{
"NDC": [
{
"NDCCode": "42291-504-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42291-504-90) ",
"NDC11Code": "42291-0504-90",
"ProductNDC": "42291-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201845",
"LabelerName": "AvKARE",
"SubstanceName": "LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "100; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220831",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium and hydrochlorothiazide is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) .",
"Description": "Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5, Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 and Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2 and its structural formula is:. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets 50/12.5 contains 50 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets 100/12.5 contains 100 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets 100/25 contains 100 mg of losartan potassium, USP and 25 mg of hydrochlorothiazide, USP. Inactive ingredients are microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, titanium dioxide and carnauba wax. Losartan potassium and hydrochlorothiazide 50/12.5 and losartan potassium and Hydrochlorothiazide 100/25 also contain D&C yellow No. 10 aluminum lake. Losartan potassium and hydrochlorothiazide tablets 50/12.5 contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets 100/12.5 contains 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets 100/25 contains 8.48 mg (0.216 mEq) of potassium."
},
{
"NDCCode": "42291-504-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (42291-504-10) ",
"NDC11Code": "42291-0504-10",
"ProductNDC": "42291-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201845",
"LabelerName": "AvKARE",
"SubstanceName": "LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "100; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220831",
"SamplePackage": "N",
"IndicationAndUsage": "Losartan potassium and hydrochlorothiazide is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) .",
"Description": "Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5, Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 and Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2 and its structural formula is:. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets 50/12.5 contains 50 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets 100/12.5 contains 100 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets 100/25 contains 100 mg of losartan potassium, USP and 25 mg of hydrochlorothiazide, USP. Inactive ingredients are microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, titanium dioxide and carnauba wax. Losartan potassium and hydrochlorothiazide 50/12.5 and losartan potassium and Hydrochlorothiazide 100/25 also contain D&C yellow No. 10 aluminum lake. Losartan potassium and hydrochlorothiazide tablets 50/12.5 contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets 100/12.5 contains 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets 100/25 contains 8.48 mg (0.216 mEq) of potassium."
},
{
"NDCCode": "24658-504-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (24658-504-90) ",
"NDC11Code": "24658-0504-90",
"ProductNDC": "24658-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078034",
"LabelerName": "PuraCap Laboratories, LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201218",
"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 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 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-4hydroxy-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, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hypromellose, iron oxides, lactose, magnesium stearate, povidone, microcrystalline cellulose, pregelatinized starch (maize), talc,colloidal silicone dioxide and titanium dioxide. Butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contain red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide."
},
{
"NDCCode": "35356-504-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-504-90)",
"NDC11Code": "35356-0504-90",
"ProductNDC": "35356-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20030117",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021434",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2017-10-10"
},
{
"NDCCode": "43547-504-09",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-504-09) ",
"NDC11Code": "43547-0504-09",
"ProductNDC": "43547-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212681",
"LabelerName": "Solco Healthcare US, LLC.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2022-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220531",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride extended release tablets contain the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP, contain 500 mg or 1,000 mg of metformin hydrochloride, USP, which is equivalent to 389.93 mg or 779.86 mg metformin. Each 500 mg tablet contains ammonium hydroxide, black iron oxide non-irradiated, colloidal silicon dioxide, crospovidone, glyceryl dibehenate, hypromellose, poly (vinyl acetate) dispersion 30 percent, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, povidone, shellac glaze (modieied) in SD-45, talc, titanium dioxide, and triethyl citrate. Each 1,000 mg tablet contains ammonium hydroxide, black iron oxide non-irradiated, colloidal silicon dioxide, crospovidone, glyceryl dibehenate, hypromellose, poly (vinyl acetate) dispersion 30 percent, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, povidone, shellac glaze (modieied) in SD-45, talc, titanium dioxide, and triethyl citrate. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "49999-504-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (49999-504-90)",
"NDC11Code": "49999-0504-90",
"ProductNDC": "49999-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19911230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063181",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-02-27"
},
{
"NDCCode": "55513-504-50",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (55513-504-50) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "55513-0504-50",
"ProductNDC": "55513-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lumakras",
"NonProprietaryName": "Sotorasib",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214665",
"LabelerName": "Amgen Inc",
"SubstanceName": "SOTORASIB",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230202",
"SamplePackage": "N",
"IndicationAndUsage": "LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).",
"Description": "Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only)."
},
{
"NDCCode": "55700-504-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (55700-504-90)",
"NDC11Code": "55700-0504-90",
"ProductNDC": "55700-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040197",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-10-23",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "60429-504-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (60429-504-90)",
"NDC11Code": "60429-0504-90",
"ProductNDC": "60429-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19931019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074174",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-11-03",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "61919-504-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (61919-504-90)",
"NDC11Code": "61919-0504-90",
"ProductNDC": "61919-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyrica",
"NonProprietaryName": "Lyrica",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021446",
"LabelerName": "Direct RX",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for adult patients with partial onset seizures, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients."
},
{
"NDCCode": "62980-504-02",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (62980-504-02) ",
"NDC11Code": "62980-0504-02",
"ProductNDC": "62980-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hyrochloride",
"ProprietaryNameSuffix": "5mg",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL; ORAL; ORAL; ORAL; ORAL; ORAL; ORAL",
"StartMarketingDate": "20150701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090551",
"LabelerName": "Vivimed Labs Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150701",
"SamplePackage": "N"
},
{
"NDCCode": "70934-504-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (70934-504-90) ",
"NDC11Code": "70934-0504-90",
"ProductNDC": "70934-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Allopurinol",
"NonProprietaryName": "Allopurinol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203154",
"LabelerName": "Denton Pharma, Inc. DBA Northwind Pharmaceuticals",
"SubstanceName": "ALLOPURINOL",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200518",
"SamplePackage": "N"
},
{
"NDCCode": "71205-504-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-504-90) ",
"NDC11Code": "71205-0504-90",
"ProductNDC": "71205-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210497",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201113",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) are aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. ( 1).",
"Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg creamy- white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: povidone, cysteine hydrochloride monohydrate, colloidal anhydrous silica, glycerol dibehanate, magnesium stearate, ethyl cellulose, polyethylene glycol, colloidal hydrated silica, triethyl citrate, methacrylic acid - ethyl acrylate copolymer , shellac, iron oxide black and propylene glycol. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test pending."
},
{
"NDCCode": "71610-504-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71610-504-60) ",
"NDC11Code": "71610-0504-60",
"ProductNDC": "71610-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Raloxifene Hydrochloride",
"NonProprietaryName": "Raloxifene Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078193",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "RALOXIFENE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201214",
"SamplePackage": "N",
"IndicationAndUsage": "Raloxifene hydrochloride tablets are an estrogen agonist/antagonist indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women. (1.1), 2 Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. (1.2), 3 Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. (1.3).",
"Description": "Raloxifene hydrochloride, USP is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is. C28H27NO4SHCl M.W. 510.05. The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene HCl, USP is an off-white to pale-yellow solid that is very slightly soluble in water. Raloxifene hydrochloride, USP is supplied in a tablet dosage form for oral administration. Each Raloxifene Hydrochloride Tablet USP contains 60 mg of raloxifene HCl, USP which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, and titanium dioxide. USP Dissolution Test Pending."
},
{
"NDCCode": "72189-504-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (72189-504-90) ",
"NDC11Code": "72189-0504-90",
"ProductNDC": "72189-504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209102",
"LabelerName": "Direct_Rx",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230803",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. [Image]. C 10H 12ClNO 2 M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate."
},
{
"NDCCode": "42291-016-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-016-90) ",
"NDC11Code": "42291-0016-90",
"ProductNDC": "42291-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anastrozole",
"NonProprietaryName": "Anastrozole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079220",
"LabelerName": "AvKARE",
"SubstanceName": "ANASTROZOLE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230206",
"SamplePackage": "N",
"IndicationAndUsage": "Anastrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets ( 1.3) .",
"Description": "Anastrozole Tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5 and its structural formula is:. Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "42291-027-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-027-90) ",
"NDC11Code": "42291-0027-90",
"ProductNDC": "42291-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076846",
"LabelerName": "AvKARE",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230622",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets are 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) .",
"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 structural formula is. C 20H 25ClN 2O 5C 6H 6O 3S M.W. 567.1. Amlodipine besylate, USP is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white to off-white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: calcium phosphate dibasic anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "42291-036-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-036-90) ",
"NDC11Code": "42291-0036-90",
"ProductNDC": "42291-036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "AvKARE",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250604",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "42291-037-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-037-90) ",
"NDC11Code": "42291-0037-90",
"ProductNDC": "42291-037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "AvKARE",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250604",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "42291-038-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-038-90) ",
"NDC11Code": "42291-0038-90",
"ProductNDC": "42291-038",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "AvKARE",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250604",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "42291-039-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-039-90) ",
"NDC11Code": "42291-0039-90",
"ProductNDC": "42291-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "AvKARE",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250604",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "42291-040-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-040-90) ",
"NDC11Code": "42291-0040-90",
"ProductNDC": "42291-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "AvKARE",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250604",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "42291-041-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-041-90) ",
"NDC11Code": "42291-0041-90",
"ProductNDC": "42291-041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisdexamfetamine Dimesylate",
"NonProprietaryName": "Lisdexamfetamine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202830",
"LabelerName": "AvKARE",
"SubstanceName": "LISDEXAMFETAMINE DIMESYLATE",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250604",
"SamplePackage": "N",
"IndicationAndUsage": "Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .",
"Description": "Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "42291-045-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42291-045-90) ",
"NDC11Code": "42291-0045-90",
"ProductNDC": "42291-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204598",
"LabelerName": "AvKARE",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "145",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Fenofibrate tablets are peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1). For treatment of adult patients with severe hypertriglyceridemia ( 1.2). Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ( 5.1).",
"Description": "Fenofibrate tablets, USP are lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula. The empirical formula is C20H21ClO4 and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&C Yellow # 10 aluminum lake, FD&C Blue # 2 / indigo caramine aluminum lake, FD&C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum."
},
{
"NDCCode": "42291-085-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42291-085-90) ",
"NDC11Code": "42291-0085-90",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anastrozole",
"NonProprietaryName": "Anastrozole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078058",
"LabelerName": "AvKARE",
"SubstanceName": "ANASTROZOLE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-15",
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"IndicationAndUsage": "Anastrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets. ( 1.3) .",
"Description": "Anastrozole Tablets USP for oral administration contain 1 mg of anastrozole, USP, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, α, α, α', α'-tetramethyl-5-(1 H-1,2,4-triazol-1-ylmethyl). Its structural formula is:. C 17H 19N 5 M.W. 293.37. Anastrozole, USP is a white to off-white crystalline powder. Anastrozole, USP has moderate aqueous solubility (0.5 mg/mL at 25°C), is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, macrogol/PEG 400, macrogol/PEG 6000, magnesium stearate, povidone, sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "42291-101-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-101-90) ",
"NDC11Code": "42291-0101-90",
"ProductNDC": "42291-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acebutolol Hydrochloride",
"NonProprietaryName": "Acebutolol Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075047",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ACEBUTOLOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20091214",
"SamplePackage": "N"
},
{
"NDCCode": "42291-102-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (42291-102-90) ",
"NDC11Code": "42291-0102-90",
"ProductNDC": "42291-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acebutolol Hydrochloride",
"NonProprietaryName": "Acebutolol Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20091214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075047",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ACEBUTOLOL HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20091214",
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},
{
"NDCCode": "42291-103-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-103-90)",
"NDC11Code": "42291-0103-90",
"ProductNDC": "42291-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetazolamide",
"NonProprietaryName": "Acetazolamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084840",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ACETAZOLAMIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "42291-108-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-108-90) ",
"NDC11Code": "42291-0108-90",
"ProductNDC": "42291-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075382",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "42291-109-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-109-90) ",
"NDC11Code": "42291-0109-90",
"ProductNDC": "42291-109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075382",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-03-07",
"PackageNdcExcludeFlag": "N",
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<ProductNDC>42291-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Losartan Potassium And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201845</ApplicationNumber>
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<SubstanceName>LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE</SubstanceName>
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<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
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<IndicationAndUsage>Losartan potassium and hydrochlorothiazide is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) .</IndicationAndUsage>
<Description>Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5, Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 and Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2 and its structural formula is:. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets 50/12.5 contains 50 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets 100/12.5 contains 100 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets 100/25 contains 100 mg of losartan potassium, USP and 25 mg of hydrochlorothiazide, USP. Inactive ingredients are microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, titanium dioxide and carnauba wax. Losartan potassium and hydrochlorothiazide 50/12.5 and losartan potassium and Hydrochlorothiazide 100/25 also contain D&C yellow No. 10 aluminum lake. Losartan potassium and hydrochlorothiazide tablets 50/12.5 contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets 100/12.5 contains 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets 100/25 contains 8.48 mg (0.216 mEq) of potassium.</Description>
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<NDC>
<NDCCode>42291-504-10</NDCCode>
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<SubstanceName>LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE</SubstanceName>
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<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Losartan potassium and hydrochlorothiazide is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2) .</IndicationAndUsage>
<Description>Losartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5, Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 and Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p-( o-1 Htetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7H 8ClN 3O 4S 2 and its structural formula is:. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Losartan potassium and hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets 50/12.5 contains 50 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets 100/12.5 contains 100 mg of losartan potassium, USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets 100/25 contains 100 mg of losartan potassium, USP and 25 mg of hydrochlorothiazide, USP. Inactive ingredients are microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose, titanium dioxide and carnauba wax. Losartan potassium and hydrochlorothiazide 50/12.5 and losartan potassium and Hydrochlorothiazide 100/25 also contain D&C yellow No. 10 aluminum lake. Losartan potassium and hydrochlorothiazide tablets 50/12.5 contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets 100/12.5 contains 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets 100/25 contains 8.48 mg (0.216 mEq) of potassium.</Description>
</NDC>
<NDC>
<NDCCode>24658-504-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (24658-504-90) </PackageDescription>
<NDC11Code>24658-0504-90</NDC11Code>
<ProductNDC>24658-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078034</ApplicationNumber>
<LabelerName>PuraCap Laboratories, LLC</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<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 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 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-4hydroxy-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, USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hypromellose, iron oxides, lactose, magnesium stearate, povidone, microcrystalline cellulose, pregelatinized starch (maize), talc,colloidal silicone dioxide and titanium dioxide. Butylated hydroxyanisole is added as a preservative. Simvastatin 10mg, 20mg, and 40 mg contain red and yellow ferric oxide. Simvastatin 80 mg contains red ferric oxide.</Description>
</NDC>
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<NDCCode>35356-504-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-504-90)</PackageDescription>
<NDC11Code>35356-0504-90</NDC11Code>
<ProductNDC>35356-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030117</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021434</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-10-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>43547-504-09</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-504-09) </PackageDescription>
<NDC11Code>43547-0504-09</NDC11Code>
<ProductNDC>43547-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220531</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212681</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride extended release tablets contain the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP, contain 500 mg or 1,000 mg of metformin hydrochloride, USP, which is equivalent to 389.93 mg or 779.86 mg metformin. Each 500 mg tablet contains ammonium hydroxide, black iron oxide non-irradiated, colloidal silicon dioxide, crospovidone, glyceryl dibehenate, hypromellose, poly (vinyl acetate) dispersion 30 percent, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, povidone, shellac glaze (modieied) in SD-45, talc, titanium dioxide, and triethyl citrate. Each 1,000 mg tablet contains ammonium hydroxide, black iron oxide non-irradiated, colloidal silicon dioxide, crospovidone, glyceryl dibehenate, hypromellose, poly (vinyl acetate) dispersion 30 percent, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, povidone, shellac glaze (modieied) in SD-45, talc, titanium dioxide, and triethyl citrate. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>49999-504-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (49999-504-90)</PackageDescription>
<NDC11Code>49999-0504-90</NDC11Code>
<ProductNDC>49999-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19911230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA063181</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>55513-504-50</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (55513-504-50) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55513-0504-50</NDC11Code>
<ProductNDC>55513-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lumakras</ProprietaryName>
<NonProprietaryName>Sotorasib</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214665</ApplicationNumber>
<LabelerName>Amgen Inc</LabelerName>
<SubstanceName>SOTORASIB</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUMAKRAS is an inhibitor of the RAS GTPase family indicated for. KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): 1 As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. (1.1).</IndicationAndUsage>
<Description>Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the molecular weight is 560.6 g/mol. The chemical name of sotorasib is 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one. The chemical structure of sotorasib is shown below. Sotorasib has pKa values of 8.06 and 4.56. The solubility of sotorasib in the aqueous media decreases over the range pH 1.2 to 6.8 from 1.3 mg/mL to 0.03 mg/mL. LUMAKRAS is supplied as film-coated tablets for oral use containing 320 mg, 240 mg or 120 mg of sotorasib. Inactive ingredients in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating material consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>55700-504-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (55700-504-90)</PackageDescription>
<NDC11Code>55700-0504-90</NDC11Code>
<ProductNDC>55700-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040197</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-23</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>60429-504-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (60429-504-90)</PackageDescription>
<NDC11Code>60429-0504-90</NDC11Code>
<ProductNDC>60429-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074174</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-11-03</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>61919-504-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (61919-504-90)</PackageDescription>
<NDC11Code>61919-0504-90</NDC11Code>
<ProductNDC>61919-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyrica</ProprietaryName>
<NonProprietaryName>Lyrica</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021446</ApplicationNumber>
<LabelerName>Direct RX</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for adult patients with partial onset seizures, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>62980-504-02</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (62980-504-02) </PackageDescription>
<NDC11Code>62980-0504-02</NDC11Code>
<ProductNDC>62980-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hyrochloride</ProprietaryName>
<ProprietaryNameSuffix>5mg</ProprietaryNameSuffix>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL; ORAL; ORAL; ORAL; ORAL; ORAL; ORAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090551</ApplicationNumber>
<LabelerName>Vivimed Labs Limited</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70934-504-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (70934-504-90) </PackageDescription>
<NDC11Code>70934-0504-90</NDC11Code>
<ProductNDC>70934-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Allopurinol</ProprietaryName>
<NonProprietaryName>Allopurinol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203154</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
<SubstanceName>ALLOPURINOL</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71205-504-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-504-90) </PackageDescription>
<NDC11Code>71205-0504-90</NDC11Code>
<ProductNDC>71205-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210497</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) are aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. ( 1).</IndicationAndUsage>
<Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg creamy- white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: povidone, cysteine hydrochloride monohydrate, colloidal anhydrous silica, glycerol dibehanate, magnesium stearate, ethyl cellulose, polyethylene glycol, colloidal hydrated silica, triethyl citrate, methacrylic acid - ethyl acrylate copolymer , shellac, iron oxide black and propylene glycol. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>71610-504-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71610-504-60) </PackageDescription>
<NDC11Code>71610-0504-60</NDC11Code>
<ProductNDC>71610-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Raloxifene Hydrochloride</ProprietaryName>
<NonProprietaryName>Raloxifene Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078193</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>RALOXIFENE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Raloxifene hydrochloride tablets are an estrogen agonist/antagonist indicated for: 1 Treatment and prevention of osteoporosis in postmenopausal women. (1.1), 2 Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. (1.2), 3 Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. (1.3).</IndicationAndUsage>
<Description>Raloxifene hydrochloride, USP is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is. C28H27NO4SHCl M.W. 510.05. The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene HCl, USP is an off-white to pale-yellow solid that is very slightly soluble in water. Raloxifene hydrochloride, USP is supplied in a tablet dosage form for oral administration. Each Raloxifene Hydrochloride Tablet USP contains 60 mg of raloxifene HCl, USP which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, and titanium dioxide. USP Dissolution Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>72189-504-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (72189-504-90) </PackageDescription>
<NDC11Code>72189-0504-90</NDC11Code>
<ProductNDC>72189-504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209102</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. [Image]. C 10H 12ClNO 2 M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>42291-016-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-016-90) </PackageDescription>
<NDC11Code>42291-0016-90</NDC11Code>
<ProductNDC>42291-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anastrozole</ProprietaryName>
<NonProprietaryName>Anastrozole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079220</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ANASTROZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anastrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets ( 1.3) .</IndicationAndUsage>
<Description>Anastrozole Tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5 and its structural formula is:. Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42291-027-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-027-90) </PackageDescription>
<NDC11Code>42291-0027-90</NDC11Code>
<ProductNDC>42291-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076846</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets are 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) .</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 structural formula is. C 20H 25ClN 2O 5C 6H 6O 3S M.W. 567.1. Amlodipine besylate, USP is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as white to off-white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: calcium phosphate dibasic anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42291-036-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-036-90) </PackageDescription>
<NDC11Code>42291-0036-90</NDC11Code>
<ProductNDC>42291-036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42291-037-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-037-90) </PackageDescription>
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<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
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<StartMarketingDatePackage>20250604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42291-038-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-038-90) </PackageDescription>
<NDC11Code>42291-0038-90</NDC11Code>
<ProductNDC>42291-038</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
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<LabelerName>AvKARE</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42291-039-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-039-90) </PackageDescription>
<NDC11Code>42291-0039-90</NDC11Code>
<ProductNDC>42291-039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42291-040-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-040-90) </PackageDescription>
<NDC11Code>42291-0040-90</NDC11Code>
<ProductNDC>42291-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42291-041-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-041-90) </PackageDescription>
<NDC11Code>42291-0041-90</NDC11Code>
<ProductNDC>42291-041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
<NonProprietaryName>Lisdexamfetamine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202830</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] , 2 Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)] . .</IndicationAndUsage>
<Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1 S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15H 25N 3O(CH 4O 3S) 2, which corresponds to a molecular weight of 455.60. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg of lisdexamfetamine dimesylate (equivalent to 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: crospovidone, isopropyl alcohol, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and one or more of the following: D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow. The imprint on the capsule shells contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42291-045-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42291-045-90) </PackageDescription>
<NDC11Code>42291-0045-90</NDC11Code>
<ProductNDC>42291-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204598</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate tablets are peroxisome proliferator receptor alpha (PPARα) activator indicated as an adjunct to diet: To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1). For treatment of adult patients with severe hypertriglyceridemia ( 1.2). Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ( 5.1).</IndicationAndUsage>
<Description>Fenofibrate tablets, USP are lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula. The empirical formula is C20H21ClO4 and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&C Yellow # 10 aluminum lake, FD&C Blue # 2 / indigo caramine aluminum lake, FD&C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum.</Description>
</NDC>
<NDC>
<NDCCode>42291-085-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42291-085-90) </PackageDescription>
<NDC11Code>42291-0085-90</NDC11Code>
<ProductNDC>42291-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anastrozole</ProprietaryName>
<NonProprietaryName>Anastrozole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078058</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>ANASTROZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anastrozole tablets are an aromatase inhibitor indicated for: 1 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) , 2 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) , 3 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets. ( 1.3) .</IndicationAndUsage>
<Description>Anastrozole Tablets USP for oral administration contain 1 mg of anastrozole, USP, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, α, α, α', α'-tetramethyl-5-(1 H-1,2,4-triazol-1-ylmethyl). Its structural formula is:. C 17H 19N 5 M.W. 293.37. Anastrozole, USP is a white to off-white crystalline powder. Anastrozole, USP has moderate aqueous solubility (0.5 mg/mL at 25°C), is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: hypromellose, lactose monohydrate, macrogol/PEG 400, macrogol/PEG 6000, magnesium stearate, povidone, sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42291-101-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-101-90) </PackageDescription>
<NDC11Code>42291-0101-90</NDC11Code>
<ProductNDC>42291-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acebutolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Acebutolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075047</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ACEBUTOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-102-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (42291-102-90) </PackageDescription>
<NDC11Code>42291-0102-90</NDC11Code>
<ProductNDC>42291-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acebutolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Acebutolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075047</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ACEBUTOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-103-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-103-90)</PackageDescription>
<NDC11Code>42291-0103-90</NDC11Code>
<ProductNDC>42291-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetazolamide</ProprietaryName>
<NonProprietaryName>Acetazolamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084840</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ACETAZOLAMIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>42291-108-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-108-90) </PackageDescription>
<NDC11Code>42291-0108-90</NDC11Code>
<ProductNDC>42291-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075382</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>42291-109-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-109-90) </PackageDescription>
<NDC11Code>42291-0109-90</NDC11Code>
<ProductNDC>42291-109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075382</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>