{
"NDC": [
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"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-628-06) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206513",
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{
"NDCCode": "65841-628-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (65841-628-06) ",
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"ProductNDC": "65841-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"DosageFormName": "TABLET",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077580",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "HALOPERIDOL",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080103",
"SamplePackage": "N"
},
{
"NDCCode": "68428-628-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-628-06) ",
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"ProductNDC": "68428-628",
"ProductTypeName": "HUMAN OTC DRUG",
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"RouteName": "ORAL",
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "SCUTELLARIA LATERIFLORA",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
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},
{
"NDCCode": "84126-628-06",
"PackageDescription": "3 CARTON in 1 CELLO PACK (84126-628-06) / 1 TUBE in 1 CARTON / 93 g in 1 TUBE",
"NDC11Code": "84126-0628-06",
"ProductNDC": "84126-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest 3d White",
"ProprietaryNameSuffix": "Advanced Arctic Fresh With Stain-blasting Foam",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
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"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
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{
"NDCCode": "68382-628-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (68382-628-01) ",
"NDC11Code": "68382-0628-01",
"ProductNDC": "68382-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206513",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200116",
"SamplePackage": "N"
},
{
"NDCCode": "68382-628-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68382-628-05) ",
"NDC11Code": "68382-0628-05",
"ProductNDC": "68382-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206513",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200116",
"SamplePackage": "N"
},
{
"NDCCode": "68382-628-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-628-10) ",
"NDC11Code": "68382-0628-10",
"ProductNDC": "68382-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206513",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200116",
"SamplePackage": "N"
},
{
"NDCCode": "68382-628-16",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (68382-628-16) ",
"NDC11Code": "68382-0628-16",
"ProductNDC": "68382-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206513",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200116",
"SamplePackage": "N"
},
{
"NDCCode": "68382-628-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-628-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-628-30) ",
"NDC11Code": "68382-0628-77",
"ProductNDC": "68382-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206513",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200116",
"SamplePackage": "N"
},
{
"NDCCode": "11673-628-09",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (11673-628-09) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "11673-0628-09",
"ProductNDC": "11673-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinus Pressure And Pain Relief",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Acetaminophen, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130503",
"EndMarketingDate": "20210626",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Target Corporation",
"SubstanceName": "ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-06-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130503",
"EndMarketingDatePackage": "20210626",
"SamplePackage": "N"
},
{
"NDCCode": "13517-628-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (13517-628-01) ",
"NDC11Code": "13517-0628-01",
"ProductNDC": "13517-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221130",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "e5 Pharma, LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "97.2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221130",
"EndMarketingDatePackage": "20260531",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg or 97.2 mg of phenobarbital. In addition each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "17205-628-00",
"PackageDescription": "30 kg in 1 DRUM (17205-628-00) ",
"NDC11Code": "17205-0628-00",
"ProductNDC": "17205-628",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Zanubrutinib",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230616",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Siegfried AG",
"SubstanceName": "ZANUBRUTINIB",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-06-20",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "16-JUN-23"
},
{
"NDCCode": "31722-556-12",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (31722-556-12) ",
"NDC11Code": "31722-0556-12",
"ProductNDC": "31722-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lopinavir And Ritonavir",
"NonProprietaryName": "Lopinavir And Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091677",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "200; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2021-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210607",
"SamplePackage": "N",
"IndicationAndUsage": "Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].",
"Description": "Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide."
},
{
"NDCCode": "31722-556-31",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (31722-556-31) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "31722-0556-31",
"ProductNDC": "31722-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lopinavir And Ritonavir",
"NonProprietaryName": "Lopinavir And Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091677",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "200; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2021-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210607",
"SamplePackage": "N",
"IndicationAndUsage": "Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].",
"Description": "Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide."
},
{
"NDCCode": "31722-556-32",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (31722-556-32) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "31722-0556-32",
"ProductNDC": "31722-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lopinavir And Ritonavir",
"NonProprietaryName": "Lopinavir And Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091677",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "200; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2021-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210607",
"SamplePackage": "N",
"IndicationAndUsage": "Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].",
"Description": "Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide."
},
{
"NDCCode": "31722-556-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (31722-556-60) ",
"NDC11Code": "31722-0556-60",
"ProductNDC": "31722-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lopinavir And Ritonavir",
"NonProprietaryName": "Lopinavir And Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091677",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "200; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2021-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210607",
"SamplePackage": "N",
"IndicationAndUsage": "Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].",
"Description": "Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide."
},
{
"NDCCode": "31722-603-12",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (31722-603-12) ",
"NDC11Code": "31722-0603-12",
"ProductNDC": "31722-603",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lopinavir And Ritonavir",
"NonProprietaryName": "Lopinavir And Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091677",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "100; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2021-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210607",
"SamplePackage": "N",
"IndicationAndUsage": "Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].",
"Description": "Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide."
},
{
"NDCCode": "31722-603-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (31722-603-60) ",
"NDC11Code": "31722-0603-60",
"ProductNDC": "31722-603",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lopinavir And Ritonavir",
"NonProprietaryName": "Lopinavir And Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091677",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "100; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2021-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210607",
"SamplePackage": "N",
"IndicationAndUsage": "Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].",
"Description": "Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide."
},
{
"NDCCode": "36800-628-02",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (36800-628-02) / 12 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "36800-0628-02",
"ProductNDC": "36800-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Multi Symptom",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210723",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "TOPCO ASSOCIATES LLC",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 2; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210723",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headachesinus congestion and pressurenasal congestionrunny nose and sneezingminor aches and pains. temporarily relieves these additional symptoms of hay fever: itching of the nose or throatitchy, watery eyes. helps clear nasal passages. helps decongest sinus openings and passages."
},
{
"NDCCode": "43269-628-01",
"PackageDescription": "29 mL in 1 TUBE (43269-628-01)",
"NDC11Code": "43269-0628-01",
"ProductNDC": "43269-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Polar Mint",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100903",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SJ Creations, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "65",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-06-08",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "43598-628-57",
"PackageDescription": "1 KIT in 1 CARTON (43598-628-57) * 3 mL in 1 VIAL (43598-860-11) * 30 mL in 1 VIAL, SINGLE-DOSE (43598-861-11) ",
"NDC11Code": "43598-0628-57",
"ProductNDC": "43598-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carmustine",
"NonProprietaryName": "Carmustine",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20211004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213207",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"Status": "Active",
"LastUpdate": "2025-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211004",
"SamplePackage": "N",
"IndicationAndUsage": "Carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following. - Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - Multiple myeloma in combination with prednisone. - Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. - Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs.",
"Description": "The active ingredient in carmustine for injection USP, is a nitrosourea with the chemical name1,3-bis(2-chloroethyl)-1-nitrosourea and a molecular weight of 214.06. The drug product is supplied as sterile lyophilized pale yellow flakes or a congealed mass, and it is highly soluble in alcohol and poorly soluble in water. Carmustine for injection USP, is administered by intravenous infusion after reconstitution, as recommended. The structural formula of carmustine USP is. Carmustine for injection USP, is available in 100 mg single dose vials of lyophilized material.Sterile diluent for constitution of carmustine is co-packaged with the active drug product for use in constitution of the lyophile. The diluent is supplied in a vial containing 3 mL of Dehydrated Alcohol Injection, USP."
},
{
"NDCCode": "49035-628-45",
"PackageDescription": "946 mL in 1 BOTTLE, PLASTIC (49035-628-45) ",
"NDC11Code": "49035-0628-45",
"ProductNDC": "49035-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160914",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Wal-Mart Stores, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160914",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "49035-628-96",
"PackageDescription": "222 mL in 1 BOTTLE, PUMP (49035-628-96) ",
"NDC11Code": "49035-0628-96",
"ProductNDC": "49035-628",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160914",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Wal-Mart Stores, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160914",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "59368-410-01",
"PackageDescription": "1 INHALER in 1 CARTON (59368-410-01) / 200 AEROSOL, METERED in 1 INHALER",
"NDC11Code": "59368-0410-01",
"ProductNDC": "59368-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol Tartrate Hfa Inhalation",
"NonProprietaryName": "Levalbuterol Tartrate",
"DosageFormName": "AEROSOL, METERED",
"RouteName": "ORAL",
"StartMarketingDate": "20161003",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021730",
"LabelerName": "Praxis, LLC",
"SubstanceName": "LEVALBUTEROL TARTRATE",
"StrengthNumber": "45",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161003",
"SamplePackage": "N",
"Description": "The active component of Levalbuterol tartrate HFA inhalation aerosol is levalbuterol tartrate, the (R)-enantiomer of albuterol. Levalbuterol tartrate is a relatively selective beta 2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. Levalbuterol tartrate has the chemical name (R)-α 1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol L-tartrate (2:1 salt), and it has the following chemical structure:. The molecular weight of levalbuterol tartrate is 628.71, and its empirical formula is (C 13H 21NO 3) 2· C 4H 6O 6. It is a white to light-yellow solid, freely soluble in water and very slightly soluble in ethanol. Levalbuterol tartrate is the generic name for (R)-albuterol tartrate in the United States. Levalbuterol tartrate HFA inhalation aerosol is a pressurized metered-dose aerosol inhaler (MDI) fitted with a dose indicator, which produces an aerosol for oral inhalation. It contains a suspension of micronized levalbuterol tartrate, propellant HFA-134a (1,1,1,2-tetrafluoroethane), Dehydrated Alcohol USP, and Oleic Acid NF. After priming with 4 actuations, each actuation of the inhaler delivers 67.8 mcg of levalbuterol tartrate (equivalent to 51.6 mcg of levalbuterol free base) from the valve and 59 mcg of levalbuterol tartrate (equivalent to 45 mcg of levalbuterol free base) from the actuator mouthpiece. Each 15 g canister provides 200 actuations (or inhalations)."
},
{
"NDCCode": "60760-628-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-628-90) ",
"NDC11Code": "60760-0628-90",
"ProductNDC": "60760-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200908",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210727",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol hydrochloride tablets, USP are adrenergic receptor blocking agents that have both selective alpha 1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride, and it has the following structure:. Labetalol HCl has the molecular formula C 19H 24N 2O 3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R, R´stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets contain 100, 200, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients lactose monohydrate, corn starch, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide and talc."
},
{
"NDCCode": "61314-628-10",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (61314-628-10) / 10 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "61314-0628-10",
"ProductNDC": "61314-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Polymyxin B Sulfate And Trimethoprim",
"NonProprietaryName": "Polymyxin B Sulfate And Trimethoprim",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19980416",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064211",
"LabelerName": "Sandoz Inc",
"SubstanceName": "POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE",
"StrengthNumber": "10000; 1",
"StrengthUnit": "[USP'U]/mL; mg/mL",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa.*. *Efficacy for this organism in this organ system was studied in fewer than 10 infections.",
"Description": "Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is a sterile antimicrobial solution for topical ophthalmic use. It has pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg. Chemical Names: Trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine sulfate (2:1), is a white, odorless, crystalline powder with a molecular weight of 678.72 and the following structural formula. Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formula are. Contains: Actives: polymyxin B sulfate 10,000 units/mL; trimethoprim sulfate equivalent to trimethoprim 1 mg/mL. Preservative: benzalkonium chloride 0.04 mg/mL. Inactives: sodium chloride; sulfuric acid; and purified water. May also contain sodium hydroxide for pH adjustment."
},
{
"NDCCode": "63187-628-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (63187-628-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "63187-0628-05",
"ProductNDC": "63187-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20091105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078434",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2021-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Ketorolac Tromethamine Ophthalmic Solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac Tromethamine Ophthalmic Solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.",
"Description": "Ketorolac Tromethamine Ophthalmic Solution is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-benzoyl-2, 3-dihydro-1H pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-l,3-propanediol(1:1) and it has the following structural formula:. The molecular formula of Ketorolac Tromethamine Ophthalmic Solution is C15H13NO3C4H11NO3. Ketorolac Tromethamine Ophthalmic Solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac Tromethamine Ophthalmic Solution is a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of Ketorolac Ophthalmic Solution is 290 mOsml/kg. Each mL of Ketorolac Tromethamine Ophthalmic Solution contains:. Active: ketorolac tromethamine 0.5%. Inactives: edetate disodium 0.1%; octoxynol 40; sodium chloride; hydrochloric acid and/or sodium hydroxide may be added to adjust the pH (6.8 to 7.4) and purified water. Preservative: benzalkonium chloride 0.01%."
},
{
"NDCCode": "72189-628-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (72189-628-90) ",
"NDC11Code": "72189-0628-90",
"ProductNDC": "72189-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hcl",
"NonProprietaryName": "Buspirone Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210907",
"LabelerName": "Direct_Rx",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250613",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets, USP in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets, USP for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets, USP for extended periods should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is N-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. [Image]. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "83324-026-06",
"PackageDescription": "177 mL in 1 BOTTLE (83324-026-06) ",
"NDC11Code": "83324-0026-06",
"ProductNDC": "83324-026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Qch Maximum Strength Mucus Relief Dm 628",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240426",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "part341",
"LabelerName": "Chain Drug Marketing Association Inc.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "20; 400",
"StrengthUnit": "mg/20mL; mg/20mL",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240426",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive. temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep."
},
{
"NDCCode": "68382-001-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-001-06) ",
"NDC11Code": "68382-0001-06",
"ProductNDC": "68382-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077584",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070413",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide."
}
]
}
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crest 3d White</ProprietaryName>
<ProprietaryNameSuffix>Advanced Arctic Fresh With Stain-blasting Foam</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
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<RouteName>DENTAL</RouteName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-628-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-628-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-628-30) </PackageDescription>
<NDC11Code>68382-0628-77</NDC11Code>
<ProductNDC>68382-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206513</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11673-628-09</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (11673-628-09) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11673-0628-09</NDC11Code>
<ProductNDC>11673-628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinus Pressure And Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130503</StartMarketingDate>
<EndMarketingDate>20210626</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-06-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130503</StartMarketingDatePackage>
<EndMarketingDatePackage>20210626</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13517-628-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (13517-628-01) </PackageDescription>
<NDC11Code>13517-0628-01</NDC11Code>
<ProductNDC>13517-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221130</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>e5 Pharma, LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>97.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221130</StartMarketingDatePackage>
<EndMarketingDatePackage>20260531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg or 97.2 mg of phenobarbital. In addition each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>17205-628-00</NDCCode>
<PackageDescription>30 kg in 1 DRUM (17205-628-00) </PackageDescription>
<NDC11Code>17205-0628-00</NDC11Code>
<ProductNDC>17205-628</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Zanubrutinib</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230616</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Siegfried AG</LabelerName>
<SubstanceName>ZANUBRUTINIB</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-06-20</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-JUN-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>31722-556-12</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (31722-556-12) </PackageDescription>
<NDC11Code>31722-0556-12</NDC11Code>
<ProductNDC>31722-556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lopinavir And Ritonavir</ProprietaryName>
<NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091677</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>200; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].</IndicationAndUsage>
<Description>Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-556-31</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 CARTON (31722-556-31) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>31722-0556-31</NDC11Code>
<ProductNDC>31722-556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lopinavir And Ritonavir</ProprietaryName>
<NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091677</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>200; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].</IndicationAndUsage>
<Description>Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-556-32</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 CARTON (31722-556-32) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>31722-0556-32</NDC11Code>
<ProductNDC>31722-556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lopinavir And Ritonavir</ProprietaryName>
<NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091677</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>200; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].</IndicationAndUsage>
<Description>Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-556-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (31722-556-60) </PackageDescription>
<NDC11Code>31722-0556-60</NDC11Code>
<ProductNDC>31722-556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lopinavir And Ritonavir</ProprietaryName>
<NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091677</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>200; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].</IndicationAndUsage>
<Description>Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-603-12</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (31722-603-12) </PackageDescription>
<NDC11Code>31722-0603-12</NDC11Code>
<ProductNDC>31722-603</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lopinavir And Ritonavir</ProprietaryName>
<NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091677</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>100; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].</IndicationAndUsage>
<Description>Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>31722-603-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (31722-603-60) </PackageDescription>
<NDC11Code>31722-0603-60</NDC11Code>
<ProductNDC>31722-603</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lopinavir And Ritonavir</ProprietaryName>
<NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091677</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>100; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].</IndicationAndUsage>
<Description>Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>36800-628-02</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (36800-628-02) / 12 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>36800-0628-02</NDC11Code>
<ProductNDC>36800-628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Multi Symptom</ProprietaryName>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210723</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>TOPCO ASSOCIATES LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 2; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headachesinus congestion and pressurenasal congestionrunny nose and sneezingminor aches and pains. temporarily relieves these additional symptoms of hay fever: itching of the nose or throatitchy, watery eyes. helps clear nasal passages. helps decongest sinus openings and passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43269-628-01</NDCCode>
<PackageDescription>29 mL in 1 TUBE (43269-628-01)</PackageDescription>
<NDC11Code>43269-0628-01</NDC11Code>
<ProductNDC>43269-628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Polar Mint</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100903</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SJ Creations, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>65</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-06-08</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43598-628-57</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (43598-628-57) * 3 mL in 1 VIAL (43598-860-11) * 30 mL in 1 VIAL, SINGLE-DOSE (43598-861-11) </PackageDescription>
<NDC11Code>43598-0628-57</NDC11Code>
<ProductNDC>43598-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carmustine</ProprietaryName>
<NonProprietaryName>Carmustine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20211004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213207</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following. - Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - Multiple myeloma in combination with prednisone. - Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. - Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs.</IndicationAndUsage>
<Description>The active ingredient in carmustine for injection USP, is a nitrosourea with the chemical name1,3-bis(2-chloroethyl)-1-nitrosourea and a molecular weight of 214.06. The drug product is supplied as sterile lyophilized pale yellow flakes or a congealed mass, and it is highly soluble in alcohol and poorly soluble in water. Carmustine for injection USP, is administered by intravenous infusion after reconstitution, as recommended. The structural formula of carmustine USP is. Carmustine for injection USP, is available in 100 mg single dose vials of lyophilized material.Sterile diluent for constitution of carmustine is co-packaged with the active drug product for use in constitution of the lyophile. The diluent is supplied in a vial containing 3 mL of Dehydrated Alcohol Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>49035-628-45</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE, PLASTIC (49035-628-45) </PackageDescription>
<NDC11Code>49035-0628-45</NDC11Code>
<ProductNDC>49035-628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160914</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Wal-Mart Stores, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49035-628-96</NDCCode>
<PackageDescription>222 mL in 1 BOTTLE, PUMP (49035-628-96) </PackageDescription>
<NDC11Code>49035-0628-96</NDC11Code>
<ProductNDC>49035-628</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160914</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Wal-Mart Stores, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59368-410-01</NDCCode>
<PackageDescription>1 INHALER in 1 CARTON (59368-410-01) / 200 AEROSOL, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59368-0410-01</NDC11Code>
<ProductNDC>59368-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol Tartrate Hfa Inhalation</ProprietaryName>
<NonProprietaryName>Levalbuterol Tartrate</NonProprietaryName>
<DosageFormName>AEROSOL, METERED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161003</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021730</ApplicationNumber>
<LabelerName>Praxis, LLC</LabelerName>
<SubstanceName>LEVALBUTEROL TARTRATE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The active component of Levalbuterol tartrate HFA inhalation aerosol is levalbuterol tartrate, the (R)-enantiomer of albuterol. Levalbuterol tartrate is a relatively selective beta 2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. Levalbuterol tartrate has the chemical name (R)-α 1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol L-tartrate (2:1 salt), and it has the following chemical structure:. The molecular weight of levalbuterol tartrate is 628.71, and its empirical formula is (C 13H 21NO 3) 2· C 4H 6O 6. It is a white to light-yellow solid, freely soluble in water and very slightly soluble in ethanol. Levalbuterol tartrate is the generic name for (R)-albuterol tartrate in the United States. Levalbuterol tartrate HFA inhalation aerosol is a pressurized metered-dose aerosol inhaler (MDI) fitted with a dose indicator, which produces an aerosol for oral inhalation. It contains a suspension of micronized levalbuterol tartrate, propellant HFA-134a (1,1,1,2-tetrafluoroethane), Dehydrated Alcohol USP, and Oleic Acid NF. After priming with 4 actuations, each actuation of the inhaler delivers 67.8 mcg of levalbuterol tartrate (equivalent to 51.6 mcg of levalbuterol free base) from the valve and 59 mcg of levalbuterol tartrate (equivalent to 45 mcg of levalbuterol free base) from the actuator mouthpiece. Each 15 g canister provides 200 actuations (or inhalations).</Description>
</NDC>
<NDC>
<NDCCode>60760-628-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-628-90) </PackageDescription>
<NDC11Code>60760-0628-90</NDC11Code>
<ProductNDC>60760-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hcl</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200908</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride tablets, USP are adrenergic receptor blocking agents that have both selective alpha 1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride, and it has the following structure:. Labetalol HCl has the molecular formula C 19H 24N 2O 3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R, R´stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets contain 100, 200, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients lactose monohydrate, corn starch, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide and talc.</Description>
</NDC>
<NDC>
<NDCCode>61314-628-10</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (61314-628-10) / 10 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>61314-0628-10</NDC11Code>
<ProductNDC>61314-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Polymyxin B Sulfate And Trimethoprim</ProprietaryName>
<NonProprietaryName>Polymyxin B Sulfate And Trimethoprim</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19980416</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064211</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE</SubstanceName>
<StrengthNumber>10000; 1</StrengthNumber>
<StrengthUnit>[USP'U]/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa.*. *Efficacy for this organism in this organ system was studied in fewer than 10 infections.</IndicationAndUsage>
<Description>Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is a sterile antimicrobial solution for topical ophthalmic use. It has pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg. Chemical Names: Trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine sulfate (2:1), is a white, odorless, crystalline powder with a molecular weight of 678.72 and the following structural formula. Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formula are. Contains: Actives: polymyxin B sulfate 10,000 units/mL; trimethoprim sulfate equivalent to trimethoprim 1 mg/mL. Preservative: benzalkonium chloride 0.04 mg/mL. Inactives: sodium chloride; sulfuric acid; and purified water. May also contain sodium hydroxide for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>63187-628-05</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (63187-628-05) > 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>63187-0628-05</NDC11Code>
<ProductNDC>63187-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20091105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078434</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketorolac Tromethamine Ophthalmic Solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac Tromethamine Ophthalmic Solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.</IndicationAndUsage>
<Description>Ketorolac Tromethamine Ophthalmic Solution is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-benzoyl-2, 3-dihydro-1H pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-l,3-propanediol(1:1) and it has the following structural formula:. The molecular formula of Ketorolac Tromethamine Ophthalmic Solution is C15H13NO3C4H11NO3. Ketorolac Tromethamine Ophthalmic Solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac Tromethamine Ophthalmic Solution is a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of Ketorolac Ophthalmic Solution is 290 mOsml/kg. Each mL of Ketorolac Tromethamine Ophthalmic Solution contains:. Active: ketorolac tromethamine 0.5%. Inactives: edetate disodium 0.1%; octoxynol 40; sodium chloride; hydrochloric acid and/or sodium hydroxide may be added to adjust the pH (6.8 to 7.4) and purified water. Preservative: benzalkonium chloride 0.01%.</Description>
</NDC>
<NDC>
<NDCCode>72189-628-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (72189-628-90) </PackageDescription>
<NDC11Code>72189-0628-90</NDC11Code>
<ProductNDC>72189-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hcl</ProprietaryName>
<NonProprietaryName>Buspirone Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210907</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets, USP in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets, USP for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets, USP for extended periods should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is N-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride. The empirical formula C21H31N5O2HCl is represented by the following structural formula. [Image]. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet), or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets, USP contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>83324-026-06</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE (83324-026-06) </PackageDescription>
<NDC11Code>83324-0026-06</NDC11Code>
<ProductNDC>83324-026</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Qch Maximum Strength Mucus Relief Dm 628</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240426</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Chain Drug Marketing Association Inc.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 400</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive. temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68382-001-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-001-06) </PackageDescription>
<NDC11Code>68382-0001-06</NDC11Code>
<ProductNDC>68382-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077584</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
</NDCList>