{
"NDC": [
{
"NDCCode": "82804-989-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (82804-989-30) ",
"NDC11Code": "82804-0989-30",
"ProductNDC": "82804-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086842",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DAPSONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2024-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240521",
"SamplePackage": "N",
"IndicationAndUsage": "Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.",
"Description": "Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose."
},
{
"NDCCode": "82804-989-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (82804-989-00) ",
"NDC11Code": "82804-0989-00",
"ProductNDC": "82804-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086842",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DAPSONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2024-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240521",
"SamplePackage": "N",
"IndicationAndUsage": "Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.",
"Description": "Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose."
},
{
"NDCCode": "82804-989-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (82804-989-11) ",
"NDC11Code": "82804-0989-11",
"ProductNDC": "82804-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086842",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DAPSONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2024-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240521",
"SamplePackage": "N",
"IndicationAndUsage": "Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.",
"Description": "Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose."
},
{
"NDCCode": "82804-989-55",
"PackageDescription": "500 TABLET in 1 BOTTLE (82804-989-55) ",
"NDC11Code": "82804-0989-55",
"ProductNDC": "82804-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086842",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DAPSONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2024-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240521",
"SamplePackage": "N",
"IndicationAndUsage": "Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.",
"Description": "Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose."
},
{
"NDCCode": "82804-989-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (82804-989-60) ",
"NDC11Code": "82804-0989-60",
"ProductNDC": "82804-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086842",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DAPSONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2024-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240521",
"SamplePackage": "N",
"IndicationAndUsage": "Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.",
"Description": "Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose."
},
{
"NDCCode": "82804-989-64",
"PackageDescription": "240 TABLET in 1 BOTTLE (82804-989-64) ",
"NDC11Code": "82804-0989-64",
"ProductNDC": "82804-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086842",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DAPSONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2024-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240521",
"SamplePackage": "N",
"IndicationAndUsage": "Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.",
"Description": "Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose."
},
{
"NDCCode": "82804-989-72",
"PackageDescription": "120 TABLET in 1 BOTTLE (82804-989-72) ",
"NDC11Code": "82804-0989-72",
"ProductNDC": "82804-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086842",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DAPSONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2024-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240521",
"SamplePackage": "N",
"IndicationAndUsage": "Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.",
"Description": "Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose."
},
{
"NDCCode": "82804-989-78",
"PackageDescription": "180 TABLET in 1 BOTTLE (82804-989-78) ",
"NDC11Code": "82804-0989-78",
"ProductNDC": "82804-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086842",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DAPSONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2024-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240521",
"SamplePackage": "N",
"IndicationAndUsage": "Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.",
"Description": "Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose."
},
{
"NDCCode": "82804-989-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (82804-989-90) ",
"NDC11Code": "82804-0989-90",
"ProductNDC": "82804-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapsone",
"NonProprietaryName": "Dapsone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086842",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "DAPSONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfone [EPC], Sulfones [CS]",
"Status": "Active",
"LastUpdate": "2024-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240521",
"SamplePackage": "N",
"IndicationAndUsage": "Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.",
"Description": "Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose."
},
{
"NDCCode": "21695-989-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (21695-989-30)",
"NDC11Code": "21695-0989-30",
"ProductNDC": "21695-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losortan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101004",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078243",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Losartan potassium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.",
"Description": "Losartan potassium is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP, is off-white to creamish-yellow powder with a molecular weight of 461.01. It is soluble in water. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Each losartan potassium tablet intended for oral administration contains 25 mg or 50 mg or 100 mg of losartan potassium. In addition, each tablet contains the following inactive ingredients: colloidal silica anhydrous, hydroxypropyl cellulose (low substituted), hypromellose, lactose monohydrate, magnesium stearate, maize starch (corn starch), microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively."
},
{
"NDCCode": "41250-989-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (41250-989-10) / 30 mL in 1 BOTTLE",
"NDC11Code": "41250-0989-10",
"ProductNDC": "41250-989",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasal",
"NonProprietaryName": "Oxymetazoline Hydrochloride",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20181120",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "OXYMETAZOLINE HYDROCHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181120",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves : 1 nasal congestion due to a cold, hay fever, or other upper respiratory allergies, 2 sinus congestion and pressure."
},
{
"NDCCode": "42385-989-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42385-989-30) ",
"NDC11Code": "42385-0989-30",
"ProductNDC": "42385-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218897",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260422",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2) Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan tablets, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as L-Valine, N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-. Its molecular formula is C24H29N5O3, its molecular weight is 435.53 g/mol, and its structural formula is. Valsartan, USP is a white to almost white powder. It is freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride and practically insoluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, iron oxides (yellow, black and/or red), hypromellose, polyethylene glycol 8000, and titanium dioxide."
},
{
"NDCCode": "43353-989-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (43353-989-30)",
"NDC11Code": "43353-0989-30",
"ProductNDC": "43353-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077955",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2017-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20161202",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) , 2 Coronary Artery Disease (1.2) Chronic Stable AnginaVasospastic Angina (Prinzmetal’s or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is:Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "49035-989-91",
"PackageDescription": "30 mL in 1 CONTAINER (49035-989-91) ",
"NDC11Code": "49035-0989-91",
"ProductNDC": "49035-989",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Swimmers Instant Ear Dry",
"NonProprietaryName": "Equate Swimmers Instant Ear Dry",
"DosageFormName": "LIQUID",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20180925",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M014",
"LabelerName": "Walmart Stores, Inc",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "950",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180925",
"SamplePackage": "N",
"IndicationAndUsage": "Dries water in the ears."
},
{
"NDCCode": "49349-989-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-989-02)",
"NDC11Code": "49349-0989-02",
"ProductNDC": "49349-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070035",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "51655-989-52",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (51655-989-52) ",
"NDC11Code": "51655-0989-52",
"ProductNDC": "51655-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209713",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".075",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220519",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions ( 5.1)] . , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5' tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4H 2O, molecular weight of 798.85 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablets USP contains the inactive ingredients corn starch, croscarmellose sodium, magnesium stearate, mannitol and sodium bicarbonate. Table 9 provides a listing of the color additives by tablet strength. Table 9. Levothyroxine Sodium Tablets USP Color Additives."
},
{
"NDCCode": "52125-989-02",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BLISTER PACK (52125-989-02)",
"NDC11Code": "52125-0989-02",
"ProductNDC": "52125-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140714",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020504",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-02-24"
},
{
"NDCCode": "52959-989-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (52959-989-30)",
"NDC11Code": "52959-0989-30",
"ProductNDC": "52959-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078155",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.",
"Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets for oral administration contain either 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, starch, talc, titanium dioxide, butylated hydroxyanisole , ascorbic acid, citric acid monohydrate, and triethyl citrate."
},
{
"NDCCode": "53329-989-30",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (53329-989-30) ",
"NDC11Code": "53329-0989-30",
"ProductNDC": "53329-989",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Senna S",
"NonProprietaryName": "Sennosides And Docusate Sodium",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180522",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Medline Industries",
"SubstanceName": "DOCUSATE SODIUM; SENNOSIDES",
"StrengthNumber": "50; 8.6",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180522",
"SamplePackage": "N"
},
{
"NDCCode": "54458-989-10",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (54458-989-10)",
"NDC11Code": "54458-0989-10",
"ProductNDC": "54458-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077584",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "54458-989-16",
"PackageDescription": "30 TABLET in 1 BOTTLE (54458-989-16) ",
"NDC11Code": "54458-0989-16",
"ProductNDC": "54458-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077584",
"LabelerName": "International Laboratories, LLC",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170711",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of paroxetine tablets, USP in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL PHARMACOLOGY —Clinical Trials). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: Change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The effects of paroxetine tablets, USP in hospitalized depressed patients have not been adequately studied. The efficacy of paroxetine tablets, USP in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY —Clinical Trials). Nevertheless, the physician who elects to use paroxetine tablets, USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Paroxetine tablets, USP are an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride hemihydrate is. Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120° to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Each paroxetine tablet, USP intended for oral administration contains paroxetine hydrochloride hemihydrate equivalent to 10 mg or 20 mg or 30 mg or 40 mg of paroxetine. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "55289-989-30",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-989-30)",
"NDC11Code": "55289-0989-30",
"ProductNDC": "55289-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Singulair",
"NonProprietaryName": "Montelukast Sodium",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "19980220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020830",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "MONTELUKAST SODIUM",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "62713-989-01",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (62713-989-01) ",
"NDC11Code": "62713-0989-01",
"ProductNDC": "62713-989",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergena Zone 9",
"ProprietaryNameSuffix": "Trees, Weeds And Grasses",
"NonProprietaryName": "Echinacea,baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Phytolacca Decandra, Trigonella Foenum-graecum, Zone 9 Tree, Zone 9 Weed, Zone 9 Grass",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Meditrend, Inc. DBA Progena Professional Formulations",
"SubstanceName": "ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ACACIA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; EUCALYPTUS GLOBULUS POLLEN; JUNIPERUS SCOPULORUM POLLEN; LIGUSTRUM VULGARE POLLEN; PROSOPIS JULIFLORA POLLEN; MORUS ALBA POLLEN; QUERCUS AGRIFOLIA POLLEN; OLEA EUROPAEA POLLEN; PHOENIX DACTYLIFERA POLLEN; PINUS STROBUS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; AILANTHUS ALTISSIMA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; ATRIPLEX CANESCENS POLLEN; AMARANTHUS PALMERI POLLEN; RUMEX CRISPUS POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; SALSOLA TRAGUS POLLEN; CYNODON DACTYLON POLLEN; BROMUS INERMIS POLLEN; BROMUS SECALINUS POLLEN; SORGHUM HALEPENSE POLLEN; POA PRATENSIS POLLEN; FESTUCA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN",
"StrengthNumber": "3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240901",
"SamplePackage": "N",
"IndicationAndUsage": "Use:This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies.*."
},
{
"NDCCode": "67544-989-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (67544-989-30) ",
"NDC11Code": "67544-0989-30",
"ProductNDC": "67544-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folic Acid",
"NonProprietaryName": "Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204418",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "FOLIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"IndicationAndUsage": "Folic acid, USP is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid, USP (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Folic acid, USP, N-[p-[[(2-amino-4- hydroxy-6-pteridinyl) methyl]- amino]benzoyl]-Lglutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid, USP are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid, USP is prepared synthetically. Folic acid, USP occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid, USP is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid, USP (sodium folate). Aqueous solutions of folic acid, USP are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. The structural formula of folic acid, USP is as follows:. Each tablet, for oral administration, contains 1 mg folic acid, USP. Folic acid tablets, USP 1 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid."
},
{
"NDCCode": "68084-989-25",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-989-25) > 1 TABLET in 1 BLISTER PACK (68084-989-95)",
"NDC11Code": "68084-0989-25",
"ProductNDC": "68084-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151005",
"EndMarketingDate": "20171231",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "American Health Packaging",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "64.8",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68382-989-30",
"PackageDescription": "30 mL in 1 VIAL (68382-989-30) ",
"NDC11Code": "68382-0989-30",
"ProductNDC": "68382-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205968",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170801",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin injection is a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3), 2 Skin and Skin Structure Infections: Complicated (1.4) and Uncomplicated (1.5), 3 Chronic bacterial prostatitis (1.6), 4 Inhalational Anthrax, Post-Exposure (1.7), 5 Plague (1.8), 6 Urinary Tract Infections: Complicated (1.9,1.10) and Uncomplicated (1.12), 7 Acute Pyelonephritis (1.11), 8 Acute Bacterial Exacerbation of Chronic Bronchitis (1.13), 9 Acute Bacterial Sinusitis (1.14).",
"Description": "Levofloxacin, USP is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. The molecular formula is C18H20FN3O4½H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order. Al+3> Cu+2 > Zn+2 > Mg+2 > Ca+2. Excipients and Description of Dosage Forms. The appearance of levofloxacin Injection may range from a clear yellow to a clear greenish-yellow solution. This does not adversely affect product potency. Levofloxacin Injection in Single-Dose Vials is a sterile, preservative-free aqueous solution of levofloxacin in Water for Injection, with pH ranging from 3.8 to 5.8."
},
{
"NDCCode": "70934-989-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-989-30) ",
"NDC11Code": "70934-0989-30",
"ProductNDC": "70934-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220707",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090548",
"LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
"SubstanceName": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220707",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C 66H 68CaF 2N 4O 10 * C 3H 8O 2 and its molecular weight is 1231.46 g/mol. Its structural formula is:. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide."
},
{
"NDCCode": "71205-989-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (71205-989-30) ",
"NDC11Code": "71205-0989-30",
"ProductNDC": "71205-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyproheptadine Hydrochloride",
"NonProprietaryName": "Cyproheptadine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207555",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CYPROHEPTADINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200415",
"SamplePackage": "N",
"IndicationAndUsage": "Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.",
"Description": "Cyproheptadine HCl USP is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline solid, with a molecular weight of 350.89, which is soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C21H21N∙HCl and the structural formula of the anhydrous salt is. C21H21N∙HCl M.W. 350.89. Cyproheptadine hydrochloride USP is available for oral administration in 4 mg tablets. Inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "71610-989-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (71610-989-30) ",
"NDC11Code": "71610-0989-30",
"ProductNDC": "71610-989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Modafinil",
"NonProprietaryName": "Modafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078963",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "MODAFINIL",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260210",
"SamplePackage": "N",
"IndicationAndUsage": "Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness.",
"Description": "Modafinil, USP is wakefulness-promoting agent for oral administration. Modafinil, USP is a racemic compound. The chemical name for modafinil, USP is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C 15H 15NO 2S and the molecular weight is 273.35. The chemical structure is. Modafinil, USP is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. Modafinil tablets, USP contain 100 mg or 200 mg of modafinil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and talc. USP dissolution test pending."
},
{
"NDCCode": "74177-989-01",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (74177-989-01) ",
"NDC11Code": "74177-0989-01",
"ProductNDC": "74177-989",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Adore Peppermint Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210105",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "K7 Design Group Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "69",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210105",
"SamplePackage": "N",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin, only when water is not available."
}
]
}
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<ApplicationNumber>ANDA086842</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
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<Description>Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose.</Description>
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<NDCCode>82804-989-00</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (82804-989-00) </PackageDescription>
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<NDCCode>82804-989-11</NDCCode>
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<NDC11Code>82804-0989-11</NDC11Code>
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<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.</IndicationAndUsage>
<Description>Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose.</Description>
</NDC>
<NDC>
<NDCCode>82804-989-55</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (82804-989-55) </PackageDescription>
<NDC11Code>82804-0989-55</NDC11Code>
<ProductNDC>82804-989</ProductNDC>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.</IndicationAndUsage>
<Description>Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose.</Description>
</NDC>
<NDC>
<NDCCode>82804-989-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (82804-989-60) </PackageDescription>
<NDC11Code>82804-0989-60</NDC11Code>
<ProductNDC>82804-989</ProductNDC>
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<LabelerName>Proficient Rx LP</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.</IndicationAndUsage>
<Description>Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose.</Description>
</NDC>
<NDC>
<NDCCode>82804-989-64</NDCCode>
<PackageDescription>240 TABLET in 1 BOTTLE (82804-989-64) </PackageDescription>
<NDC11Code>82804-0989-64</NDC11Code>
<ProductNDC>82804-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086842</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.</IndicationAndUsage>
<Description>Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose.</Description>
</NDC>
<NDC>
<NDCCode>82804-989-72</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (82804-989-72) </PackageDescription>
<NDC11Code>82804-0989-72</NDC11Code>
<ProductNDC>82804-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086842</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.</IndicationAndUsage>
<Description>Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose.</Description>
</NDC>
<NDC>
<NDCCode>82804-989-78</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (82804-989-78) </PackageDescription>
<NDC11Code>82804-0989-78</NDC11Code>
<ProductNDC>82804-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086842</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.</IndicationAndUsage>
<Description>Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose.</Description>
</NDC>
<NDC>
<NDCCode>82804-989-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (82804-989-90) </PackageDescription>
<NDC11Code>82804-0989-90</NDC11Code>
<ProductNDC>82804-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapsone</ProprietaryName>
<NonProprietaryName>Dapsone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086842</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>DAPSONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfone [EPC], Sulfones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dermatitis herpetiformis: (D.H.). Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.</IndicationAndUsage>
<Description>Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and in-soluble in fixed and vegetable oils. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose.</Description>
</NDC>
<NDC>
<NDCCode>21695-989-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (21695-989-30)</PackageDescription>
<NDC11Code>21695-0989-30</NDC11Code>
<ProductNDC>21695-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losortan Potassium</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101004</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078243</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Losartan potassium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.</IndicationAndUsage>
<Description>Losartan potassium is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C22H22ClKN6O, and its structural formula is. Losartan potassium USP, is off-white to creamish-yellow powder with a molecular weight of 461.01. It is soluble in water. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Each losartan potassium tablet intended for oral administration contains 25 mg or 50 mg or 100 mg of losartan potassium. In addition, each tablet contains the following inactive ingredients: colloidal silica anhydrous, hydroxypropyl cellulose (low substituted), hypromellose, lactose monohydrate, magnesium stearate, maize starch (corn starch), microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Losartan potassium 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
</NDC>
<NDC>
<NDCCode>41250-989-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41250-989-10) / 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>41250-0989-10</NDC11Code>
<ProductNDC>41250-989</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasal</ProprietaryName>
<NonProprietaryName>Oxymetazoline Hydrochloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20181120</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>OXYMETAZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves : 1 nasal congestion due to a cold, hay fever, or other upper respiratory allergies, 2 sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42385-989-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42385-989-30) </PackageDescription>
<NDC11Code>42385-0989-30</NDC11Code>
<ProductNDC>42385-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218897</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2) Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan tablets, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as L-Valine, N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-. Its molecular formula is C24H29N5O3, its molecular weight is 435.53 g/mol, and its structural formula is. Valsartan, USP is a white to almost white powder. It is freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride and practically insoluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, iron oxides (yellow, black and/or red), hypromellose, polyethylene glycol 8000, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-989-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43353-989-30)</PackageDescription>
<NDC11Code>43353-0989-30</NDC11Code>
<ProductNDC>43353-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077955</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) , 2 Coronary Artery Disease (1.2) Chronic Stable AnginaVasospastic Angina (Prinzmetal’s or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is:Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>49035-989-91</NDCCode>
<PackageDescription>30 mL in 1 CONTAINER (49035-989-91) </PackageDescription>
<NDC11Code>49035-0989-91</NDC11Code>
<ProductNDC>49035-989</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Swimmers Instant Ear Dry</ProprietaryName>
<NonProprietaryName>Equate Swimmers Instant Ear Dry</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20180925</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M014</ApplicationNumber>
<LabelerName>Walmart Stores, Inc</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>950</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dries water in the ears.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49349-989-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (49349-989-02)</PackageDescription>
<NDC11Code>49349-0989-02</NDC11Code>
<ProductNDC>49349-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070035</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>51655-989-52</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (51655-989-52) </PackageDescription>
<NDC11Code>51655-0989-52</NDC11Code>
<ProductNDC>51655-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209713</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>.075</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions ( 5.1)] . , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3',5,5' tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4H 2O, molecular weight of 798.85 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablets USP contains the inactive ingredients corn starch, croscarmellose sodium, magnesium stearate, mannitol and sodium bicarbonate. Table 9 provides a listing of the color additives by tablet strength. Table 9. Levothyroxine Sodium Tablets USP Color Additives.</Description>
</NDC>
<NDC>
<NDCCode>52125-989-02</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BLISTER PACK (52125-989-02)</PackageDescription>
<NDC11Code>52125-0989-02</NDC11Code>
<ProductNDC>52125-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140714</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020504</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-24</LastUpdate>
</NDC>
<NDC>
<NDCCode>52959-989-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (52959-989-30)</PackageDescription>
<NDC11Code>52959-0989-30</NDC11Code>
<ProductNDC>52959-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078155</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets for oral administration contain either 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, starch, talc, titanium dioxide, butylated hydroxyanisole , ascorbic acid, citric acid monohydrate, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>53329-989-30</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (53329-989-30) </PackageDescription>
<NDC11Code>53329-0989-30</NDC11Code>
<ProductNDC>53329-989</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Senna S</ProprietaryName>
<NonProprietaryName>Sennosides And Docusate Sodium</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180522</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Medline Industries</LabelerName>
<SubstanceName>DOCUSATE SODIUM; SENNOSIDES</SubstanceName>
<StrengthNumber>50; 8.6</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54458-989-10</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (54458-989-10)</PackageDescription>
<NDC11Code>54458-0989-10</NDC11Code>
<ProductNDC>54458-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077584</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54458-989-16</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (54458-989-16) </PackageDescription>
<NDC11Code>54458-0989-16</NDC11Code>
<ProductNDC>54458-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077584</ApplicationNumber>
<LabelerName>International Laboratories, LLC</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of paroxetine tablets, USP in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL PHARMACOLOGY —Clinical Trials). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: Change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The effects of paroxetine tablets, USP in hospitalized depressed patients have not been adequately studied. The efficacy of paroxetine tablets, USP in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY —Clinical Trials). Nevertheless, the physician who elects to use paroxetine tablets, USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Paroxetine tablets, USP are an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride hemihydrate is. Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120° to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Each paroxetine tablet, USP intended for oral administration contains paroxetine hydrochloride hemihydrate equivalent to 10 mg or 20 mg or 30 mg or 40 mg of paroxetine. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55289-989-30</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55289-989-30)</PackageDescription>
<NDC11Code>55289-0989-30</NDC11Code>
<ProductNDC>55289-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Singulair</ProprietaryName>
<NonProprietaryName>Montelukast Sodium</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980220</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020830</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MONTELUKAST SODIUM</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>62713-989-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (62713-989-01) </PackageDescription>
<NDC11Code>62713-0989-01</NDC11Code>
<ProductNDC>62713-989</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergena Zone 9</ProprietaryName>
<ProprietaryNameSuffix>Trees, Weeds And Grasses</ProprietaryNameSuffix>
<NonProprietaryName>Echinacea,baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Phytolacca Decandra, Trigonella Foenum-graecum, Zone 9 Tree, Zone 9 Weed, Zone 9 Grass</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Meditrend, Inc. DBA Progena Professional Formulations</LabelerName>
<SubstanceName>ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ACACIA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; EUCALYPTUS GLOBULUS POLLEN; JUNIPERUS SCOPULORUM POLLEN; LIGUSTRUM VULGARE POLLEN; PROSOPIS JULIFLORA POLLEN; MORUS ALBA POLLEN; QUERCUS AGRIFOLIA POLLEN; OLEA EUROPAEA POLLEN; PHOENIX DACTYLIFERA POLLEN; PINUS STROBUS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; AILANTHUS ALTISSIMA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; ATRIPLEX CANESCENS POLLEN; AMARANTHUS PALMERI POLLEN; RUMEX CRISPUS POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; SALSOLA TRAGUS POLLEN; CYNODON DACTYLON POLLEN; BROMUS INERMIS POLLEN; BROMUS SECALINUS POLLEN; SORGHUM HALEPENSE POLLEN; POA PRATENSIS POLLEN; FESTUCA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use:This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies.*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67544-989-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (67544-989-30) </PackageDescription>
<NDC11Code>67544-0989-30</NDC11Code>
<ProductNDC>67544-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folic Acid</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204418</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>FOLIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Folic acid, USP is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid, USP (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Folic acid, USP, N-[p-[[(2-amino-4- hydroxy-6-pteridinyl) methyl]- amino]benzoyl]-Lglutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid, USP are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid, USP is prepared synthetically. Folic acid, USP occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid, USP is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid, USP (sodium folate). Aqueous solutions of folic acid, USP are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. The structural formula of folic acid, USP is as follows:. Each tablet, for oral administration, contains 1 mg folic acid, USP. Folic acid tablets, USP 1 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>68084-989-25</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-989-25) > 1 TABLET in 1 BLISTER PACK (68084-989-95)</PackageDescription>
<NDC11Code>68084-0989-25</NDC11Code>
<ProductNDC>68084-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151005</StartMarketingDate>
<EndMarketingDate>20171231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>64.8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68382-989-30</NDCCode>
<PackageDescription>30 mL in 1 VIAL (68382-989-30) </PackageDescription>
<NDC11Code>68382-0989-30</NDC11Code>
<ProductNDC>68382-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205968</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacin injection is a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4). : 1 Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3), 2 Skin and Skin Structure Infections: Complicated (1.4) and Uncomplicated (1.5), 3 Chronic bacterial prostatitis (1.6), 4 Inhalational Anthrax, Post-Exposure (1.7), 5 Plague (1.8), 6 Urinary Tract Infections: Complicated (1.9,1.10) and Uncomplicated (1.12), 7 Acute Pyelonephritis (1.11), 8 Acute Bacterial Exacerbation of Chronic Bronchitis (1.13), 9 Acute Bacterial Sinusitis (1.14).</IndicationAndUsage>
<Description>Levofloxacin, USP is a synthetic broad-spectrum antibacterial agent for oral and intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1. The Chemical Structure of Levofloxacin. The molecular formula is C18H20FN3O4½H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order. Al+3> Cu+2 > Zn+2 > Mg+2 > Ca+2. Excipients and Description of Dosage Forms. The appearance of levofloxacin Injection may range from a clear yellow to a clear greenish-yellow solution. This does not adversely affect product potency. Levofloxacin Injection in Single-Dose Vials is a sterile, preservative-free aqueous solution of levofloxacin in Water for Injection, with pH ranging from 3.8 to 5.8.</Description>
</NDC>
<NDC>
<NDCCode>70934-989-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-989-30) </PackageDescription>
<NDC11Code>70934-0989-30</NDC11Code>
<ProductNDC>70934-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220707</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090548</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220707</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C 66H 68CaF 2N 4O 10 * C 3H 8O 2 and its molecular weight is 1231.46 g/mol. Its structural formula is:. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71205-989-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (71205-989-30) </PackageDescription>
<NDC11Code>71205-0989-30</NDC11Code>
<ProductNDC>71205-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyproheptadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyproheptadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207555</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CYPROHEPTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.</IndicationAndUsage>
<Description>Cyproheptadine HCl USP is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline solid, with a molecular weight of 350.89, which is soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C21H21N∙HCl and the structural formula of the anhydrous salt is. C21H21N∙HCl M.W. 350.89. Cyproheptadine hydrochloride USP is available for oral administration in 4 mg tablets. Inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>71610-989-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71610-989-30) </PackageDescription>
<NDC11Code>71610-0989-30</NDC11Code>
<ProductNDC>71610-989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Modafinil</ProprietaryName>
<NonProprietaryName>Modafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078963</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>MODAFINIL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE], Sympathomimetic-like Agent [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Modafinil, USP is wakefulness-promoting agent for oral administration. Modafinil, USP is a racemic compound. The chemical name for modafinil, USP is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C 15H 15NO 2S and the molecular weight is 273.35. The chemical structure is. Modafinil, USP is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. Modafinil tablets, USP contain 100 mg or 200 mg of modafinil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and talc. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>74177-989-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (74177-989-01) </PackageDescription>
<NDC11Code>74177-0989-01</NDC11Code>
<ProductNDC>74177-989</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Adore Peppermint Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>K7 Design Group Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>69</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin, only when water is not available.</IndicationAndUsage>
</NDC>
</NDCList>