{
"NDC": [
{
"NDCCode": "71919-324-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-324-07) ",
"NDC11Code": "71919-0324-07",
"ProductNDC": "71919-324",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Graphites",
"NonProprietaryName": "Graphite",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "GRAPHITE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "43063-324-07",
"PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-324-07)",
"NDC11Code": "43063-0324-07",
"ProductNDC": "43063-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076361",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2016-12-22"
},
{
"NDCCode": "64092-324-07",
"PackageDescription": "222 mL in 1 BOTTLE, PUMP (64092-324-07)",
"NDC11Code": "64092-0324-07",
"ProductNDC": "64092-324",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Wash",
"ProprietaryNameSuffix": "Pear",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160630",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Great Lakes Wholesale, Marketing, and Sales, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".222",
"StrengthUnit": "g/222mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"IndicationAndUsage": "Decrease bacteria on the skin.",
"Description": "GLS PERSONAL CARE SOLUTIONS. Antibacterial Foaming Hand Soap. Kills 99.99% of Germs. Leaves Skin Feeling Soft & Smooth. Enriched with Moisturizers. 7.5 fl oz (222mL)."
},
{
"NDCCode": "71919-324-08",
"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-324-08) ",
"NDC11Code": "71919-0324-08",
"ProductNDC": "71919-324",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Graphites",
"NonProprietaryName": "Graphite",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "GRAPHITE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "71919-324-09",
"PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-324-09) ",
"NDC11Code": "71919-0324-09",
"ProductNDC": "71919-324",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Graphites",
"NonProprietaryName": "Graphite",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "GRAPHITE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "71919-324-10",
"PackageDescription": "100 mL in 1 BOTTLE, GLASS (71919-324-10) ",
"NDC11Code": "71919-0324-10",
"ProductNDC": "71919-324",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Graphites",
"NonProprietaryName": "Graphite",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "GRAPHITE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "0591-2682-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-2682-01) ",
"NDC11Code": "00591-2682-01",
"ProductNDC": "0591-2682",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180530",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209758",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "5",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180530",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Citrate extended-release tablets are a citrate salt of potassium indicated for the management of: 1 Renal tubular acidosis (RTA) with calcium stones (1.1), 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).",
"Description": "Potassium Citrate extended-release tablets, USP are a citrate salt of potassium. It has the following chemical structure. K3C6H5O7 H2O M.W. 324.41. Potassium Citrate extended-release tablets, USP are tan to yellowish, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, USP, 10 mEq (1080 mg) potassium citrate, USP, and 15 mEq (1620 mg) potassium citrate, USP each. Inactive ingredients include carnauba wax and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "0591-2729-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-2729-01) ",
"NDC11Code": "00591-2729-01",
"ProductNDC": "0591-2729",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180530",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209758",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "10",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180530",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Citrate extended-release tablets are a citrate salt of potassium indicated for the management of: 1 Renal tubular acidosis (RTA) with calcium stones (1.1), 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).",
"Description": "Potassium Citrate extended-release tablets, USP are a citrate salt of potassium. It has the following chemical structure. K3C6H5O7 H2O M.W. 324.41. Potassium Citrate extended-release tablets, USP are tan to yellowish, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, USP, 10 mEq (1080 mg) potassium citrate, USP, and 15 mEq (1620 mg) potassium citrate, USP each. Inactive ingredients include carnauba wax and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "0591-2742-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-2742-01) ",
"NDC11Code": "00591-2742-01",
"ProductNDC": "0591-2742",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180530",
"EndMarketingDate": "20270228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209758",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "15",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180530",
"EndMarketingDatePackage": "20270228",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Citrate extended-release tablets are a citrate salt of potassium indicated for the management of: 1 Renal tubular acidosis (RTA) with calcium stones (1.1), 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).",
"Description": "Potassium Citrate extended-release tablets, USP are a citrate salt of potassium. It has the following chemical structure. K3C6H5O7 H2O M.W. 324.41. Potassium Citrate extended-release tablets, USP are tan to yellowish, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, USP, 10 mEq (1080 mg) potassium citrate, USP, and 15 mEq (1620 mg) potassium citrate, USP each. Inactive ingredients include carnauba wax and magnesium stearate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "13310-153-07",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (13310-153-07)",
"NDC11Code": "13310-0153-07",
"ProductNDC": "13310-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qualaquin",
"NonProprietaryName": "Quinine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021799",
"LabelerName": "AR Scientific Inc.",
"SubstanceName": "QUININE SULFATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "QUALAQUIN (quinine sulfate) is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. QUALAQUIN oral capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].",
"Description": "QUALAQUIN (quinine sulfate) is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. QUALAQUIN is supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc."
},
{
"NDCCode": "16590-324-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (16590-324-30)",
"NDC11Code": "16590-0324-30",
"ProductNDC": "16590-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040161",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following form:Each tablet, for oral administration, contains 20 mg of dicyclomine hydrochloride. They also contain the following inactive ingredients: Anhydrous Lactose, FDandC Blue No. 1 Lake, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose.Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethylester, hydrochloride with the structural formula. DICYCLOMINE 20MG STRUCTURE IMAGE. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether."
},
{
"NDCCode": "16590-324-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (16590-324-60)",
"NDC11Code": "16590-0324-60",
"ProductNDC": "16590-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040161",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following form:Each tablet, for oral administration, contains 20 mg of dicyclomine hydrochloride. They also contain the following inactive ingredients: Anhydrous Lactose, FDandC Blue No. 1 Lake, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose.Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethylester, hydrochloride with the structural formula. DICYCLOMINE 20MG STRUCTURE IMAGE. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether."
},
{
"NDCCode": "16590-324-72",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (16590-324-72)",
"NDC11Code": "16590-0324-72",
"ProductNDC": "16590-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040161",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following form:Each tablet, for oral administration, contains 20 mg of dicyclomine hydrochloride. They also contain the following inactive ingredients: Anhydrous Lactose, FDandC Blue No. 1 Lake, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose.Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethylester, hydrochloride with the structural formula. DICYCLOMINE 20MG STRUCTURE IMAGE. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether."
},
{
"NDCCode": "16590-324-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (16590-324-90)",
"NDC11Code": "16590-0324-90",
"ProductNDC": "16590-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040161",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following form:Each tablet, for oral administration, contains 20 mg of dicyclomine hydrochloride. They also contain the following inactive ingredients: Anhydrous Lactose, FDandC Blue No. 1 Lake, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose.Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethylester, hydrochloride with the structural formula. DICYCLOMINE 20MG STRUCTURE IMAGE. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether."
},
{
"NDCCode": "16590-595-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (16590-595-30)",
"NDC11Code": "16590-0595-30",
"ProductNDC": "16590-595",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qualaquin",
"NonProprietaryName": "Quinine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021799",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "QUININE SULFATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "QUALAQUIN (quinine sulfate) is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. QUALAQUIN oral capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].",
"Description": "QUALAQUIN (quinine sulfate) is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. QUALAQUIN is supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc."
},
{
"NDCCode": "16590-595-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (16590-595-60)",
"NDC11Code": "16590-0595-60",
"ProductNDC": "16590-595",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qualaquin",
"NonProprietaryName": "Quinine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021799",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "QUININE SULFATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "QUALAQUIN (quinine sulfate) is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. QUALAQUIN oral capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].",
"Description": "QUALAQUIN (quinine sulfate) is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. QUALAQUIN is supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc."
},
{
"NDCCode": "16590-595-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (16590-595-90)",
"NDC11Code": "16590-0595-90",
"ProductNDC": "16590-595",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qualaquin",
"NonProprietaryName": "Quinine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021799",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "QUININE SULFATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "QUALAQUIN (quinine sulfate) is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. QUALAQUIN oral capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].",
"Description": "QUALAQUIN (quinine sulfate) is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. QUALAQUIN is supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc."
},
{
"NDCCode": "16714-029-03",
"PackageDescription": "3 POUCH in 1 CARTON (16714-029-03) / 21 d in 1 POUCH (16714-029-01) ",
"NDC11Code": "16714-0029-03",
"ProductNDC": "16714-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etonogestrel And Ethinyl Estradiol Vaginal Ring",
"NonProprietaryName": "Etonogestrel And Ethinyl Estradiol Vaginal Ring",
"DosageFormName": "RING",
"RouteName": "VAGINAL",
"StartMarketingDate": "20231101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211157",
"LabelerName": "Northstar Rx LLC",
"SubstanceName": "ETHINYL ESTRADIOL; ETONOGESTREL",
"StrengthNumber": ".015; .12",
"StrengthUnit": "mg/d; mg/d",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "FOR VAGINAL USE ONLYEtonogestrel and ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy.",
"Description": "Etonogestrel and ethinyl estradiol vaginal ring is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. Etonogestrel and ethinyl estradiol vaginal ring is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. Etonogestrel and ethinyl estradiol vaginal ring is not made with natural rubber latex. Etonogestrel and ethinyl estradiol vaginal ring has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows."
},
{
"NDCCode": "35356-324-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-324-60)",
"NDC11Code": "35356-0324-60",
"ProductNDC": "35356-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etodolac",
"NonProprietaryName": "Etodolac",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076174",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "ETODOLAC",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-06-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "42571-324-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-324-05) ",
"NDC11Code": "42571-0324-05",
"ProductNDC": "42571-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211745",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine extended-release tablet is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2, 6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy) propyl]-, (±)-. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, and acetonitrile; slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid copolymer Type C (Copolymer based on ethyl acrylate and methacrylic acid and the surface-active agent such as sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose and sodium hydroxide. Additional inactive ingredients for the 500 mg tablet include Macrogol/PEG, polyvinyl alcohol, polysorbate 80, sodium lauryl sulfate, talc, Iron Oxide Yellow, Iron Oxide Red and titanium dioxide; additional inactive ingredients for the 1000 mg tablet include lactose monohydrate, triacetin, Iron Oxide Yellow and titanium dioxide."
},
{
"NDCCode": "42571-324-11",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (42571-324-11) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (42571-324-32) ",
"NDC11Code": "42571-0324-11",
"ProductNDC": "42571-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211745",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine extended-release tablet is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2, 6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy) propyl]-, (±)-. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, and acetonitrile; slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid copolymer Type C (Copolymer based on ethyl acrylate and methacrylic acid and the surface-active agent such as sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose and sodium hydroxide. Additional inactive ingredients for the 500 mg tablet include Macrogol/PEG, polyvinyl alcohol, polysorbate 80, sodium lauryl sulfate, talc, Iron Oxide Yellow, Iron Oxide Red and titanium dioxide; additional inactive ingredients for the 1000 mg tablet include lactose monohydrate, triacetin, Iron Oxide Yellow and titanium dioxide."
},
{
"NDCCode": "42571-324-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-324-60) ",
"NDC11Code": "42571-0324-60",
"ProductNDC": "42571-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211745",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine extended-release tablet is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2, 6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy) propyl]-, (±)-. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, and acetonitrile; slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid copolymer Type C (Copolymer based on ethyl acrylate and methacrylic acid and the surface-active agent such as sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose and sodium hydroxide. Additional inactive ingredients for the 500 mg tablet include Macrogol/PEG, polyvinyl alcohol, polysorbate 80, sodium lauryl sulfate, talc, Iron Oxide Yellow, Iron Oxide Red and titanium dioxide; additional inactive ingredients for the 1000 mg tablet include lactose monohydrate, triacetin, Iron Oxide Yellow and titanium dioxide."
},
{
"NDCCode": "42571-324-64",
"PackageDescription": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-324-64) ",
"NDC11Code": "42571-0324-64",
"ProductNDC": "42571-324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranolazine",
"NonProprietaryName": "Ranolazine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211745",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "RANOLAZINE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.",
"Description": "Ranolazine extended-release tablet is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2, 6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy) propyl]-, (±)-. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, and acetonitrile; slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid copolymer Type C (Copolymer based on ethyl acrylate and methacrylic acid and the surface-active agent such as sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose and sodium hydroxide. Additional inactive ingredients for the 500 mg tablet include Macrogol/PEG, polyvinyl alcohol, polysorbate 80, sodium lauryl sulfate, talc, Iron Oxide Yellow, Iron Oxide Red and titanium dioxide; additional inactive ingredients for the 1000 mg tablet include lactose monohydrate, triacetin, Iron Oxide Yellow and titanium dioxide."
},
{
"NDCCode": "49708-153-07",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (49708-153-07) ",
"NDC11Code": "49708-0153-07",
"ProductNDC": "49708-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qualaquin",
"NonProprietaryName": "Quinine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021799",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "QUININE SULFATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20050812",
"SamplePackage": "N",
"IndicationAndUsage": "QUALAQUIN is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. Limitations of Use. QUALAQUIN is not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].",
"Description": "QUALAQUIN (quinine sulfate) is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. QUALAQUIN is supplied for oral administration as capsules containing 324 mg of the active ingredient, quinine sulfate, USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc."
},
{
"NDCCode": "51862-148-03",
"PackageDescription": "3 POUCH in 1 CARTON (51862-148-03) / 21 d in 1 POUCH (51862-148-01) ",
"NDC11Code": "51862-0148-03",
"ProductNDC": "51862-148",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloette",
"NonProprietaryName": "Etonogestrel And Ethinyl Estradiol",
"DosageFormName": "INSERT, EXTENDED RELEASE",
"RouteName": "VAGINAL",
"StartMarketingDate": "20221201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211328",
"LabelerName": "Mayne Pharma Inc.",
"SubstanceName": "ETHINYL ESTRADIOL; ETONOGESTREL",
"StrengthNumber": ".015; .12",
"StrengthUnit": "mg/d; mg/d",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20221201",
"SamplePackage": "N",
"IndicationAndUsage": "FOR VAGINAL USE ONLY. Haloette® is indicated for use by females of reproductive age to prevent pregnancy.",
"Description": "Haloette (etonogestrel and ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. Haloette is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. Haloette is not made with natural rubber latex. Haloette has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows."
},
{
"NDCCode": "53489-141-07",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-07) ",
"NDC11Code": "53489-0141-07",
"ProductNDC": "53489-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinidine Gluconate",
"NonProprietaryName": "Quinidine Gluconate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19870210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089338",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "QUINIDINE GLUCONATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2018-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19870210",
"SamplePackage": "N",
"IndicationAndUsage": "Conversion of atrial fibrillation/flutter. In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine gluconate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine gluconate should be discontinued.",
"Description": "Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with Class Ia activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine gluconate is the gluconate salt of quinidine; its chemical name is cinchonan-9-ol, 6'-methoxy-, (9S)-, mono-D-gluconate; its structural formula is. Its empirical formula is C20H24N2O2 C6H12O7, and its molecular weight is 520.58, of which 62.3% is quinidine base. Each quinidine gluconate extended-release tablet contains 324 mg of quinidine gluconate (202 mg of quinidine base) in a matrix to provide extended-release; the inactive ingredients include corn starch, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, and sodium alginate. This product complies with USP Drug Release Test 5."
},
{
"NDCCode": "53489-700-07",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (53489-700-07) ",
"NDC11Code": "53489-0700-07",
"ProductNDC": "53489-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinine Sulfate",
"NonProprietaryName": "Quinine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120723",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021799",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "QUININE SULFATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120723",
"SamplePackage": "N",
"IndicationAndUsage": "Quinine sulfate capsules are an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. Limitations of Use. Quinine sulfate oral capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].",
"Description": "Quinine sulfate capsules are a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. Quinine sulfate capsules, USP are supplied for oral administration as capsules containing 324 mg of the active ingredient, quinine sulfate, USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc."
},
{
"NDCCode": "54868-4832-1",
"PackageDescription": "3 POUCH in 1 BOX (54868-4832-1) > 1 INSERT, EXTENDED RELEASE in 1 POUCH",
"NDC11Code": "54868-4832-01",
"ProductNDC": "54868-4832",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nuvaring",
"NonProprietaryName": "Etonogestrel And Ethinyl Estradiol",
"DosageFormName": "INSERT, EXTENDED RELEASE",
"RouteName": "VAGINAL",
"StartMarketingDate": "20111104",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021187",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ETONOGESTREL; ETHINYL ESTRADIOL",
"StrengthNumber": "11.7; 2.7",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "NuvaRing® is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Like oral contraceptives, NuvaRing® is highly effective if used as recommended in this label. In three large clinical trials of 13 cycles of NuvaRing® use, pregnancy rates were between one and two per 100 women-years of use. Table III lists the pregnancy rates for users of various contraceptive methods.",
"Description": "NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol).When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. NuvaRing® is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. NuvaRing® is latex-free. NuvaRing® has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows."
},
{
"NDCCode": "54868-5644-0",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-5644-0)",
"NDC11Code": "54868-5644-00",
"ProductNDC": "54868-5644",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20060724",
"MarketingCategoryName": "ANDA",
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"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "1080",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
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"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Potassium citrate extended-release tablets are indicated for the management of renal tubular acidosis (RTA) with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones.",
"Description": "Potassium citrate USP is a citrate salt of potassium and has the chemical name 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tripotassium salt, monohydrate. Its molecular formula is K3C6H 5O7.H2O , and its structural formula is: M.W. 324.41. Potassium citrate USP is a white granular powder that is soluble in water at 154 g/100 ml, almost insoluble in alcohol, and insoluble in organic solvents. Potassium citrate extended-release tablets USP are supplied as wax matrix tablets, containing 5 mEq (540 mg) potassium citrate or 10 mEq (1080 mg) potassium citrate, for oral administration. In addition, potassium citrate extended-release tablets USP contain the inactive ingredients carnauba wax, magnesium stearate and stearic acid."
},
{
"NDCCode": "54868-5644-1",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-5644-1)",
"NDC11Code": "54868-5644-01",
"ProductNDC": "54868-5644",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20060724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077440",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "1080",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Potassium citrate extended-release tablets are indicated for the management of renal tubular acidosis (RTA) with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones.",
"Description": "Potassium citrate USP is a citrate salt of potassium and has the chemical name 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tripotassium salt, monohydrate. Its molecular formula is K3C6H 5O7.H2O , and its structural formula is: M.W. 324.41. Potassium citrate USP is a white granular powder that is soluble in water at 154 g/100 ml, almost insoluble in alcohol, and insoluble in organic solvents. Potassium citrate extended-release tablets USP are supplied as wax matrix tablets, containing 5 mEq (540 mg) potassium citrate or 10 mEq (1080 mg) potassium citrate, for oral administration. In addition, potassium citrate extended-release tablets USP contain the inactive ingredients carnauba wax, magnesium stearate and stearic acid."
}
]
}
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<PackageDescription>15 mL in 1 VIAL, GLASS (71919-324-07) </PackageDescription>
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<ProductNDC>71919-324</ProductNDC>
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<SubstanceName>GRAPHITE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDCCode>43063-324-07</NDCCode>
<PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-324-07)</PackageDescription>
<NDC11Code>43063-0324-07</NDC11Code>
<ProductNDC>43063-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076361</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>64092-324-07</NDCCode>
<PackageDescription>222 mL in 1 BOTTLE, PUMP (64092-324-07)</PackageDescription>
<NDC11Code>64092-0324-07</NDC11Code>
<ProductNDC>64092-324</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Wash</ProprietaryName>
<ProprietaryNameSuffix>Pear</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Great Lakes Wholesale, Marketing, and Sales, Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.222</StrengthNumber>
<StrengthUnit>g/222mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Decrease bacteria on the skin.</IndicationAndUsage>
<Description>GLS PERSONAL CARE SOLUTIONS. Antibacterial Foaming Hand Soap. Kills 99.99% of Germs. Leaves Skin Feeling Soft & Smooth. Enriched with Moisturizers. 7.5 fl oz (222mL).</Description>
</NDC>
<NDC>
<NDCCode>71919-324-08</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (71919-324-08) </PackageDescription>
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<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>GRAPHITE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>71919-324-09</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (71919-324-09) </PackageDescription>
<NDC11Code>71919-0324-09</NDC11Code>
<ProductNDC>71919-324</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>GRAPHITE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-324-10</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-324-10) </PackageDescription>
<NDC11Code>71919-0324-10</NDC11Code>
<ProductNDC>71919-324</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Graphites</ProprietaryName>
<NonProprietaryName>Graphite</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
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<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>GRAPHITE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0591-2682-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-2682-01) </PackageDescription>
<NDC11Code>00591-2682-01</NDC11Code>
<ProductNDC>0591-2682</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Citrate</ProprietaryName>
<NonProprietaryName>Potassium Citrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180530</StartMarketingDate>
<EndMarketingDate>20270630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209758</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>POTASSIUM CITRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180530</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Citrate extended-release tablets are a citrate salt of potassium indicated for the management of: 1 Renal tubular acidosis (RTA) with calcium stones (1.1), 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).</IndicationAndUsage>
<Description>Potassium Citrate extended-release tablets, USP are a citrate salt of potassium. It has the following chemical structure. K3C6H5O7 H2O M.W. 324.41. Potassium Citrate extended-release tablets, USP are tan to yellowish, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, USP, 10 mEq (1080 mg) potassium citrate, USP, and 15 mEq (1620 mg) potassium citrate, USP each. Inactive ingredients include carnauba wax and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0591-2729-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-2729-01) </PackageDescription>
<NDC11Code>00591-2729-01</NDC11Code>
<ProductNDC>0591-2729</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Citrate</ProprietaryName>
<NonProprietaryName>Potassium Citrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180530</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209758</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>POTASSIUM CITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180530</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Citrate extended-release tablets are a citrate salt of potassium indicated for the management of: 1 Renal tubular acidosis (RTA) with calcium stones (1.1), 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).</IndicationAndUsage>
<Description>Potassium Citrate extended-release tablets, USP are a citrate salt of potassium. It has the following chemical structure. K3C6H5O7 H2O M.W. 324.41. Potassium Citrate extended-release tablets, USP are tan to yellowish, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, USP, 10 mEq (1080 mg) potassium citrate, USP, and 15 mEq (1620 mg) potassium citrate, USP each. Inactive ingredients include carnauba wax and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0591-2742-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0591-2742-01) </PackageDescription>
<NDC11Code>00591-2742-01</NDC11Code>
<ProductNDC>0591-2742</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Citrate</ProprietaryName>
<NonProprietaryName>Potassium Citrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180530</StartMarketingDate>
<EndMarketingDate>20270228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209758</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>POTASSIUM CITRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180530</StartMarketingDatePackage>
<EndMarketingDatePackage>20270228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Citrate extended-release tablets are a citrate salt of potassium indicated for the management of: 1 Renal tubular acidosis (RTA) with calcium stones (1.1), 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).</IndicationAndUsage>
<Description>Potassium Citrate extended-release tablets, USP are a citrate salt of potassium. It has the following chemical structure. K3C6H5O7 H2O M.W. 324.41. Potassium Citrate extended-release tablets, USP are tan to yellowish, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, USP, 10 mEq (1080 mg) potassium citrate, USP, and 15 mEq (1620 mg) potassium citrate, USP each. Inactive ingredients include carnauba wax and magnesium stearate. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>13310-153-07</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (13310-153-07)</PackageDescription>
<NDC11Code>13310-0153-07</NDC11Code>
<ProductNDC>13310-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qualaquin</ProprietaryName>
<NonProprietaryName>Quinine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021799</ApplicationNumber>
<LabelerName>AR Scientific Inc.</LabelerName>
<SubstanceName>QUININE SULFATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>QUALAQUIN (quinine sulfate) is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. QUALAQUIN oral capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>QUALAQUIN (quinine sulfate) is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. QUALAQUIN is supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc.</Description>
</NDC>
<NDC>
<NDCCode>16590-324-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (16590-324-30)</PackageDescription>
<NDC11Code>16590-0324-30</NDC11Code>
<ProductNDC>16590-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040161</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following form:Each tablet, for oral administration, contains 20 mg of dicyclomine hydrochloride. They also contain the following inactive ingredients: Anhydrous Lactose, FDandC Blue No. 1 Lake, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose.Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethylester, hydrochloride with the structural formula. DICYCLOMINE 20MG STRUCTURE IMAGE. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>16590-324-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (16590-324-60)</PackageDescription>
<NDC11Code>16590-0324-60</NDC11Code>
<ProductNDC>16590-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040161</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following form:Each tablet, for oral administration, contains 20 mg of dicyclomine hydrochloride. They also contain the following inactive ingredients: Anhydrous Lactose, FDandC Blue No. 1 Lake, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose.Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethylester, hydrochloride with the structural formula. DICYCLOMINE 20MG STRUCTURE IMAGE. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>16590-324-72</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (16590-324-72)</PackageDescription>
<NDC11Code>16590-0324-72</NDC11Code>
<ProductNDC>16590-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040161</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following form:Each tablet, for oral administration, contains 20 mg of dicyclomine hydrochloride. They also contain the following inactive ingredients: Anhydrous Lactose, FDandC Blue No. 1 Lake, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose.Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethylester, hydrochloride with the structural formula. DICYCLOMINE 20MG STRUCTURE IMAGE. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>16590-324-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (16590-324-90)</PackageDescription>
<NDC11Code>16590-0324-90</NDC11Code>
<ProductNDC>16590-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040161</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following form:Each tablet, for oral administration, contains 20 mg of dicyclomine hydrochloride. They also contain the following inactive ingredients: Anhydrous Lactose, FDandC Blue No. 1 Lake, Lactose Monohydrate, Magnesium Stearate, and Microcrystalline Cellulose.Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethylester, hydrochloride with the structural formula. DICYCLOMINE 20MG STRUCTURE IMAGE. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.</Description>
</NDC>
<NDC>
<NDCCode>16590-595-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (16590-595-30)</PackageDescription>
<NDC11Code>16590-0595-30</NDC11Code>
<ProductNDC>16590-595</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qualaquin</ProprietaryName>
<NonProprietaryName>Quinine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021799</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>QUININE SULFATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>QUALAQUIN (quinine sulfate) is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. QUALAQUIN oral capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>QUALAQUIN (quinine sulfate) is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. QUALAQUIN is supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc.</Description>
</NDC>
<NDC>
<NDCCode>16590-595-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (16590-595-60)</PackageDescription>
<NDC11Code>16590-0595-60</NDC11Code>
<ProductNDC>16590-595</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qualaquin</ProprietaryName>
<NonProprietaryName>Quinine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021799</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>QUININE SULFATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>QUALAQUIN (quinine sulfate) is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. QUALAQUIN oral capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>QUALAQUIN (quinine sulfate) is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. QUALAQUIN is supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc.</Description>
</NDC>
<NDC>
<NDCCode>16590-595-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (16590-595-90)</PackageDescription>
<NDC11Code>16590-0595-90</NDC11Code>
<ProductNDC>16590-595</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qualaquin</ProprietaryName>
<NonProprietaryName>Quinine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021799</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>QUININE SULFATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>QUALAQUIN (quinine sulfate) is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. QUALAQUIN oral capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>QUALAQUIN (quinine sulfate) is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. QUALAQUIN is supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc.</Description>
</NDC>
<NDC>
<NDCCode>16714-029-03</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (16714-029-03) / 21 d in 1 POUCH (16714-029-01) </PackageDescription>
<NDC11Code>16714-0029-03</NDC11Code>
<ProductNDC>16714-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etonogestrel And Ethinyl Estradiol Vaginal Ring</ProprietaryName>
<NonProprietaryName>Etonogestrel And Ethinyl Estradiol Vaginal Ring</NonProprietaryName>
<DosageFormName>RING</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20231101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211157</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<SubstanceName>ETHINYL ESTRADIOL; ETONOGESTREL</SubstanceName>
<StrengthNumber>.015; .12</StrengthNumber>
<StrengthUnit>mg/d; mg/d</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOR VAGINAL USE ONLYEtonogestrel and ethinyl estradiol vaginal ring is indicated for use by females of reproductive age to prevent pregnancy.</IndicationAndUsage>
<Description>Etonogestrel and ethinyl estradiol vaginal ring is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. Etonogestrel and ethinyl estradiol vaginal ring is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. Etonogestrel and ethinyl estradiol vaginal ring is not made with natural rubber latex. Etonogestrel and ethinyl estradiol vaginal ring has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows.</Description>
</NDC>
<NDC>
<NDCCode>35356-324-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-324-60)</PackageDescription>
<NDC11Code>35356-0324-60</NDC11Code>
<ProductNDC>35356-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etodolac</ProprietaryName>
<NonProprietaryName>Etodolac</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076174</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ETODOLAC</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42571-324-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-324-05) </PackageDescription>
<NDC11Code>42571-0324-05</NDC11Code>
<ProductNDC>42571-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211745</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine extended-release tablet is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2, 6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy) propyl]-, (±)-. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, and acetonitrile; slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid copolymer Type C (Copolymer based on ethyl acrylate and methacrylic acid and the surface-active agent such as sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose and sodium hydroxide. Additional inactive ingredients for the 500 mg tablet include Macrogol/PEG, polyvinyl alcohol, polysorbate 80, sodium lauryl sulfate, talc, Iron Oxide Yellow, Iron Oxide Red and titanium dioxide; additional inactive ingredients for the 1000 mg tablet include lactose monohydrate, triacetin, Iron Oxide Yellow and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42571-324-11</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (42571-324-11) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (42571-324-32) </PackageDescription>
<NDC11Code>42571-0324-11</NDC11Code>
<ProductNDC>42571-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211745</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine extended-release tablet is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2, 6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy) propyl]-, (±)-. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, and acetonitrile; slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid copolymer Type C (Copolymer based on ethyl acrylate and methacrylic acid and the surface-active agent such as sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose and sodium hydroxide. Additional inactive ingredients for the 500 mg tablet include Macrogol/PEG, polyvinyl alcohol, polysorbate 80, sodium lauryl sulfate, talc, Iron Oxide Yellow, Iron Oxide Red and titanium dioxide; additional inactive ingredients for the 1000 mg tablet include lactose monohydrate, triacetin, Iron Oxide Yellow and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42571-324-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-324-60) </PackageDescription>
<NDC11Code>42571-0324-60</NDC11Code>
<ProductNDC>42571-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211745</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine extended-release tablet is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2, 6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy) propyl]-, (±)-. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, and acetonitrile; slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid copolymer Type C (Copolymer based on ethyl acrylate and methacrylic acid and the surface-active agent such as sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose and sodium hydroxide. Additional inactive ingredients for the 500 mg tablet include Macrogol/PEG, polyvinyl alcohol, polysorbate 80, sodium lauryl sulfate, talc, Iron Oxide Yellow, Iron Oxide Red and titanium dioxide; additional inactive ingredients for the 1000 mg tablet include lactose monohydrate, triacetin, Iron Oxide Yellow and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42571-324-64</NDCCode>
<PackageDescription>180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-324-64) </PackageDescription>
<NDC11Code>42571-0324-64</NDC11Code>
<ProductNDC>42571-324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranolazine</ProprietaryName>
<NonProprietaryName>Ranolazine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211745</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>RANOLAZINE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.</IndicationAndUsage>
<Description>Ranolazine extended-release tablet is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N (2, 6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy) propyl]-, (±)-. It has an empirical formula of C 24H 33N 3O 4, a molecular weight of 427.54 g/mole, and the following structural formula:. Ranolazine is a white to off-white crystalline powder. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, and acetonitrile; slightly soluble in toluene. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: hypromellose, magnesium stearate, methacrylic acid copolymer Type C (Copolymer based on ethyl acrylate and methacrylic acid and the surface-active agent such as sodium lauryl sulfate and polysorbate 80), microcrystalline cellulose and sodium hydroxide. Additional inactive ingredients for the 500 mg tablet include Macrogol/PEG, polyvinyl alcohol, polysorbate 80, sodium lauryl sulfate, talc, Iron Oxide Yellow, Iron Oxide Red and titanium dioxide; additional inactive ingredients for the 1000 mg tablet include lactose monohydrate, triacetin, Iron Oxide Yellow and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49708-153-07</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (49708-153-07) </PackageDescription>
<NDC11Code>49708-0153-07</NDC11Code>
<ProductNDC>49708-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qualaquin</ProprietaryName>
<NonProprietaryName>Quinine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021799</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>QUININE SULFATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>QUALAQUIN is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. Limitations of Use. QUALAQUIN is not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>QUALAQUIN (quinine sulfate) is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. QUALAQUIN is supplied for oral administration as capsules containing 324 mg of the active ingredient, quinine sulfate, USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc.</Description>
</NDC>
<NDC>
<NDCCode>51862-148-03</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (51862-148-03) / 21 d in 1 POUCH (51862-148-01) </PackageDescription>
<NDC11Code>51862-0148-03</NDC11Code>
<ProductNDC>51862-148</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloette</ProprietaryName>
<NonProprietaryName>Etonogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>INSERT, EXTENDED RELEASE</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20221201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211328</ApplicationNumber>
<LabelerName>Mayne Pharma Inc.</LabelerName>
<SubstanceName>ETHINYL ESTRADIOL; ETONOGESTREL</SubstanceName>
<StrengthNumber>.015; .12</StrengthNumber>
<StrengthUnit>mg/d; mg/d</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOR VAGINAL USE ONLY. Haloette® is indicated for use by females of reproductive age to prevent pregnancy.</IndicationAndUsage>
<Description>Haloette (etonogestrel and ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. Haloette is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. Haloette is not made with natural rubber latex. Haloette has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows.</Description>
</NDC>
<NDC>
<NDCCode>53489-141-07</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53489-141-07) </PackageDescription>
<NDC11Code>53489-0141-07</NDC11Code>
<ProductNDC>53489-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quinidine Gluconate</ProprietaryName>
<NonProprietaryName>Quinidine Gluconate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089338</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>QUINIDINE GLUCONATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Conversion of atrial fibrillation/flutter. In patients with symptomatic atrial fibrillation/flutter whose symptoms are not adequately controlled by measures that reduce the rate of ventricular response, quinidine gluconate is indicated as a means of restoring normal sinus rhythm. If this use of quinidine gluconate does not restore sinus rhythm within a reasonable time (see DOSAGE AND ADMINISTRATION), then quinidine gluconate should be discontinued.</IndicationAndUsage>
<Description>Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with Class Ia activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine gluconate is the gluconate salt of quinidine; its chemical name is cinchonan-9-ol, 6'-methoxy-, (9S)-, mono-D-gluconate; its structural formula is. Its empirical formula is C20H24N2O2 C6H12O7, and its molecular weight is 520.58, of which 62.3% is quinidine base. Each quinidine gluconate extended-release tablet contains 324 mg of quinidine gluconate (202 mg of quinidine base) in a matrix to provide extended-release; the inactive ingredients include corn starch, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, and sodium alginate. This product complies with USP Drug Release Test 5.</Description>
</NDC>
<NDC>
<NDCCode>53489-700-07</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (53489-700-07) </PackageDescription>
<NDC11Code>53489-0700-07</NDC11Code>
<ProductNDC>53489-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quinine Sulfate</ProprietaryName>
<NonProprietaryName>Quinine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120723</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021799</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>QUININE SULFATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quinine sulfate capsules are an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. Limitations of Use. Quinine sulfate oral capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>Quinine sulfate capsules are a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. Quinine sulfate capsules, USP are supplied for oral administration as capsules containing 324 mg of the active ingredient, quinine sulfate, USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc.</Description>
</NDC>
<NDC>
<NDCCode>54868-4832-1</NDCCode>
<PackageDescription>3 POUCH in 1 BOX (54868-4832-1) > 1 INSERT, EXTENDED RELEASE in 1 POUCH</PackageDescription>
<NDC11Code>54868-4832-01</NDC11Code>
<ProductNDC>54868-4832</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nuvaring</ProprietaryName>
<NonProprietaryName>Etonogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>INSERT, EXTENDED RELEASE</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20111104</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021187</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>ETONOGESTREL; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>11.7; 2.7</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>NuvaRing® is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Like oral contraceptives, NuvaRing® is highly effective if used as recommended in this label. In three large clinical trials of 13 cycles of NuvaRing® use, pregnancy rates were between one and two per 100 women-years of use. Table III lists the pregnancy rates for users of various contraceptive methods.</IndicationAndUsage>
<Description>NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol).When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. NuvaRing® is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. NuvaRing® is latex-free. NuvaRing® has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows.</Description>
</NDC>
<NDC>
<NDCCode>54868-5644-0</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-5644-0)</PackageDescription>
<NDC11Code>54868-5644-00</NDC11Code>
<ProductNDC>54868-5644</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Citrate</ProprietaryName>
<NonProprietaryName>Potassium Citrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077440</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>POTASSIUM CITRATE</SubstanceName>
<StrengthNumber>1080</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Potassium citrate extended-release tablets are indicated for the management of renal tubular acidosis (RTA) with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones.</IndicationAndUsage>
<Description>Potassium citrate USP is a citrate salt of potassium and has the chemical name 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tripotassium salt, monohydrate. Its molecular formula is K3C6H 5O7.H2O , and its structural formula is: M.W. 324.41. Potassium citrate USP is a white granular powder that is soluble in water at 154 g/100 ml, almost insoluble in alcohol, and insoluble in organic solvents. Potassium citrate extended-release tablets USP are supplied as wax matrix tablets, containing 5 mEq (540 mg) potassium citrate or 10 mEq (1080 mg) potassium citrate, for oral administration. In addition, potassium citrate extended-release tablets USP contain the inactive ingredients carnauba wax, magnesium stearate and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>54868-5644-1</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (54868-5644-1)</PackageDescription>
<NDC11Code>54868-5644-01</NDC11Code>
<ProductNDC>54868-5644</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Citrate</ProprietaryName>
<NonProprietaryName>Potassium Citrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077440</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>POTASSIUM CITRATE</SubstanceName>
<StrengthNumber>1080</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Potassium citrate extended-release tablets are indicated for the management of renal tubular acidosis (RTA) with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones.</IndicationAndUsage>
<Description>Potassium citrate USP is a citrate salt of potassium and has the chemical name 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tripotassium salt, monohydrate. Its molecular formula is K3C6H 5O7.H2O , and its structural formula is: M.W. 324.41. Potassium citrate USP is a white granular powder that is soluble in water at 154 g/100 ml, almost insoluble in alcohol, and insoluble in organic solvents. Potassium citrate extended-release tablets USP are supplied as wax matrix tablets, containing 5 mEq (540 mg) potassium citrate or 10 mEq (1080 mg) potassium citrate, for oral administration. In addition, potassium citrate extended-release tablets USP contain the inactive ingredients carnauba wax, magnesium stearate and stearic acid.</Description>
</NDC>
</NDCList>