080605</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Hill Manufacturing Co., Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.62</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-10-23</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50491-585-07</NDCCode>
<PackageDescription>700 mL in 1 BAG (50491-585-07)</PackageDescription>
<NDC11Code>50491-0585-07</NDC11Code>
<ProductNDC>50491-585</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Foam Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Dixie Packing & Seal Company</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59779-585-07</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (59779-585-07) / 6 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59779-0585-07</NDC11Code>
<ProductNDC>59779-585</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Allergy Relief</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090320</StartMarketingDate>
<EndMarketingDate>20280131</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090320</StartMarketingDatePackage>
<EndMarketingDatePackage>20280131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny noseitchy, watery eyessneezingitching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62257-585-07</NDCCode>
<PackageDescription>700 mL in 1 BAG (62257-585-07)</PackageDescription>
<NDC11Code>62257-0585-07</NDC11Code>
<ProductNDC>62257-585</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fast</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20071220</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>ABC Compounding Co., Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63533-585-07</NDCCode>
<PackageDescription>700 mL in 1 BAG (63533-585-07)</PackageDescription>
<NDC11Code>63533-0585-07</NDC11Code>
<ProductNDC>63533-585</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Han-i-foam</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Momar Incorporated</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin, only when water is not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63830-585-07</NDCCode>
<PackageDescription>700 mL in 1 BAG (63830-585-07)</PackageDescription>
<NDC11Code>63830-0585-07</NDC11Code>
<ProductNDC>63830-585</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prevent</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Pro Chem, Incorporated</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin, only when water is not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67147-585-07</NDCCode>
<PackageDescription>700 mL in 1 BAG (67147-585-07)</PackageDescription>
<NDC11Code>67147-0585-07</NDC11Code>
<ProductNDC>67147-585</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Al Cafoam</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Apple Products, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin, only when water is not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68654-585-07</NDCCode>
<PackageDescription>700 mL in 1 BAG (68654-585-07)</PackageDescription>
<NDC11Code>68654-0585-07</NDC11Code>
<ProductNDC>68654-585</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foamahol</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Share Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin, only when water is not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-585-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-585-07) </PackageDescription>
<NDC11Code>71919-0585-07</NDC11Code>
<ProductNDC>71919-585</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rhus Venenata</ProprietaryName>
<NonProprietaryName>Toxicodendron Vernix Leafy Twig</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100305</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>TOXICODENDRON VERNIX LEAFY TWIG</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76463-585-07</NDCCode>
<PackageDescription>700 mL in 1 BAG (76463-585-07)</PackageDescription>
<NDC11Code>76463-0585-07</NDC11Code>
<ProductNDC>76463-585</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foam Aid</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Gil Manufacturing, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.62</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin, only when water is not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33342-002-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-002-07) </PackageDescription>
<NDC11Code>33342-0002-07</NDC11Code>
<ProductNDC>33342-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamivudine</ProprietaryName>
<NonProprietaryName>Lamivudine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090198</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>LAMIVUDINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamivudine is nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV.</IndicationAndUsage>
<Description>Lamivudine USP is a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine USP is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine USP is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine USP has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3 g per mol. It has the following structural formula. Lamivudine USP is a white to off-white crystalline solid with a solubility of approximately 70 mg per mL in water at 20°C. Lamivudine tablets, USP are for oral administration. Each scored 150-mg film-coated tablet contains 150 mg of lamivudine USP and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. Each 300-mg film-coated tablet contains 300 mg of lamivudine USP and the inactive ingredients black iron oxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>33342-013-07</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (33342-013-07) </PackageDescription>
<NDC11Code>33342-0013-07</NDC11Code>
<ProductNDC>33342-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Efavirenz</ProprietaryName>
<NonProprietaryName>Efavirenz</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091579</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>EFAVIRENZ</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.</IndicationAndUsage>
<Description>Efavirenz, USP is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as(S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro4(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its empirical formula is C14H9ClF3NO2 and its structural formula is: Efavirenz,USP is a white to slightly pink crystalline powder with a molecular mass of 315.68. It is practically insoluble in water (<10 microgram/mL). Tablets: Efavirenz USP is available as film-coated tablets for oral administration containing 600 mg of efavirenz and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating contains Opadry Yellow,consisting of hydroxypropylmethyl cellulose, titanium dioxide, polyethylene glycol and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>33342-024-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-024-07) </PackageDescription>
<NDC11Code>33342-0024-07</NDC11Code>
<ProductNDC>33342-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famciclovir</ProprietaryName>
<NonProprietaryName>Famciclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201022</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>FAMCICLOVIR</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famciclovir, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients(1.1) Herpes labialis (cold sores) o Treatment of recurrent episodes Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes Herpes zoster (shingles) Human Immunodeficiency Virus (HIV) -Infected Adult Patients(1.2) Treatment of recurrent episodes of orolabial or genital herpesLimitation of Use The efficacy and safety of famciclovir tablets have not been established for: Patients with first episode of genital herpes Patients with ophthalmic zoster Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV- infected patients Black and African American patients with recurrent genital herpes.</IndicationAndUsage>
<Description>The active ingredient in famciclovir tablets, USP is famciclovir, USP an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir,USP is known as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate. Its molecular formula is C14H19N5O4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure. Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08. Famciclovir tablets,USP contain 125 mg, 250 mg, or 500 mg of famciclovir, USP together with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, anhydrous lactose, magnesium stearate, polyethylene glycols, sodium starch glycolate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>33342-025-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-025-07) </PackageDescription>
<NDC11Code>33342-0025-07</NDC11Code>
<ProductNDC>33342-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famciclovir</ProprietaryName>
<NonProprietaryName>Famciclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201022</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>FAMCICLOVIR</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famciclovir, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients(1.1) Herpes labialis (cold sores) o Treatment of recurrent episodes Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes Herpes zoster (shingles) Human Immunodeficiency Virus (HIV) -Infected Adult Patients(1.2) Treatment of recurrent episodes of orolabial or genital herpesLimitation of Use The efficacy and safety of famciclovir tablets have not been established for: Patients with first episode of genital herpes Patients with ophthalmic zoster Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV- infected patients Black and African American patients with recurrent genital herpes.</IndicationAndUsage>
<Description>The active ingredient in famciclovir tablets, USP is famciclovir, USP an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir,USP is known as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate. Its molecular formula is C14H19N5O4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure. Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08. Famciclovir tablets,USP contain 125 mg, 250 mg, or 500 mg of famciclovir, USP together with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, anhydrous lactose, magnesium stearate, polyethylene glycols, sodium starch glycolate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>33342-026-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-026-07) </PackageDescription>
<NDC11Code>33342-0026-07</NDC11Code>
<ProductNDC>33342-026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famciclovir</ProprietaryName>
<NonProprietaryName>Famciclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201022</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>FAMCICLOVIR</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famciclovir, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients(1.1) Herpes labialis (cold sores) o Treatment of recurrent episodes Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes Herpes zoster (shingles) Human Immunodeficiency Virus (HIV) -Infected Adult Patients(1.2) Treatment of recurrent episodes of orolabial or genital herpesLimitation of Use The efficacy and safety of famciclovir tablets have not been established for: Patients with first episode of genital herpes Patients with ophthalmic zoster Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV- infected patients Black and African American patients with recurrent genital herpes.</IndicationAndUsage>
<Description>The active ingredient in famciclovir tablets, USP is famciclovir, USP an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir,USP is known as 2-[2-(2-amino-9H-purin-9-yl)ethyl]-1,3-propanediol diacetate. Its molecular formula is C14H19N5O4; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure. Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08. Famciclovir tablets,USP contain 125 mg, 250 mg, or 500 mg of famciclovir, USP together with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, anhydrous lactose, magnesium stearate, polyethylene glycols, sodium starch glycolate and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>33342-027-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-027-07) </PackageDescription>
<NDC11Code>33342-0027-07</NDC11Code>
<ProductNDC>33342-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201146</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride, USP are a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride USP is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride USP is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride USP is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, pregelatinised starch, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate. The film coating contains talc, propylene glycol, hypromellose and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent. Inactive ingredients in 23 mg tablets include hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and hypromellose. The film coating includes ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. USP Dissolution Test pending. Donepezil hydrochloride orally disintegrating tablets USP are available for oral administration. Each donepezil hydrochloride orally disintegrating tablets contains 5 or 10 mg of donepezil hydrochloride USP. Inactive ingredients are mannitol, crospovidone, sucralose, sodium chloride, ferric oxide yellow and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>33342-028-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-028-07) </PackageDescription>
<NDC11Code>33342-0028-07</NDC11Code>
<ProductNDC>33342-028</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201146</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride, USP are a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride USP is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride USP is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride USP is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, pregelatinised starch, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate. The film coating contains talc, propylene glycol, hypromellose and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent. Inactive ingredients in 23 mg tablets include hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and hypromellose. The film coating includes ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. USP Dissolution Test pending. Donepezil hydrochloride orally disintegrating tablets USP are available for oral administration. Each donepezil hydrochloride orally disintegrating tablets contains 5 or 10 mg of donepezil hydrochloride USP. Inactive ingredients are mannitol, crospovidone, sucralose, sodium chloride, ferric oxide yellow and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>33342-029-07</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (33342-029-07) </PackageDescription>
<NDC11Code>33342-0029-07</NDC11Code>
<ProductNDC>33342-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201787</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride, USP are a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride USP is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride USP is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride USP is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, pregelatinised starch, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate. The film coating contains talc, propylene glycol, hypromellose and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent. Inactive ingredients in 23 mg tablets include hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and hypromellose. The film coating includes ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. USP Dissolution Test pending. Donepezil hydrochloride orally disintegrating tablets USP are available for oral administration. Each donepezil hydrochloride orally disintegrating tablets contains 5 or 10 mg of donepezil hydrochloride USP. Inactive ingredients are mannitol, crospovidone, sucralose, sodium chloride, ferric oxide yellow and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>33342-030-07</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (33342-030-07) </PackageDescription>
<NDC11Code>33342-0030-07</NDC11Code>
<ProductNDC>33342-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201787</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride, USP are a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride USP is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride USP is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile, and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride USP is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, pregelatinised starch, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate. The film coating contains talc, propylene glycol, hypromellose and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent. Inactive ingredients in 23 mg tablets include hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and hypromellose. The film coating includes ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. USP Dissolution Test pending. Donepezil hydrochloride orally disintegrating tablets USP are available for oral administration. Each donepezil hydrochloride orally disintegrating tablets contains 5 or 10 mg of donepezil hydrochloride USP. Inactive ingredients are mannitol, crospovidone, sucralose, sodium chloride, ferric oxide yellow and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>33342-041-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-041-07) </PackageDescription>
<NDC11Code>33342-0041-07</NDC11Code>
<ProductNDC>33342-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202255</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil Tablets, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3 d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4 methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets, USP are formulated as white to off-white, diamond shaped film-coated tablets containing sildenafil citrate, USP equivalent to 25 mg, 50 mg, or 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate and microcrystalline cellulose. The film coating ingredient contains: Hypromellose, titanium dioxide, triacetin.</Description>
</NDC>
<NDC>
<NDCCode>33342-042-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-042-07) </PackageDescription>
<NDC11Code>33342-0042-07</NDC11Code>
<ProductNDC>33342-042</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202255</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil Tablets, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3 d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4 methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets, USP are formulated as white to off-white, diamond shaped film-coated tablets containing sildenafil citrate, USP equivalent to 25 mg, 50 mg, or 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate and microcrystalline cellulose. The film coating ingredient contains: Hypromellose, titanium dioxide, triacetin.</Description>
</NDC>
<NDC>
<NDCCode>33342-043-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-043-07) </PackageDescription>
<NDC11Code>33342-0043-07</NDC11Code>
<ProductNDC>33342-043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202255</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil Tablets, USP an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3 d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4 methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets, USP are formulated as white to off-white, diamond shaped film-coated tablets containing sildenafil citrate, USP equivalent to 25 mg, 50 mg, or 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate and microcrystalline cellulose. The film coating ingredient contains: Hypromellose, titanium dioxide, triacetin.</Description>
</NDC>
<NDC>
<NDCCode>33342-044-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-044-07) </PackageDescription>
<NDC11Code>33342-0044-07</NDC11Code>
<ProductNDC>33342-044</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202230</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium USP and the following inactive ingredients: silicified microcrystalline cellulose, lactose monohydrate, corn starch, povidone, collodial silicon dioxide, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium USP 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>33342-045-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-045-07) </PackageDescription>
<NDC11Code>33342-0045-07</NDC11Code>
<ProductNDC>33342-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202230</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium USP and the following inactive ingredients: silicified microcrystalline cellulose, lactose monohydrate, corn starch, povidone, collodial silicon dioxide, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium USP 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>33342-046-07</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (33342-046-07) </PackageDescription>
<NDC11Code>33342-0046-07</NDC11Code>
<ProductNDC>33342-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202230</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
<Description>Losartan potassium USP are an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium USP, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium USP and the following inactive ingredients: silicified microcrystalline cellulose, lactose monohydrate, corn starch, povidone, collodial silicon dioxide, magnesium stearate, hydroxypropyl cellulose, hypromellose, and titanium dioxide. Losartan potassium USP 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48mg (0.216 mEq), respectively.</Description>
</NDC>
</NDCList>