{
"NDC": [
{
"NDCCode": "43598-986-72",
"PackageDescription": "3 BOTTLE in 1 CARTON (43598-986-72) / 24 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0986-72",
"ProductNDC": "43598-986",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Habitrol",
"ProprietaryNameSuffix": "Nicotine Polacrilex Lozenge Mint",
"NonProprietaryName": "Nicotine Polacrilex Lozenge 2 Mg",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20210521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212796",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210521",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "82804-986-72",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-72) ",
"NDC11Code": "82804-0986-72",
"ProductNDC": "82804-986",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204165",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240521",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel is a P2Y12 platelet inhibitor indicated for: 1 Acute coronary syndrome1. For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1)2. For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. (1.1), 2 Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. (1.2).",
"Description": "Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S )-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H )- acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2S∙H2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is freely soluble in methanol, practically insoluble in ether. It has a specific optical rotation of about +56°. Clopidogrel for oral administration is provided as either pink colored, round shaped, biconvex, de-bossed, film coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink colored, modified oval shaped, de-bossed film coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose and hydrogenated castor oil as inactive ingredients. The film coating contains hypromellose, titanium dioxide, polyethylene glycol, red iron oxide, and yellow iron oxide."
},
{
"NDCCode": "43598-986-13",
"PackageDescription": "5 BOTTLE in 1 CARTON (43598-986-13) / 27 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0986-13",
"ProductNDC": "43598-986",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Habitrol",
"ProprietaryNameSuffix": "Nicotine Polacrilex Lozenge Mint",
"NonProprietaryName": "Nicotine Polacrilex Lozenge 2 Mg",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20210521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212796",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210521",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43598-986-24",
"PackageDescription": "1 BOTTLE in 1 CARTON (43598-986-24) / 24 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0986-24",
"ProductNDC": "43598-986",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Habitrol",
"ProprietaryNameSuffix": "Nicotine Polacrilex Lozenge Mint",
"NonProprietaryName": "Nicotine Polacrilex Lozenge 2 Mg",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20210521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212796",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210521",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43598-986-27",
"PackageDescription": "1 BOTTLE in 1 CARTON (43598-986-27) / 27 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0986-27",
"ProductNDC": "43598-986",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Habitrol",
"ProprietaryNameSuffix": "Nicotine Polacrilex Lozenge Mint",
"NonProprietaryName": "Nicotine Polacrilex Lozenge 2 Mg",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20210521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212796",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210521",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43598-484-72",
"PackageDescription": "3 BOTTLE in 1 CARTON (43598-484-72) / 24 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0484-72",
"ProductNDC": "43598-484",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20200911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212983",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200911",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43598-485-72",
"PackageDescription": "3 BOTTLE in 1 CARTON (43598-485-72) / 24 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0485-72",
"ProductNDC": "43598-485",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20200911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212983",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200911",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43598-486-72",
"PackageDescription": "3 BOTTLE in 1 CARTON (43598-486-72) / 24 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0486-72",
"ProductNDC": "43598-486",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20200609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212796",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43598-487-72",
"PackageDescription": "3 BOTTLE in 1 CARTON (43598-487-72) / 24 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0487-72",
"ProductNDC": "43598-487",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20200609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212796",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43598-488-72",
"PackageDescription": "3 BOTTLE in 1 CARTON (43598-488-72) / 24 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0488-72",
"ProductNDC": "43598-488",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213233",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43598-489-72",
"PackageDescription": "3 BOTTLE in 1 CARTON (43598-489-72) / 24 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0489-72",
"ProductNDC": "43598-489",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213233",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43598-746-72",
"PackageDescription": "240 CAPSULE in 1 BOTTLE (43598-746-72) ",
"NDC11Code": "43598-0746-72",
"ProductNDC": "43598-746",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Icosapent Ethyl",
"NonProprietaryName": "Icosapent Ethyl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230417",
"EndMarketingDate": "20270531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209499",
"LabelerName": "Dr. Reddy's Laboratories, Inc.",
"SubstanceName": "ICOSAPENT ETHYL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230417",
"EndMarketingDatePackage": "20270531",
"SamplePackage": "N",
"IndicationAndUsage": "Icosapent ethyl capsules are indicated: : 1 as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.",
"Description": "Icosapent ethyl capsules, a lipid-regulating agent, is supplied as a 0.5 gram transparent natural colored oval shaped, liquid-filled soft gelatin capsule for oral use. Each icosapent ethyl capsule contains 0.5 grams of icosapent ethyl (in a 0.5 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure. Icosapent ethyl capsules also contain the following inactive ingredients: alpha tocopherol, gelatin, glycerin, mannitol, sorbitol, and purified water. The imprinting Opacode NSP-78-18022 White contains, ammonium hydroxide, macrogol, polyvinyl acetate phthalate, propylene glycol and titanium dioxide."
},
{
"NDCCode": "43598-984-72",
"PackageDescription": "3 BOTTLE in 1 CARTON (43598-984-72) / 24 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0984-72",
"ProductNDC": "43598-984",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Habitrol Lozenge",
"ProprietaryNameSuffix": "Cherry",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20211130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213233",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211130",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43598-985-72",
"PackageDescription": "3 BOTTLE in 1 CARTON (43598-985-72) / 24 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0985-72",
"ProductNDC": "43598-985",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Habitrol Lozenge",
"ProprietaryNameSuffix": "Cherry",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20210820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213233",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211130",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "43598-987-72",
"PackageDescription": "3 BOTTLE in 1 CARTON (43598-987-72) / 24 LOZENGE in 1 BOTTLE",
"NDC11Code": "43598-0987-72",
"ProductNDC": "43598-987",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Habitrol",
"ProprietaryNameSuffix": "Nicotine Polacrilex Lozenge Mint",
"NonProprietaryName": "Nicotine Polacrilex Lozenge 4 Mg",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20210521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212796",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210521",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "62135-986-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (62135-986-60) ",
"NDC11Code": "62135-0986-60",
"ProductNDC": "62135-986",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cilostazol",
"NonProprietaryName": "Cilostazol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20041123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077021",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "CILOSTAZOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250827",
"SamplePackage": "N",
"IndicationAndUsage": "Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance.",
"Description": "Cilostazol, USP is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). The empirical formula of cilostazol is C 20H 27N 5O 2, and its molecular weight is 369.46. Cilostazol is 6-[4-(1-cyclohexyl-1 H-tetrazol-5-yl)butoxy]-3,4-dihydro-2(1 H)-quinolinone, CAS-73963-72-1. The structural formula is. Cilostazol occurs as white to off-white crystals or as a crystalline powder that is slightly soluble in methanol and ethanol, and is practically insoluble in water, 0.1 N HCl, and 0.1 N NaOH. Cilostazol Tablets, USP for oral administration are available in 50 mg and 100 mg white to off white, round, flat faced, beveled edge, debossed tablets. Each tablet, in addition to the active ingredient, contains the following inactive ingredients: carboxymethyl cellulose calcium, magnesium stearate, methylcellulose, microcrystalline cellulose, pregelatinized starch, and purified water."
},
{
"NDCCode": "64679-986-01",
"PackageDescription": "1 CARTON in 1 CARTON (64679-986-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON",
"NDC11Code": "64679-0986-01",
"ProductNDC": "64679-986",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefotaxime",
"NonProprietaryName": "Cefotaxime",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20080829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065197",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "CEFOTAXIME SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20080829",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment. Cefotaxime for injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes* (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens*, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus*, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Providencia stuartii, Morganella morganii*, Providencia rettgeri*, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species*, Klebsiella species*, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis*), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum*). Cefotaxime for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species*, Escherichia coli, Citrobacter species (including C. freundii*), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Morganella morganii, Providencia rettgeri*, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species*, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus* species) Proteus mirabilis*, and Clostridium species*. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes*), Pseudomonas species (including P. aeruginosa*), and Proteus mirabilis*. (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae* and Escherichia coli*. (*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections. Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, cefotaxime for injection, USP has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime for injection, USP. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, cefotaxime for injection, USP may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if cefotaxime for injection, USP is used concomitantly with an aminoglycoside.",
"Description": "Cefotaxime for injection, USP is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). Cefotaxime for injection, USP contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of cefotaxime for injection, USP range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4. The molecular formula is C16H16N5NaO7S2 and the molecular weight is 477.45. Cefotaxime for injection, USP is supplied as a dry powder in conventional vials. Each vial contains cefotaxime sodium equivalent to 500 mg, 1 g or 2 g of cefotaxime."
},
{
"NDCCode": "64679-986-02",
"PackageDescription": "10 CARTON in 1 CARTON (64679-986-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (64679-986-01) ",
"NDC11Code": "64679-0986-02",
"ProductNDC": "64679-986",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefotaxime",
"NonProprietaryName": "Cefotaxime",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20080829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065197",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "CEFOTAXIME SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20080829",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment. Cefotaxime for injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes* (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens*, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus*, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Providencia stuartii, Morganella morganii*, Providencia rettgeri*, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species*, Klebsiella species*, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis*), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum*). Cefotaxime for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species*, Escherichia coli, Citrobacter species (including C. freundii*), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Morganella morganii, Providencia rettgeri*, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species*, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus* species) Proteus mirabilis*, and Clostridium species*. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes*), Pseudomonas species (including P. aeruginosa*), and Proteus mirabilis*. (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae* and Escherichia coli*. (*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections. Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, cefotaxime for injection, USP has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime for injection, USP. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, cefotaxime for injection, USP may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if cefotaxime for injection, USP is used concomitantly with an aminoglycoside.",
"Description": "Cefotaxime for injection, USP is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). Cefotaxime for injection, USP contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of cefotaxime for injection, USP range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4. The molecular formula is C16H16N5NaO7S2 and the molecular weight is 477.45. Cefotaxime for injection, USP is supplied as a dry powder in conventional vials. Each vial contains cefotaxime sodium equivalent to 500 mg, 1 g or 2 g of cefotaxime."
},
{
"NDCCode": "64679-986-03",
"PackageDescription": "25 CARTON in 1 CARTON (64679-986-03) > 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (64679-986-01) ",
"NDC11Code": "64679-0986-03",
"ProductNDC": "64679-986",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefotaxime",
"NonProprietaryName": "Cefotaxime",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20080829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065197",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "CEFOTAXIME SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20080829",
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"IndicationAndUsage": "Treatment. Cefotaxime for injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes* (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens*, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus*, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Providencia stuartii, Morganella morganii*, Providencia rettgeri*, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species*, Klebsiella species*, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis*), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum*). Cefotaxime for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species*, Escherichia coli, Citrobacter species (including C. freundii*), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Morganella morganii, Providencia rettgeri*, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species*, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus* species) Proteus mirabilis*, and Clostridium species*. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes*), Pseudomonas species (including P. aeruginosa*), and Proteus mirabilis*. (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae* and Escherichia coli*. (*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections. Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, cefotaxime for injection, USP has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime for injection, USP. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, cefotaxime for injection, USP may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if cefotaxime for injection, USP is used concomitantly with an aminoglycoside.",
"Description": "Cefotaxime for injection, USP is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). Cefotaxime for injection, USP contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of cefotaxime for injection, USP range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4. The molecular formula is C16H16N5NaO7S2 and the molecular weight is 477.45. Cefotaxime for injection, USP is supplied as a dry powder in conventional vials. Each vial contains cefotaxime sodium equivalent to 500 mg, 1 g or 2 g of cefotaxime."
},
{
"NDCCode": "64679-986-04",
"PackageDescription": "50 CARTON in 1 CARTON (64679-986-04) > 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (64679-986-01) ",
"NDC11Code": "64679-0986-04",
"ProductNDC": "64679-986",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefotaxime",
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"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
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"LabelerName": "Wockhardt USA LLC.",
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"StrengthUnit": "g/1",
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"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20080829",
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"IndicationAndUsage": "Treatment. Cefotaxime for injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes* (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens*, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus*, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Providencia stuartii, Morganella morganii*, Providencia rettgeri*, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species*, Klebsiella species*, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis*), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum*). Cefotaxime for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species*, Escherichia coli, Citrobacter species (including C. freundii*), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Morganella morganii, Providencia rettgeri*, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species*, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus* species) Proteus mirabilis*, and Clostridium species*. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes*), Pseudomonas species (including P. aeruginosa*), and Proteus mirabilis*. (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae* and Escherichia coli*. (*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections. Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, cefotaxime for injection, USP has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime for injection, USP. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, cefotaxime for injection, USP may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if cefotaxime for injection, USP is used concomitantly with an aminoglycoside.",
"Description": "Cefotaxime for injection, USP is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). Cefotaxime for injection, USP contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of cefotaxime for injection, USP range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4. The molecular formula is C16H16N5NaO7S2 and the molecular weight is 477.45. Cefotaxime for injection, USP is supplied as a dry powder in conventional vials. Each vial contains cefotaxime sodium equivalent to 500 mg, 1 g or 2 g of cefotaxime."
},
{
"NDCCode": "43598-975-58",
"PackageDescription": "10 VIAL in 1 CARTON (43598-975-58) / 100 mL in 1 VIAL (43598-975-11) ",
"NDC11Code": "43598-0975-58",
"ProductNDC": "43598-975",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209307",
"LabelerName": "Dr.Reddy's Laboratories Inc",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200817",
"SamplePackage": "N",
"Description": "Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride, USP is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride, USP has a molecular weight of 236.7 and the empirical formula is C13H16N2HCl and the structural formula is. Dexmedetomidine hydrochloride, USP is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride, USP equivalent to 4 mcg (0.004 mg) of dexmedetomidine and 9 mg sodium chloride in water and is ready to be used. The solution is preservative-free and contains no additives or chemical stabilizers."
},
{
"NDCCode": "43598-976-58",
"PackageDescription": "10 VIAL in 1 CARTON (43598-976-58) / 50 mL in 1 VIAL (43598-976-11) ",
"NDC11Code": "43598-0976-58",
"ProductNDC": "43598-976",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
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"LabelerName": "Dr.Reddy's Laboratories Inc",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
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"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200817",
"SamplePackage": "N",
"Description": "Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride, USP is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride, USP has a molecular weight of 236.7 and the empirical formula is C13H16N2HCl and the structural formula is. Dexmedetomidine hydrochloride, USP is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride, USP equivalent to 4 mcg (0.004 mg) of dexmedetomidine and 9 mg sodium chloride in water and is ready to be used. The solution is preservative-free and contains no additives or chemical stabilizers."
},
{
"NDCCode": "0065-0530-01",
"PackageDescription": "30 mL in 1 BOTTLE (0065-0530-01) ",
"NDC11Code": "00065-0530-01",
"ProductNDC": "0065-0530",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eye Stream",
"NonProprietaryName": "Purified Water",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19900930",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "WATER",
"StrengthNumber": "986",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19900930",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N"
},
{
"NDCCode": "0065-0530-04",
"PackageDescription": "118 mL in 1 BOTTLE (0065-0530-04) ",
"NDC11Code": "00065-0530-04",
"ProductNDC": "0065-0530",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eye Stream",
"NonProprietaryName": "Purified Water",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "WATER",
"StrengthNumber": "986",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19900930",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N"
},
{
"NDCCode": "11673-986-07",
"PackageDescription": "10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (11673-986-07) ",
"NDC11Code": "11673-0986-07",
"ProductNDC": "11673-986",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Loratadine",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20190410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206214",
"LabelerName": "TARGET CORPORATION",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190426",
"SamplePackage": "N"
},
{
"NDCCode": "11673-986-30",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (11673-986-30) ",
"NDC11Code": "11673-0986-30",
"ProductNDC": "11673-986",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Loratadine",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20190410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206214",
"LabelerName": "TARGET CORPORATION",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190426",
"SamplePackage": "N"
},
{
"NDCCode": "12213-593-13",
"PackageDescription": "986 L in 1 CYLINDER (12213-593-13) ",
"NDC11Code": "12213-0593-13",
"ProductNDC": "12213-593",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrous Oxide",
"NonProprietaryName": "Nitrous Oxide",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19960601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206009",
"LabelerName": "NEXAIR, LLC",
"SubstanceName": "NITROUS OXIDE",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19960601",
"SamplePackage": "N"
},
{
"NDCCode": "13537-986-24",
"PackageDescription": "1 TUBE in 1 BOX (13537-986-24) > 4 g in 1 TUBE (13537-986-23) ",
"NDC11Code": "13537-0986-24",
"ProductNDC": "13537-986",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Pro Hidracolor 3 In 1 Moisturizing, Color And Perfecting Effect Spf 25",
"ProprietaryNameSuffix": "(bronce Metallic) - Brown",
"NonProprietaryName": "Octinoxate And Zinc Oxide",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160712",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD DUNS",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": ".075; .0392",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160712",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-986-01",
"PackageDescription": "1 TUBE in 1 CARTON (16714-986-01) / 15 g in 1 TUBE",
"NDC11Code": "16714-0986-01",
"ProductNDC": "16714-986",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209535",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220421",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water."
},
{
"NDCCode": "16714-986-02",
"PackageDescription": "1 TUBE in 1 CARTON (16714-986-02) / 30 g in 1 TUBE",
"NDC11Code": "16714-0986-02",
"ProductNDC": "16714-986",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209535",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220421",
"SamplePackage": "N",
"IndicationAndUsage": "Triamcinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water."
}
]
}
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<NDCList>
<NDC>
<NDCCode>43598-986-72</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (43598-986-72) / 24 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0986-72</NDC11Code>
<ProductNDC>43598-986</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Habitrol</ProprietaryName>
<ProprietaryNameSuffix>Nicotine Polacrilex Lozenge Mint</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine Polacrilex Lozenge 2 Mg</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212796</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82804-986-72</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-986-72) </PackageDescription>
<NDC11Code>82804-0986-72</NDC11Code>
<ProductNDC>82804-986</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204165</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel is a P2Y12 platelet inhibitor indicated for: 1 Acute coronary syndrome1. For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1)2. For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. (1.1), 2 Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. (1.2).</IndicationAndUsage>
<Description>Clopidogrel bisulfate is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S )-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H )- acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2S∙H2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate, USP is a white to off-white powder. It is freely soluble in methanol, practically insoluble in ether. It has a specific optical rotation of about +56°. Clopidogrel for oral administration is provided as either pink colored, round shaped, biconvex, de-bossed, film coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink colored, modified oval shaped, de-bossed film coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose and hydrogenated castor oil as inactive ingredients. The film coating contains hypromellose, titanium dioxide, polyethylene glycol, red iron oxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>43598-986-13</NDCCode>
<PackageDescription>5 BOTTLE in 1 CARTON (43598-986-13) / 27 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0986-13</NDC11Code>
<ProductNDC>43598-986</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Habitrol</ProprietaryName>
<ProprietaryNameSuffix>Nicotine Polacrilex Lozenge Mint</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine Polacrilex Lozenge 2 Mg</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212796</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-986-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (43598-986-24) / 24 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0986-24</NDC11Code>
<ProductNDC>43598-986</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Habitrol</ProprietaryName>
<ProprietaryNameSuffix>Nicotine Polacrilex Lozenge Mint</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine Polacrilex Lozenge 2 Mg</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212796</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-986-27</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (43598-986-27) / 27 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0986-27</NDC11Code>
<ProductNDC>43598-986</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Habitrol</ProprietaryName>
<ProprietaryNameSuffix>Nicotine Polacrilex Lozenge Mint</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine Polacrilex Lozenge 2 Mg</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212796</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-484-72</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (43598-484-72) / 24 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0484-72</NDC11Code>
<ProductNDC>43598-484</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212983</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-485-72</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (43598-485-72) / 24 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0485-72</NDC11Code>
<ProductNDC>43598-485</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212983</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-486-72</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (43598-486-72) / 24 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0486-72</NDC11Code>
<ProductNDC>43598-486</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212796</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-487-72</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (43598-487-72) / 24 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0487-72</NDC11Code>
<ProductNDC>43598-487</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212796</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-488-72</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (43598-488-72) / 24 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0488-72</NDC11Code>
<ProductNDC>43598-488</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213233</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-489-72</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (43598-489-72) / 24 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0489-72</NDC11Code>
<ProductNDC>43598-489</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213233</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-746-72</NDCCode>
<PackageDescription>240 CAPSULE in 1 BOTTLE (43598-746-72) </PackageDescription>
<NDC11Code>43598-0746-72</NDC11Code>
<ProductNDC>43598-746</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Icosapent Ethyl</ProprietaryName>
<NonProprietaryName>Icosapent Ethyl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230417</StartMarketingDate>
<EndMarketingDate>20270531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209499</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories, Inc.</LabelerName>
<SubstanceName>ICOSAPENT ETHYL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230417</StartMarketingDatePackage>
<EndMarketingDatePackage>20270531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Icosapent ethyl capsules are indicated: : 1 as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.</IndicationAndUsage>
<Description>Icosapent ethyl capsules, a lipid-regulating agent, is supplied as a 0.5 gram transparent natural colored oval shaped, liquid-filled soft gelatin capsule for oral use. Each icosapent ethyl capsule contains 0.5 grams of icosapent ethyl (in a 0.5 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure. Icosapent ethyl capsules also contain the following inactive ingredients: alpha tocopherol, gelatin, glycerin, mannitol, sorbitol, and purified water. The imprinting Opacode NSP-78-18022 White contains, ammonium hydroxide, macrogol, polyvinyl acetate phthalate, propylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43598-984-72</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (43598-984-72) / 24 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0984-72</NDC11Code>
<ProductNDC>43598-984</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Habitrol Lozenge</ProprietaryName>
<ProprietaryNameSuffix>Cherry</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213233</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-985-72</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (43598-985-72) / 24 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0985-72</NDC11Code>
<ProductNDC>43598-985</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Habitrol Lozenge</ProprietaryName>
<ProprietaryNameSuffix>Cherry</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213233</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-987-72</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (43598-987-72) / 24 LOZENGE in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0987-72</NDC11Code>
<ProductNDC>43598-987</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Habitrol</ProprietaryName>
<ProprietaryNameSuffix>Nicotine Polacrilex Lozenge Mint</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine Polacrilex Lozenge 4 Mg</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212796</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62135-986-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (62135-986-60) </PackageDescription>
<NDC11Code>62135-0986-60</NDC11Code>
<ProductNDC>62135-986</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cilostazol</ProprietaryName>
<NonProprietaryName>Cilostazol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077021</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>CILOSTAZOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance.</IndicationAndUsage>
<Description>Cilostazol, USP is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). The empirical formula of cilostazol is C 20H 27N 5O 2, and its molecular weight is 369.46. Cilostazol is 6-[4-(1-cyclohexyl-1 H-tetrazol-5-yl)butoxy]-3,4-dihydro-2(1 H)-quinolinone, CAS-73963-72-1. The structural formula is. Cilostazol occurs as white to off-white crystals or as a crystalline powder that is slightly soluble in methanol and ethanol, and is practically insoluble in water, 0.1 N HCl, and 0.1 N NaOH. Cilostazol Tablets, USP for oral administration are available in 50 mg and 100 mg white to off white, round, flat faced, beveled edge, debossed tablets. Each tablet, in addition to the active ingredient, contains the following inactive ingredients: carboxymethyl cellulose calcium, magnesium stearate, methylcellulose, microcrystalline cellulose, pregelatinized starch, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>64679-986-01</NDCCode>
<PackageDescription>1 CARTON in 1 CARTON (64679-986-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON</PackageDescription>
<NDC11Code>64679-0986-01</NDC11Code>
<ProductNDC>64679-986</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefotaxime</ProprietaryName>
<NonProprietaryName>Cefotaxime</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20080829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065197</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>CEFOTAXIME SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment. Cefotaxime for injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes* (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens*, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus*, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Providencia stuartii, Morganella morganii*, Providencia rettgeri*, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species*, Klebsiella species*, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis*), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum*). Cefotaxime for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species*, Escherichia coli, Citrobacter species (including C. freundii*), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Morganella morganii, Providencia rettgeri*, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species*, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus* species) Proteus mirabilis*, and Clostridium species*. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes*), Pseudomonas species (including P. aeruginosa*), and Proteus mirabilis*. (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae* and Escherichia coli*. (*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections. Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, cefotaxime for injection, USP has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime for injection, USP. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, cefotaxime for injection, USP may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if cefotaxime for injection, USP is used concomitantly with an aminoglycoside.</IndicationAndUsage>
<Description>Cefotaxime for injection, USP is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). Cefotaxime for injection, USP contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of cefotaxime for injection, USP range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4. The molecular formula is C16H16N5NaO7S2 and the molecular weight is 477.45. Cefotaxime for injection, USP is supplied as a dry powder in conventional vials. Each vial contains cefotaxime sodium equivalent to 500 mg, 1 g or 2 g of cefotaxime.</Description>
</NDC>
<NDC>
<NDCCode>64679-986-02</NDCCode>
<PackageDescription>10 CARTON in 1 CARTON (64679-986-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (64679-986-01) </PackageDescription>
<NDC11Code>64679-0986-02</NDC11Code>
<ProductNDC>64679-986</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefotaxime</ProprietaryName>
<NonProprietaryName>Cefotaxime</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20080829</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065197</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>CEFOTAXIME SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080829</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Treatment. Cefotaxime for injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes* (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens*, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus*, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Providencia stuartii, Morganella morganii*, Providencia rettgeri*, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species*, Klebsiella species*, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis*), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum*). Cefotaxime for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species*, Escherichia coli, Citrobacter species (including C. freundii*), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Morganella morganii, Providencia rettgeri*, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species*, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus* species) Proteus mirabilis*, and Clostridium species*. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes*), Pseudomonas species (including P. aeruginosa*), and Proteus mirabilis*. (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae* and Escherichia coli*. (*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections. Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, cefotaxime for injection, USP has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime for injection, USP. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, cefotaxime for injection, USP may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if cefotaxime for injection, USP is used concomitantly with an aminoglycoside.</IndicationAndUsage>
<Description>Cefotaxime for injection, USP is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). Cefotaxime for injection, USP contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of cefotaxime for injection, USP range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4. The molecular formula is C16H16N5NaO7S2 and the molecular weight is 477.45. Cefotaxime for injection, USP is supplied as a dry powder in conventional vials. Each vial contains cefotaxime sodium equivalent to 500 mg, 1 g or 2 g of cefotaxime.</Description>
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<IndicationAndUsage>Treatment. Cefotaxime for injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes* (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens*, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus*, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Providencia stuartii, Morganella morganii*, Providencia rettgeri*, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species*, Klebsiella species*, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis*), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum*). Cefotaxime for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species*, Escherichia coli, Citrobacter species (including C. freundii*), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Morganella morganii, Providencia rettgeri*, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species*, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus* species) Proteus mirabilis*, and Clostridium species*. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes*), Pseudomonas species (including P. aeruginosa*), and Proteus mirabilis*. (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae* and Escherichia coli*. (*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections. Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, cefotaxime for injection, USP has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime for injection, USP. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, cefotaxime for injection, USP may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if cefotaxime for injection, USP is used concomitantly with an aminoglycoside.</IndicationAndUsage>
<Description>Cefotaxime for injection, USP is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). Cefotaxime for injection, USP contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of cefotaxime for injection, USP range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4. The molecular formula is C16H16N5NaO7S2 and the molecular weight is 477.45. Cefotaxime for injection, USP is supplied as a dry powder in conventional vials. Each vial contains cefotaxime sodium equivalent to 500 mg, 1 g or 2 g of cefotaxime.</Description>
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<IndicationAndUsage>Treatment. Cefotaxime for injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections, including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes* (Group A streptococci) and other streptococci (excluding enterococci, e.g., Enterococcus faecalis), Staphylococcus aureus (penicillinase and non-penicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens*, Enterobacter species, indole positive Proteus and Pseudomonas species (including P. aeruginosa). (2) Genitourinary infections. Urinary tract infections caused by Enterococcus species, Staphylococcus epidermidis, Staphylococcus aureus*, (penicillinase and non-penicillinase producing), Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Providencia stuartii, Morganella morganii*, Providencia rettgeri*, Serratia marcescens and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase producing strains. (3) Gynecologic infections, including pelvic inflammatory disease, endometritis and pelvic cellulitis caused by Staphylococcus epidermidis, Streptococcus species, Enterococcus species, Enterobacter species*, Klebsiella species*, Escherichia coli, Proteus mirabilis, Bacteroides species (including Bacteroides fragilis*), Clostridium species, and anaerobic cocci (including Peptostreptococcus species and Peptococcus species) and Fusobacterium species (including F. nucleatum*). Cefotaxime for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added. (4) Bacteremia/Septicemia caused by Escherichia coli, Klebsiella species, and Serratia marcescens, Staphylococcus aureus and Streptococcus species (including S. pneumonia). (5) Skin and skin structure infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing), Staphylococcus epidermidis, Streptococcus pyogenes (Group A streptococci) and other streptococci, Enterococcus species, Acinetobacter species*, Escherichia coli, Citrobacter species (including C. freundii*), Enterobacter species, Klebsiella species, Proteus mirabilis, Proteus vulgaris*, Morganella morganii, Providencia rettgeri*, Pseudomonas species, Serratia marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus species). (6) Intra-abdominal infections including peritonitis caused by Streptococcus species*, Escherichia coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus* species and Peptococcus* species) Proteus mirabilis*, and Clostridium species*. (7) Bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), Streptococcus species (including S. pyogenes*), Pseudomonas species (including P. aeruginosa*), and Proteus mirabilis*. (8) Central nervous system infections, e.g., meningitis and ventriculitis, caused by Neisseria meningitidis, Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae* and Escherichia coli*. (*) Efficacy for this organism, in this organ system, has been studied in fewer than 10 infections. Although many strains of enterococci (e.g., S. faecalis) and Pseudomonas species are resistant to cefotaxime sodium in vitro, cefotaxime for injection, USP has been used successfully in treating patients with infections caused by susceptible organisms. Specimens for bacteriologic culture should be obtained prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime for injection, USP. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. In certain cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, cefotaxime for injection, USP may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if cefotaxime for injection, USP is used concomitantly with an aminoglycoside.</IndicationAndUsage>
<Description>Cefotaxime for injection, USP is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). Cefotaxime for injection, USP contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of cefotaxime for injection, USP range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4. The molecular formula is C16H16N5NaO7S2 and the molecular weight is 477.45. Cefotaxime for injection, USP is supplied as a dry powder in conventional vials. Each vial contains cefotaxime sodium equivalent to 500 mg, 1 g or 2 g of cefotaxime.</Description>
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<Description>Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride, USP is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride, USP has a molecular weight of 236.7 and the empirical formula is C13H16N2HCl and the structural formula is. Dexmedetomidine hydrochloride, USP is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride, USP equivalent to 4 mcg (0.004 mg) of dexmedetomidine and 9 mg sodium chloride in water and is ready to be used. The solution is preservative-free and contains no additives or chemical stabilizers.</Description>
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<Description>Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride, USP is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride, USP has a molecular weight of 236.7 and the empirical formula is C13H16N2HCl and the structural formula is. Dexmedetomidine hydrochloride, USP is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride, USP equivalent to 4 mcg (0.004 mg) of dexmedetomidine and 9 mg sodium chloride in water and is ready to be used. The solution is preservative-free and contains no additives or chemical stabilizers.</Description>
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<NonProprietaryName>Nitrous Oxide</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19960601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206009</ApplicationNumber>
<LabelerName>NEXAIR, LLC</LabelerName>
<SubstanceName>NITROUS OXIDE</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13537-986-24</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-986-24) > 4 g in 1 TUBE (13537-986-23) </PackageDescription>
<NDC11Code>13537-0986-24</NDC11Code>
<ProductNDC>13537-986</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Pro Hidracolor 3 In 1 Moisturizing, Color And Perfecting Effect Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(bronce Metallic) - Brown</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160712</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD DUNS</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.075; .0392</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-986-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (16714-986-01) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>16714-0986-01</NDC11Code>
<ProductNDC>16714-986</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209535</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>16714-986-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (16714-986-02) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>16714-0986-02</NDC11Code>
<ProductNDC>16714-986</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209535</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triamcinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. The structural formula is. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide, USP per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
</NDC>
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