{
"NDC": [
{
"NDCCode": "73107-105-39",
"PackageDescription": "5000 mL in 1 BOTTLE (73107-105-39) ",
"NDC11Code": "73107-0105-39",
"ProductNDC": "73107-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"NonProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part333A",
"LabelerName": "TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Health care personnel hand rub to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "73107-102-39",
"PackageDescription": "5000 mL in 1 BOTTLE (73107-102-39) ",
"NDC11Code": "73107-0102-39",
"ProductNDC": "73107-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konix",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200407",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler Sanayi ve Tic. AS",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200407",
"SamplePackage": "N",
"IndicationAndUsage": "Health care personnel hand rub to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "33342-105-39",
"PackageDescription": "9 BLISTER PACK in 1 CARTON (33342-105-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "33342-0105-39",
"ProductNDC": "33342-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203359",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160614",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder manic episodes (1.2) Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with \"F75”), 300 mg (capsule-shaped, white, one side debossed with \"F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "68820-105-39",
"PackageDescription": "15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68820-105-39)",
"NDC11Code": "68820-0105-39",
"ProductNDC": "68820-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091123",
"LabelerName": "Orchid Healthcare (a division of Orchid Chemicals & Pharmaceuticals Ltd.)",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "76237-105-39",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (76237-105-39)",
"NDC11Code": "76237-0105-39",
"ProductNDC": "76237-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074342",
"LabelerName": "McKesson Contract Packaging",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-03-14",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "84126-105-39",
"PackageDescription": "396.8 g in 1 JAR (84126-105-39) ",
"NDC11Code": "84126-0105-39",
"ProductNDC": "84126-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Beauty Fab Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry",
"NonProprietaryName": "Colloidal Oatmeal",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "OATMEAL",
"StrengthNumber": ".5",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250401",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites."
},
{
"NDCCode": "73107-105-30",
"PackageDescription": "30 mL in 1 BOTTLE (73107-105-30) ",
"NDC11Code": "73107-0105-30",
"ProductNDC": "73107-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"NonProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part333A",
"LabelerName": "TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Health care personnel hand rub to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "73107-105-31",
"PackageDescription": "50 mL in 1 BOTTLE (73107-105-31) ",
"NDC11Code": "73107-0105-31",
"ProductNDC": "73107-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"NonProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part333A",
"LabelerName": "TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Health care personnel hand rub to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "73107-105-32",
"PackageDescription": "85 mL in 1 BOTTLE (73107-105-32) ",
"NDC11Code": "73107-0105-32",
"ProductNDC": "73107-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"NonProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part333A",
"LabelerName": "TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Health care personnel hand rub to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "73107-105-33",
"PackageDescription": "100 mL in 1 BOTTLE (73107-105-33) ",
"NDC11Code": "73107-0105-33",
"ProductNDC": "73107-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"NonProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part333A",
"LabelerName": "TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Health care personnel hand rub to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "73107-105-34",
"PackageDescription": "150 mL in 1 BOTTLE (73107-105-34) ",
"NDC11Code": "73107-0105-34",
"ProductNDC": "73107-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"NonProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part333A",
"LabelerName": "TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Health care personnel hand rub to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "73107-105-35",
"PackageDescription": "200 mL in 1 BOTTLE (73107-105-35) ",
"NDC11Code": "73107-0105-35",
"ProductNDC": "73107-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"NonProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part333A",
"LabelerName": "TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Health care personnel hand rub to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "73107-105-36",
"PackageDescription": "250 mL in 1 BOTTLE (73107-105-36) ",
"NDC11Code": "73107-0105-36",
"ProductNDC": "73107-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"NonProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part333A",
"LabelerName": "TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Health care personnel hand rub to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "73107-105-37",
"PackageDescription": "500 mL in 1 BOTTLE (73107-105-37) ",
"NDC11Code": "73107-0105-37",
"ProductNDC": "73107-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"NonProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part333A",
"LabelerName": "TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Health care personnel hand rub to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "73107-105-38",
"PackageDescription": "1000 mL in 1 BOTTLE (73107-105-38) ",
"NDC11Code": "73107-0105-38",
"ProductNDC": "73107-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"NonProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part333A",
"LabelerName": "TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Health care personnel hand rub to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "73107-105-40",
"PackageDescription": "5 mL in 1 PACKET (73107-105-40) ",
"NDC11Code": "73107-0105-40",
"ProductNDC": "73107-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"NonProprietaryName": "Konix Alcohol Antiseptic Hand Rub",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part333A",
"LabelerName": "TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Health care personnel hand rub to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "23155-216-31",
"PackageDescription": "5 mL in 1 VIAL, GLASS (23155-216-31) ",
"NDC11Code": "23155-0216-31",
"ProductNDC": "23155-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cidofovir Dihydrate",
"NonProprietaryName": "Cidofovir Dihydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202501",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "CIDOFOVIR",
"StrengthNumber": "375",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2023-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120806",
"SamplePackage": "N",
"IndicationAndUsage": "Cidofovir injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS. DESCRIPTION OF CLINICAL TRIALS. Three phase II/III controlled trials of cidofovir injection have been conducted in HIV-infected patients with CMV retinitis. Delayed Versus Immediate Therapy (Study 105). In stage 1 of this open-label trial, conducted by the Studies of the Ocular Complications of AIDS (SOCA) Clinical Research Group, 29 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 3 mg/kg every other week) or to have cidofovir injection delayed until progression of CMV retinitis13. In stage 2 of this trial, an additional 35 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 5 mg/kg every other week), immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 3 mg/kg every other week), or to have cidofovir injection delayed until progression of CMV retinitis. Of the 64 patients in this study, 12 were randomized to 5 mg/kg maintenance therapy, 26 to 3 mg/kg maintenance therapy, and 26 to delayed therapy. Of the 12 patients enrolled in the 5 mg/kg maintenance group, 5 patients progressed, 5 patients discontinued therapy and 2 patients had no progression at study completion. Based on masked readings of retinal photographs, the median [95% confidence interval (CI)] time to retinitis progression was not reached (25, not reached) for the 5 mg/kg maintenance group. Median (95% CI) time to the alternative endpoint of retinitis progression or study drug discontinuation was 44 days (24, 207) for the 5 mg/kg maintenance group. Patients receiving 5 mg/kg maintenance had delayed time to retinitis progression compared to patients receiving 3 mg/kg maintenance or deferred therapy. Delayed Versus Immediate Therapy (Study 106). In an open-label trial, 48 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 5 mg/kg every other week), or to have cidofovir injection delayed until progression of CMV retinitis14. Patient baseline characteristics and disposition are shown in Table 3. Of 25 and 23 patients in the immediate and delayed groups respectively, 23 and 21 were evaluable for retinitis progression as determined by retinal photography. Based on masked readings of retinal photographs, the median [95% confidence interval (CI)] times to retinitis progression were 120 days (40, 134) and 22 days (10, 27) for the immediate and delayed therapy groups, respectively. This difference was statistically significant. However, because of the limited number of patients remaining on treatment over time (3 of 25 patients received cidofovir injection for 120 days or longer), the median time to progression for the immediate therapy group was difficult to precisely estimate. Median (95% CI) times to the alternative endpoint of retinitis progression or study drug discontinuation (including adverse events, withdrawn consent, and systemic CMV disease) were 52 days (37, 85) and 22 days (13, 27) for the immediate and delayed therapy groups, respectively. This difference was statistically significant. Time to progression estimates from this study may not be directly comparable to estimates reported for other therapies. Dose-response study of cidofovir injection (Study 107). In an open-label trial, 100 patients with relapsing CMV retinitis were randomized to receive 5 mg/kg once a week for 2 weeks and then either 5 mg/kg (n = 49) or 3 mg/kg (n = 51) every other week. Enrolled patients had been diagnosed with CMV retinitis an average of 390 days prior to randomization and had received a median of 3.8 prior courses of systemic CMV therapy. Eighty four of the 100 patients were considered evaluable for progression by serial retinal photographs (43 randomized to 5 mg/kg and 41 randomized to 3 mg/kg). Twenty-six and 21 patients discontinued therapy due to either an adverse event, intercurrent illness, excluded medication, or withdrawn consent in the 5 mg/kg and 3 mg/kg groups, respectively. Thirty-eight of the 100 randomized patients had progressed according to masked assessment of serial retinal photographs (13 randomized to 5 mg/kg and 25 randomized to 3 mg/kg). Using retinal photographs, the median (95% CI) times to retinitis progression for the 5 mg/kg and 3 mg/kg groups were 115 days (70, not reached) and 49 days (35, 52), respectively. This difference was statistically significant. Similar to Study 106, the median time to retinitis progression for the 5 mg/kg group was difficult to precisely estimate due to the limited number of patients remaining on treatment over time (4 of the 49 patients in the 5 mg/kg group were treated for 115 days or longer). Median (95% CI) times to the alternative endpoint of retinitis progression or study drug discontinuation were 49 days (38, 63) and 35 days (27, 39) for the 5 mg/kg and 3 mg/kg groups, respectively. This difference was statistically significant.",
"Description": "The chemical name of cidofovir USP is 1-[(S)-3-hydroxy-2-(phosphonomethoxy)propyl]cytosine dihydrate (HPMPC), with the molecular formula of C8H14N3O6P2H2O and a molecular weight of 315.22 (279.19 for anhydrous). The chemical structure is. Cidofovir USP is a white crystalline powder with an aqueous solubility of ≥ 170 mg/mL at pH 6 to 8 and a log P (octanol/aqueous buffer, pH 7.1) value of -3.3. Cidofovir Injection, USP is a sterile, hypertonic aqueous solution for intravenous infusion only. The solution is clear and colorless. It is supplied in clear glass vials, each containing 375 mg of anhydrous cidofovir USP in 5 mL aqueous solution at a concentration of 75 mg/mL. The formulation is pH-adjusted to 7.4 (range 7.1 to 7.7) with sodium hydroxide and/or hydrochloric acid and contains no preservatives. The appropriate volume of Cidofovir Injection must be removed from the single-dose vial and diluted prior to administration (see DOSAGE AND ADMINISTRATION). MICROBIOLOGY. Mechanism of Action. Cidofovir suppresses cytomegalovirus (CMV) replication by selective inhibition of viral DNA synthesis. Biochemical data support selective inhibition of CMV DNA polymerase by cidofovir diphosphate, the active intracellular metabolite of cidofovir. Cidofovir diphosphate inhibits herpesvirus polymerases at concentrations that are 8- to 600-fold lower than those needed to inhibit human cellular DNA polymerases alpha, beta, and gamma1, 2, 3. Incorporation of cidofovir into the growing viral DNA chain results in reductions in the rate of viral DNA synthesis. In Vitro Susceptibility. Cidofovir is active in vitro against a variety of laboratory and clinical isolates of CMV and other herpesviruses (Table 1). Controlled clinical studies of efficacy have been limited to patients with AIDS and CMV retinitis. Table 1. Cidofovir Inhibition of Virus Multiplication in Cell Culture. Resistance. CMV isolates with reduced susceptibility to cidofovir have been selected in vitro in the presence of high concentrations of cidofovir4. IC50 values for selected resistant isolates ranged from 7 to 15 μM. There are insufficient data at this time to assess the frequency or the clinical significance of the development of resistant isolates following cidofovir injection administration to patients. The possibility of viral resistance should be considered for patients who show a poor clinical response or experience recurrent retinitis progression during therapy. Cross Resistance. Cidofovir-resistant isolates selected in vitro following exposure to increasing concentrations of cidofovir were assessed for susceptibility to ganciclovir and foscarnet4. All were cross resistant to ganciclovir, but remained susceptible to foscarnet. Ganciclovir or ganciclovir/foscarnet-resistant isolates that are cross resistant to cidofovir have been obtained from drug naive patients and from patients following ganciclovir or ganciclovir/ foscarnet therapy. To date, the majority of ganciclovir-resistant isolates are UL97 gene product (phosphokinase) mutants and remain susceptible to cidofovir5. Reduced susceptibility to cidofovir, however, has been reported for DNA polymerase mutants of CMV which are resistant to ganciclovir6–9. To date, all clinical isolates which exhibit high level resistance to ganciclovir, due to mutations in both the DNA polymerase and UL97 genes, have been shown to be cross resistant to cidofovir. Cidofovir is active against some, but not all, CMV isolates which are resistant to foscarnet10–12. The incidence of foscarnet-resistant isolates that are resistant to cidofovir is not known. A few triple-drug resistant isolates have been described. Genotypic analysis of two of these triple-resistant isolates revealed several point mutations in the CMV DNA polymerase gene. The clinical significance of the development of these cross-resistant isolates is not known."
},
{
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"PackageDescription": "9 BLISTER PACK in 1 CARTON (33342-057-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "33342-0057-39",
"ProductNDC": "33342-057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irbesartan And Hydrochlorothiazide",
"NonProprietaryName": "Irbesartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202414",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "IRBESARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "150; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
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"IndicationAndUsage": "Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy.Irbesartan and hydrochlorothiazide tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of irbesartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks.Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with irbesartan and hydrochlorothiazide tablets compared to irbesartan or hydrochlorothiazide (HCTZ) monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with irbesartan and hydrochlorothiazide tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b. *For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to-treat analysis).The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone). The likelihood of achieving these goals on irbesartan and hydrochlorothiazide tablets rises to about 40% (systolic) or 70% (diastolic).",
"Description": "Irbesartan and hydrochlorothiazide tablets USP are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and hydrochlorothiazide tablets, USP are available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide. All dosage strengths contain the following inactive ingredients: carboxymethylcellulose calcium, sodium starch glycolate, talc, povidone, colloidal silicon dioxide, and magnesium stearate. The 300/12.5 and 150/12.5 mg peach film-coated tablets contain ferric oxide red, ferric oxide yellow, hypromellose-2910, PEG-3000, titanium dioxide and lactose monohydrate."
},
{
"NDCCode": "33342-058-39",
"PackageDescription": "9 BLISTER PACK in 1 CARTON (33342-058-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "33342-0058-39",
"ProductNDC": "33342-058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irbesartan And Hydrochlorothiazide",
"NonProprietaryName": "Irbesartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202414",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "IRBESARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "300; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
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"IndicationAndUsage": "Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy.Irbesartan and hydrochlorothiazide tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of irbesartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks.Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with irbesartan and hydrochlorothiazide tablets compared to irbesartan or hydrochlorothiazide (HCTZ) monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with irbesartan and hydrochlorothiazide tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b. *For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to-treat analysis).The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone). The likelihood of achieving these goals on irbesartan and hydrochlorothiazide tablets rises to about 40% (systolic) or 70% (diastolic).",
"Description": "Irbesartan and hydrochlorothiazide tablets USP are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and hydrochlorothiazide tablets, USP are available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide. All dosage strengths contain the following inactive ingredients: carboxymethylcellulose calcium, sodium starch glycolate, talc, povidone, colloidal silicon dioxide, and magnesium stearate. The 300/12.5 and 150/12.5 mg peach film-coated tablets contain ferric oxide red, ferric oxide yellow, hypromellose-2910, PEG-3000, titanium dioxide and lactose monohydrate."
},
{
"NDCCode": "33342-105-11",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (33342-105-11) ",
"NDC11Code": "33342-0105-11",
"ProductNDC": "33342-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203359",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-05",
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"IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder manic episodes (1.2) Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with \"F75”), 300 mg (capsule-shaped, white, one side debossed with \"F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
},
{
"NDCCode": "33342-105-15",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (33342-105-15) ",
"NDC11Code": "33342-0105-15",
"ProductNDC": "33342-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203359",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-05",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder manic episodes (1.2) Bipolar disorder, depressive episodes (1.2).",
"Description": "Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with \"F75”), 300 mg (capsule-shaped, white, one side debossed with \"F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine."
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"NDC11Code": "35000-0769-71",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Speed Stick",
"ProprietaryNameSuffix": "Invisible Dry Power",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "105",
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"IndicationAndUsage": "reduces underarm wetness."
},
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"NDCCode": "35000-771-71",
"PackageDescription": "39.6 g in 1 CONTAINER (35000-771-71) ",
"NDC11Code": "35000-0771-71",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lady Speed Stick Invisible Dry",
"ProprietaryNameSuffix": "Shower Fresh",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
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"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "105",
"StrengthUnit": "mg/g",
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"LastUpdate": "2025-12-06",
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"IndicationAndUsage": "reduces underarm wetness."
},
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"NDCCode": "35000-781-71",
"PackageDescription": "39.6 g in 1 CONTAINER (35000-781-71) ",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ladies Speed Stick Invisible Dry",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20260222",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "105",
"StrengthUnit": "mg/g",
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"LastUpdate": "2026-04-09",
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"IndicationAndUsage": "reduces underarm wetness."
},
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"NDCCode": "44567-105-10",
"PackageDescription": "10 VIAL in 1 TRAY (44567-105-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
"NDC11Code": "44567-0105-10",
"ProductNDC": "44567-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20120510",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062772",
"LabelerName": "WG Critical Care, LLC",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20120510",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:. Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and non-penicillinase producing), H. influenzae and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin-G-susceptible staphylococci and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp. and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. Indicated surgical procedures should be performed. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Ampicillin for Injection, USP the monosodium salt of [2S-[2a, 5a, 6b(S*)]]-6- [(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. It has the following chemical structure. The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8.0 to 10.0. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. Ampicillin for Injection, USP is supplied in vials equivalent to 125 mg, 250 mg, 500 mg, 1 gram or 2 grams of ampicillin. It is to be administered by intravenous or intramuscular routes."
},
{
"NDCCode": "70860-105-20",
"PackageDescription": "10 VIAL in 1 CARTON (70860-105-20) > 20 mL in 1 VIAL (70860-105-41) ",
"NDC11Code": "70860-0105-20",
"ProductNDC": "70860-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205694",
"LabelerName": "Athenex Pharmaceutical Division, LLC.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/20mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170915",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.",
"Description": "Vancomycin Hydrochloride for Injection, USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9] oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:."
},
{
"NDCCode": "72526-105-11",
"PackageDescription": "1 SYRINGE, GLASS in 1 KIT (72526-105-11) / .25 mL in 1 SYRINGE, GLASS",
"NDC11Code": "72526-0105-11",
"ProductNDC": "72526-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erzofri Extended-release",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20241210",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216352",
"LabelerName": "Shandong Luye Pharmaceutical Co., Ltd.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "39",
"StrengthUnit": "mg/.25mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241210",
"SamplePackage": "N",
"IndicationAndUsage": "ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .",
"Description": "ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5."
},
{
"NDCCode": "83634-105-30",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-105-30) / 15 mL in 1 VIAL, SINGLE-DOSE (83634-105-41) ",
"NDC11Code": "83634-0105-30",
"ProductNDC": "83634-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin And Tazobactam",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065523",
"LabelerName": "Avenacy, LLC",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "3; .375",
"StrengthUnit": "g/15mL; g/15mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250201",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: : 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1) , 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2) , 3 Skin and skin structure infections in adults (1.3) , 4 Female pelvic infections in adults (1.4) , 5 Community-acquired pneumonia in adults (1.5) .",
"Description": "Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:. Piperacillin and Tazobactam for Injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Piperacillin and Tazobactam for Injection, USP, is a white to off-white sterile, lyophilized powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. This product does not contain excipients or preservatives. Each Piperacillin and Tazobactam for Injection, USP 2.25 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 grams of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each Piperacillin and Tazobactam for Injection, USP 3.375 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 grams of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each Piperacillin and Tazobactam for Injection, USP 4.5 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 grams of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Meets USP Organic Impurities Test 3."
},
{
"NDCCode": "73107-005-01",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (73107-005-01) / 10 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "73107-0005-01",
"ProductNDC": "73107-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Joydrops Climax Control Male Genital Desensitizer",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250818",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunleri Sanayi Ve Ticaret AS.",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250818",
"SamplePackage": "N"
},
{
"NDCCode": "73107-008-01",
"PackageDescription": "120 mL in 1 BOTTLE (73107-008-01) ",
"NDC11Code": "73107-0008-01",
"ProductNDC": "73107-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Konix Povidone Iodine Topical Antiseptic",
"NonProprietaryName": "Povidone-iodine",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250818",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS",
"SubstanceName": "POVIDONE-IODINE",
"StrengthNumber": "75",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250818",
"SamplePackage": "N",
"IndicationAndUsage": "For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection. First aid to help reduce the risk of skin infection in minor cuts, scrapes, and burns."
}
]
}
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<NDCCode>73107-105-39</NDCCode>
<PackageDescription>5000 mL in 1 BOTTLE (73107-105-39) </PackageDescription>
<NDC11Code>73107-0105-39</NDC11Code>
<ProductNDC>73107-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Konix Alcohol Antiseptic Hand Rub</ProprietaryName>
<NonProprietaryName>Konix Alcohol Antiseptic Hand Rub</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200512</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Health care personnel hand rub to help reduce bacteria that potentially can cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73107-102-39</NDCCode>
<PackageDescription>5000 mL in 1 BOTTLE (73107-102-39) </PackageDescription>
<NDC11Code>73107-0102-39</NDC11Code>
<ProductNDC>73107-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Konix</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200407</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler Sanayi ve Tic. AS</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Health care personnel hand rub to help reduce bacteria that potentially can cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33342-105-39</NDCCode>
<PackageDescription>9 BLISTER PACK in 1 CARTON (33342-105-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0105-39</NDC11Code>
<ProductNDC>33342-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203359</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder manic episodes (1.2) Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with "F75”), 300 mg (capsule-shaped, white, one side debossed with "F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
</NDC>
<NDC>
<NDCCode>68820-105-39</NDCCode>
<PackageDescription>15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68820-105-39)</PackageDescription>
<NDC11Code>68820-0105-39</NDC11Code>
<ProductNDC>68820-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091123</ApplicationNumber>
<LabelerName>Orchid Healthcare (a division of Orchid Chemicals & Pharmaceuticals Ltd.)</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>76237-105-39</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (76237-105-39)</PackageDescription>
<NDC11Code>76237-0105-39</NDC11Code>
<ProductNDC>76237-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074342</ApplicationNumber>
<LabelerName>McKesson Contract Packaging</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-03-14</LastUpdate>
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<IndicationAndUsage>Health care personnel hand rub to help reduce bacteria that potentially can cause disease.</IndicationAndUsage>
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<NDCCode>23155-216-31</NDCCode>
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<IndicationAndUsage>Cidofovir injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS. DESCRIPTION OF CLINICAL TRIALS. Three phase II/III controlled trials of cidofovir injection have been conducted in HIV-infected patients with CMV retinitis. Delayed Versus Immediate Therapy (Study 105). In stage 1 of this open-label trial, conducted by the Studies of the Ocular Complications of AIDS (SOCA) Clinical Research Group, 29 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 3 mg/kg every other week) or to have cidofovir injection delayed until progression of CMV retinitis13. In stage 2 of this trial, an additional 35 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 5 mg/kg every other week), immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 3 mg/kg every other week), or to have cidofovir injection delayed until progression of CMV retinitis. Of the 64 patients in this study, 12 were randomized to 5 mg/kg maintenance therapy, 26 to 3 mg/kg maintenance therapy, and 26 to delayed therapy. Of the 12 patients enrolled in the 5 mg/kg maintenance group, 5 patients progressed, 5 patients discontinued therapy and 2 patients had no progression at study completion. Based on masked readings of retinal photographs, the median [95% confidence interval (CI)] time to retinitis progression was not reached (25, not reached) for the 5 mg/kg maintenance group. Median (95% CI) time to the alternative endpoint of retinitis progression or study drug discontinuation was 44 days (24, 207) for the 5 mg/kg maintenance group. Patients receiving 5 mg/kg maintenance had delayed time to retinitis progression compared to patients receiving 3 mg/kg maintenance or deferred therapy. Delayed Versus Immediate Therapy (Study 106). In an open-label trial, 48 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 5 mg/kg every other week), or to have cidofovir injection delayed until progression of CMV retinitis14. Patient baseline characteristics and disposition are shown in Table 3. Of 25 and 23 patients in the immediate and delayed groups respectively, 23 and 21 were evaluable for retinitis progression as determined by retinal photography. Based on masked readings of retinal photographs, the median [95% confidence interval (CI)] times to retinitis progression were 120 days (40, 134) and 22 days (10, 27) for the immediate and delayed therapy groups, respectively. This difference was statistically significant. However, because of the limited number of patients remaining on treatment over time (3 of 25 patients received cidofovir injection for 120 days or longer), the median time to progression for the immediate therapy group was difficult to precisely estimate. Median (95% CI) times to the alternative endpoint of retinitis progression or study drug discontinuation (including adverse events, withdrawn consent, and systemic CMV disease) were 52 days (37, 85) and 22 days (13, 27) for the immediate and delayed therapy groups, respectively. This difference was statistically significant. Time to progression estimates from this study may not be directly comparable to estimates reported for other therapies. Dose-response study of cidofovir injection (Study 107). In an open-label trial, 100 patients with relapsing CMV retinitis were randomized to receive 5 mg/kg once a week for 2 weeks and then either 5 mg/kg (n = 49) or 3 mg/kg (n = 51) every other week. Enrolled patients had been diagnosed with CMV retinitis an average of 390 days prior to randomization and had received a median of 3.8 prior courses of systemic CMV therapy. Eighty four of the 100 patients were considered evaluable for progression by serial retinal photographs (43 randomized to 5 mg/kg and 41 randomized to 3 mg/kg). Twenty-six and 21 patients discontinued therapy due to either an adverse event, intercurrent illness, excluded medication, or withdrawn consent in the 5 mg/kg and 3 mg/kg groups, respectively. Thirty-eight of the 100 randomized patients had progressed according to masked assessment of serial retinal photographs (13 randomized to 5 mg/kg and 25 randomized to 3 mg/kg). Using retinal photographs, the median (95% CI) times to retinitis progression for the 5 mg/kg and 3 mg/kg groups were 115 days (70, not reached) and 49 days (35, 52), respectively. This difference was statistically significant. Similar to Study 106, the median time to retinitis progression for the 5 mg/kg group was difficult to precisely estimate due to the limited number of patients remaining on treatment over time (4 of the 49 patients in the 5 mg/kg group were treated for 115 days or longer). Median (95% CI) times to the alternative endpoint of retinitis progression or study drug discontinuation were 49 days (38, 63) and 35 days (27, 39) for the 5 mg/kg and 3 mg/kg groups, respectively. This difference was statistically significant.</IndicationAndUsage>
<Description>The chemical name of cidofovir USP is 1-[(S)-3-hydroxy-2-(phosphonomethoxy)propyl]cytosine dihydrate (HPMPC), with the molecular formula of C8H14N3O6P2H2O and a molecular weight of 315.22 (279.19 for anhydrous). The chemical structure is. Cidofovir USP is a white crystalline powder with an aqueous solubility of ≥ 170 mg/mL at pH 6 to 8 and a log P (octanol/aqueous buffer, pH 7.1) value of -3.3. Cidofovir Injection, USP is a sterile, hypertonic aqueous solution for intravenous infusion only. The solution is clear and colorless. It is supplied in clear glass vials, each containing 375 mg of anhydrous cidofovir USP in 5 mL aqueous solution at a concentration of 75 mg/mL. The formulation is pH-adjusted to 7.4 (range 7.1 to 7.7) with sodium hydroxide and/or hydrochloric acid and contains no preservatives. The appropriate volume of Cidofovir Injection must be removed from the single-dose vial and diluted prior to administration (see DOSAGE AND ADMINISTRATION). MICROBIOLOGY. Mechanism of Action. Cidofovir suppresses cytomegalovirus (CMV) replication by selective inhibition of viral DNA synthesis. Biochemical data support selective inhibition of CMV DNA polymerase by cidofovir diphosphate, the active intracellular metabolite of cidofovir. Cidofovir diphosphate inhibits herpesvirus polymerases at concentrations that are 8- to 600-fold lower than those needed to inhibit human cellular DNA polymerases alpha, beta, and gamma1, 2, 3. Incorporation of cidofovir into the growing viral DNA chain results in reductions in the rate of viral DNA synthesis. In Vitro Susceptibility. Cidofovir is active in vitro against a variety of laboratory and clinical isolates of CMV and other herpesviruses (Table 1). Controlled clinical studies of efficacy have been limited to patients with AIDS and CMV retinitis. Table 1. Cidofovir Inhibition of Virus Multiplication in Cell Culture. Resistance. CMV isolates with reduced susceptibility to cidofovir have been selected in vitro in the presence of high concentrations of cidofovir4. IC50 values for selected resistant isolates ranged from 7 to 15 μM. There are insufficient data at this time to assess the frequency or the clinical significance of the development of resistant isolates following cidofovir injection administration to patients. The possibility of viral resistance should be considered for patients who show a poor clinical response or experience recurrent retinitis progression during therapy. Cross Resistance. Cidofovir-resistant isolates selected in vitro following exposure to increasing concentrations of cidofovir were assessed for susceptibility to ganciclovir and foscarnet4. All were cross resistant to ganciclovir, but remained susceptible to foscarnet. Ganciclovir or ganciclovir/foscarnet-resistant isolates that are cross resistant to cidofovir have been obtained from drug naive patients and from patients following ganciclovir or ganciclovir/ foscarnet therapy. To date, the majority of ganciclovir-resistant isolates are UL97 gene product (phosphokinase) mutants and remain susceptible to cidofovir5. Reduced susceptibility to cidofovir, however, has been reported for DNA polymerase mutants of CMV which are resistant to ganciclovir6–9. To date, all clinical isolates which exhibit high level resistance to ganciclovir, due to mutations in both the DNA polymerase and UL97 genes, have been shown to be cross resistant to cidofovir. Cidofovir is active against some, but not all, CMV isolates which are resistant to foscarnet10–12. The incidence of foscarnet-resistant isolates that are resistant to cidofovir is not known. A few triple-drug resistant isolates have been described. Genotypic analysis of two of these triple-resistant isolates revealed several point mutations in the CMV DNA polymerase gene. The clinical significance of the development of these cross-resistant isolates is not known.</Description>
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<NonProprietaryName>Irbesartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120927</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202414</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>IRBESARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>150; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-09</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy.Irbesartan and hydrochlorothiazide tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of irbesartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks.Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with irbesartan and hydrochlorothiazide tablets compared to irbesartan or hydrochlorothiazide (HCTZ) monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with irbesartan and hydrochlorothiazide tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b. *For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to-treat analysis).The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone). The likelihood of achieving these goals on irbesartan and hydrochlorothiazide tablets rises to about 40% (systolic) or 70% (diastolic).</IndicationAndUsage>
<Description>Irbesartan and hydrochlorothiazide tablets USP are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and hydrochlorothiazide tablets, USP are available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide. All dosage strengths contain the following inactive ingredients: carboxymethylcellulose calcium, sodium starch glycolate, talc, povidone, colloidal silicon dioxide, and magnesium stearate. The 300/12.5 and 150/12.5 mg peach film-coated tablets contain ferric oxide red, ferric oxide yellow, hypromellose-2910, PEG-3000, titanium dioxide and lactose monohydrate.</Description>
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<NDC>
<NDCCode>33342-058-39</NDCCode>
<PackageDescription>9 BLISTER PACK in 1 CARTON (33342-058-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>33342-058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irbesartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Irbesartan And Hydrochlorothiazide</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20120927</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202414</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>IRBESARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>300; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-09</LastUpdate>
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<IndicationAndUsage>Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy.Irbesartan and hydrochlorothiazide tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of irbesartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks.Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with irbesartan and hydrochlorothiazide tablets compared to irbesartan or hydrochlorothiazide (HCTZ) monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with irbesartan and hydrochlorothiazide tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b. *For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to-treat analysis).The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone). The likelihood of achieving these goals on irbesartan and hydrochlorothiazide tablets rises to about 40% (systolic) or 70% (diastolic).</IndicationAndUsage>
<Description>Irbesartan and hydrochlorothiazide tablets USP are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and its structural formula is. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and hydrochlorothiazide tablets, USP are available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide. All dosage strengths contain the following inactive ingredients: carboxymethylcellulose calcium, sodium starch glycolate, talc, povidone, colloidal silicon dioxide, and magnesium stearate. The 300/12.5 and 150/12.5 mg peach film-coated tablets contain ferric oxide red, ferric oxide yellow, hypromellose-2910, PEG-3000, titanium dioxide and lactose monohydrate.</Description>
</NDC>
<NDC>
<NDCCode>33342-105-11</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (33342-105-11) </PackageDescription>
<NDC11Code>33342-0105-11</NDC11Code>
<ProductNDC>33342-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203359</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-05</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder manic episodes (1.2) Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with "F75”), 300 mg (capsule-shaped, white, one side debossed with "F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<NDCCode>33342-105-15</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (33342-105-15) </PackageDescription>
<NDC11Code>33342-0105-15</NDC11Code>
<ProductNDC>33342-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203359</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder manic episodes (1.2) Bipolar disorder, depressive episodes (1.2).</IndicationAndUsage>
<Description>Quetiapine fumarate USP is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water.Quetiapine tablets USP are supplied for oral administration as 25 mg (round, peach, one side debossed with “F71”), 50 mg (round, white, one side debossed with “F72”), 100 mg (round, yellow one side debossed with “F73”), 200 mg (round, white, one side debossed with "F75”), 300 mg (capsule-shaped, white, one side debossed with "F76”), and 400 mg (capsule-shaped, yellow, one side debossed with “F77”) tablets.Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, colloidal silicon di-oxide, hypromellose, polyethylene glycol, and titanium dioxide.The 25 mg tablets contain red ferric oxide and yellow ferric oxide and the 100 mg and 400 mg tablets contain only yellow ferric oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.39 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.51 mg of quetiapine fumarate equivalent to 400 mg quetiapine.</Description>
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<NDC>
<NDCCode>35000-769-71</NDCCode>
<PackageDescription>39.6 g in 1 CONTAINER (35000-769-71) </PackageDescription>
<NDC11Code>35000-0769-71</NDC11Code>
<ProductNDC>35000-769</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Speed Stick</ProprietaryName>
<ProprietaryNameSuffix>Invisible Dry Power</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>105</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-01</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
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<NDC>
<NDCCode>35000-771-71</NDCCode>
<PackageDescription>39.6 g in 1 CONTAINER (35000-771-71) </PackageDescription>
<NDC11Code>35000-0771-71</NDC11Code>
<ProductNDC>35000-771</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lady Speed Stick Invisible Dry</ProprietaryName>
<ProprietaryNameSuffix>Shower Fresh</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>105</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
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<NDC>
<NDCCode>35000-781-71</NDCCode>
<PackageDescription>39.6 g in 1 CONTAINER (35000-781-71) </PackageDescription>
<NDC11Code>35000-0781-71</NDC11Code>
<ProductNDC>35000-781</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ladies Speed Stick Invisible Dry</ProprietaryName>
<ProprietaryNameSuffix>Powder Fresh</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260222</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>105</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>44567-105-10</NDCCode>
<PackageDescription>10 VIAL in 1 TRAY (44567-105-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>44567-0105-10</NDC11Code>
<ProductNDC>44567-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20120510</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062772</ApplicationNumber>
<LabelerName>WG Critical Care, LLC</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:. Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and non-penicillinase producing), H. influenzae and Group A beta-hemolytic Streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria. Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin-G-susceptible staphylococci and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp. and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. Indicated surgical procedures should be performed. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Ampicillin for Injection, USP the monosodium salt of [2S-[2a, 5a, 6b(S*)]]-6- [(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. It has the following chemical structure. The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8.0 to 10.0. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. Ampicillin for Injection, USP is supplied in vials equivalent to 125 mg, 250 mg, 500 mg, 1 gram or 2 grams of ampicillin. It is to be administered by intravenous or intramuscular routes.</Description>
</NDC>
<NDC>
<NDCCode>70860-105-20</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (70860-105-20) > 20 mL in 1 VIAL (70860-105-41) </PackageDescription>
<NDC11Code>70860-0105-20</NDC11Code>
<ProductNDC>70860-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205694</ApplicationNumber>
<LabelerName>Athenex Pharmaceutical Division, LLC.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/20mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride for Injection, USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 gram vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9] oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>72526-105-11</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 KIT (72526-105-11) / .25 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>72526-0105-11</NDC11Code>
<ProductNDC>72526-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erzofri Extended-release</ProprietaryName>
<NonProprietaryName>Paliperidone Palmitate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216352</ApplicationNumber>
<LabelerName>Shandong Luye Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>PALIPERIDONE PALMITATE</SubstanceName>
<StrengthNumber>39</StrengthNumber>
<StrengthUnit>mg/.25mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .</IndicationAndUsage>
<Description>ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>83634-105-30</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (83634-105-30) / 15 mL in 1 VIAL, SINGLE-DOSE (83634-105-41) </PackageDescription>
<NDC11Code>83634-0105-30</NDC11Code>
<ProductNDC>83634-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065523</ApplicationNumber>
<LabelerName>Avenacy, LLC</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>3; .375</StrengthNumber>
<StrengthUnit>g/15mL; g/15mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: : 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1) , 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2) , 3 Skin and skin structure infections in adults (1.3) , 4 Female pelvic infections in adults (1.4) , 5 Community-acquired pneumonia in adults (1.5) .</IndicationAndUsage>
<Description>Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is:. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is:. Piperacillin and Tazobactam for Injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Piperacillin and Tazobactam for Injection, USP, is a white to off-white sterile, lyophilized powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. This product does not contain excipients or preservatives. Each Piperacillin and Tazobactam for Injection, USP 2.25 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 grams of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each Piperacillin and Tazobactam for Injection, USP 3.375 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 grams of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each Piperacillin and Tazobactam for Injection, USP 4.5 gram single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 grams of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Meets USP Organic Impurities Test 3.</Description>
</NDC>
<NDC>
<NDCCode>73107-005-01</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (73107-005-01) / 10 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>73107-0005-01</NDC11Code>
<ProductNDC>73107-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Joydrops Climax Control Male Genital Desensitizer</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250818</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunleri Sanayi Ve Ticaret AS.</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73107-008-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (73107-008-01) </PackageDescription>
<NDC11Code>73107-0008-01</NDC11Code>
<ProductNDC>73107-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Konix Povidone Iodine Topical Antiseptic</ProprietaryName>
<NonProprietaryName>Povidone-iodine</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250818</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection. First aid to help reduce the risk of skin infection in minor cuts, scrapes, and burns.</IndicationAndUsage>
</NDC>
</NDCList>