{
"NDC": [
{
"NDCCode": "42385-915-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-915-90) ",
"NDC11Code": "42385-0915-90",
"ProductNDC": "42385-915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213541",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "600; 200; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211222",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.",
"Description": "Efavirenz, emtricitabine and tenofovir disoproxil fumarate is a fixed-dose combination tablet containing EFV, FTC, and TDF. EFV is a non-nucleoside reverse transcriptase inhibitor (NNRTI). FTC is a synthetic nucleoside analog of cytidine. TDF, which is converted in vivo to tenofovir, is an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each film coated tablet contains efavirenz, USP 600 mg; emtricitabine, USP 200 mg and tenofovir disoproxil fumarate 300 mg equivalent to 245 mg of tenofovir disoproxil as active ingredients. The tablets include the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablets are film coated with a coating material containing black iron oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide. Efavirenz: EFV is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz, USP is a white to off white powder with a molecular mass of 315.67. It is practically insoluble in water (less than 10 mcg/mL). Emtricitabine: The chemical name of FTC is 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl] cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula:Emtricitabine, USP is a white to almost white crystalline powder. It is freely soluble in water. Tenofovir DF: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is 9-[(R)-2[[bis[[(isopropoxycarbonyl)oxy]-methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P●C4H4O4 and a molecular weight of 635.52. It has the following structural formula:TDF is a white to off white powder. It is slightly soluble in water at 25°C."
},
{
"NDCCode": "42385-915-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42385-915-30) ",
"NDC11Code": "42385-0915-30",
"ProductNDC": "42385-915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213541",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "600; 200; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211222",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.",
"Description": "Efavirenz, emtricitabine and tenofovir disoproxil fumarate is a fixed-dose combination tablet containing EFV, FTC, and TDF. EFV is a non-nucleoside reverse transcriptase inhibitor (NNRTI). FTC is a synthetic nucleoside analog of cytidine. TDF, which is converted in vivo to tenofovir, is an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each film coated tablet contains efavirenz, USP 600 mg; emtricitabine, USP 200 mg and tenofovir disoproxil fumarate 300 mg equivalent to 245 mg of tenofovir disoproxil as active ingredients. The tablets include the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablets are film coated with a coating material containing black iron oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide. Efavirenz: EFV is chemically described as (S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz, USP is a white to off white powder with a molecular mass of 315.67. It is practically insoluble in water (less than 10 mcg/mL). Emtricitabine: The chemical name of FTC is 5-Fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl] cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula:Emtricitabine, USP is a white to almost white crystalline powder. It is freely soluble in water. Tenofovir DF: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is 9-[(R)-2[[bis[[(isopropoxycarbonyl)oxy]-methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P●C4H4O4 and a molecular weight of 635.52. It has the following structural formula:TDF is a white to off white powder. It is slightly soluble in water at 25°C."
},
{
"NDCCode": "12854-915-90",
"PackageDescription": "33000 g in 1 DRUM (12854-915-90) ",
"NDC11Code": "12854-0915-90",
"ProductNDC": "12854-915",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "19971224",
"EndMarketingDate": "20241128",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "sanofi-aventis Deutschland GmbH",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "24-DEC-97",
"EndMarketingDatePackage": "28-NOV-24"
},
{
"NDCCode": "35356-915-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (35356-915-90)",
"NDC11Code": "35356-0915-90",
"ProductNDC": "35356-915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078414",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-04-11",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "40032-915-09",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (40032-915-09) ",
"NDC11Code": "40032-0915-09",
"ProductNDC": "40032-915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206347",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160121",
"SamplePackage": "N",
"IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.",
"Description": "Potassium chloride extended-release tablet USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. Potassium chloride extended-release tablet USP 10 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white crystalline powder. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is. freely soluble in water and insoluble in alcohol. Potassium chloride extended-release tablet USP is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride extended-release tablet USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, ethylcellulose, triethyl citrate, ethyl alcohol and isopropyl alcohol. USP Assay Test Pending."
},
{
"NDCCode": "43386-915-09",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-915-09) ",
"NDC11Code": "43386-0915-09",
"ProductNDC": "43386-915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206347",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160121",
"SamplePackage": "N",
"IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with, 2 hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a, 3 lower dose of diuretic, which may be sufficient without leading to hypokalemia., 4 2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized, 5 patients or patients with significant cardiac arrhythmias.",
"Description": "Potassium chloride extended-release tablet USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. Potassium chloride extended-release tablet USP 10 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white crystalline powder. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is. freely soluble in water and insoluble in alcohol. Potassium chloride extended-release tablet USP is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride extended-release tablet USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, ethylcellulose, triethyl citrate, ethyl alcohol and isopropyl alcohol. USP Assay Test Pending."
},
{
"NDCCode": "45802-915-01",
"PackageDescription": "1 TUBE in 1 CARTON (45802-915-01) > 90 g in 1 TUBE",
"NDC11Code": "45802-0915-01",
"ProductNDC": "45802-915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perrigo Benzoyl Peroxide",
"ProprietaryNameSuffix": "Aqueous Base",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081204",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Perrigo New York Inc",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "10",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "59726-915-90",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (59726-915-90) / 90 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "59726-0915-90",
"ProductNDC": "59726-915",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "All Day Allergy Relief",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191030",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075209",
"LabelerName": "P & L Development, LLC",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191030",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes , 4 itching of the nose or throat."
},
{
"NDCCode": "62207-915-57",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62207-915-57) ",
"NDC11Code": "62207-0915-57",
"ProductNDC": "62207-915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214686",
"LabelerName": "Granules India Ltd",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230101",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release capsules are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP, occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive ingredients: ethylcellulose, hydroxypropyl cellulose.The empty gelatin capsules contain gelatin and titanium dioxide; the 10 mEq capsules contain FD&C Blue #1, FD&C Red #3 and FD&C Yellow #6. In addition, for 8mEq capsule imprinting ink black contains shellac, propylene glycol, black iron oxide, potassium hydroxide and for 10mEq white ink contains shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "63187-915-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (63187-915-90) ",
"NDC11Code": "63187-0915-90",
"ProductNDC": "63187-915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091604",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170901",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).",
"Description": "Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white to almost white crystalline powder soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105° to 112°C. Ramipril’s chemical name is (2S,3aS,6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1-ethyl ester.The inactive ingredients present are pregelatinized starch and silica hydrophobic, colloidal anhydrous. The empty hard gelatin capsule shells contain gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, the 1.25 mg capsule shell contains iron oxide yellow, 2.5 mg capsule shell contains D&C yellow 10 and FD&C red 40, the 5 mg capsule shell contains FD&C blue 1 and FD&C red 40, and the 10 mg capsule shell contains FD&C blue 1. The capsules are printed with edible ink containing black iron oxide and shellac.The structural formula for ramipril is. Its molecular formula is C23H32N2O5 and its molecular weight is 416.5.Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "68382-915-16",
"PackageDescription": "90 TABLET in 1 BOTTLE (68382-915-16) ",
"NDC11Code": "68382-0915-16",
"ProductNDC": "68382-915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erlotinib",
"NonProprietaryName": "Erlotinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213065",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "ERLOTINIB HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200430",
"SamplePackage": "N",
"IndicationAndUsage": "Erlotinib tablets are a kinase inhibitor indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1), 2 First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2).",
"Description": "Erlotinib tablet, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy) -4-quinazolinamine hydrochloride. Erlotinib tablet contains erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride has the molecular formula C22H23N3O4HCl and a molecular weight of 429.90. The molecule has a pKa of 5.35 at 25°C. Erlotinib hydrochloride is off white to pale yellow powder. It is slightly soluble in methanol and practically insoluble in acetonitrile and acetone. Aqueous solubility of erlotinib hydrochloride at 25˚C is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.2 to 9.5, maximal solubility of approximately 0.15 mg/mL occurs at a pH of approximately 2. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "71205-915-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (71205-915-90) ",
"NDC11Code": "71205-0915-90",
"ProductNDC": "71205-915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071457",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2022-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210714",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C16H13ClN2O2 MW = 300.74 Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 15 mg and 30 mg are for oral administration.15 mg and 30 mg CapsulesActive Ingredient: temazepam USP. 15 mg Capsules. Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide."
},
{
"NDCCode": "71610-915-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71610-915-60) ",
"NDC11Code": "71610-0915-60",
"ProductNDC": "71610-915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077214",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250623",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem Tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies ( 14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.",
"Description": "Zolpidem Tartrate Tablets, USP contains Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem Tartrate Tablets, USP is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, Zolpidem is N, N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem Tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Zolpidem Tartrate Tablet, USP includes the following inactive ingredients: lactose anhydrous, sodium starch glycolate, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate. The 10 mg tablets also contain Opadry II (white) and the 5 mg tablets contain Opadry II (pink). Opadry II (white) contains hypromellose, polyeth ylene glycol, polydextrose, titanium dioxide, and triacetin. Opadry II (pink) contains hypromellose, FD&C Red no. 40 aluminum lake, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, polyeth ylene glycol, polydextrose, titanium dioxide, and triacetin. Meets USP Dissolution Test 3."
},
{
"NDCCode": "76420-915-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (76420-915-90) ",
"NDC11Code": "76420-0915-90",
"ProductNDC": "76420-915",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron Hydrochloride",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078539",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250128",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.",
"Description": "The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C 18H 19N 3OHCl2H 2O, representing a molecular weight of 365.9 g/mol. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6."
},
{
"NDCCode": "42385-903-09",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-903-09) ",
"NDC11Code": "42385-0903-09",
"ProductNDC": "42385-903",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209882",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190115",
"SamplePackage": "N"
},
{
"NDCCode": "42385-904-09",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-904-09) ",
"NDC11Code": "42385-0904-09",
"ProductNDC": "42385-904",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209882",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190115",
"SamplePackage": "N"
},
{
"NDCCode": "42385-913-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-913-90) ",
"NDC11Code": "42385-0913-90",
"ProductNDC": "42385-913",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190726",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212114",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "200; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190726",
"SamplePackage": "N"
},
{
"NDCCode": "42385-924-99",
"PackageDescription": "3 BOTTLE in 1 CARTON (42385-924-99) / 90 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "42385-0924-99",
"ProductNDC": "42385-924",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pirfenidone",
"NonProprietaryName": "Pirfenidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212722",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "PIRFENIDONE",
"StrengthNumber": "267",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
"Status": "Active",
"LastUpdate": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220719",
"SamplePackage": "N",
"IndicationAndUsage": "Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
"Description": "Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as a white opaque hard gelatin capsules containing 267 mg of pirfenidone USP for oral administration and as film-coated tablets containing 267 mg (yellow), 534 mg (orange) and 801 mg (brown) pirfenidone USP. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-Methyl-1-Phenyl-1H-pyridin-2-one or 5-Methyl-1-phenylpyridin-2(1H)-one. Pirfenidone USP is a white to pale yellow or pink color solid, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. Pirfenidone capsules, USP contain pirfenidone USP and the following inactive ingredients: croscarmellose sodium, isomalt, and magnesium stearate. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes black iron oxide, brown iron oxide, propylene glycol, and shellac. Pirfenidone tablets, USP contain pirfenidone USP and the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally 267 mg tablets contain iron oxide yellow. 534 mg tablets contain FD&C yellow #6. 801 mg tablets contain black iron oxide and iron oxide red."
},
{
"NDCCode": "42385-925-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-925-90) ",
"NDC11Code": "42385-0925-90",
"ProductNDC": "42385-925",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pirfenidone",
"NonProprietaryName": "Pirfenidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212722",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "PIRFENIDONE",
"StrengthNumber": "534",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
"Status": "Active",
"LastUpdate": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220719",
"SamplePackage": "N",
"IndicationAndUsage": "Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
"Description": "Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as a white opaque hard gelatin capsules containing 267 mg of pirfenidone USP for oral administration and as film-coated tablets containing 267 mg (yellow), 534 mg (orange) and 801 mg (brown) pirfenidone USP. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-Methyl-1-Phenyl-1H-pyridin-2-one or 5-Methyl-1-phenylpyridin-2(1H)-one. Pirfenidone USP is a white to pale yellow or pink color solid, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. Pirfenidone capsules, USP contain pirfenidone USP and the following inactive ingredients: croscarmellose sodium, isomalt, and magnesium stearate. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes black iron oxide, brown iron oxide, propylene glycol, and shellac. Pirfenidone tablets, USP contain pirfenidone USP and the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally 267 mg tablets contain iron oxide yellow. 534 mg tablets contain FD&C yellow #6. 801 mg tablets contain black iron oxide and iron oxide red."
},
{
"NDCCode": "42385-926-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-926-90) ",
"NDC11Code": "42385-0926-90",
"ProductNDC": "42385-926",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pirfenidone",
"NonProprietaryName": "Pirfenidone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212722",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "PIRFENIDONE",
"StrengthNumber": "801",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
"Status": "Active",
"LastUpdate": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220719",
"SamplePackage": "N",
"IndicationAndUsage": "Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
"Description": "Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as a white opaque hard gelatin capsules containing 267 mg of pirfenidone USP for oral administration and as film-coated tablets containing 267 mg (yellow), 534 mg (orange) and 801 mg (brown) pirfenidone USP. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-Methyl-1-Phenyl-1H-pyridin-2-one or 5-Methyl-1-phenylpyridin-2(1H)-one. Pirfenidone USP is a white to pale yellow or pink color solid, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. Pirfenidone capsules, USP contain pirfenidone USP and the following inactive ingredients: croscarmellose sodium, isomalt, and magnesium stearate. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes black iron oxide, brown iron oxide, propylene glycol, and shellac. Pirfenidone tablets, USP contain pirfenidone USP and the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally 267 mg tablets contain iron oxide yellow. 534 mg tablets contain FD&C yellow #6. 801 mg tablets contain black iron oxide and iron oxide red."
},
{
"NDCCode": "42385-928-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-928-90) ",
"NDC11Code": "42385-0928-90",
"ProductNDC": "42385-928",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212786",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "600; 300; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2023-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.",
"Description": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets contain efavirenz (EFV), an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI), lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir), a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are for oral administration. Each film coated tablet contains efavirenz USP 600 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz: The chemical name of efavirenz is (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL).Lamivudine: The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water.Tenofovir Disoproxil Fumarate: The chemical name of tenofovir DF is 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula: Tenofovir DF is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75."
},
{
"NDCCode": "42385-929-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-929-90) ",
"NDC11Code": "42385-0929-90",
"ProductNDC": "42385-929",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213038",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "400; 300; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2024-05-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.",
"Description": "Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75."
},
{
"NDCCode": "42385-929-91",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-929-91) ",
"NDC11Code": "42385-0929-91",
"ProductNDC": "42385-929",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213038",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "400; 300; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2024-05-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.",
"Description": "Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75."
},
{
"NDCCode": "42385-935-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-935-90) ",
"NDC11Code": "42385-0935-90",
"ProductNDC": "42385-935",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210606",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "54",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200113",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 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). , 2 For treatment of adult patients with severe hypertriglyceridemia ( 1.2). .",
"Description": "Fenofibrate tablet, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82 ᵒC. Fenofibrate, USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Each 54 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB yellow powder. The opadry AMB yellow powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide, D&C yellow #10 aluminum lake, FD & C blue #2/indigo carmine aluminum lake, FD & C yellow #6/sunset yellow FCF aluminum lake and xanthan gum. Each 160 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB white powder. The Opadry AMB white powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. Fenofibrate tablets, USP meets USP Dissolution Test 3."
},
{
"NDCCode": "42385-936-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-936-90) ",
"NDC11Code": "42385-0936-90",
"ProductNDC": "42385-936",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210606",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200113",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 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). , 2 For treatment of adult patients with severe hypertriglyceridemia ( 1.2). .",
"Description": "Fenofibrate tablet, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82 ᵒC. Fenofibrate, USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Each 54 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB yellow powder. The opadry AMB yellow powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide, D&C yellow #10 aluminum lake, FD & C blue #2/indigo carmine aluminum lake, FD & C yellow #6/sunset yellow FCF aluminum lake and xanthan gum. Each 160 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB white powder. The Opadry AMB white powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. Fenofibrate tablets, USP meets USP Dissolution Test 3."
},
{
"NDCCode": "42385-940-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-940-90) ",
"NDC11Code": "42385-0940-90",
"ProductNDC": "42385-940",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214513",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240123",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3."
},
{
"NDCCode": "42385-941-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-941-90) ",
"NDC11Code": "42385-0941-90",
"ProductNDC": "42385-941",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214513",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240123",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3."
},
{
"NDCCode": "42385-942-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-942-90) ",
"NDC11Code": "42385-0942-90",
"ProductNDC": "42385-942",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214513",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240123",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3."
},
{
"NDCCode": "42385-943-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (42385-943-90) ",
"NDC11Code": "42385-0943-90",
"ProductNDC": "42385-943",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214513",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240123",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated. To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3."
},
{
"NDCCode": "42385-944-90",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-944-90) ",
"NDC11Code": "42385-0944-90",
"ProductNDC": "42385-944",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibric Acid Delayed-release",
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"LabelerName": "Laurus Labs Limited",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-01",
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"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Fenofibric acid delayed-release capsules are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to: 1 Reduce TG in patients with severe hypertriglyceridemia ( 1.1). , 2 Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.2). .",
"Description": "Fenofibric acid delayed-release capsules are lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula. The molecular formula is C 22H 28ClNO 5 and the molecular weight is 421.9. Choline fenofibrate is very soluble in water and freely soluble in methanol. The melting point is approximately 210°C. Choline fenofibrate is a white to off-white crystalline powder. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2208, methacrylic acid and ethyl acrylate copolymer dispersion (sodium lauryl sulfate, polysorbate 80 and methacrylic acid and ethyl acrylate copolymer), povidone, sodium stearyl fumarate, talc and triethyl citrate. Capsule shell contains: gelatin, iron oxide black, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. Additionally, 45 mg contains: iron oxide red. 135 mg contains: FD & C blue 1, FD & C red 3, FD & C red 40. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
}
]
}
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<PackageDescription>33000 g in 1 DRUM (12854-915-90) </PackageDescription>
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<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
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<LabelerName>sanofi-aventis Deutschland GmbH</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078414</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-11</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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<NDC>
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<ProductNDC>40032-915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20160121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206347</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
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<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
<Description>Potassium chloride extended-release tablet USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. Potassium chloride extended-release tablet USP 10 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white crystalline powder. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is. freely soluble in water and insoluble in alcohol. Potassium chloride extended-release tablet USP is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride extended-release tablet USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, ethylcellulose, triethyl citrate, ethyl alcohol and isopropyl alcohol. USP Assay Test Pending.</Description>
</NDC>
<NDC>
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<ApplicationNumber>ANDA206347</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with, 2 hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a, 3 lower dose of diuretic, which may be sufficient without leading to hypokalemia., 4 2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized, 5 patients or patients with significant cardiac arrhythmias.</IndicationAndUsage>
<Description>Potassium chloride extended-release tablet USP 20 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. Potassium chloride extended-release tablet USP 10 mEq K is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white crystalline powder. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is. freely soluble in water and insoluble in alcohol. Potassium chloride extended-release tablet USP is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride extended-release tablet USP begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: microcrystalline cellulose, croscarmellose sodium, ethylcellulose, triethyl citrate, ethyl alcohol and isopropyl alcohol. USP Assay Test Pending.</Description>
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<ProprietaryName>Perrigo Benzoyl Peroxide</ProprietaryName>
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<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
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<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
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<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>All Day Allergy Relief</ProprietaryName>
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<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes , 4 itching of the nose or throat.</IndicationAndUsage>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214686</ApplicationNumber>
<LabelerName>Granules India Ltd</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium chloride extended-release capsules are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP, occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive ingredients: ethylcellulose, hydroxypropyl cellulose.The empty gelatin capsules contain gelatin and titanium dioxide; the 10 mEq capsules contain FD&C Blue #1, FD&C Red #3 and FD&C Yellow #6. In addition, for 8mEq capsule imprinting ink black contains shellac, propylene glycol, black iron oxide, potassium hydroxide and for 10mEq white ink contains shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>63187-915-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (63187-915-90) </PackageDescription>
<NDC11Code>63187-0915-90</NDC11Code>
<ProductNDC>63187-915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091604</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).</IndicationAndUsage>
<Description>Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white to almost white crystalline powder soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105° to 112°C. Ramipril’s chemical name is (2S,3aS,6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1-ethyl ester.The inactive ingredients present are pregelatinized starch and silica hydrophobic, colloidal anhydrous. The empty hard gelatin capsule shells contain gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, the 1.25 mg capsule shell contains iron oxide yellow, 2.5 mg capsule shell contains D&C yellow 10 and FD&C red 40, the 5 mg capsule shell contains FD&C blue 1 and FD&C red 40, and the 10 mg capsule shell contains FD&C blue 1. The capsules are printed with edible ink containing black iron oxide and shellac.The structural formula for ramipril is. Its molecular formula is C23H32N2O5 and its molecular weight is 416.5.Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
</NDC>
<NDC>
<NDCCode>68382-915-16</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68382-915-16) </PackageDescription>
<NDC11Code>68382-0915-16</NDC11Code>
<ProductNDC>68382-915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erlotinib</ProprietaryName>
<NonProprietaryName>Erlotinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213065</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>ERLOTINIB HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Erlotinib tablets are a kinase inhibitor indicated for: 1 The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1), 2 First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2).</IndicationAndUsage>
<Description>Erlotinib tablet, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy) -4-quinazolinamine hydrochloride. Erlotinib tablet contains erlotinib as the hydrochloride salt that has the following structural formula. Erlotinib hydrochloride has the molecular formula C22H23N3O4HCl and a molecular weight of 429.90. The molecule has a pKa of 5.35 at 25°C. Erlotinib hydrochloride is off white to pale yellow powder. It is slightly soluble in methanol and practically insoluble in acetonitrile and acetone. Aqueous solubility of erlotinib hydrochloride at 25˚C is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.2 to 9.5, maximal solubility of approximately 0.15 mg/mL occurs at a pH of approximately 2. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71205-915-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (71205-915-90) </PackageDescription>
<NDC11Code>71205-0915-90</NDC11Code>
<ProductNDC>71205-915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temazepam</ProprietaryName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071457</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2022-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C16H13ClN2O2 MW = 300.74 Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 15 mg and 30 mg are for oral administration.15 mg and 30 mg CapsulesActive Ingredient: temazepam USP. 15 mg Capsules. Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-915-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71610-915-60) </PackageDescription>
<NDC11Code>71610-0915-60</NDC11Code>
<ProductNDC>71610-915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077214</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem Tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies ( 14)]. The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Zolpidem Tartrate Tablets, USP contains Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem Tartrate Tablets, USP is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, Zolpidem is N, N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure. Zolpidem Tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each Zolpidem Tartrate Tablet, USP includes the following inactive ingredients: lactose anhydrous, sodium starch glycolate, colloidal silicon dioxide, microcrystalline cellulose, magnesium stearate. The 10 mg tablets also contain Opadry II (white) and the 5 mg tablets contain Opadry II (pink). Opadry II (white) contains hypromellose, polyeth ylene glycol, polydextrose, titanium dioxide, and triacetin. Opadry II (pink) contains hypromellose, FD&C Red no. 40 aluminum lake, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, polyeth ylene glycol, polydextrose, titanium dioxide, and triacetin. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>76420-915-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (76420-915-90) </PackageDescription>
<NDC11Code>76420-0915-90</NDC11Code>
<ProductNDC>76420-915</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078539</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C 18H 19N 3OHCl2H 2O, representing a molecular weight of 365.9 g/mol. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6.</Description>
</NDC>
<NDC>
<NDCCode>42385-903-09</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-903-09) </PackageDescription>
<NDC11Code>42385-0903-09</NDC11Code>
<ProductNDC>42385-903</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209882</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>850</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42385-904-09</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-904-09) </PackageDescription>
<NDC11Code>42385-0904-09</NDC11Code>
<ProductNDC>42385-904</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209882</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42385-913-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-913-90) </PackageDescription>
<NDC11Code>42385-0913-90</NDC11Code>
<ProductNDC>42385-913</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Emtricitabine And Tenofovir Disoproxil Fumarate</ProprietaryName>
<NonProprietaryName>Emtricitabine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190726</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212114</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>200; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190726</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42385-924-99</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (42385-924-99) / 90 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>42385-0924-99</NDC11Code>
<ProductNDC>42385-924</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pirfenidone</ProprietaryName>
<NonProprietaryName>Pirfenidone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212722</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>PIRFENIDONE</SubstanceName>
<StrengthNumber>267</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
<Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as a white opaque hard gelatin capsules containing 267 mg of pirfenidone USP for oral administration and as film-coated tablets containing 267 mg (yellow), 534 mg (orange) and 801 mg (brown) pirfenidone USP. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-Methyl-1-Phenyl-1H-pyridin-2-one or 5-Methyl-1-phenylpyridin-2(1H)-one. Pirfenidone USP is a white to pale yellow or pink color solid, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. Pirfenidone capsules, USP contain pirfenidone USP and the following inactive ingredients: croscarmellose sodium, isomalt, and magnesium stearate. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes black iron oxide, brown iron oxide, propylene glycol, and shellac. Pirfenidone tablets, USP contain pirfenidone USP and the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally 267 mg tablets contain iron oxide yellow. 534 mg tablets contain FD&C yellow #6. 801 mg tablets contain black iron oxide and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>42385-925-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-925-90) </PackageDescription>
<NDC11Code>42385-0925-90</NDC11Code>
<ProductNDC>42385-925</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pirfenidone</ProprietaryName>
<NonProprietaryName>Pirfenidone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212722</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>PIRFENIDONE</SubstanceName>
<StrengthNumber>534</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
<Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as a white opaque hard gelatin capsules containing 267 mg of pirfenidone USP for oral administration and as film-coated tablets containing 267 mg (yellow), 534 mg (orange) and 801 mg (brown) pirfenidone USP. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-Methyl-1-Phenyl-1H-pyridin-2-one or 5-Methyl-1-phenylpyridin-2(1H)-one. Pirfenidone USP is a white to pale yellow or pink color solid, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. Pirfenidone capsules, USP contain pirfenidone USP and the following inactive ingredients: croscarmellose sodium, isomalt, and magnesium stearate. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes black iron oxide, brown iron oxide, propylene glycol, and shellac. Pirfenidone tablets, USP contain pirfenidone USP and the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally 267 mg tablets contain iron oxide yellow. 534 mg tablets contain FD&C yellow #6. 801 mg tablets contain black iron oxide and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>42385-926-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-926-90) </PackageDescription>
<NDC11Code>42385-0926-90</NDC11Code>
<ProductNDC>42385-926</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pirfenidone</ProprietaryName>
<NonProprietaryName>Pirfenidone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212722</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>PIRFENIDONE</SubstanceName>
<StrengthNumber>801</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
<Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as a white opaque hard gelatin capsules containing 267 mg of pirfenidone USP for oral administration and as film-coated tablets containing 267 mg (yellow), 534 mg (orange) and 801 mg (brown) pirfenidone USP. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-Methyl-1-Phenyl-1H-pyridin-2-one or 5-Methyl-1-phenylpyridin-2(1H)-one. Pirfenidone USP is a white to pale yellow or pink color solid, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. Pirfenidone capsules, USP contain pirfenidone USP and the following inactive ingredients: croscarmellose sodium, isomalt, and magnesium stearate. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes black iron oxide, brown iron oxide, propylene glycol, and shellac. Pirfenidone tablets, USP contain pirfenidone USP and the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally 267 mg tablets contain iron oxide yellow. 534 mg tablets contain FD&C yellow #6. 801 mg tablets contain black iron oxide and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>42385-928-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-928-90) </PackageDescription>
<NDC11Code>42385-0928-90</NDC11Code>
<ProductNDC>42385-928</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName>
<NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212786</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>600; 300; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-17</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.</IndicationAndUsage>
<Description>Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets contain efavirenz (EFV), an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI), lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir), a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are for oral administration. Each film coated tablet contains efavirenz USP 600 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz: The chemical name of efavirenz is (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL).Lamivudine: The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water.Tenofovir Disoproxil Fumarate: The chemical name of tenofovir DF is 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula: Tenofovir DF is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75.</Description>
</NDC>
<NDC>
<NDCCode>42385-929-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-929-90) </PackageDescription>
<NDC11Code>42385-0929-90</NDC11Code>
<ProductNDC>42385-929</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName>
<NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213038</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>400; 300; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.</IndicationAndUsage>
<Description>Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75.</Description>
</NDC>
<NDC>
<NDCCode>42385-929-91</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-929-91) </PackageDescription>
<NDC11Code>42385-0929-91</NDC11Code>
<ProductNDC>42385-929</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</ProprietaryName>
<NonProprietaryName>Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213038</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE</SubstanceName>
<StrengthNumber>400; 300; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.</IndicationAndUsage>
<Description>Efavirenz, lamivudine and tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Each film coated tablet contains efavirenz USP 400 mg, lamivudine USP 300 mg and tenofovir disoproxil fumarate 300 mg equivalent to tenofovir disoproxil 245 mg. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. Efavirenz:Efavirenz (EFV) is an HIV-1 specific, non-nucleoside, reverse transcriptase inhibitor (NNRTI). Efavirenz is chemically described as (S)-6-Chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one. Its molecular formula is C14H9ClF3NO2 and its structural formula is. Efavirenz USP is a white to off white powder with a molecular mass of 315.67. It is soluble in methanol and practically insoluble in water (< 10 microgram/mL). Lamivudine:Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV.The chemical name of lamivudine is (-)-1-[(2R,5S)-2-(Hydroxy methyl)-1,3-oxathiolan-5-yl]cytosine. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26 g per mol. It has the following structural formula. Lamivudine USP is a white or almost white powder and is soluble in water. Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate (TDF) (a prodrug of tenofovir) is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5' -monophosphate. Tenofovir exhibits activity against HIV-1 reverse transcriptase. The chemical name of tenofovir disoproxil fumarateis 9-[(R)-2- [[bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10PC4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off white powder freely soluble in dimethyl formamide, soluble in methanol and slightly soluble in water at 25°C. It has a partition coefficient (log p) of 0.75.</Description>
</NDC>
<NDC>
<NDCCode>42385-935-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-935-90) </PackageDescription>
<NDC11Code>42385-0935-90</NDC11Code>
<ProductNDC>42385-935</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210606</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>54</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 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). , 2 For treatment of adult patients with severe hypertriglyceridemia ( 1.2). .</IndicationAndUsage>
<Description>Fenofibrate tablet, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82 ᵒC. Fenofibrate, USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Each 54 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB yellow powder. The opadry AMB yellow powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide, D&C yellow #10 aluminum lake, FD & C blue #2/indigo carmine aluminum lake, FD & C yellow #6/sunset yellow FCF aluminum lake and xanthan gum. Each 160 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB white powder. The Opadry AMB white powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. Fenofibrate tablets, USP meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>42385-936-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-936-90) </PackageDescription>
<NDC11Code>42385-0936-90</NDC11Code>
<ProductNDC>42385-936</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210606</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 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). , 2 For treatment of adult patients with severe hypertriglyceridemia ( 1.2). .</IndicationAndUsage>
<Description>Fenofibrate tablet, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82 ᵒC. Fenofibrate, USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Each 54 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB yellow powder. The opadry AMB yellow powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide, D&C yellow #10 aluminum lake, FD & C blue #2/indigo carmine aluminum lake, FD & C yellow #6/sunset yellow FCF aluminum lake and xanthan gum. Each 160 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB white powder. The Opadry AMB white powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. Fenofibrate tablets, USP meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>42385-940-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-940-90) </PackageDescription>
<NDC11Code>42385-0940-90</NDC11Code>
<ProductNDC>42385-940</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214513</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>42385-941-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-941-90) </PackageDescription>
<NDC11Code>42385-0941-90</NDC11Code>
<ProductNDC>42385-941</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214513</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
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<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3.</Description>
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<NDCCode>42385-942-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-942-90) </PackageDescription>
<NDC11Code>42385-0942-90</NDC11Code>
<ProductNDC>42385-942</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214513</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3.</Description>
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<NDC>
<NDCCode>42385-943-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-943-90) </PackageDescription>
<NDC11Code>42385-0943-90</NDC11Code>
<ProductNDC>42385-943</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214513</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated. To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3.</Description>
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<NDC>
<NDCCode>42385-944-90</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-944-90) </PackageDescription>
<NDC11Code>42385-0944-90</NDC11Code>
<ProductNDC>42385-944</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibric Acid Delayed-release</ProprietaryName>
<NonProprietaryName>Fenofibric Acid</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211626</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>FENOFIBRIC ACID</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-01</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibric acid delayed-release capsules are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to: 1 Reduce TG in patients with severe hypertriglyceridemia ( 1.1). , 2 Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.2). .</IndicationAndUsage>
<Description>Fenofibric acid delayed-release capsules are lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula. The molecular formula is C 22H 28ClNO 5 and the molecular weight is 421.9. Choline fenofibrate is very soluble in water and freely soluble in methanol. The melting point is approximately 210°C. Choline fenofibrate is a white to off-white crystalline powder. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2208, methacrylic acid and ethyl acrylate copolymer dispersion (sodium lauryl sulfate, polysorbate 80 and methacrylic acid and ethyl acrylate copolymer), povidone, sodium stearyl fumarate, talc and triethyl citrate. Capsule shell contains: gelatin, iron oxide black, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. Additionally, 45 mg contains: iron oxide red. 135 mg contains: FD & C blue 1, FD & C red 3, FD & C red 40. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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