{
"NDC": [
{
"NDCCode": "58407-252-16",
"PackageDescription": "473 mL in 1 BOTTLE (58407-252-16) ",
"NDC11Code": "58407-0252-16",
"ProductNDC": "58407-252",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Atuss Da",
"NonProprietaryName": "Brompheniramine Maleate, Chlophedianol Hydrochloride, Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181120",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Magna Pharmceuticals, Inc.",
"SubstanceName": "BROMPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "2; 12.5; 30",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181120",
"SamplePackage": "N",
"IndicationAndUsage": "Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 nasal congestion, 3 reduces swelling of nasal passages, 4 runny nose, 5 sneezing, 6 itchy, watery eyes, 7 itching of the nose or throat."
},
{
"NDCCode": "58407-252-01",
"PackageDescription": "6 BOTTLE in 1 CARTON (58407-252-01) > 15 mL in 1 BOTTLE",
"NDC11Code": "58407-0252-01",
"ProductNDC": "58407-252",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Atuss Da",
"NonProprietaryName": "Brompheniramine Maleate, Chlophedianol Hydrochloride, Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181120",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Magna Pharmceuticals, Inc.",
"SubstanceName": "BROMPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "2; 12.5; 30",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181120",
"SamplePackage": "Y",
"IndicationAndUsage": "Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 nasal congestion, 3 reduces swelling of nasal passages, 4 runny nose, 5 sneezing, 6 itchy, watery eyes, 7 itching of the nose or throat."
},
{
"NDCCode": "58407-252-04",
"PackageDescription": "118 mL in 1 BOTTLE (58407-252-04) ",
"NDC11Code": "58407-0252-04",
"ProductNDC": "58407-252",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Atuss Da",
"NonProprietaryName": "Brompheniramine Maleate, Chlophedianol Hydrochloride, Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20181120",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Magna Pharmceuticals, Inc.",
"SubstanceName": "BROMPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "2; 12.5; 30",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181120",
"SamplePackage": "N",
"IndicationAndUsage": "Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 nasal congestion, 3 reduces swelling of nasal passages, 4 runny nose, 5 sneezing, 6 itchy, watery eyes, 7 itching of the nose or throat."
},
{
"NDCCode": "58407-125-16",
"PackageDescription": "473 mL in 1 BOTTLE (58407-125-16)",
"NDC11Code": "58407-0125-16",
"ProductNDC": "58407-125",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Statuss Green",
"NonProprietaryName": "Chlorcyclizine Hydrochloride, Codeine Phosphate, And Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20111220",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Magna Pharmaceuticals, Inc.",
"SubstanceName": "CHLORCYCLIZINE HYDROCHLORIDE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "12.5; 9; 30",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "58407-239-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (58407-239-16)",
"NDC11Code": "58407-0239-16",
"ProductNDC": "58407-239",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Z-tuss",
"ProprietaryNameSuffix": "E",
"NonProprietaryName": "Codeine Phosphate/guaifenesin/pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20111012",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Magna Pharmaceuticals, Inc.",
"SubstanceName": "CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "9; 200; 30",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "58407-920-16",
"PackageDescription": "473 mL in 1 BOTTLE (58407-920-16) ",
"NDC11Code": "58407-0920-16",
"ProductNDC": "58407-920",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Z-tuss",
"ProprietaryNameSuffix": "Ac",
"NonProprietaryName": "Chlorpheniramine Maleate, Codeine Phosphate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110111",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Magna Pharmaceuticals, Inc.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE",
"StrengthNumber": "2; 9",
"StrengthUnit": "mg/5mL; mg/5mL",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"PackageNdcExcludeFlag": "Y",
"ProductNdcExcludeFlag": "Y",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "41520-252-16",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (41520-252-16) > 8 TABLET in 1 BLISTER PACK",
"NDC11Code": "41520-0252-16",
"ProductNDC": "41520-252",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Drowz Away",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100831",
"EndMarketingDate": "20200831",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part340",
"LabelerName": "Care One (American Sales Company)",
"SubstanceName": "CAFFEINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100831",
"EndMarketingDatePackage": "20200831",
"SamplePackage": "N"
},
{
"NDCCode": "50804-252-16",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (50804-252-16) > 8 TABLET in 1 BLISTER PACK",
"NDC11Code": "50804-0252-16",
"ProductNDC": "50804-252",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Aid",
"ProprietaryNameSuffix": "Regular Strength",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140228",
"EndMarketingDate": "20200101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part338",
"LabelerName": "Good Sense (Geiss, Destin & Dunn, Inc.)",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140228",
"EndMarketingDatePackage": "20200101",
"SamplePackage": "N"
},
{
"NDCCode": "55312-252-16",
"PackageDescription": "16 BLISTER PACK in 1 CARTON (55312-252-16) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "55312-0252-16",
"ProductNDC": "55312-252",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sleep Nighttime Sleep Aid",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140228",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part338",
"LabelerName": "Western Family Foods, Inc.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140228",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "63941-252-16",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (63941-252-16) > 8 TABLET in 1 BLISTER PACK",
"NDC11Code": "63941-0252-16",
"ProductNDC": "63941-252",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stay Awake",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Caffeine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100921",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part340",
"LabelerName": "Valu Merchandisers Company (Best Choice)",
"SubstanceName": "CAFFEINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness."
},
{
"NDCCode": "68382-252-16",
"PackageDescription": "90 TABLET in 1 BOTTLE (68382-252-16) ",
"NDC11Code": "68382-0252-16",
"ProductNDC": "68382-252",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181121",
"EndMarketingDate": "20260401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206536",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181121",
"EndMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: 1 To reduce the risk of:Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemiaHypertriglyceridemia.",
"Description": "Atorvastatin calcium (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H- pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in alcohol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, and talc."
},
{
"NDCCode": "69543-252-16",
"PackageDescription": "473 mL in 1 BOTTLE (69543-252-16) ",
"NDC11Code": "69543-0252-16",
"ProductNDC": "69543-252",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Virtussin Ac",
"NonProprietaryName": "Codeine Phosphate And Guaifenesin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150707",
"EndMarketingDate": "20230331",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Virtus Pharmaceuticals",
"SubstanceName": "CODEINE PHOSPHATE; GUAIFENESIN",
"StrengthNumber": "10; 100",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150707",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "76439-252-16",
"PackageDescription": "473 mL in 1 BOTTLE (76439-252-16)",
"NDC11Code": "76439-0252-16",
"ProductNDC": "76439-252",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Virtussin Ac",
"NonProprietaryName": "Codeine Phosphate And Guaifenesin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Virtus Pharmaceuticals LLC",
"SubstanceName": "CODEINE PHOSPHATE; GUAIFENESIN",
"StrengthNumber": "10; 100",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2017-09-07"
},
{
"NDCCode": "10135-798-41",
"PackageDescription": "250 mL in 1 BOTTLE, GLASS (10135-798-41) ",
"NDC11Code": "10135-0798-41",
"ProductNDC": "10135-798",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20250501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217782",
"LabelerName": "Marlex Pharmaceuticals, Inc",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250501",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine oral suspension is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.",
"Description": "Oxcarbazepine is an AED available as a 300 mg/5 mL (60 mg/mL) oral suspension for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo- 5 H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is:. Oxcarbazepine, USP is a light orange to creamish white or off white powder. It is soluble in acetic acid; sparingly soluble in chloroform, in chloromethane; practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine oral suspension, USP contains the following inactive ingredients: ascorbic acid; microcrystalline cellulose and carboxymethyl cellulose sodium; xanthan gum; polyoxyl stearate type-I; methyl paraben; propylene glycol; propyl paraben; purified water; sodium saccharin; sorbic acid; sorbitol solution 70% non-crystallizing; plum flavor 0527036. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "25021-252-51",
"PackageDescription": "1 VIAL in 1 CARTON (25021-252-51) / 80 mL in 1 VIAL",
"NDC11Code": "25021-0252-51",
"ProductNDC": "25021-252",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mitomycin",
"NonProprietaryName": "Mitomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216648",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "MITOMYCIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/80mL",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230615",
"SamplePackage": "N",
"IndicationAndUsage": "Mitomycin for Injection is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.",
"Description": "Mitomycin (also known as mitomycin and/or mitomycin-C) is an antibiotic isolated from the broth of Streptomyces caespitosus which has been shown to have antitumor activity. The compound is heat stable, has a high melting point, and is freely soluble in organic solvents. Mitomycin for Injection, USP is a sterile dry mixture of mitomycin and mannitol, which when reconstituted with Sterile Water for Injection provides a solution for intravenous administration. Each Single-Dose vial contains mitomycin 40 mg and mannitol 80 mg. Each mL of reconstituted solution will contain 0.5 mg mitomycin and have a pH between 6.0 and 8.0. Mitomycin is a blue-violet crystalline powder with the molecular formula of C15H18N4O5, and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane and it has the following structural formula;."
},
{
"NDCCode": "33342-259-67",
"PackageDescription": "1 BOTTLE in 1 CARTON (33342-259-67) / 250 mL in 1 BOTTLE",
"NDC11Code": "33342-0259-67",
"ProductNDC": "33342-259",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20250711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207300",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250711",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine oral suspension, USP is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.",
"Description": "Oxcarbazepine is an AED available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5Hdibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a light orange to creamish white or off-white powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27. Oxcarbazepine oral suspension, USP contains the following inactive ingredients: carboxymethylcellulose sodium noncrystallizing sorbitol solution, microcrystalline cellulose and carboxymethylcellulose sodium, ascorbic acid, methyl paraben, propyl paraben, sorbic acid, propylene glycol, saccharin sodium, colloidal silicon dioxide, flavour plum, hydrochloride acid, sodium hydroxide and purified water."
},
{
"NDCCode": "53436-252-30",
"PackageDescription": "30 PACKET in 1 CARTON (53436-252-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET (53436-252-01) ",
"NDC11Code": "53436-0252-30",
"ProductNDC": "53436-252",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Veltassa",
"NonProprietaryName": "Patiromer",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20151023",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205739",
"LabelerName": "Vifor Pharma, Inc.",
"SubstanceName": "PATIROMER",
"StrengthNumber": "25.2",
"StrengthUnit": "g/1",
"Pharm_Classes": "Potassium Binder [EPC], Potassium Ion Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151023",
"SamplePackage": "N",
"IndicationAndUsage": "Veltassa is indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older. Limitation of Use: Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2)].",
"Description": "Veltassa is a powder for suspension in water for oral administration. The active ingredient is patiromer sorbitex calcium which consists of the active moiety, patiromer, a non-absorbed potassium-binding polymer, and a calcium-sorbitol counterion. Each gram of patiromer is equivalent to a nominal amount of 2 grams of patiromer sorbitex calcium. The chemical name for patiromer sorbitex calcium is cross-linked polymer of calcium 2-fluoroprop-2-enoate with diethenylbenzene and octa-1,7-diene, combination with D-glucitol. Patiromer sorbitex calcium is an amorphous, free-flowing powder that is composed of individual spherical beads. Patiromer sorbitex calcium is insoluble in solvents such as water, 0.1 M HCl, n-heptane and methanol. The chemical structure of patiromer sorbitex calcium is presented in Figure 1. Figure 1: Chemical Structure of Patiromer Sorbitex Calcium. Each packet of Veltassa contains 1 gram, 8.4 grams, 16.8 grams or 25.2 grams of patiromer, the active moiety. The inactive ingredient is xanthan gum."
},
{
"NDCCode": "53746-193-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (53746-193-01) ",
"NDC11Code": "53746-0193-01",
"ProductNDC": "53746-193",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078432",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "275",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070426",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen sodium tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.",
"Description": "Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen sodium, USP is (S)-6-methoxy- α -methyl-2 naphthaleneacetic acid, sodium salt. Naproxen sodium, USP has the following structures. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen sodium, USP is available as blue tablets containing 275 mg of naproxen sodium, USP and as blue tablets containing 550 mg of naproxen sodium, USP for oral administration. The inactive ingredients are croscarmellose sodium, macrogol, magnesium stearate, polyvinyl alcohol, povidone, talc, titanium dioxide and FD&C Blue #2."
},
{
"NDCCode": "53746-193-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (53746-193-05) ",
"NDC11Code": "53746-0193-05",
"ProductNDC": "53746-193",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078432",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "275",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070426",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen sodium tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.",
"Description": "Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen sodium, USP is (S)-6-methoxy- α -methyl-2 naphthaleneacetic acid, sodium salt. Naproxen sodium, USP has the following structures. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen sodium, USP is available as blue tablets containing 275 mg of naproxen sodium, USP and as blue tablets containing 550 mg of naproxen sodium, USP for oral administration. The inactive ingredients are croscarmellose sodium, macrogol, magnesium stearate, polyvinyl alcohol, povidone, talc, titanium dioxide and FD&C Blue #2."
},
{
"NDCCode": "53746-194-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (53746-194-01) ",
"NDC11Code": "53746-0194-01",
"ProductNDC": "53746-194",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078432",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "550",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070426",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen sodium tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.",
"Description": "Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen sodium, USP is (S)-6-methoxy- α -methyl-2 naphthaleneacetic acid, sodium salt. Naproxen sodium, USP has the following structures. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen sodium, USP is available as blue tablets containing 275 mg of naproxen sodium, USP and as blue tablets containing 550 mg of naproxen sodium, USP for oral administration. The inactive ingredients are croscarmellose sodium, macrogol, magnesium stearate, polyvinyl alcohol, povidone, talc, titanium dioxide and FD&C Blue #2."
},
{
"NDCCode": "53746-194-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (53746-194-05) ",
"NDC11Code": "53746-0194-05",
"ProductNDC": "53746-194",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078432",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "550",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070426",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen sodium tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.",
"Description": "Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen sodium, USP is (S)-6-methoxy- α -methyl-2 naphthaleneacetic acid, sodium salt. Naproxen sodium, USP has the following structures. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen sodium, USP is available as blue tablets containing 275 mg of naproxen sodium, USP and as blue tablets containing 550 mg of naproxen sodium, USP for oral administration. The inactive ingredients are croscarmellose sodium, macrogol, magnesium stearate, polyvinyl alcohol, povidone, talc, titanium dioxide and FD&C Blue #2."
},
{
"NDCCode": "59651-785-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-785-01) ",
"NDC11Code": "59651-0785-01",
"ProductNDC": "59651-785",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261016",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219241",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261016",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.",
"Description": "Oxcarbazepine extended-release tablets are an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine, USP is light orange to creamish white or off-white powder. Oxcarbazepine, USP is soluble in acetic acid (33 g/L), sparingly soluble in chloroform (17 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 70 mg/L (0.07 g/L) at pH 7.0, 25°C. The molecular formula is C15H12N2O2 and its molecular weight is 252.27. Oxcarbazepine extended-release tablets contain the following inactive ingredients: fumaric acid, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, povidone, pregelatinized starch (maize), silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide. In addition 150 mg and 600 mg contains ferrosoferric oxide and iron oxide yellow and 300 mg and 600 mg contains iron oxide red. In addition the tablets are imprinted with black ink containing ferrosoferric oxide, propylene glycol and shellac. The 150 mg oxcarbazepine extended-release tablets each contain 1 mg of sodium. The 300 mg oxcarbazepine extended-release tablets each contain 2 mg of sodium. The 600 mg oxcarbazepine extended-release tablets each contain 4 mg of sodium."
},
{
"NDCCode": "59651-786-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-786-01) ",
"NDC11Code": "59651-0786-01",
"ProductNDC": "59651-786",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261016",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219241",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261016",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.",
"Description": "Oxcarbazepine extended-release tablets are an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine, USP is light orange to creamish white or off-white powder. Oxcarbazepine, USP is soluble in acetic acid (33 g/L), sparingly soluble in chloroform (17 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 70 mg/L (0.07 g/L) at pH 7.0, 25°C. The molecular formula is C15H12N2O2 and its molecular weight is 252.27. Oxcarbazepine extended-release tablets contain the following inactive ingredients: fumaric acid, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, povidone, pregelatinized starch (maize), silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide. In addition 150 mg and 600 mg contains ferrosoferric oxide and iron oxide yellow and 300 mg and 600 mg contains iron oxide red. In addition the tablets are imprinted with black ink containing ferrosoferric oxide, propylene glycol and shellac. The 150 mg oxcarbazepine extended-release tablets each contain 1 mg of sodium. The 300 mg oxcarbazepine extended-release tablets each contain 2 mg of sodium. The 600 mg oxcarbazepine extended-release tablets each contain 4 mg of sodium."
},
{
"NDCCode": "59651-787-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-787-01) ",
"NDC11Code": "59651-0787-01",
"ProductNDC": "59651-787",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261016",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219241",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261016",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.",
"Description": "Oxcarbazepine extended-release tablets are an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine, USP is light orange to creamish white or off-white powder. Oxcarbazepine, USP is soluble in acetic acid (33 g/L), sparingly soluble in chloroform (17 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 70 mg/L (0.07 g/L) at pH 7.0, 25°C. The molecular formula is C15H12N2O2 and its molecular weight is 252.27. Oxcarbazepine extended-release tablets contain the following inactive ingredients: fumaric acid, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, povidone, pregelatinized starch (maize), silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide. In addition 150 mg and 600 mg contains ferrosoferric oxide and iron oxide yellow and 300 mg and 600 mg contains iron oxide red. In addition the tablets are imprinted with black ink containing ferrosoferric oxide, propylene glycol and shellac. The 150 mg oxcarbazepine extended-release tablets each contain 1 mg of sodium. The 300 mg oxcarbazepine extended-release tablets each contain 2 mg of sodium. The 600 mg oxcarbazepine extended-release tablets each contain 4 mg of sodium."
},
{
"NDCCode": "60505-4128-5",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4128-5) ",
"NDC11Code": "60505-4128-05",
"ProductNDC": "60505-4128",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213369",
"LabelerName": "Apotex Corp.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240903",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.",
"Description": "Oxcarbazepine extended-release tablet is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine, USP for once-a-day oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is light orange to creamish white or off-white powder. Oxcarbazepine is soluble in acetic acid, sparingly soluble in chloroform and practically insoluble in water. The molecular formula is C15H12N2O2 and its molecular weight is 252.27 g/mol. Oxcarbazepine extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (300 mg, 600 mg tablets only), ferric oxide yellow (150 mg, 300 mg tablets only), hydroxypropyl methyl cellulose, iron oxide black (300 mg tablet only), magnesium stearate, polyethylene glycol, polyvinyl alcohol, sorbitol, talc, titanium dioxide (300 mg, 600 mg tablets only)."
},
{
"NDCCode": "60505-4128-7",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4128-7) ",
"NDC11Code": "60505-4128-07",
"ProductNDC": "60505-4128",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213369",
"LabelerName": "Apotex Corp.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240903",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.",
"Description": "Oxcarbazepine extended-release tablet is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine, USP for once-a-day oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is light orange to creamish white or off-white powder. Oxcarbazepine is soluble in acetic acid, sparingly soluble in chloroform and practically insoluble in water. The molecular formula is C15H12N2O2 and its molecular weight is 252.27 g/mol. Oxcarbazepine extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (300 mg, 600 mg tablets only), ferric oxide yellow (150 mg, 300 mg tablets only), hydroxypropyl methyl cellulose, iron oxide black (300 mg tablet only), magnesium stearate, polyethylene glycol, polyvinyl alcohol, sorbitol, talc, titanium dioxide (300 mg, 600 mg tablets only)."
},
{
"NDCCode": "60505-4129-5",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4129-5) ",
"NDC11Code": "60505-4129-05",
"ProductNDC": "60505-4129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213369",
"LabelerName": "Apotex Corp.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240903",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.",
"Description": "Oxcarbazepine extended-release tablet is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine, USP for once-a-day oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is light orange to creamish white or off-white powder. Oxcarbazepine is soluble in acetic acid, sparingly soluble in chloroform and practically insoluble in water. The molecular formula is C15H12N2O2 and its molecular weight is 252.27 g/mol. Oxcarbazepine extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (300 mg, 600 mg tablets only), ferric oxide yellow (150 mg, 300 mg tablets only), hydroxypropyl methyl cellulose, iron oxide black (300 mg tablet only), magnesium stearate, polyethylene glycol, polyvinyl alcohol, sorbitol, talc, titanium dioxide (300 mg, 600 mg tablets only)."
},
{
"NDCCode": "60505-4129-7",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4129-7) ",
"NDC11Code": "60505-4129-07",
"ProductNDC": "60505-4129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213369",
"LabelerName": "Apotex Corp.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240903",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.",
"Description": "Oxcarbazepine extended-release tablet is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine, USP for once-a-day oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is light orange to creamish white or off-white powder. Oxcarbazepine is soluble in acetic acid, sparingly soluble in chloroform and practically insoluble in water. The molecular formula is C15H12N2O2 and its molecular weight is 252.27 g/mol. Oxcarbazepine extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (300 mg, 600 mg tablets only), ferric oxide yellow (150 mg, 300 mg tablets only), hydroxypropyl methyl cellulose, iron oxide black (300 mg tablet only), magnesium stearate, polyethylene glycol, polyvinyl alcohol, sorbitol, talc, titanium dioxide (300 mg, 600 mg tablets only)."
},
{
"NDCCode": "60505-4130-5",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4130-5) ",
"NDC11Code": "60505-4130-05",
"ProductNDC": "60505-4130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213369",
"LabelerName": "Apotex Corp.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240903",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.",
"Description": "Oxcarbazepine extended-release tablet is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine, USP for once-a-day oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is light orange to creamish white or off-white powder. Oxcarbazepine is soluble in acetic acid, sparingly soluble in chloroform and practically insoluble in water. The molecular formula is C15H12N2O2 and its molecular weight is 252.27 g/mol. Oxcarbazepine extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (300 mg, 600 mg tablets only), ferric oxide yellow (150 mg, 300 mg tablets only), hydroxypropyl methyl cellulose, iron oxide black (300 mg tablet only), magnesium stearate, polyethylene glycol, polyvinyl alcohol, sorbitol, talc, titanium dioxide (300 mg, 600 mg tablets only)."
},
{
"NDCCode": "60505-4130-7",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4130-7) ",
"NDC11Code": "60505-4130-07",
"ProductNDC": "60505-4130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213369",
"LabelerName": "Apotex Corp.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240903",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.",
"Description": "Oxcarbazepine extended-release tablet is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine, USP for once-a-day oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is light orange to creamish white or off-white powder. Oxcarbazepine is soluble in acetic acid, sparingly soluble in chloroform and practically insoluble in water. The molecular formula is C15H12N2O2 and its molecular weight is 252.27 g/mol. Oxcarbazepine extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (300 mg, 600 mg tablets only), ferric oxide yellow (150 mg, 300 mg tablets only), hydroxypropyl methyl cellulose, iron oxide black (300 mg tablet only), magnesium stearate, polyethylene glycol, polyvinyl alcohol, sorbitol, talc, titanium dioxide (300 mg, 600 mg tablets only)."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>58407-252-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (58407-252-16) </PackageDescription>
<NDC11Code>58407-0252-16</NDC11Code>
<ProductNDC>58407-252</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Atuss Da</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate, Chlophedianol Hydrochloride, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Magna Pharmceuticals, Inc.</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 nasal congestion, 3 reduces swelling of nasal passages, 4 runny nose, 5 sneezing, 6 itchy, watery eyes, 7 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58407-252-01</NDCCode>
<PackageDescription>6 BOTTLE in 1 CARTON (58407-252-01) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58407-0252-01</NDC11Code>
<ProductNDC>58407-252</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Atuss Da</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate, Chlophedianol Hydrochloride, Pseudoephedrine Hydrochloride</NonProprietaryName>
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<StartMarketingDate>20181120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Magna Pharmceuticals, Inc.</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2; 12.5; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181120</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 nasal congestion, 3 reduces swelling of nasal passages, 4 runny nose, 5 sneezing, 6 itchy, watery eyes, 7 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58407-252-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (58407-252-04) </PackageDescription>
<NDC11Code>58407-0252-04</NDC11Code>
<ProductNDC>58407-252</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Atuss Da</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate, Chlophedianol Hydrochloride, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Magna Pharmceuticals, Inc.</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2; 12.5; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: : 1 cough due to minor throat and bronchial irritation, 2 nasal congestion, 3 reduces swelling of nasal passages, 4 runny nose, 5 sneezing, 6 itchy, watery eyes, 7 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58407-125-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (58407-125-16)</PackageDescription>
<NDC11Code>58407-0125-16</NDC11Code>
<ProductNDC>58407-125</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Statuss Green</ProprietaryName>
<NonProprietaryName>Chlorcyclizine Hydrochloride, Codeine Phosphate, And Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111220</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Magna Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CHLORCYCLIZINE HYDROCHLORIDE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 9; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>58407-239-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (58407-239-16)</PackageDescription>
<NDC11Code>58407-0239-16</NDC11Code>
<ProductNDC>58407-239</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Z-tuss</ProprietaryName>
<ProprietaryNameSuffix>E</ProprietaryNameSuffix>
<NonProprietaryName>Codeine Phosphate/guaifenesin/pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111012</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Magna Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>9; 200; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>58407-920-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (58407-920-16) </PackageDescription>
<NDC11Code>58407-0920-16</NDC11Code>
<ProductNDC>58407-920</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Z-tuss</ProprietaryName>
<ProprietaryNameSuffix>Ac</ProprietaryNameSuffix>
<NonProprietaryName>Chlorpheniramine Maleate, Codeine Phosphate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110111</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Magna Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>2; 9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<PackageNdcExcludeFlag>Y</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>Y</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>41520-252-16</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (41520-252-16) > 8 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41520-0252-16</NDC11Code>
<ProductNDC>41520-252</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Drowz Away</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100831</StartMarketingDate>
<EndMarketingDate>20200831</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part340</ApplicationNumber>
<LabelerName>Care One (American Sales Company)</LabelerName>
<SubstanceName>CAFFEINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100831</StartMarketingDatePackage>
<EndMarketingDatePackage>20200831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50804-252-16</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (50804-252-16) > 8 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50804-0252-16</NDC11Code>
<ProductNDC>50804-252</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Aid</ProprietaryName>
<ProprietaryNameSuffix>Regular Strength</ProprietaryNameSuffix>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140228</StartMarketingDate>
<EndMarketingDate>20200101</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part338</ApplicationNumber>
<LabelerName>Good Sense (Geiss, Destin & Dunn, Inc.)</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140228</StartMarketingDatePackage>
<EndMarketingDatePackage>20200101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55312-252-16</NDCCode>
<PackageDescription>16 BLISTER PACK in 1 CARTON (55312-252-16) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55312-0252-16</NDC11Code>
<ProductNDC>55312-252</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sleep Nighttime Sleep Aid</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140228</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part338</ApplicationNumber>
<LabelerName>Western Family Foods, Inc.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140228</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63941-252-16</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (63941-252-16) > 8 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63941-0252-16</NDC11Code>
<ProductNDC>63941-252</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stay Awake</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Caffeine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100921</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part340</ApplicationNumber>
<LabelerName>Valu Merchandisers Company (Best Choice)</LabelerName>
<SubstanceName>CAFFEINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68382-252-16</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68382-252-16) </PackageDescription>
<NDC11Code>68382-0252-16</NDC11Code>
<ProductNDC>68382-252</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181121</StartMarketingDate>
<EndMarketingDate>20260401</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206536</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181121</StartMarketingDatePackage>
<EndMarketingDatePackage>20260401</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: 1 To reduce the risk of:Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemiaHypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin calcium (atorvastatin) is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H- pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in alcohol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, and talc.</Description>
</NDC>
<NDC>
<NDCCode>69543-252-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (69543-252-16) </PackageDescription>
<NDC11Code>69543-0252-16</NDC11Code>
<ProductNDC>69543-252</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Virtussin Ac</ProprietaryName>
<NonProprietaryName>Codeine Phosphate And Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150707</StartMarketingDate>
<EndMarketingDate>20230331</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Virtus Pharmaceuticals</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; GUAIFENESIN</SubstanceName>
<StrengthNumber>10; 100</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150707</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76439-252-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (76439-252-16)</PackageDescription>
<NDC11Code>76439-0252-16</NDC11Code>
<ProductNDC>76439-252</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Virtussin Ac</ProprietaryName>
<NonProprietaryName>Codeine Phosphate And Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131211</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Virtus Pharmaceuticals LLC</LabelerName>
<SubstanceName>CODEINE PHOSPHATE; GUAIFENESIN</SubstanceName>
<StrengthNumber>10; 100</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-09-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>10135-798-41</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, GLASS (10135-798-41) </PackageDescription>
<NDC11Code>10135-0798-41</NDC11Code>
<ProductNDC>10135-798</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217782</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxcarbazepine oral suspension is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
<Description>Oxcarbazepine is an AED available as a 300 mg/5 mL (60 mg/mL) oral suspension for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo- 5 H-dibenz[b, f]azepine-5-carboxamide, and its structural formula is:. Oxcarbazepine, USP is a light orange to creamish white or off white powder. It is soluble in acetic acid; sparingly soluble in chloroform, in chloromethane; practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine oral suspension, USP contains the following inactive ingredients: ascorbic acid; microcrystalline cellulose and carboxymethyl cellulose sodium; xanthan gum; polyoxyl stearate type-I; methyl paraben; propylene glycol; propyl paraben; purified water; sodium saccharin; sorbic acid; sorbitol solution 70% non-crystallizing; plum flavor 0527036. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>25021-252-51</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (25021-252-51) / 80 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0252-51</NDC11Code>
<ProductNDC>25021-252</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mitomycin</ProprietaryName>
<NonProprietaryName>Mitomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216648</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>MITOMYCIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/80mL</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mitomycin for Injection is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.</IndicationAndUsage>
<Description>Mitomycin (also known as mitomycin and/or mitomycin-C) is an antibiotic isolated from the broth of Streptomyces caespitosus which has been shown to have antitumor activity. The compound is heat stable, has a high melting point, and is freely soluble in organic solvents. Mitomycin for Injection, USP is a sterile dry mixture of mitomycin and mannitol, which when reconstituted with Sterile Water for Injection provides a solution for intravenous administration. Each Single-Dose vial contains mitomycin 40 mg and mannitol 80 mg. Each mL of reconstituted solution will contain 0.5 mg mitomycin and have a pH between 6.0 and 8.0. Mitomycin is a blue-violet crystalline powder with the molecular formula of C15H18N4O5, and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane and it has the following structural formula;.</Description>
</NDC>
<NDC>
<NDCCode>33342-259-67</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (33342-259-67) / 250 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>33342-0259-67</NDC11Code>
<ProductNDC>33342-259</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207300</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxcarbazepine oral suspension, USP is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
<Description>Oxcarbazepine is an AED available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5Hdibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a light orange to creamish white or off-white powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27. Oxcarbazepine oral suspension, USP contains the following inactive ingredients: carboxymethylcellulose sodium noncrystallizing sorbitol solution, microcrystalline cellulose and carboxymethylcellulose sodium, ascorbic acid, methyl paraben, propyl paraben, sorbic acid, propylene glycol, saccharin sodium, colloidal silicon dioxide, flavour plum, hydrochloride acid, sodium hydroxide and purified water.</Description>
</NDC>
<NDC>
<NDCCode>53436-252-30</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (53436-252-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET (53436-252-01) </PackageDescription>
<NDC11Code>53436-0252-30</NDC11Code>
<ProductNDC>53436-252</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Veltassa</ProprietaryName>
<NonProprietaryName>Patiromer</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151023</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205739</ApplicationNumber>
<LabelerName>Vifor Pharma, Inc.</LabelerName>
<SubstanceName>PATIROMER</SubstanceName>
<StrengthNumber>25.2</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Potassium Binder [EPC], Potassium Ion Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Veltassa is indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older. Limitation of Use: Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2)].</IndicationAndUsage>
<Description>Veltassa is a powder for suspension in water for oral administration. The active ingredient is patiromer sorbitex calcium which consists of the active moiety, patiromer, a non-absorbed potassium-binding polymer, and a calcium-sorbitol counterion. Each gram of patiromer is equivalent to a nominal amount of 2 grams of patiromer sorbitex calcium. The chemical name for patiromer sorbitex calcium is cross-linked polymer of calcium 2-fluoroprop-2-enoate with diethenylbenzene and octa-1,7-diene, combination with D-glucitol. Patiromer sorbitex calcium is an amorphous, free-flowing powder that is composed of individual spherical beads. Patiromer sorbitex calcium is insoluble in solvents such as water, 0.1 M HCl, n-heptane and methanol. The chemical structure of patiromer sorbitex calcium is presented in Figure 1. Figure 1: Chemical Structure of Patiromer Sorbitex Calcium. Each packet of Veltassa contains 1 gram, 8.4 grams, 16.8 grams or 25.2 grams of patiromer, the active moiety. The inactive ingredient is xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>53746-193-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (53746-193-01) </PackageDescription>
<NDC11Code>53746-0193-01</NDC11Code>
<ProductNDC>53746-193</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078432</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>275</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen sodium tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen sodium, USP is (S)-6-methoxy- α -methyl-2 naphthaleneacetic acid, sodium salt. Naproxen sodium, USP has the following structures. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen sodium, USP is available as blue tablets containing 275 mg of naproxen sodium, USP and as blue tablets containing 550 mg of naproxen sodium, USP for oral administration. The inactive ingredients are croscarmellose sodium, macrogol, magnesium stearate, polyvinyl alcohol, povidone, talc, titanium dioxide and FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>53746-193-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (53746-193-05) </PackageDescription>
<NDC11Code>53746-0193-05</NDC11Code>
<ProductNDC>53746-193</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078432</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>275</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen sodium tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen sodium, USP is (S)-6-methoxy- α -methyl-2 naphthaleneacetic acid, sodium salt. Naproxen sodium, USP has the following structures. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen sodium, USP is available as blue tablets containing 275 mg of naproxen sodium, USP and as blue tablets containing 550 mg of naproxen sodium, USP for oral administration. The inactive ingredients are croscarmellose sodium, macrogol, magnesium stearate, polyvinyl alcohol, povidone, talc, titanium dioxide and FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>53746-194-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (53746-194-01) </PackageDescription>
<NDC11Code>53746-0194-01</NDC11Code>
<ProductNDC>53746-194</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078432</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen sodium tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen sodium, USP is (S)-6-methoxy- α -methyl-2 naphthaleneacetic acid, sodium salt. Naproxen sodium, USP has the following structures. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen sodium, USP is available as blue tablets containing 275 mg of naproxen sodium, USP and as blue tablets containing 550 mg of naproxen sodium, USP for oral administration. The inactive ingredients are croscarmellose sodium, macrogol, magnesium stearate, polyvinyl alcohol, povidone, talc, titanium dioxide and FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>53746-194-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (53746-194-05) </PackageDescription>
<NDC11Code>53746-0194-05</NDC11Code>
<ProductNDC>53746-194</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078432</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen sodium tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen sodium, USP is (S)-6-methoxy- α -methyl-2 naphthaleneacetic acid, sodium salt. Naproxen sodium, USP has the following structures. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen sodium, USP is available as blue tablets containing 275 mg of naproxen sodium, USP and as blue tablets containing 550 mg of naproxen sodium, USP for oral administration. The inactive ingredients are croscarmellose sodium, macrogol, magnesium stearate, polyvinyl alcohol, povidone, talc, titanium dioxide and FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>59651-785-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-785-01) </PackageDescription>
<NDC11Code>59651-0785-01</NDC11Code>
<ProductNDC>59651-785</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261016</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219241</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.</IndicationAndUsage>
<Description>Oxcarbazepine extended-release tablets are an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine, USP is light orange to creamish white or off-white powder. Oxcarbazepine, USP is soluble in acetic acid (33 g/L), sparingly soluble in chloroform (17 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 70 mg/L (0.07 g/L) at pH 7.0, 25°C. The molecular formula is C15H12N2O2 and its molecular weight is 252.27. Oxcarbazepine extended-release tablets contain the following inactive ingredients: fumaric acid, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, povidone, pregelatinized starch (maize), silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide. In addition 150 mg and 600 mg contains ferrosoferric oxide and iron oxide yellow and 300 mg and 600 mg contains iron oxide red. In addition the tablets are imprinted with black ink containing ferrosoferric oxide, propylene glycol and shellac. The 150 mg oxcarbazepine extended-release tablets each contain 1 mg of sodium. The 300 mg oxcarbazepine extended-release tablets each contain 2 mg of sodium. The 600 mg oxcarbazepine extended-release tablets each contain 4 mg of sodium.</Description>
</NDC>
<NDC>
<NDCCode>59651-786-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-786-01) </PackageDescription>
<NDC11Code>59651-0786-01</NDC11Code>
<ProductNDC>59651-786</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261016</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219241</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.</IndicationAndUsage>
<Description>Oxcarbazepine extended-release tablets are an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine, USP is light orange to creamish white or off-white powder. Oxcarbazepine, USP is soluble in acetic acid (33 g/L), sparingly soluble in chloroform (17 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 70 mg/L (0.07 g/L) at pH 7.0, 25°C. The molecular formula is C15H12N2O2 and its molecular weight is 252.27. Oxcarbazepine extended-release tablets contain the following inactive ingredients: fumaric acid, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, povidone, pregelatinized starch (maize), silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide. In addition 150 mg and 600 mg contains ferrosoferric oxide and iron oxide yellow and 300 mg and 600 mg contains iron oxide red. In addition the tablets are imprinted with black ink containing ferrosoferric oxide, propylene glycol and shellac. The 150 mg oxcarbazepine extended-release tablets each contain 1 mg of sodium. The 300 mg oxcarbazepine extended-release tablets each contain 2 mg of sodium. The 600 mg oxcarbazepine extended-release tablets each contain 4 mg of sodium.</Description>
</NDC>
<NDC>
<NDCCode>59651-787-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-787-01) </PackageDescription>
<NDC11Code>59651-0787-01</NDC11Code>
<ProductNDC>59651-787</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261016</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219241</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
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<IndicationAndUsage>Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.</IndicationAndUsage>
<Description>Oxcarbazepine extended-release tablets are an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is. Oxcarbazepine, USP is light orange to creamish white or off-white powder. Oxcarbazepine, USP is soluble in acetic acid (33 g/L), sparingly soluble in chloroform (17 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 70 mg/L (0.07 g/L) at pH 7.0, 25°C. The molecular formula is C15H12N2O2 and its molecular weight is 252.27. Oxcarbazepine extended-release tablets contain the following inactive ingredients: fumaric acid, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, povidone, pregelatinized starch (maize), silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide. In addition 150 mg and 600 mg contains ferrosoferric oxide and iron oxide yellow and 300 mg and 600 mg contains iron oxide red. In addition the tablets are imprinted with black ink containing ferrosoferric oxide, propylene glycol and shellac. The 150 mg oxcarbazepine extended-release tablets each contain 1 mg of sodium. The 300 mg oxcarbazepine extended-release tablets each contain 2 mg of sodium. The 600 mg oxcarbazepine extended-release tablets each contain 4 mg of sodium.</Description>
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<IndicationAndUsage>Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.</IndicationAndUsage>
<Description>Oxcarbazepine extended-release tablet is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine, USP for once-a-day oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is light orange to creamish white or off-white powder. Oxcarbazepine is soluble in acetic acid, sparingly soluble in chloroform and practically insoluble in water. The molecular formula is C15H12N2O2 and its molecular weight is 252.27 g/mol. Oxcarbazepine extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (300 mg, 600 mg tablets only), ferric oxide yellow (150 mg, 300 mg tablets only), hydroxypropyl methyl cellulose, iron oxide black (300 mg tablet only), magnesium stearate, polyethylene glycol, polyvinyl alcohol, sorbitol, talc, titanium dioxide (300 mg, 600 mg tablets only).</Description>
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<IndicationAndUsage>Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.</IndicationAndUsage>
<Description>Oxcarbazepine extended-release tablet is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine, USP for once-a-day oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is light orange to creamish white or off-white powder. Oxcarbazepine is soluble in acetic acid, sparingly soluble in chloroform and practically insoluble in water. The molecular formula is C15H12N2O2 and its molecular weight is 252.27 g/mol. Oxcarbazepine extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (300 mg, 600 mg tablets only), ferric oxide yellow (150 mg, 300 mg tablets only), hydroxypropyl methyl cellulose, iron oxide black (300 mg tablet only), magnesium stearate, polyethylene glycol, polyvinyl alcohol, sorbitol, talc, titanium dioxide (300 mg, 600 mg tablets only).</Description>
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<IndicationAndUsage>Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.</IndicationAndUsage>
<Description>Oxcarbazepine extended-release tablet is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine, USP for once-a-day oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is light orange to creamish white or off-white powder. Oxcarbazepine is soluble in acetic acid, sparingly soluble in chloroform and practically insoluble in water. The molecular formula is C15H12N2O2 and its molecular weight is 252.27 g/mol. Oxcarbazepine extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (300 mg, 600 mg tablets only), ferric oxide yellow (150 mg, 300 mg tablets only), hydroxypropyl methyl cellulose, iron oxide black (300 mg tablet only), magnesium stearate, polyethylene glycol, polyvinyl alcohol, sorbitol, talc, titanium dioxide (300 mg, 600 mg tablets only).</Description>
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<IndicationAndUsage>Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.</IndicationAndUsage>
<Description>Oxcarbazepine extended-release tablet is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine, USP for once-a-day oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is light orange to creamish white or off-white powder. Oxcarbazepine is soluble in acetic acid, sparingly soluble in chloroform and practically insoluble in water. The molecular formula is C15H12N2O2 and its molecular weight is 252.27 g/mol. Oxcarbazepine extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (300 mg, 600 mg tablets only), ferric oxide yellow (150 mg, 300 mg tablets only), hydroxypropyl methyl cellulose, iron oxide black (300 mg tablet only), magnesium stearate, polyethylene glycol, polyvinyl alcohol, sorbitol, talc, titanium dioxide (300 mg, 600 mg tablets only).</Description>
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<IndicationAndUsage>Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.</IndicationAndUsage>
<Description>Oxcarbazepine extended-release tablet is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine, USP for once-a-day oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is light orange to creamish white or off-white powder. Oxcarbazepine is soluble in acetic acid, sparingly soluble in chloroform and practically insoluble in water. The molecular formula is C15H12N2O2 and its molecular weight is 252.27 g/mol. Oxcarbazepine extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (300 mg, 600 mg tablets only), ferric oxide yellow (150 mg, 300 mg tablets only), hydroxypropyl methyl cellulose, iron oxide black (300 mg tablet only), magnesium stearate, polyethylene glycol, polyvinyl alcohol, sorbitol, talc, titanium dioxide (300 mg, 600 mg tablets only).</Description>
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<IndicationAndUsage>Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.</IndicationAndUsage>
<Description>Oxcarbazepine extended-release tablet is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine, USP for once-a-day oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is light orange to creamish white or off-white powder. Oxcarbazepine is soluble in acetic acid, sparingly soluble in chloroform and practically insoluble in water. The molecular formula is C15H12N2O2 and its molecular weight is 252.27 g/mol. Oxcarbazepine extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (300 mg, 600 mg tablets only), ferric oxide yellow (150 mg, 300 mg tablets only), hydroxypropyl methyl cellulose, iron oxide black (300 mg tablet only), magnesium stearate, polyethylene glycol, polyvinyl alcohol, sorbitol, talc, titanium dioxide (300 mg, 600 mg tablets only).</Description>
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